Running head: IMPLEMENTING A RISK INDEX TOOL 1 · Figure 4 2016 Patient Population by Age and Sex...

Running head: IMPLEMENTING A RISK INDEX TOOL 1

A Quality Improvement Project: Implementing a Risk Index Tool to Guide

Naloxone Prescribing in Patients on Chronic Opioid Therapy

Peggie L. Powell

VCU School of Nursing – DNP Program

DNP Project Advisor: Holly Buchanan, DNP, ANP-BC

DNP Project Content Expert: Manhal Saleeby, MD

DNP Project Team Member: Juli J. Moseley, PharmD

IMPLEMENTING A RISK INDEX TOOL 2

Table of Contents

List of Tables ................................................................................................................................. 4

List of Figures ................................................................................................................................ 5

Abstract .......................................................................................................................................... 6

Introduction .................................................................................................................................... 7

Problem Statement ......................................................................................................................... 8

Purpose ............................................................................................................................. 10

Clinical Question ...…………………............…….......................................................... 10

Review of the Literature .............................................................................................................. 11

Background and Significance ...................................................................................................... 22

Conceptual Framework .................................................................................................... 24

Needs Assessment ............................................................................................................ 25

Key Stakeholders ............................................................................................................. 31

Barriers and Facilitators ................................................................................................... 33

Benchmarks ...................................................................................................................... 34

Budget .............................................................................................................................. 35

Project Description........................................................................................................................ 37

Project Mission ................................................................................................................ 38

Goals and Objectives ....................................................................................................... 38

Outcome Measures ........................................................................................................... 39

Project Design .............................................................................................................................. 42

Methods ............................................................................................................................ 42

Potential Risks and Threats .............................................................................................. 49


Project Evaluation Plan ................................................................................................................ 50

Data Analysis Plan ........................................................................................................... 53

Discussion and Implications ........................................................................................................ 55

Clinical Implications ........................................................................................................ 56

DNP Essentials ................................................................................................................. 57

Quality and Safety ............................................................................................................ 57

Plan for Sustainability ...................................................................................................... 58

References .................................................................................................................................... 64

Appendix A Flow Diagram of the Search Process ................................................................... 71

Appendix B RIOSORD Tool used in the Veterans’ Health Administration ........................... 72

Appendix C RIOSORD Tool used in the Commercial Insurance Population ......................... 73

Appendix D Proposed DNP Project Budget ............................................................................. 74

Appendix E The Stetler Model of Research Utilization .......................................................... 75

Appendix F Example of a Naloxotel Comprehensive Progress Note ..................................... 76

Appendix G Example of a Naloxotel Prior Authorization Letter ............................................. 77

Appendix H Opioid Overdose Symptoms and Resuscitation Instructions ............................... 78

Appendix I Nurse Checklist for Naloxone Training ............................................................... 79

Appendix J Overdose Prevention Tips and Naloxone Resources ........................................... 80

Appendix K Proposed DNP Project Timeline .......................................................................... 81

Appendix L RIOSORD Provider Satisfaction Survey ............................................................. 82

Appendix M Relationship of the DNP Essentials to the DNP Project ...................................... 83


List of Tables

Table 1 Conversion of Opioid Dose to Morphine Milligram Equivalents ....................... 15

Table 2 Project Application of the Stetler Model of Research Utilization ...................... 25

Table 3 Benefits of DNP Project to Patients and Institution ............................................. 36

Table 4 DNP Project Goals and Objectives ...................................................................... 39

Table 5 Covariates Analyzed in the IMS RIOSORD Tool ............................................... 40

Table 6 Aligning Goals and Objectives with Outcome Measures .................................... 41

Table 7 Conversion of RIOSORD Score to Risk Class and Probability of Overdose or

Serious OIRD ....................................................................................................... 45

Table 8 Steps to Achieve Sustainability Objectives ......................................................... 61


List of Figures

Figure 1 Comparison of prescription opioid sales and death rates ....................................... 9

Figure 2 Prescription opioid overdose deaths from 2001 to 2014 ..................................... 26

Figure 3 Distribution of the economic burden of prescription opioid overdose, abuse,

and dependence .................................................................................................... 28

Figure 4 2016 Patient Population by Age and Sex ............................................................. 29

Figure 5 2016 Patient Population by Insurance .................................................................. 30

Figure 6 The different formulations of naloxone available to prescribe ............................ 48

Figure 7 The predicted probability (risk classes, by percentiles) versus observed incidence

of overdose or serious opioid-induced respiratory depression ............................ 52


Abstract

Background: Chronic pain and the treatment of chronic pain are challenges faced by healthcare

providers across the nation. Patients who take opioids for chronic pain significantly increase

their risk for serious opioid-induced respiratory depression (OIRD) and overdose if they do not

take the medication as prescribed. Due to the rise in opioid overdose deaths, much attention is

focused on improving prescribing practices for opioid pain medication in the treatment of

chronic noncancer pain. A recommended risk mitigation strategy is to co-prescribe naloxone

when prescribing opioids for patients at high risk for overdose. Purpose: The purpose of this

project is to implement a validated risk assessment strategy that may reduce and/or prevent

overdose deaths from prescription opioids. Design: The project will utilize a prospective cohort

study design in which the Risk Index for Overdose or Serious Opioid-Induced Respiratory

Depression (RIOSORD) tool will be used to evaluate appropriate patients risk of overdose or

serious OIRD and examine how the tools use influences the prescribing practice of naloxone as a

rescue medication for patients on chronic opioid therapy. Outcome measures: Primary outcome

measures include the calculated RIOSORD score for each patient assessed, the number of high-

risk patients, and the number of naloxone prescriptions provided. Secondary outcome measures

include an analysis of the individual covariates from the RIOSORD tool. Implications:

Utilizing a validated, risk assessment tool to increase access to naloxone aligns well with the

national call for action to reduce opioid overdoses and promote safe opioid prescribing.

Keywords: chronic opioid therapy, overdose, naloxone, risk assessment


A Quality Improvement Project: Implementing a Risk Index Tool to Guide

Naloxone Prescribing in Patients on Chronic Opioid Therapy

Chronic pain and the treatment of chronic pain are public health challenges faced by

healthcare providers across the nation. Chronic pain is defined as pain that lasts longer than

three months or past the time expected for normal tissue healing; chronic pain may be the result

of an underlying medical condition or disease, injury, inflammation, medical treatment, or an

unknown cause (Dowell, Haegerich, & Chou, 2016). For the purpose of this project, chronic

pain is used to reference chronic noncancer pain (CNCP).

It is estimated that over 100 million people in the United States suffer from chronic pain

and that chronic opioid therapy (COT) may be an appropriate treatment for some of these

chronic pain sufferers (Volkow, 2014). According to Dowell et al. (2016), evidence indicates

that short-term use of opioid pain medication is effective in reducing pain and improving

functional status in persons with noncancer nociceptive and neuropathic pain in randomized

clinical trials lasting ≤12 weeks. However, only a few studies have been conducted to rigorously

assess the long-term benefits of opioids (i.e., at least one year later) in patients with CNCP

(Dowell et al., 2016).

Despite the lack of evidence to support use of long-term opioid therapy in the

management of CNCP, its use has increased substantially in recent years and has been

accompanied by an increase in drug related deaths (Cheung et al., 2014; Volkow, 2014). From

1999 to 2014, more than 165,000 persons died from opioid overdoses in the United States

(Dowell et al., 2016). Manchikanti et al. (2014) estimate that Americans consume 99% of the

world’s supply of hydrocodone and 83% of the world’s supply of oxycodone. Prescription

opioid-related deaths have quadrupled in the United States since 1999 and approximately 80% of


these deaths are due to unintentional overdose (Rudd, Aleshire, Zibbell, & Gladden, 2016;

Zedler, Xie, et al., 2015).

Opioids are highly addictive in certain populations due to the release within the brain of a

naturally occurring neurotransmitter called dopamine. Dopamine creates pleasurable sensations

that are reinforcing for continued behavior (National Institute on Drug Abuse [NIDA], 2014).

This addictive nature of opioids makes them vulnerable to misuse and abuse (Cheung et al.,

2014). Patients who take opioids for chronic pain significantly increase their risk for negative

adverse events if they do not take the medication as prescribed (e.g., taking more than

prescribed, taking them by an alternate route, or taking them in combination with certain other

medications and/or alcohol). Opioids depress the central nervous system, which can result in

serious, life-threatening consequences such as sedation, respiratory depression, and potentially

death. The combined effects from alcohol and other medications significantly increase the risk

for overdose and death (World Health Organization [WHO], 2014).

Problem Statement

Overdose deaths have increased in parallel to prescriptions written for opioid pain

medication (Rudd et al., 2016; Dowell et al., 2016). Figure 1 demonstrates a comparison of

prescription opioid sales and death rates from 1999 to 2013. Dowell et al. (2016) note that

prescriptions written by primary care providers account for nearly half of all opioid sales. It was

also noted that opioid prescribing rates among healthcare providers increased 7.3% per capita

from 2007 to 2012 with rates increased more for family practice, general practice, and internal

medicine (Dowell et al., 2016). Overall, healthcare providers in the United States wrote 259

million prescriptions for opioids in 2012; this equates to one prescription for every adult in


America (Dowell et al., 2016). In 2014, overdose deaths from prescription opioids increased to

approximately 19,000 deaths in the United States; this is more than three times the number

reported in 2001 (Substance Abuse and Mental Health Services Administration [SAMHSA],

2016b). Considering the potentially fatal outcome of overdose, much attention is focused on

improving prescribing practices for opioid pain medication in the treatment of CNCP. Such

statistics are staggering and indicate the need for a call to action to reduce the opioid overdose

epidemic. These findings also demonstrate the importance of utilizing strategies to reduce or

prevent overdose deaths from prescription opioids in addition to recommendations for safe

opioid prescribing for those with chronic pain.

Figure 1. Comparison of prescription opioid sales and death rates. This chart

demonstrates a comparison of prescription opioid sales in relation to death

rates from opioid use during years 1999 through 2013.

Source: *Automation of Reports and Consolidated Orders System of the

Druge Enforcement Administration (2012 data not available); **CDC,

National Vital Statistics System mortality data, 2015.


Both the Centers for Disease Control and Prevention (CDC) and SAMHSA recommend

that clinicians consider a co-prescription for naloxone when prescribing opioids for patients at

high risk of overdose as a risk mitigation strategy. Naloxone is an opioid antagonist that can

reverse respiratory depression and prevent death if administered in a timely fashion to a person

suspected of an opioid overdose. The CDC indicates that naloxone distribution programs are

associated with reduced risk for overdose death at the community level (Dowell et al., 2016).

Additionally, it is noted that friends and family are capable of administering naloxone once they

are properly educated and trained (Dowell et al., 2016; WHO, 2014).

Purpose of the Project

The purpose of this project is to implement a risk assessment strategy that may reduce

and/or prevent overdose deaths from prescription opioids. Specifically, this project will utilize a

validated risk assessment tool that quantifies a patient’s risk of overdose or serious opioid-

induced respiratory depression (OIRD) and examine how its utilization influences the

prescribing practice of naloxone as a rescue medication for patients on COT. The project will

also examine current naloxone prescribing patterns and potential factors influencing a provider’s

decision to co-prescribe naloxone prior to implementing a risk assessment tool. Additionally, the

project will assess provider satisfaction and ease of use. Implementing measures to improve

opioid prescribing practices supports the CDC’s goal for access to safe, effective pain treatment

while reducing risk for overdose (Dowell et al., 2016).

Clinical Question

The recommendation to prescribe naloxone for patients at increased risk of opioid

overdose raises the clinical questions of how to determine which patients are at increased risk

and how to measure risk of unintentional overdose in patients on COT. Neither SAMHSA nor


the CDC makes a recommendation for use of a specific tool. Available risk mitigation strategies

such as provider education, written opioid agreements, urine drug screens, prescription drug

monitoring programs, and screening for aberrant behavior may be beneficial in assessing for

misuse or abuse but they do not assess for or measure risk of overdose or OIRD. The only

published tool that provides an actual quantitative measure of overdose risk from opioid pain

medication is the Risk Index for Overdose or Serious Opioid-Induced Respiratory Depression

(RIOSORD; Zedler, Xie, et al., 2015). Considering the increased use of COT to treat CNCP and

the subsequent rise in opioid-related deaths, the PICOT question addressed in this Doctor of

Nursing Practice (DNP) project is: Among providers who prescribe COT, does use of the

RIOSORD assessment tool, compared to not using a risk-screening tool, increase the prescribing

practice of naloxone over a six-month period?

Review of the Literature

Methods

Relevant literature was reviewed for evidence addressing the use of opioids to treat

chronic pain and available risk mitigation strategies to reduce misuse, abuse, and overdose. The

electronic databases utilized in the search process were PubMed, the Cumulative Index to

Nursing and Allied Health Literature (CINAHL), the Cochrane Library, PsychInfo, and National

Guideline Clearinghouse. Key terms used in the search process were chronic opioid therapy,

overdose, naloxone, and risk assessment; these terms were combined utilizing the Boolean

operator “AND”. The search was limited to English language, peer reviewed journal articles,

and a publication date of 2011-2016. Studies were included if abstracts were available as well as

access to full text, were conducted within the United States, and limited to adults only. One

additional study was included based on the review of an article from the literature search. A total


of 613 records were identified, which was narrowed to 520 records after removing duplicates.

The titles and abstracts of the 520 articles were screened for inclusion. Articles were excluded (n

= 391) if they focused on specific opioid pain medications or illicit drugs; applied directly to

cancer-related pain, palliative care, or end of life; involved in-patient, hospital, or operative

settings; pertained directly to drug screening or testing; pertained to substance use disorder or

addiction; or involved pregnant women or children. A total of 129 full-text articles were further

reviewed for eligibility and 17 articles were included in this DNP project. Appendix A contains

a flow diagram of the search process. Common themes noted in the review of literature include

the use of opioid guidelines, the risk of overdose in relation to morphine-equivalent dose (MED)

and opioid formulation, and the use of risk instruments and other mitigation strategies such as the

SAMHSA toolkit and the RIOSORD tool to assess for aberrant behavior and risk of overdose.

Opioid guidelines. Opioid prescribing guidelines provide recommendations for

clinicians who prescribe opioids for persons with pain. However, multiple guidelines are

available and there is no consensus on which guideline clinicians should follow. In a systematic

review of available guidelines, Nuckols et al. (2014) note that recommendations provided by the

professional organizations American Pain Society and American Academy of Pain Medicine are

of high quality and are applicable to a broad range of adults with pain. Dowell et al. (2016) also

note that state and federal agencies such as the Washington Agency Medical Directors Group

(2015) and the U.S. Department of Veterans Affairs/Department of Defense (2010) provide their

own recommendations for opioid prescribing which are of good quality. Common elements

noted across most of these guidelines are recommendations for dosing thresholds and dosing

titration in addition to risk mitigation strategies such as the use of risk assessment tools,


treatment agreements, urine drug screenings, and the use of state prescription drug monitoring

programs (Dowell et al., 2016).

There is, however, considerable variability in specific recommendations such as the range

of dosing thresholds (MED of 90 to 200mg/day), the intended audience such as primary care

versus pain specialists, and the strength of the evidence upon which recommendations are based

(Cheung et al., 2014; Dowell et al., 2016). There is no clear consensus on a reasonable MED in

the treatment of CNCP but 100 to 120 mg morphine equivalents seems to be a reference level for

heightened caution due to evidence of increased morbidity and mortality at these doses (Cheung

et al., 2014). Recommendations from the CDC opioid guideline are directed at primary care

clinicians treating chronic pain and are based on a systematic review of the best available

evidence along with expert, public, and stakeholder input (Dowell et al., 2016). The literature

review performed by the CDC expanded upon a previously published systematic review

sponsored by the Agency for Healthcare Research and Quality (AHRQ) in 2014 on the efficacy

and risks of long-term opioid therapy for chronic pain. Additional literature searches were

conducted to identify new studies and to update the existing review; there were 39 studies from

the AHRQ review and seven more studies from the updated review. Review of the evidence

sought to address five clinical concerns regarding the use of long-term opioid therapy to treat

chronic pain:

1. effectiveness and comparative effectiveness;

2. harms and adverse events;

3. dosing strategies;

4. risk assessment and risk mitigation strategies; and

5. effect of opioid therapy for acute pain on long-term use (Dowell et al., 2016).

The first four concerns were addressed in the previous 2014 AHRQ-sponsored systematic

review. However, the fifth concern was added for the purpose of developing the 2016 CDC


guideline and the updated systematic review was performed to address it. Thus,

recommendations from the CDC guideline provides guidance on determining when to initiate or

continue opioids for chronic pain; opioid selection, dosage, duration, follow-up, and

discontinuation; and assessing risk and addressing harms of opioid use. Common factors

associated with an increased risk of opioid overdose identified by Dowell et al. (2016) include

the following:

use of extended-release or long-acting (ER/LA) opioid formulations;

MED >100mg/day;

a co-concurring prescription for benzodiazepines;

increased duration of opioid use;

the presence of sleep apnea or other sleep-disordered breathing;

renal and/or hepatic insufficiency;

older age (i.e., >65 years old);

pregnancy;

depression or other mental health conditions; and

alcohol or other substance use disorder(s).

Opioid prescribing guidelines are intended to promote safe opioid prescribing and to

improve patient outcomes. When making clinical decisions, prescribers are encouraged to

consider the patient-provider relationship in addition to the patient’s individual circumstances

including pain relief and benefit from COT; functional status and quality of life; medication side

effects; warning signs for addiction, abuse, or misuse; and any mood changes. These factors are

often referred to as the “five A’s” of analgesia therapy: activity, analgesia, adverse effects, and

aberrant behaviors, and affect (Agency for Clinical Innovation, n.d.).

Morphine-equivalent dose. Calculating the total daily dose of opioids helps to identify

patients who may benefit from closer monitoring, reduction of dose, prescribing of naloxone, or

other measures to reduce risk of overdose (CDC, 2016d). In order to calculate the total daily

dose, the clinician determines the dose of each opioid that the patient takes, converts dose(s) into

morphine milligram equivalents (MME) according to the CDC’s MME conversion factor in


Table 1, and then adds them all together. This conversion is referred to as the morphine

equivalent dose (MED) and is expressed as mg/day.

Higher doses of opioids are associated with an increased risk of overdose and death,

although some risk is associated even with relatively low doses (MED 20-50mg/day; CDC,

2016d). A randomized controlled trial conducted by Chou et al. (2015) found a significant

increase in risk of overdose when comparing MED 20-49mg/day to 200mg/day. The adjusted

odds ratio was 1.32 for MED 20-49mg/day, 95% CI [0.94, 1.84] compared to 2.88 for MED at

least 200mg/day, 95% CI [1.79, 4.63]. Another randomized controlled trial by Dowell et al.

(2015) found an adjusted odds ratio of 2.08 for MED 1-140mg/day, 95% CI [1.55, 2.78]

compared to 6.14 for MED ≥450mg/day, 95% CI [4.92, 7.66]. Nuckols et al. (2014) note that

Table 1

Conversion of Opioid Dose to Morphine Milligram Equivalents

Opioid Conversion Factor

Codeine 0.15

Fentanyl transdermal (in mcg/hr) 2.4

Hydrocodone 1

Hydromorphone 4

Methadone

1-20 mg/day 4

21-40 mg/day 8

41-60 mg/day 10

> 61-80 mg/day 12

Morphine 1

Oxycodone 1.5

Oxymorphone 3

Note. Doses are in mg/day except where noted.

Source: Centers for Disease Control and Prevention. (2016c,

August 25). Injury prevention & control: Opioid overdose,

guideline resources. Retrieved September 5, 2016, from

http://www.cdc.gov/drugoverdose/prescribing/resources.html


risk for serious or fatal overdose increased 1.9 to 3.1 fold with MED 50-100 mg/day and

increased even more dramatically with MED >100 to 200 mg/day. Two studies conducted by

Zedler indicated similar findings: odds ratio 4.96 for MED >100mg/day, 95% CI [3.24, 7.61]

(Zedler, Xie, et al., 2015) and odds ratio 4.1 for MED ≥100 mg/day, 95% CI [2.6, 6.5] (Zedler et

al., 2014). The CDC recommends prescribing the lowest effective dose, to “start low and go

slow”, and to avoid increasing to MED >90mg/day if possible. Morphine equivalent doses of

>50mg/day increase risk of overdose by at least two times the risk associated with <20mg/day

(CDC, 2016d).

Opioid formulations. The use of extended-release or long-acting opioid formulations is

associated with greater risk for overdose (Dowell et al., 2016; Zedler, Xie, et al., 2015). In a

2014 study conducted by Zedler et al., ER/LA opioid formulations were significantly associated

with increased risk of toxicity and overdose. Additionally, Nuckols et al. (2014) suggest that

only experienced clinicians prescribe methadone and that clinicians in general need to be aware

of risks associated with fentanyl patches. The CDC (2016d) notes that the MED conversion

factor for methadone increases at higher doses and absorption of fentanyl is affected by heat and

other factors such as patient weight. Sensitivity analysis by Wakeland, Schmidt, Gilson,

Haddox, and Webster (2011) suggests that the increase in opioid-related deaths may be related to

prescriber perception of reduced risk with use of long-acting opioids. Wakeland et al. (2011)

also suggest that prescriber education on the use of ER/LA opioids may be effective in reducing

opioid deaths, but little empirical evidence exists to support this finding.

Risk assessment tools. Various risk assessment tools are available to assess for aberrant

behavior in patients for whom opioids are prescribed or considered. These include the Opioid

Risk Tool (ORT), Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R),


Brief Pain Inventory (BPI), and the Chronic Opioid Misuse Measure (COMM). A systematic

review by Nuckols et al. (2014) noted that the self-administered SOAPP-R and COMM

performed well in higher-quality observational studies for detecting aberrant behavior.

However, the CDC opioid prescribing guideline notes that there is insufficient evidence that the

use of such tools is beneficial in identifying risks associated with opioid overdose, abuse, or

addiction (Dowell et al., 2016). This recommendation is based on the variability of sensitivity

and specificity scores for each tool: ORT sensitivity 0.58-0.75 and specificity 0.54-0.86 in five

studies; SOAPP-R sensitivity 0.25 and 0.53 and specificity 0.62 and 0.73 in two studies, and BPI

sensitivity 0.73 and 0.83, specificity 0.43 and 0.88 in two studies (Dowell et al., 2016). It is also

important to note that results gained from the use of self-report questionnaire tools are subject to

the validity of the patient’s answers.

The aforementioned risk assessment tools identify patients at risk for aberrant behavior in

relation to opioid therapy but the tools do not measure the patient’s risk for overdose or

respiratory depression. Thus, tools that screen for overdose or serious OIRD are needed. The

retrospective study conducted by Zedler, Xie, et al. in 2015 indicates that patients at increased

risk of overdose or serious OIRD are likely to benefit from a co-prescription for naloxone as do

recommendations provided by SAMHSA (2016b) and the CDC (Dowell et al., 2016). The

RIOSORD tool is the only published tool that actually measures a patient’s risk for possible

overdose or OIRD. This tool is explored in more depth below.

Dowell et al. (2016) note that there is insufficient evidence that patient education, pill

counts, written treatment agreements, urine drug screens, or use of state prescription drug

monitoring programs are beneficial at mitigating risks but that most experts agree that co-

prescribing naloxone should be considered for patients at increased risk for overdose. Although


the effectiveness of treatment agreements, urine drug screenings, and use of state prescription

drug monitoring programs is not demonstrated in research studies to date, their use is

recommended by most opioid prescribing guidelines. Additionally, Nuckols et al. (2014)

indicate that such risk assessment tools are helpful in monitoring patients on COT and may be

beneficial in curbing abuse and misuse of opioids, which in turn reduces the risk of overdose.

The SAMHSA Opioid Overdose Prevention Toolkit and the RIOSORD tool are discussed below.

SAMHSA toolkit. In August 2015, the Virginia Department of Health issued a letter to

all clinicians encouraging adoption of the SAMHSA Opioid Overdose Prevention Toolkit. This

toolkit provides information for prescribers to use as recommendations to mitigate risks when

prescribing opioid pain medications in addition to expanding access to naloxone in Virginia

(Levine, Brown, & Ferguson, 2015). SAMHSA (2016b) stresses that healthcare providers can

reduce the toll of opioid overdose through the care they take in prescribing opioids and

monitoring the patient’s response, as well as by identifying and addressing overdose. SAMHSA

(2016b) identified five strategies for opioid overdose prevention:

encourage providers, persons at high risk, family members, and others to learn how to

prevent and manage opioid overdose;

ensure access to treatment for individuals who are misusing or addicted to opioids or who

have other substance use disorders;

ensure ready access to naloxone;

encourage the public to call 911; and

encourage prescribers to use state Prescription Drug Monitoring Programs.

As previously mentioned, SAMHSA recommend that clinicians consider a co-prescription of

naloxone for patients at high risk of overdose but no specific screening tool with which to

measure overdose risk is provided or recommended.

RIOSORD tool. Zedler, Xie, et al. developed the RIOSORD (i.e., Risk Index for

Overdose or Serious Opioid-Induced Respiratory Depression) tool in 2015 using a retrospective,


case-control analysis of health care data from the Veteran’s Heath Administration (VHA)

inpatient and outpatient databases. Items included in the RIOSORD tool were selected from

variables found to have a statistically significant association with overdose or serious OIRD (see

Appendix B). Zedler, Xie, et al. (2015) found that the following factors are associated with an

increased odds ratio for overdose or OIRD: ER/LA opioid formulations, route of administration,

MED >100mg/day, and receipt of opioid prescriptions from multiple providers. These findings

are consistent with those identified in the CDC guideline as risk factors for overdose. Zedler,

Xie, et al. (2015) also notes that persons possessing the above-mentioned risk factors also

demonstrated greater health care utilization than controls. Variables with the most significant

positive associations were used to develop the RIOSORD tool: MED >100mg/day, history of

opioid dependence, hospitalization during the 6 months before the overdose or serious OIRD

event, liver disease, and the use of ER/LA opioids (Zedler, Xie, et al., 2015).

The RIOSORD tool provides a quantitative risk assessment for opioid overdose that is

evidence-based and is intended to provide clinical decision support. The tool demonstrated good

calibration and discrimination (i.e., predicted probability) between patients with and without

serious OIRD in the VHA population; the average predicted probability was 3% in the lowest

risk class and 94% in the highest (Zedler, Xie, et al., 2015). The personalized risk assessment

provided by the RIOSORD tool is useful in determining if an alternate medication, dose, or

formulation may reduce risk for OIRD; if clinical or behavioral recommendations are indicated;

or if a co-prescription for naloxone is recommended. The VHA sample included only men with

the majority being >55 years old. Hence, the validity of the results is unclear in other

populations such as younger patients, women, or those with commercial insurance. It is also


important to note that studies of the RIOSORD tool focused on the use of prescription opioids

and did not include use of heroin or opioids used for non-medical purposes.

Later in 2015, the original RIOSORD tool (VHA RIOSORD) was modified and further

validated in a retrospective, nested, case-control study of over 18 million patients from the

United States with a pharmacy claim for an opioid between January 1, 2009 and December 31,

2013 (Zedler, Saunders, Joyce, Vick, & Murrelle, 2015). This sample consisted of a much larger

population from the IMS PharMetrics Plus™ database of integrated commercial health plan

claims that is comprised of both medical and pharmacy claims. The objective of this study was

to validate and extend the RIOSORD tool in a larger population that is more representative of

medical users of prescription opioids in the United States (Zedler, Saunders, et al., 2015). The

IMS sample was deemed more representative because it included patients younger than 55 years

of age, females, and patients with commercial insurance in comparison to the VHA sample.

Zedler, Saunders, et al. (2015) found that the predictive performance of the revised RIOSORD

(IMS RIOSORD) in this large commercial insurance database was excellent and similar to the

VHA RIOSORD performance. The strongest predictors of overdose or serious OIRD in the IMS

population consisted of eight coexisting clinical conditions (e.g., neuropsychiatric disorders and

impaired drug metabolism or excretion) and eight characteristics of the prescribed opioid (e.g.,

specific medication characteristics and concomitant benzodiazepines or anti-depressants; Zedler,

Saunders, et al., 2015). Multivariable modeling of these covariates in the IMS population

demonstrated a C-statistic of 0.90, which indicates excellent discrimination between cases and

controls (Zedler, Saunders, et al., 2015).

The RIOSORD tool used in the commercial insurance population consisted of 16

questions with a total score of 146 points versus 17 questions with a total score of 115 points in


the VHA RIOSORD (see Appendix C). Covariates in the previously developed VHA RIOSORD

were modified as necessary to accommodate differences in the available commercial insurance

data population (Zedler, Saunders, et al., 2015). The total score in points corresponds with a risk

class that ranges from 1 to 7 with 1 being the lowest risk and 7 being the highest risk. The

average predictive probability of an event across the seven risk classes ranged from 2% in the

lowest risk class (0-4 points) to 83% in the highest risk class (>42 points; Zedler, Saunders, et

al., 2015). Patients identified as having increased risk for overdose or serious OIRD would

benefit from interventions to mitigate the risk of opioid overdose such as a co-prescription for

naloxone. Zedler, Saunders, et al. (2015) however, did not make a recommendation as to which

risk class she would start to consider a co-prescription for naloxone; instead, this decision is left

to the clinician that is prescribing the opioid. Nonetheless, use of the RIOSORD tool provides an

excellent opportunity to provide patient education regarding their individual risk of serious

OIRD.

Discussion

Misuse and abuse of opioids can lead to serious adverse outcomes such as overdose and

possibly death, which present an increasingly severe public health problem in the United States

(Wakeland et al., 2011). A great deal of the evidence demonstrates the need for increased

provider awareness in addition to increased vigilance with prescribing opioid pain medication to

address this epidemic. Provider education should focus on risk mitigation strategies including

the safe use of ER/LA opioid formulations, use of <100mg/day MED if possible, utilization of

risk assessment tools, adequate monitoring of patients’ opioid usage, recognition of high quality

opioid prescribing guidelines, and a co-prescription for naloxone to prevent opioid overdose

deaths. Several screening tools exist to assess for aberrant prescription drug-related behaviors


but only one tool assesses for the risk of overdose or the likelihood of OIRD. Nonetheless, use

of all available screening tools is encouraged because they can provide opportunity to expand the

patient-provider relationship and encourage open communication.

The aim of this project is to utilize the RIOSORD tool to identify individuals on COT

that are at increased risk of unintentional opioid overdose or serious OIRD and provide them

with a co-prescription of naloxone as a means to encourage safe opioid use and prevent overdose

deaths. The RIOSORD is the first tool intended to provide clinicians with the clinical decision

support to assess the risk of serious OIRD and determine the possible need for naloxone. This

tool provides a current, quantitative, evidence-based risk assessment that is able to determine

baseline risk status and provide on-going risk monitoring at future appointments. Review of the

literature clearly indicates that more rigorous, high quality studies are needed to provide

evidence-based practice recommendations in the care of patients on long-term opioid therapy.

Background and Significance

Historically, clinicians have used opioid pain medications to treat acute conditions such

as post-operative pain and pain related to trauma in addition to pain associated with cancer

and/or life-limiting illness (i.e., palliative care; Juurlink & Dhalla, 2012). However, in recent

decades, the United States has seen a dramatic increase in opioid prescribing for many chronic

pain conditions (Alford, 2016). Chronic pain is a significant problem for millions of Americans

and many may have disabling symptoms that interfere with day-to-day functions at home or in

the workplace (Juurlink & Dhalla, 2012). Recommended treatment for chronic pain incorporates

a multimodal approach with pain medication being only one part of the treatment plan.

However, access to recommended multidisciplinary services is sometimes limited by factors

such as cost, lack of insurance, non-coverage of services, lack of transportation, lack of services


in rural areas, and co-morbid health conditions that may limit treatment options such as surgery

(Juurlink & Dhalla, 2012). Due to such limitations, clinicians may initiate opioid pain

medication early in the management of chronic pain.

The use of long-term opioids to treat CNCP became common in the 1990s. The rise in

opioid use during this time coincided with the introduction of several new opioid formulations

such as OxyContin®, an extended-release oxycodone (without abuse deterrent properties) that

was introduced in 1995 within the United States (Juurlink & Dhalla, 2012). The American

Academy of Pain Management (AAPM) and the American Pain Society (APS) also endorsed

chronic opioid therapy during this time. Both the AAPM and the APS encouraged liberal use of

opioids to treat chronic pain based on research that indicated the development of addiction was

low when opioids were used for the relief of pain (Juurlink & Dhalla, 2012). In 2000, the Joint

Commission introduced new pain management standards, which emphasized that patients have

the right to pain relief (Manchikanti et al., 2012). The Joint Commission recommended regular

evaluation of pain in hospitalized patients as the “fifth vital sign” although pain is subjective and

not an objective measurement such as heart rate or temperature (Juurlink & Dhalla, 2012).

Support from national organizations along with the use of opioids in high doses and aggressive

pharmaceutical marketing has contributed to the prevalence of the opioid overdose epidemic.

Unfortunately, growth in the use of opioid pain medication to treat chronic pain has been

associated with increased misuse of prescription opioids and an increase in deaths due to

unintentional overdose (Alford, 2016).

Evidence indicates that patients on COT who are at risk of overdose are likely to benefit

from co-prescribing of naloxone. A study funded by the National Institutes of Health

demonstrated that naloxone can be successfully prescribed to a substantial proportion of patients


receiving COT and that naloxone co-prescribing was associated with reduced opioid-related

emergency room visits (Coffin et al., 2016). The RIOSORD provides clinicians with a validated

risk assessment tool with the ability to identify which patients may benefit from receiving a co-

prescription for naloxone. Fudin (2015) indicates that clinicians and even pharmacists can utilize

the RIOSORD tool to screen patients for risk of unintentional overdose or OIRD. Discussion of

the patient’s RIOSORD score provides an opportunity for a conversation about the possibility of

unintentional overdose and the benefits of risk-reduction strategies such as the co-prescribing

and use of naloxone. It is felt that use of the RIOSORD tool is a practical approach to screen for

risk of overdose in clinical practice and provide guidance on naloxone prescribing (Zedler, Xie,

et al., 2015; Fudin, 2015).

Conceptual Framework

The Stetler model of research utilization is the selected conceptual framework for this

project as it provides the structure and guidance needed to evaluate the literature, synthesize the

evidence, and initiate translation of information into practice. The Stetler model is an evidence-

based practice model that helps practitioners to incorporate evidence into daily practice and to

create formal change within an organization (National Collaborating Centre for Methods and

Tools, 2011). The model consists of five phases that serve as steps in identifying and utilizing

tasks to facilitate safe and effective evidence-based practice (Dang et al., 2015). Table 2 outlines

the phases involved in the Stetler model of research utilization and the specific tasks involved in

the application of each phase to this project.

The primary goal of this project is to utilize the RIOSORD score to guide naloxone

prescribing, which may reduce or prevent opioid-related deaths. The Stetler model of research

utilization is appropriate for this project because it is a practitioner-oriented model that utilizes


the critical thinking process to develop evidence-based practice changes. Implementation of the

RIOSORD tool to quantify a patient’s risk of overdose and increase access to naloxone

demonstrates effective use of evidence-based practice change by the clinician.

Needs Assessment

Drug overdose deaths in the United States hit record numbers in 2014 and at least half of

all opioid overdose deaths involved a prescription opioid (CDC, 2016c). Figure 2 demonstrates

the total number of U.S. overdose deaths involving opioid pain relievers from 2001 to 2014. The

total number of deaths increased by 3.4 times during that period (NIDA, 2015). Based on the

NIDA statistics, 78 Americans die every day from an opioid overdose and nearly half of a

million people died from opioid overdose from 2000 to 2014 (CDC, 2016c). The CDC (2016c)

acknowledges that overdoses from prescription opioid pain relievers are a driving factor in the

15-year increase in opioid overdose deaths. The most common opioids involved in overdose

Table 2

Project Application of the Stetler Model of Research Utilization

Phase Task

1. Preparation Identify problem, background and significance,

needs assessment, and outcome measures

2. Validation Review literature, synthesize evidence, and

assess tool validity

3. Comparative

Evaluation/Decision Making

Discuss findings, applicability and feasibility,

and additional information needed

4. Translation/Application Utilize evidence and implement change

5. Evaluation Measure outcomes, evaluate change

effectiveness, and disseminate findings


deaths are methadone, oxycodone, and hydrocodone (CDC, 2016b). Deaths from opioid

overdoses between 1999 and 2014 were highest among people aged 25 to 54 years of age; non-

Hispanic whites and American Indian or Alaskan Natives, compared to non-Hispanic blacks and

Hispanics; and men, but the mortality gap between men and women is closing (CDC, 2016b).

There were approximately 1.5 times more drug overdose deaths in the United States than deaths

from motor vehicle crashes in 2014 (CDC, 2016b).

The CDC analyzed data from the National Vital Statistics System multiple cause-of-death

mortality files for years 2013 and 2014 in order to track trends and shifting characteristics of

drug overdose deaths (Rudd et al., 2016). Results from this analysis noted significant increases

in drug overdose death rates in the Northeast, Midwest, and South census regions; the five states

with the highest rates of death were West Virginia, New Mexico, New Hampshire, Kentucky and

Ohio in 2014 (Rudd et al., 2016). Statistically significant increases in overdose death rate due to

Figure 2. Prescription opioid overdose deaths from 2001 to 2014. This chart illustrates

the number of overdose deaths from prescription opioids; the chart is overlayed with a

line graph to show number of deaths by females and males.

Source: CDC Wonder; National Institute on Drug Abuse; National Institutes of Health;

U.S. Department of Health and Human Services.

02,0004,0006,0008,000

10,00012,00014,00016,00018,00020,000

Total Female Male


drug overdose were also noted in Alabama, Georgia, Illinois, Indiana, Maine, Maryland,

Massachusetts, Michigan, New Hampshire, New Mexico, North Dakota, Ohio, Pennsylvania,

and Virginia (Rudd et al., 2016). Specifically, there was a 14.7% increase in overdose death rate

within the state of Virginia (Rudd et al., 2016). In Virginia, there was a total of 980 deaths with

an age adjusted rate of 11.7% in 2014 compared to 854 deaths with an age adjusted rate of 10.2%

in 2013 (Rudd et al., 2016). In 2013, Virginia’s Medicaid program spent $28 million on

members admitted to emergency departments and hospitals for treatment of substance use

disorder with $10 million of this spending occurring in Southwest Virginia (VCU School of

Medicine, 2016). Opioid prescriptions alone cost Medicaid $26 million annually (VCU School

of Medicine, 2016).

The total economic burden for opioid-related overdose, abuse, and dependence in the

United States is estimated to be $78.5 billion (Florence, Zhou, Luo, & Xu, 2016). Figure 3

provides an overview of the distribution of the economic burden of prescription opioid overdose,

abuse, and dependence. Over one-third of this amount ($28.9 billion) is due to increased health

care and substance abuse treatment costs and approximately one-quarter of the cost is borne by

the public sector in health care, substance abuse treatment, and criminal justice costs (Florence et

al., 2016). Fatal cases account for just over one quarter of the costs ($21.5 billion; Florence et

al., 2016).

Although many people benefit from prescription opioid pain medication to manage pain,

prescription opioids are often diverted for improper use (SAMHSA, 2016a). According to the

2013 and 2014 National Survey on Drug Use and Health, 50.5% of people who misused

prescription painkillers got them for free from a friend or relative compared to 22.1% who got

them from a prescriber (SAMHSA, 2016a). The CDC notes that individuals at highest risk of


overdose are about four times more likely than the average user to buy the drugs from a dealer or

other stranger (CDC, 2016a). Implementing safer opioid prescribing practices and utilizing the

CDC guideline may help to reduce the amount of prescription opioids available for nonmedical

use.

The clinical setting for the DNP project is Virginia Commonwealth University

Community Memorial Hospital (VCU-CMH) Pain Management Services, which is a pain

management office in a rural setting with one physician and one nurse practitioner. The practice

is a hospital-owned entity with affiliation to a larger health system that is located over 60 miles

away and it is the only pain management practice within the immediate area. Between the two

Figure 3. Distribution of the opioid economic burden. This pie chart depicts the distribution

of the economic burden from prescription opioid overdose, abuse, and dependence.

Source: Florence, C. S.; Zhou, C.; Luo, F.; Xu, L. (2013). The economic burden of

prescription opioid overdose, abuse, and dependence in the United States. Medical Care,

54(10), pp. 901-906, doi: 10.1097/MLR.0000000000000625

Copyright © 2016 Medical Care. Published by Lippincott Williams & Wilkins.


providers, a mean of 264 established patients and 31 new patients are seen per month. The

physician sees all new patients for the first visit encounter. The patient population at VCU-CMH

Pain Management Services is 68% white, 38% African American, and 1% other race; 60% of the

patients are between 40 and 64 years of age and 60% are female. Forty-eight percent of the

population has Medicare insurance. This information is depicted in Figures 4 and 5.

Patients are seen at least every three months for routine follow-up, assessment, and

medication refills. The majority of patients are prescribed an opioid pain medication. According

to the CDC (2016a), an estimated 1 out of 5 patients with noncancer pain are prescribed opioids

in an office-based setting. Virginia is cited as prescribing opioid pain medications to 72-82.1 out

Figure 4. VCU-CMH Pain Management Services patient population. This chart

demonstrates the patient population by age and sex per month for 2016.

Jan Feb Mar Apr May Jun Jul Aug Sept

18-39 yr 42 41 47 40 43 41 32 45 38

40-64 yr 194 210 205 223 223 251 197 220 208

>64 yr 94 107 92 103 117 112 94 117 102

Female 105 213 238 241 255 294 110 236 239

Male 226 146 109 124 128 110 213 142 109

0

50

100

150

200

250

300

350

Nu

mb

er

of

Pat

ien

ts

Patients per Month

2016 Patient Population by Age and Sex

18-39 yr 40-64 yr >64 yr Female Male


of 100 persons (CDC, 2016a). Nationally, the lowest concentration is 52-71 per 100 persons and

the highest 96-143 per 100 persons (CDC, 2016a). All of Virginia’s surrounding states are

among those with the highest prescribing rates including North Carolina, which is less than 20

miles away from VCU-CMH Pain Management Services.

National statistics indicate that most opioid overdose deaths occur in persons aged 25-54

years of age, non-Hispanic whites, and men. The majority of patients seen at VCU-CMH Pain

Management Services fit into at least two of these categories, although VCU-CMH sees fewer

patients 18-39 years of age than any other age group. Even though men are most likely to die of

an opioid overdose, women are more likely to use prescription opioids, which is demonstrated in

the clinic’s demographics noted above (CDC, 2016a). Data from the CDC (2016a) also indicates

that the economic burden of prescription opioid overdose (in addition to abuse and dependence)

Figure 5. VCU-CMH Pain Management Services patient population. This

pie chart demonstrates patient population by insurance for 2016.

48%

27%

17%

4%2% 2%

2016 Patient Population by Insurance

Medicare

Private

Medicaid

Worker's Compensation

Uninsured

CHAMPUS/VA


falls mostly onto the private sector (18%) and Medicaid populations (7%). Forty-four percent of

the patients at VCU-CMH Pain Management Services are insured by private (27%) and

Medicaid (17%) insurances.

Demographic similarities between VCU-CMH Pain Management Services patient

population and national/state statistics of persons affected by opioid-related overdoses and

clinician prescribing practices clearly indicate the need for risk mitigation strategies to reduce

opioid-related morbidity and mortality. Safer opioid prescribing includes taking measures to

protect patients with chronic pain who are medically dependent on opioid pain medication to

improve their functional status and quality of life. Such efforts include use of recommendations

from the CDC guideline for prescribing opioids for chronic pain, patient and provider education

on the correct use of opioid pain medication for chronic pain, and expanding access to and the

use of naloxone. Evaluating patients for risk of overdose will help to determine which patients

would most benefit from the availability of in-home naloxone.

Key Stakeholders

The increasing prevalence of opioid overdose, misuse, and abuse signifies the need for

change among medical societies and policymakers to help improve this public health burden.

Initiatives to reduce the opioid overdose epidemic can strengthen relationships among

stakeholders such as policymakers, clinicians, pharmacists, pharmaceutical companies, law

enforcement, first responders, health insurers, healthcare systems, communities, and families.

The Virginia General Assembly passed legislation in 2015 to expand access to naloxone so that

family members and other individuals can possess and use naloxone to reverse an opioid

overdose at home or in the community if needed (Levine et al., 2015). Additionally, the Virginia

Board of Pharmacy approved a protocol for the prescribing and dispensing of naloxone and the


Virginia Department of Behavioral Health & Developmental Services (DBHDS) Office of

Substance Abuse Services established REVIVE! as the Opioid Overdose and Naloxone

Education (ONE) program for the Commonwealth of Virginia. The REVIVE! ONE program

provides education on how to recognize and respond to an opioid overdose including

administration of naloxone. This training program is available to professionals, stakeholders,

and others with an interest in the opioid overdose epidemic.

In August 2016, Dr. Vivek H. Murthy, the U.S. Surgeon General, initiated the

TurnTheTide campaign to raise awareness of the opioid overdose epidemic. Clinicians were

asked “to pledge their commitment to turn the tide on the opioid crisis” (Murthy, 2016, para. 5).

This pledge recommended that clinicians become educated in the treatment of pain, screen

patients for opioid use disorder and provide referral to evidence-based treatment if needed, and

to treat addiction as a chronic illness and not a moral failing (Murthy, 2016). Lastly, the CDC

developed a funded program called Prevention for States that provides specific state health

departments with resources to advance interventions for preventing prescription drug overdoses

(CDC, 2016e). Such resources include maximizing prescription drug monitoring programs,

community or insurer/health system interventions, state policy evaluations, and rapid response

projects. Clinicians and other healthcare professionals are encouraged to engage with local

agencies, law enforcement, community advocates, community service boards, and other

community partners to create local solutions to address opioid overdose and treatment at the

local and regional levels (Levine et al., 2015).

In accordance with national calls to improve opioid prescribing practices and reduce the

risk of opioid-related deaths, the intended audiences for this project are patients on COT and

prescribers of opioids. The key stakeholders involved are the patients in addition to their


families and communities, the prescribers and clinical staff, and management of the clinical

setting, which includes the office manager, the vice-president of physician services, and the chief

executive officers from both the local hospital (CMH) and its affiliate partnership (VCU Health

System). Decisions within the office are made through collaboration between the two providers,

office manager, and the vice-president of physician services with approval from the local

hospital’s chief executive officer as needed.

Barriers and Facilitators

A major potential barrier to the project includes limited time during appointments to

screen for risk of overdose or OIRD. This barrier may affect whether the screening is performed,

as well as the ability to provide adequate patient education on risk of overdose and use of

naloxone to prevent overdose deaths. Lack of prescription drug coverage and the high cost of

certain naloxone delivery systems may limit patient access to naloxone. Some insurances require

a prior authorization for certain naloxone delivery systems, which is time consuming for both the

office staff and clinicians. A majority of insurances provides coverage for generic naloxone

administered intranasally via a syringe and atomizer, but this delivery method is cumbersome

and more difficult to administer than commercially available pre-prepared, ready-to-use delivery

systems (e.g., the Evzio® Auto-Injector and Narcan® Nasal Spray). Possible strategies to

overcome these barriers include utilizing patient assistance programs from the pharmaceutical

company or developing a pre-authorization letter template that is tailored to the patient’s needs.

These strategies may hasten the prior authorization process and thus reduce patient wait time for

this life-saving medication.

The office staff and clinicians at VCU-CMH Pain Management are dedicated to quality

care and patient safety in the treatment of chronic pain conditions. The staff demonstrates


effective teamwork and is knowledgeable of the patient population and their needs, which are

important attributes when incorporating change within an established system. Other strengths

that will facilitate project implementation include use of written opioid agreements with all

patients on COT, use of an electronic medical record (EMR) with the ability to track prescribing

practices, and use of referral guidelines to ensure the appropriateness of patients referred to the

office for chronic pain treatment.

Benchmarks

In March of 2015, Health and Human Services Secretary Burwell introduced the Opioid

Initiative to address opioid-related morbidity and mortality in the United States (U.S. Department

of Health and Human Services [HHS], n.d.). The initiative targets the following three focus

areas: 1) reforming prescribing practices to reduce excess opioid prescribing; 2) improving

naloxone development, distribution, and access; and 3) expanding access to medication-assisted

treatment (HHS, n.d.). Selected metrics to measure progress toward the agency priority goal of

reducing opioid-related morbidity and mortality include:

a decrease in the total morphine milligram equivalents dispensed in the U.S. outpatient

retail pharmacy setting by 10%;

an increase in the number of prescriptions dispensed for naloxone in the U.S. outpatient

retail pharmacy setting by 15%; and

an increase in the number of unique patients receiving prescriptions for buprenorphine

and naltrexone in the U.S. outpatient retail pharmacy setting by 10% (HHS, n.d.).

No other quality measures or benchmarks exist on opioid overdose deaths in patients on

COT or the practice of co-prescribing naloxone among clinicians. The Drug Policy Alliance

(2016) notes that the nation needs new metrics in which to measure the success of our nation's

drug policies and that the primary measure of effectiveness should be a reduction in opioid-

related harm such as overdose deaths versus measuring for slight fluctuations in drug use. A

scientific analysis performed by NIDA found a 1,170% increase in prescriptions of naloxone


dispensed from retail pharmacies in the U.S. between the fourth quarter of 2013 and the second

quarter of 2015 (NIDA, 2016). Many organizations such as SAMHSA, CDC, NIDA, World

Health Organization, and U.S. Department of Health and Human Services recommend expanding

of the use of naloxone as an effective strategy to reduce opioid-related deaths. An appropriate

goal to gauge the success of this DNP project would be a 15% increase in the number of

prescriptions written for naloxone by clinicians at VCU-CMH Pain Management as noted in the

aforementioned agency priority goal. Although another important measure would be a reduction

in the total morphine milligram equivalents prescribed, that metric is not within the scope of this

project.

Budget

In terms of economic analysis, the cost-consequence analysis method pertains to this

project because it allows for comparison between costs and health-related outcomes so that

stakeholders can form their own opinions regarding the best treatment option. The outcome is to

prevent opioid-related deaths by utilizing the RIOSORD score to guide naloxone prescribing;

ultimately, the pertinent health outcomes of consideration are that of life or death for patients’

receiving COT. Use of naloxone in an opioid-related emergency is a life-saving measure that is

effective in preventing death or other possible detrimental effects. However, lack of naloxone

availability contributes to negative outcomes that lead to consequential expenses such as

hospitalization or funeral expenses. These consequential expenses result in increased costs to

third party payers such as insurance companies or the family. Except for the cost of a medication

that goes unused, there are no negative consequences associated with prescribing naloxone to a

high-risk patient who never has an opioid-related emergency. However, one must consider cost

to the patient or insurance company for obtaining the medication in comparison to costs of a


negative outcome. Table 3 provides a summary of benefits of this DNP project to both the

patient and the institution.

A cost analysis was performed to evaluate the potential cost and sustainment of outcomes

of this DNP project. The major expense associated with the project is for materials and supplies,

which will be used to make copies of the RIOSORD questionnaire and patient education

handouts on signs of overdose and naloxone administration. An electronic version of the

RIOSORD tool, referred to as Naloxotel, will be utilized to screen patients for risk of overdose.

Use of Naloxotel will be provided free of charge by Dr. Jeffrey Fudin from Remitigate, LLC.

However, copies of the completed questionnaires will be required to facilitate data collection and

entry, and a copy will be provided to the patient if desired. Educational videos on naloxone

administration are available at no cost via the PrescribetoPrevent.org and www.narcan.com

websites. Total direct costs of the project are $155.97. The indirect costs are expenses that are

already associated with the established practice setting and thus will not add to costs of project

Table 3

Benefits of DNP Project to Patients and Institution

Benefits to Patient Benefits to Institution

Provision of a life-saving medication if

needed

Adherence to opioid prescribing

recommendations

Opportunity to receive education on

contributing factors for increased risk of

overdose or serious OIRD

Implementation of a decision support tool to

quantify risk for overdose or serious OIRD

Increased access to naloxone Utilization of forward thinking risk

mitigation strategies

Quality care with improved outcomes and

increased safety for those on COT

Patient safety, improved outcomes, and

quality care for patients requiring COT

Notes. COT = chronic opioid therapy; OIRD = opioid-induced respiratory depression.


implementation. These costs include that for the two providers that will screen patients for

overdose as well as additional office staff (i.e., two nurses and one clerical worker), facilities,

and the EMR with electronic prescribing capability. Total indirect costs are $61,938.00 for a six-

month period. Provider and nurse salary is based on a total of 120 hours per staff member for the

six months; this allows for ten minutes per patient (five minutes for the clerical worker) with a

projected total of 1,440 patients screened (i.e., 720 patients per provider/nurse). A detailed

budget for the DNP project is presented in Appendix D. The minimal direct costs associated

with this DNP project should not hinder future sustainment of its efforts. Once patients receive

their initial overdose or serious OIRD screening, it can be repeated annually or as needed to

update the individual’s risk index and reinforce overdose education and prevention efforts.

Annual use will also provide an opportunity to renew the naloxone prescription if out of date.

Project Description

This DNP quality improvement project examines the associations between COT, the

opioid overdose epidemic, and the possibility of serious OIRD in patients receiving COT.

Inappropriate opioid pain medication use in addition to prescribing high doses of opioids (i.e.,

>100mg MED) are contributory to the increased morbidity and mortality in patients on COT

secondary to the possibility of serious OIRD. This project strives to promote quality care to

those suffering with CNCP while encouraging safe opioid prescribing and safe opioid use. The

DNP project team consists of the DNP student who will lead as the project investigator; a clinical

advisor assigned by the school of nursing, and two content experts who were selected by the

DNP student. The first content expert is an anesthesiologist who is board certified in pain

management and the second content expert is a doctor of pharmacy at a local retail pharmacy.

The Stetler model of research utilization is the selected conceptual framework to provide


structure and guidance for the translation of evidence-based research into practice change for this

DNP project. Appendix E provides a schematic of the Stetler model. In addition to aligning

well with national calls for safer opioid prescribing, this DNP project enhances the current state

of practice at VCU-CMH Pain Management Services through increased awareness for overdose

risk screening and the existence of a validated risk assessment tool.

Mission Statement

The mission of this project is to provide effective pain management treatment to those

with various chronic pain conditions in compliance with current pain management guidelines

while concentrating on patient safety and quality outcomes through the provision of naloxone to

those determined to be at an increased risk of serious OIRD. The project mission is reflective of

the organizational mission, which is to provide excellence in the delivery of healthcare (VCU

Health CMH, 2016). Organizational quality improvement strategic plans that correlate to the

DNP project include a focus on quality and excellence, creating patient-focused systems, and

meeting growth demands of the outpatient population. Such strategic plans help to unify future

directions and purposes of VCU-CMH with its medical staff while considering the community’s

needs and prioritization of areas for improvement. The organization’s vision is to be a national

leader in healthcare through continuous improvement while recognizing the following values:

integrity at all levels; compassion and service towards others; teamwork that revolves around

respectful and collegial relationships among physicians, employees, patients, and volunteers;

ethical behavior; excellence in our processes and outcomes; and professionalism (VCU Health

CMH, 2016).

Goals and Objectives


The DNP student, as the project investigator, defines the scope of this project in two

primary goals directed at the project intervention/clinicians (goal #1) and the patient population

(goal #2). Table 4 summarizes the primary goals and corresponding objectives.

Outcome Measures

Primary outcome measures include the calculated RIOSORD score for each patient

assessed, the number of high-risk patients, and the number of naloxone prescriptions provided.

Secondary outcome measures include an analysis of the individual covariates from the IMS

Table 4

DNP Project Goals and Objectives

Goal #1 Goal #2

Reduce or prevent opioid-related overdoses

over the six-month project period.

Demonstrate safe opioid use as evidenced

by lack of a serious OIRD event or proper

treatment of a serious OIRD event over

the six-month project period.

Objectives: Objectives:

1. Familiarize clinicians with factors

associated with increased risk of overdose

and/or serious OIRD in patients on COT.

2. Provide information on development of

the RIOSORD tool including differences

in the VHA and IMS populations.

3. Implement use of the IMS RIOSORD tool

in clinical practice to assess risk of

overdose or serious OIRD.

4. Utilize the RIOSORD risk index score to

guide naloxone co-prescribing in patients

on COT found to be at increased risk of

overdose or serious OIRD.

1. Educate patients on factors associated

with increased risk of overdose or

serious OIRD.

2. Provide patient’s with individualized

risk of overdose or serious OIRD

based on RIOSORD score.

3. Provide a co-prescription of naloxone

to use in an opioid-related emergency

if needed.

4. Educate patient and family/friends on

the signs and treatment of opioid

overdose including the proper use of

naloxone.

Note. COT = chronic opioid therapy; IMS = commercial insurance; OIRD = opioid-induced

respiratory depression; RIOSORD = Risk Index for Overdose or Serious Opioid-Induced

Respiratory Depression; VHA = Veteran’s Health Administration.


RIOSORD tool itself (e.g., certain co-morbid health conditions over the past six months and

current medication consumption). Table 5 provides an outline of these covariates.

Table 6 provides a description of how the project goals and objectives link to the primary

and secondary outcome measures. Other secondary long-term outcomes of interest include

whether an overdose or serious OIRD event occurred; if so, did the patient have naloxone

available to use, was naloxone used, and results of the serious OIRD event. However, data for

such long-term outcomes will not be collected as a longitudinal study for longer than six months

would be necessary to obtain this data.

Table 5

Covariates Analyzed in the IMS RIOSORD Tool

Co-morbid Health Conditions Current Medication Consumption

Substance use disorder

Bipolar disorder or schizophrenia

Stroke or other cerebrovascular disease

Chronic kidney disease (with clinically

significant renal impairment)

Heart failure

Non-malignant pancreatic disease

Chronic pulmonary disease

Chronic headache

Fentanyl (transdermal or transmucosal)

Morphine

Methadone

Hydromorphone

ER/LA opioid formulation (including

any of the above named opioids)

Concomitant benzodiazepine use

Concomitant anti-depressant use

Current opioid dose >100mg MED

(includes all prescription opioids

consumed on a daily basis)

Note. ER/LA = extended-release/long-acting; IMS = commercial insurance; MED =

morphine equivalent dose.

Adapted from: Zedler, B., Saunders, W., Joyce, A., Vick, C., & Murrelle, L. (2015).

Validation of a screening risk index for overdose or serious prescription opioid-induced

respiratory depression. Poster session presented at the 2015 American Academy of Pain

Medicine Annual Meeting, National Harbor, MD.


Table 6

Aligning Goals and Objectives with Outcome Measures

Goals/Objectives Outcome Measures

Goal #1: Reduce or prevent opioid-related

overdoses over the six-month project period.

Objectives: Primary Outcomes:

1. Familiarize clinicians with factors associated

with increased risk of overdose and/or serious

OIRD in patients on COT.

2. Provide information on development of the

RIOSORD tool including differences in the

VHA and IMS populations.

(Review of the DNP project proposal

will meet objectives 1-2.)

3. Implement use of the IMS RIOSORD tool in

clinical practice to assess risk of overdose or

serious OIRD.

1. Calculated RIOSORD score for

each patient assessed.

2. Number of patients determined to

be “increased risk” for overdose or

serious OIRD.

4. Utilize the RIOSORD risk index score to guide

naloxone co-prescribing in patients on COT

found to be at increased risk of overdose or

serious OIRD.

3. Number of prescriptions written

for naloxone.

Goal #2: Demonstrate safe opioid use as

evidenced by lack of a serious OIRD event or

proper treatment of a serious OIRD event over the

six-month project period.

Objectives: Secondary Outcomes:

1. Educate patients on factors associated with

increased risk of overdose or serious OIRD.

2. Provide patient’s with individualized risk of

overdose or serious OIRD based on RIOSORD

score.

3. Provide a co-prescription of naloxone to use in

an opioid-related emergency if needed.

4. Educate patient and family/friends on the signs

and treatment of opioid overdose including the

proper use of naloxone.

1. Assess for presence of covariates

included in the RIOSORD tool.

(Administering and reviewing

RIOSORD results with the patient

will also satisfy objectives 1-4.)

Note. COT = chronic opioid therapy; DNP = Doctor of Nursing Practice; IMS = commercial

insurance; OIRD = opioid-induced respiratory depression; RIOSORD =Risk Index for

Overdose or serious opioid-induced respiratory depression; VHA = Veteran’s Health

Administration.


Project Design

The DNP project will utilize a prospective cohort study design in which the RIOSORD

tool will be used to evaluate risk of overdose or serious OIRD and examine how the tools use

influences the prescribing practice of naloxone as a rescue medication for patients on COT.

Additionally, a retrospective chart review will be performed to determine naloxone prescribing

patterns and factors influencing a provider’s decision to co-prescribe naloxone prior to

implementing a risk assessment tool such as the RIOSORD.

Methods

Subjects. Inclusion criteria for the study include clinicians who prescribe opioid pain

medication for 90 days or longer in patients with chronic pain (i.e., pain lasting three months or

beyond the expected duration of healing; Dowell et al., 2016). Data will be collected on both the

prescribers and the patients. Only established patients with a chronic pain condition who are

prescribed continuous opioid pain medication(s) for 90 days or longer will be screened for

overdose or serious OIRD risk screening process. New patients will not be screened at their

initial visit due to time constraints of the office visit and other information that must be reviewed

at the initial visit; however, these patients may be screened at subsequent visits. Exclusion

criteria includes patients who have not been prescribed continuous opioid pain medication(s) for

at least 90 days or who have not had a chronic pain condition for at least three months, anyone

less than 18 years of age, and patients scheduled for an initial encounter (e.g., new patient

appointment).

Setting. The site chosen for the DNP project is a chronic pain management office

located in rural Southside Virginia that serves a wide range of patients over the age of 18 years

with various chronic pain conditions. Although the office is located in Mecklenburg County,


most patients travel from the surrounding seven counties (i.e., Halifax, Charlotte, Lunenburg,

Brunswick, Greensville, Nottoway, and Prince Edward) for pain management treatment. The

next closest pain management office is located 42 miles away in Roanoke Rapids, North

Carolina.

Southside Virginia shares a long border with North Carolina that equals 9,082 square

miles (University of Virginia [UVA], 2011). Southside Virginia occupies more than one-fifth of

the state’s land mass, but contains only 6% of its total population (UVA, 2011). According to

the 2010 census, the total population for Southside Virginia was 504,660 persons with a 1.4%

growth rate and a population density of 56 persons per square mile (UVA, 2011). In regards to

race and ethnicity, 64% of the population is white, 32% is black, 2% Hispanic, and 2% other

including Asian (UVA, 2011). Labor force statistics show that 31% of adults 25-64 years old

were either not working or looking for work in 2011 which is higher than state (20%) and

national (22%) levels of out-of-labor force adults (UVA, 2011). Unemployment was 10.8% in

2009, higher than Virginia’s unemployment rate (7.5%) and the national rate (9.7%; UVA,

2011). Regarding household income, more than 36% earn less than $25,000 per year, 17% fall

below the poverty line (compared to 10% statewide), and 13% receive food stamps (UVA,

2011). Overall, 32% of Southside households do not have adequate income to meet their regular

expenditures (e.g., housing, food, and transportation) without help from government programs,

family and friends, or local organizations (UVA, 2011).

The pain management office has one physician and one nurse practitioner who serve

patients within a 150-mile radius. The physician is an anesthesiologist with board certification in

pain management for 11 years and a total of 28 years in practice; the nurse practitioner is board

certified in Family Practice with three years of pain management experience and approximately


10 years of primary care experience. Other office resources include two licensed practical nurses

with a combined total of 40 years of nursing experience, one clerical worker with twenty years of

medical office experience, and an office manager with 29 years of medical office management

experience.

Tools. The RIOSORD tool designed for use in the commercial insurance or general

population (IMS RIOSORD) will be the tool implemented in the project to screen for risk of

serious OIRD in patients that meet the above-stated inclusion criteria. The IMS RIOSORD tool

is a 16-item questionnaire that is designed to be completed by the clinician. The first eight

questions inquire if the patient being screened has had either an inpatient, outpatient, or

emergency department visit over the last six months for certain medical conditions including

substance use disorder, bipolar/schizophrenia, chronic kidney disease with clinically significant

renal impairment, heart failure, non-malignant pancreatic disease, chronic pulmonary disease, or

chronic headache. The last eight questions are in relation to medications consumed by the

patient including fentanyl, morphine, methadone, hydromorphone, an ER/LA formulation of any

opioid, a benzodiazepine, an anti-depressant, and if the patient’s maximum prescribed opioid

dose is >100mg MED.

Once the questionnaire is completed, the first step is to determine the RIOSORD score;

the maximum score for the 16-item questionnaire is 146 points. The second step involves

identification of the risk class for overdose or serious OIRD, which corresponds to an average

probability of overdose or serious OIRD. Table 7 provides a conversion of the IMS RIOSORD

score in points to risk class and average probability of overdose or serious OIRD. A copy of the

IMS RIOSORD tool is provided in Appendix C.


Remitigate, LLC will provide access to an electronic version of the RIOSORD tool called

Naloxotel. Remitigate, LLC was founded in 2015 by pain therapeutics pharmacist Dr. Jeffrey

Fudin in collaboration with Dr. Nadia Shahzad and Dr. Nicholas W. D. Jarrett; the company

provides software solutions for medical professionals who care for patients taking long-term

opioids (Remitigate, LLC, n.d.). Naloxotel is a software application that assigns a percent risk of

OIRD based on a validated multivariate linear regression model coupled with drug interactions

based on the research by Zedler, Xie, et al. (Remitigate, LLC, n.d.). The software application

will enable clinicians and even pharmacists to generate a comprehensive progress note of the

OIRD assessment that can be printed and scanned or transferred into the patient’s EMR. The

Table 7

Conversion of RIOSORD Score to Risk Class and Probability of Overdose

or Serious OIRD

RIOSORD Score

(Points)

Risk Class Average Probability of

Overdose or Serious OIRD

0-4 1 2%

5-7 2 5%

8-9 3 7%

10-17 4 15%

18-25 5 30%

26-41 6 55%

>42 7 83%

Note. OIRD = opioid-induced respiratory depression; RIOSORD = Risk

Index for Overdose or Serious Opioid-Induced Respiratory Depression.

Adapted from Zedler, B., Saunders, W., Joyce, A., Vick, C., & Murrelle, L.

(2015). Validation of a screening risk index for overdose or serious

prescription opioid-induced respiratory depression. Poster session

presented at the 2015 American Academy of Pain Medicine Annual

Meeting, National Harbor, MD.


software also has the capability to create a prior authorization request letter for in-home naloxone

access (Remitigate, LLC, n.d.). Permission to use the Naloxotel application along with free

software access through December 31, 2017 has been granted to the project team members that

are directly involved in data collection (i.e., the DNP student and content expert). Naloxotel

training will be completed prior to the start of the project, which merely involves using the

software a few times to become familiar with its applications and features. The providers

involved in the use of the application (i.e., the DNP student and content expert) will discuss use

of the application and clarify any concerns or questions of its use with Dr. Fudin prior to start of

the project. Examples of the comprehensive progress note and prior authorization letter

generated by Naloxotel are provided in Appendices F and G.

Intervention and Data Collection. The intervention is to co-prescribe naloxone to

patients on COT found to have an increased risk of serious OIRD as a rescue medication to use

in the event of an opioid-related emergency. Neither study conducted by Zedler, Xie, et al.

(2015) nor Zedler, Saunders, et al. (2015) indicates a recommended score in which to qualify

patients for a co-prescription of naloxone. However, in a study conducted by Cleary, Raouf,

Nguyen, Carpenter, and Fudin (2016) utilizing the VHA RIOSORD tool, a RIOSORD score of

>25 points was chosen to qualify patients for naloxone for in-home use due to the associated

>14% probability for OIRD. Using the VHA RIOSORD cut-off score as a guide, an IMS

RIOSORD score of >10 will be used in this project to determine which patients are viewed as

“increased risk” for opioid overdose or serious OIRD. An IMS RIOSORD score of 10-17

corresponds to risk class 4, which carries a 15% probability of serious OIRD (Zedler, Saunders,

et al., 2015). The patients that are determined to be “increased risk” will receive the

intervention, which is a co-prescription for naloxone. The Naloxotel prior authorization letter


states the patient has received education on opioid risk factors, how to minimize such risks, and

was offered naloxone for in-home use and that the patient has agreed to fill the prescription for

naloxone. Thus, patient education on the purpose and proper administration of naloxone is

warranted.

Naloxone hydrochloride is a short-acting, non-addictive, opioid antagonist that is used for

respiratory or central nervous system depression from opioid overdose with over 30 years of

proven effectiveness if administered correctly and in a timely fashion (Merlin, Ariyaprakai, &

Fh, 2015; Zedler et al., 2014). In 1971, naloxone received US Food and Drug Administration

approval and subsequently became the standard first-line agent in the emergency setting for rapid

reversal of accidental or intentional opioid overdose (Merlin et al., 2015). Naloxone is available

in many different forms including generic and brand name versions. Generic naloxone is

available as an intramuscular injection or an intranasal mucosal atomizer may be used for

intranasal delivery. Brand name versions of naloxone include the Evzio Auto-Injector or the

Narcan Nasal Spray. See Figure 6 for a pictorial of the different formulations of naloxone that

are available to prescribe.

In addition to co-prescribing naloxone, education will be provided on the symptoms of

opioid overdose, rescue breathing, and proper administration of naloxone (education must be

specific to the prescribed method of delivery). An example of a patient education handout on

opioid overdose symptoms and resuscitation instructions is provided in Appendix H. Free

instructional video downloads are available from PrescribetoPrevent.org on how to administer

generic intramuscular and intranasal naloxone as well as the brand name Evzio Auto-Injector. A

video demonstration on the use of the brand name Narcan Nasal Spray is available at

www.narcan.com. The videos can be used in the office for patient education and training on


naloxone administration but patients may also access the videos at home to educate family and

friends on naloxone administration. The office nurses will be beneficial in providing assistance

with patient education on naloxone training. Appendix I contains a nurse checklist to ensure that

naloxone training is consistent and that patients receive the appropriate education depending on

type of naloxone delivery system prescribed. One important aspect of naloxone training is to

advise patients to inform family and/or friends where the naloxone is stored in addition to proper

Narcan Nasal Spray Generic naloxone with intranasal

(brand name) mucosal atomizer

Evzio Auto-Injector Generic naloxone for

(brand name) intramuscular injection

Figure 6. Naloxone delivery systems. This pictorial demonstrates the various

formulations of naloxone delivery systems that are available to prescribe.


use of the prescribed formulation of naloxone. Education on the use of the prescribed naloxone

device is crucial to ensure correct administration and delivery of the life-saving medication. For

example, if prescribing the generic naloxone intranasal spray, it is important that the patient and

family/friend knows how to assemble the intranasal mucosal atomizer device and that half of the

dose is administered in one nostril followed by the other half in the opposite nostril. However, if

the brand named Narcan Nasal Spray is prescribed, the full dose is administered in only one

nostril. It is also important to remind patients to be aware of expiration dates on the naloxone

and to request refills as needed based on use and expiration of the product. Appendix J contains

a patient education handout that provides naloxone resources and overdose prevention tips.

Timeline. DNP project implementation is expected to begin in February 2017 pending

approval or exemption from the Internal Review Board of VCU Health System. A student

affiliation agreement for students at VCU Health System entities will be secured prior to the start

date. This agreement confers access to patient information, use of medical records, and the

confidentiality of patient data and/or health information. The DNP student as well as

representatives from VCU Health System and CMH sign this agreement.

The project will be conducted for a total of six months with an expected end date of

August 2017. Prior to implementation of the actual project, at least two Plan-Do-Study-Act

(PDSA) cycles will be conducted in January 2017 to test the planned practice change and

determine if any modifications are needed with implementation. Communication within the

project practice setting will be conducted during the daily morning huddles and as needed

throughout the day to address any deficiencies or clarify any concerns among the project team

members and other available staff resources. Project evaluation will begin in September 2017

and end in December 2017. Appendix K provides a detailed timeline of the DNP project.


Potential Risks and Threats

A foreseeable risk to the success of this project is that a patient does experience an

overdose or serious OIRD event and does not have naloxone available for in-home use. It would

be important to determine if the patient had been assessed for risk of serious OIRD, if naloxone

was prescribed, and if the patient filled the naloxone prescription. The lack of naloxone

availability is a contributory cause of opioid overdose deaths in patients on COT and a primary

reason for this DNP project. This could be a result of the patient not filling the prescription, lack

of coverage by insurance, high out-of-pocket cost for the prescription, or family/friends not

knowing where the naloxone is stored. Another potential risk or threat is the inability to use the

naloxone appropriately by family members or friends. Due to the timeliness of this topic in the

midst of the opioid overdose epidemic, prescribing practices of naloxone are starting to increase

despite the use of a validated tool to assess risk of overdose or serious OIRD. This could be

viewed as a threat to the project and affect comparison to designated benchmark goals.

Project Evaluation

Implementation of a risk mitigation strategy such as the RIOSORD tool and utilizing

recommendations for safe opioid prescribing practices in patients on COT aligns well with

national goals to improve access to safe, effective pain treatment and reducing the risk for

overdose with prescription opioids (i.e., CDC and National Pain Strategy; Dowell et al., 2016).

As previously mentioned, the metric in which to gauge the success of this DNP project is a 15%

increase in the number of prescriptions written for naloxone by clinicians at VCU-CMH Pain

Management. This benchmark aligns well with the HHS Opioid Initiative agency priority goal

of reducing opioid-related morbidity and mortality, which includes a 15% increase in the number


of prescriptions dispensed for naloxone in the U.S. outpatient retail pharmacy setting as one of

the outcome measures.

The IMS RIOSORD tool will be used to assess patients’ risk for serious OIRD if the

patient meets pre-determined inclusion criteria described under Subjects in the Methods section.

An IMS RIOSORD score of >10 will be used as the cut-off score to determine which patients are

at “increased risk” for overdose or serious OIRD; this score corresponds to a 15% probability of

overdose or serious OIRD. Multivariable logistic regression modeling of the strongest OIRD-

associated variables within the commercial insurance population demonstrated a C-statistic of

0.90, which indicates excellent discrimination between cases and controls (Zedler, Saunders, et

al., 2015). Such models are considered strong and reliable if the C-statistic is greater than 0.8,

which indicates that the probability of predicting the outcome is better than by chance alone

(University of Manitoba, 2011). Covariates from the original VHA RIOSORD tool were

modified to accommodate for differences in the commercial insurance population and point

values were assigned to the most statistically significant RIOSORD predictors based on the

corresponding β-coefficients (Zedler, Saunders, et al., 2015). Thus, the 16 covariates included in

the IMS RIOSORD were found to be statistically significantly associated with serious OIRD in

the commercial insurance population. These particular covariates were selected with an effort to

balance both the scientific and statistical robustness of each variable’s association with OIRD

against the need for a practical yet brief instrument that possesses optimum simplicity and

accuracy when completed by a clinician within a typically busy care setting (Zedler, Saunders, et

al., 2015). The predictive validity of the IMS RIOSORD tool was assessed by comparing the

distribution of predicted probabilities, by percentiles, with the observed incidence of overdose or

serious OIRD within the study sample (Zedler, Saunders, et al., 2015). Among the seven risk


classes, the average predictive probability of a serious OIRD event ranged from 2% in the lowest

risk class (class 1, 0-4 points) to 83% in the highest risk class (class 7, >42 points), and the

observed occurrence of overdose or serious OIRD increased commensurately (Zedler, Saunders,

et al., 2015). Figure 7 demonstrates the increase in predictive probability compared to the

observed occurrence of overdose or serious OIRD.

At the end of the six-month project period, both providers will complete the RIOSORD

Provider Satisfaction Survey as a summative assessment of this project. The survey assesses for

ease of use and provider satisfaction with the RIOSORD tool. Such information is helpful to

Figure 7. The predicted probability versus observed incidence of overdose or serious

OIRD. This chart demonstrates the predicted probability (risk classes, by percentiles)

versus observed incidence of overdose or serious OIRD.

Note. OIRD = opioid-induced respiratory depression.

Source: Zedler, B., Saunders, W., Joyce, A., Vick, C., & Murrelle, L. (2015). Validation

of a screening risk index for overdose or serious prescription opioid-induced respiratory

depression. Poster session presented at the 2015 American Academy of Pain Medicine

Annual Meeting, National Harbor, MD.


gain insight into the clinical applicability and feasibility of continued use of the RIOSORD tool,

which will be summarized in the project evaluation. The DNP student developed this survey due

to lack of a pre-existing questionnaire that addressed provider satisfaction and ease of use. The

RIOSORD Provider Satisfaction Survey is provided in Appendix L.

Data Analysis Plan

A copy of each RIOSORD questionnaire will be imported or scanned into each patient’s

EMR and a copy will be kept by the project investigator (DNP student) for data collection. Data

from the questionnaire will be transferred into a Microsoft Excel spreadsheet for future data

analysis (i.e., total RIOSORD score, risk class, probability of overdose or serious OIRD, and

presence of individual covariates from the RIOSORD tool). Project data will be de-identified as

to be compliant with the Health Insurance Portability and Accountability Act, which ensures the

protection of individually identifiable health information. Patient name, chart number, and date

of birth will not be recorded as to protect patient identification; instead, a random identification

number will be assigned to each patient included in the project. This information will be stored

in a single password protected document that only the project investigator can access. Data will

be saved on a password protected encrypted flash drive that will remain in the sole possession of

the project investigator (i.e., DNP student). The project investigator will also be the only person

collecting and maintaining data as to maintain consistency in the data collection process.

However, it is possible that input from the visit provider will be necessary for clarification

purposes on occasion. Other information to collect includes patient demographics (e.g., age,

race, and gender), date of visit/RIOSORD assessment, visit provider, date of onset of chronic

pain, length of time on COT, prescribed opioid(s), total MED of all prescribed opioid(s), whether


naloxone was prescribed (or previously prescribed), and formulation of naloxone prescribed.

This information will be obtained by review of each patients’ EMR.

During the six months of project implementation, the project investigator will also

conduct a retrospective chart reviews to obtain information on factors that may have influenced a

provider to co-prescribe naloxone prior to project implementation. Data will be extracted from

patient visits of the six months prior to the project start date to serve as comparison data. Data to

collect during the retrospective chart reviews includes date of data extraction, number of eligible

patients, number of times naloxone was prescribed, and contributing factors that influenced

naloxone prescribing. This information will be obtained from a combination of sources

including the daily schedule for each provider, the medication list to determine if patient was

“eligible” (e.g., prescribed opioids for 90 days or longer) and if naloxone was prescribed, and

review of previous office notes to infer contributing factors for prescribing naloxone.

Summary statistics will be used to provide a description of primary outcome #1

(calculated RIOSORD score for each patient assessed). Such descriptive/summary statistics of

the RIOSORD score include measures of central tendency (mean, median, and mode) and

measures of dispersion (standard deviation, range, and quartiles). Primary outcomes #2 (the

number of patients determined to be “increased risk” for overdose or serious OIRD) and #3 (the

number of prescriptions written for naloxone) will be reported as an overall count and percentage

of those screened. In order to determine if the benchmark goal of a 15% increase in naloxone

prescribing is met, both the count and percentages of naloxone prescribing for six months before

and six months after implementation of the RIOSORD tool will be collected and compared. A

control chart (i.e., P-chart) can be utilized to demonstrate the average number of naloxone

prescriptions written per week both before and after implementation of the RIOSORD tool and


thus evaluate the effectiveness of the RIOSORD tool in increasing naloxone prescribing. A P-

chart (“P” stands for “percent” or “proportion”) is used to demonstrate count data of

nonconforming units (e.g., yes/no, pass/fail, either/or; Carey, 2003). The nonconforming unit in

this study is whether naloxone was co-prescribed (i.e., yes/no). It may be beneficial to post the

P-chart in a common staff area in order to monitor progress of the DNP project and to promote

use of the RIOSORD tool. A possible limitation of the project’s findings include that the DNP

student is both the project investigator and a subject in the project, which introduces the potential

for bias.

Inferential statistics will be used to analyze secondary outcome measures, which include

covariates from the RIOSORD tool itself. A statistical analysis such as multiple logistic

regression that seeks a relationship between the dependent and independent variable(s) is

appropriate for this outcome measure because this test inquires if one measure predicts the other,

if one measure depends on the other, or if there is a trend between two sets of measures.

Multiple logistic regression models estimate the odds probability of the dependent variable (i.e.,

whether or not naloxone is co-prescribed) occurring as the values of the independent variables

(i.e., covariates of the RIOSORD tool) change (Keller & Kelvin, 2013). An odds ratio measures

how much more likely an outcome is to occur given certain conditions or exposures; statistical

significance of the odds ratio is determined by the p-value (Keller & Kelvin, 2013). The

dependent variable in logistic regression models is dichotomous (i.e., having two categories) and

the independent variable(s) can be of any measurement (Keller & Kelvin, 2013). The advantage

of multiple logistic regression is that it allows for computation of odds ratios that are adjusted to

account for the effect of other variables on both the risk factor and the outcome (Keller &

Kelvin, 2013). JMP Pro 12 data analysis software will be used to conduct statistical analyses.


Discussion and Implications

Review of the literature regarding management of CNCP with COT strongly indicates the

need for rigorous, high quality studies that evaluate and promote patient safety and quality

improvement outcomes. Treating chronic pain patients can be challenging and requires a

multimodal plan of care. The potential for misuse, abuse, addiction, or overdose should be

recognized as part of this plan in addition to increasing access to naloxone. Utilizing the

RIOSORD tool in clinical practice will identify patients at risk for accidental overdose, which

can lead to OIRD and possibly death. The RIOSORD score can guide naloxone prescribing to

identify which patients are most likely to benefit from the availability of in-home naloxone.

Rather than providing a naloxone prescription to all individuals prescribed an opioid, the

RIOSORD score will provide a quantitative risk measurement to guide this decision.

Clinical Implications

Utilizing a validated, risk assessment tool to increase access to naloxone aligns well with

the national call for action to reduce opioid overdoses and promote safe opioid prescribing. The

implications for this project specifically include the ability to educate patients on their risk for

OIRD (or overdose), increase provider knowledge on factors that contribute to increased risk for

OIRD, increase access to naloxone for the clinic’s patient population, and thus reduce or prevent

opioid-related overdose. Implications for future practice are to raise awareness to the availability

of the RIOSORD tool and promote its use. The project also anticipates the ability to provide

information on feasibility of RIOSORD use in clinical practice as well as generalizability based

on data obtained from provider satisfaction surveys. Other implications inferred from the

literature review include the need to increase provider education within the pain management

arena including utilization of the CDC guideline for prescribing opioids for chronic pain in


addition to increasing access to naloxone, recognition of substance use disorder, and referral for

medication-assisted therapy when needed. Zedler, Xie, et al. (2015) note that patients that are

prescribed ER/LA opioid formulations, MED >100mg/day, and/or opioids from multiple

providers are prone to greater healthcare utilization. Clinical implications of this DNP project

(i.e., patient education on OIRD, provider knowledge on risk factors for OIRD, and increasing

access to naloxone) include a possible reduction in unnecessary utilization of healthcare services

for opioid-related emergencies. Recommendations for future research include the need to

monitor patients for use of in-home naloxone. Studies should include the identification of

variables that contribute to the need for naloxone and their relation to those included in the

RIOSORD assessment. Continuous process improvement and monitoring the reliability of the

tools performance is crucial to its success and recommendations for use.

DNP Essentials. Using the Stetler model of research utilization as its guide, this DNP

project seeks to demonstrate synthesis of information from the available literature and utilization

of its findings to implement a practice change. The project will support learnings from the

Virginia Commonwealth University School of Nursing DNP program curriculum and

demonstrate an understanding of the foundations expected of a DNP prepared nurse. Once

completed, the project will fully meet The Essentials of Doctoral Education for Advanced

Nursing Practice developed by the American Association of Colleges of Nursing in October

2006. The DNP Essentials consist of required foundational competencies and curricular

elements of the DNP program that are core to all advanced practice nursing roles (American

Association of Colleges of Nursing, 2006). There are eight foundational DNP Essentials.

Appendix M provides a table outlining the relationship the DNP Essentials to this DNP project.


Quality and Safety. This DNP project is a quality improvement initiative for practice

change. The aforementioned purpose is to implement a risk assessment strategy that may reduce

and/or prevent overdose deaths from prescription opioids. At this time, there is no local or

national protocol in place to guide the recommendation to increase access to naloxone.

However, the RIOSORD provides the capability to fulfill this need. Implementation of the

RIOSORD tool will seek to identify individuals on COT that are at increased risk of serious

OIRD or unintentional overdose and serve as a guide to provide a co-prescription for in-home

naloxone if needed in the event of an opioid related emergency. The aims demonstrate an

evidence-based approach to improve patient outcomes, increase quality of care, and promote safe

opioid use and safe opioid prescribing practices.

In order to ensure quality of the project itself, the Stetler model of research utilization

served as a framework for project planning. The Stetler model aligns well with the revised

Standards for Quality Improvement Reporting Excellence (SQUIRE 2.0) guidelines, which

supports the reporting of findings from systems level projects to improve the quality, safety, and

value of healthcare (SQUIRE, 2015). In order to fulfill SQUIRE guidelines, baseline

measurement of variables should be obtained. Measurement of current naloxone prescribing

practices will serve as a comparison to evaluate the effectiveness of the proposed practice

change. A 15% increase in naloxone prescribing is the set goal to measure success of the

practice change. Detailed information about the intervention in addition to validity and

reliability on utilization of any clinical tools should be addressed. The RIOSORD is a validated

tool that has demonstrated reliability in both the VHA and IMS populations. Utilization of the

SQUIRE 2.0 guidelines not only helps to ensure the quality of a project but also improves the

ability to generalize findings to similar situations or replicate findings in similar populations.


Plan for Sustainability

The preliminary plan for sustainability includes strategic planning to promote the

ongoing use of the RIOSORD tool to assess risk for overdose and OIRD, the need to reassess

risk status regularly, and the need to follow-up with patients in relation to prescribing naloxone.

Establishing a strategic plan that includes transparency and sustainability objectives is beneficial

to the success of the practice change and its continued use. Transparency allows for the free

flow of ideas and the ability to discuss what is and is not working among all participants in the

DNP project. Sustainability objectives for this project are to continue use of the RIOSORD tool,

maintain an up-to-date RIOSORD score yearly or as needed, and provide adequate patient

education on overdose and OIRD in relation to COT so that patients will follow through with

recommendations for in-home naloxone. Table 8 provides an outline of recommended steps to

achieve the above objectives. The project investigator will be responsible for steps during

initiation of the project; however, as the project progresses and benefits of the RIOSORD tool

become evident, clinical staff will become empowered to continue its use. Transparency, early

involvement, and buy-in from the clinical staff will promote sustainment of the project.

The project investigator will serve as the project champion and will provide regular

project updates to stakeholders and the health system’s local decision makers. Stakeholders and

decision makers will need to be educated on the importance of the DNP project and its

contribution to local and national calls for help in reducing the opioid overdose epidemic. Such

informational updates will be beneficial to identify potential decision makers to win over as well

as who might be the best contact(s). Informational training sessions will be provided for clinical

providers and staff to ensure that patients are educated properly and consistently. A patient

education checklist will aid in ensuring this expectation. Stakeholders, decision makers, and


clinical providers/staff will be encouraged to contact the project investigator as needed with any

questions or concerns. The project investigator will utilize available resources in providing

appropriate information to stakeholders and decision makers. A faculty advisor from VCU

School of Nursing DNP program and two content experts (i.e., a pain management specialist and

a doctor of pharmacy) are included in the DNP project team; they will serve as consultants to the

project investigator (i.e., DNP student) as needed. Dr. Jeffrey Fudin from Remitigate, LLC will

serve as a contact for the Naloxotel software application. Heather Thomson, MS, Associate

Director of Medical Science, Director of Health Economics and Outcomes Research of kaléo

Pharma has been a beneficial resource to provide information and feedback during the project

proposal and implementation phases in addition to helping establish contact with Dr. Barbara

Zedler who developed the RIOSORD tool.

On-going operational costs specific to this project include printing supplies and cost for

use of the Naloxotel software. Dr. Jeffrey Fudin has granted free access until December 31,

2017 for now. However, the yearly rate to continue use is $25.00/year per user to utilize the

PC/Mac versions of the Naloxotel software; a mobile application is not available at this time. An

alternative would be to utilize a paper version of the RIOSORD tool but that would increase the

cost of printing supplies. Benefits to the continued use of the electronic software includes the

ability to choose whether the patient is from the general population or is a U.S. military veteran,

built-in calculations for the RIOSORD score and MED of prescribed opioids, and generation of a

prior authorization letter regarding the patient’s individualized RIOSORD score including need

for in-home naloxone. The current EMR is slated to convert to Cerner in the fall of 2017, which

should not pose a problem with use of the Naloxotel software application itself. The planned

process of uploading or scanning RIOSORD results into the EMR should be feasible with


continued use. No other capital equipment depreciation or replacement is anticipated at this

time.

Table 8

Steps to Achieve Sustainability Objectives

Steps to achieve

objective:

Who does

the work? What does success look like?

What resources

are needed?

• Due date:

1. Identify staff

concerns regarding

RIOSORD use.

• PI Staff questions answered and

solutions provided in regards to

use of RIOSORD.

Staff time

• Daily

2. Monitor for proper

use of RIOSORD

tool.

• PI Naloxotel software is properly

utilized to obtain RIOSORD

score.

PI Time

• Weekly

3. Utilize an EMR

clinical alert to

repeat RIOSORD

screening yearly.

• PI

• Clinical

Providers

Clinical providers repeat

RIOSORD screening yearly;

EMR clinical alert resets.

Clinical alert

development;

clinical provider

time

• Yearly

4. Encourage clinical

providers to repeat

RIOSORD

screening as needed.

• PI

• Clinical

Providers

RIOSORD screening updated

when there are changes in

patient’s medical or

psychological status,

medications, and/or MED status;

naloxone prescription renewed if

indicated.

Clinical provider

time

• As needed

5. Educate patients on

the risk of overdose

and OIRD with

COT, purpose of in-

home naloxone, and

delivery method of

prescribed naloxone.

• Clinical

Providers

• Nursing

staff

Patients on COT are

knowledgeable of the risk for

overdose and OIRD and proper

use of prescribed naloxone

device.

Staff training

sessions; clinical

provider/nursing

staff time

• January 2017

(training)

• On-going

6. Monitor patient

compliance on

filling naloxone

prescription.

• Clinical

Providers

• Nursing

staff

Patients fill prescription for

naloxone as recommended and

inform family/friends of its

location and use.

Staff training

sessions; clinical

provider/nursing

staff time


• January 2017

(training)

• On-going

7. Identify patient’s

questions and

concerns regarding

RIOSORD score

and/or naloxone use.

• Clinical

Provider

• Nursing

staff

Patient questions and concerns

on RIOSORD score and/or

naloxone use are

answered/solved.

Clinical

provider/nursing

staff time

• On-going

8. Monitor for use of

in-home naloxone.

• Clinical

Provider

• Nursing

staff

Patients report on use of

naloxone at follow-up

appointments and ask for refill

as needed.

Clinical

provider/nursing

staff time

• On-going

9. Perform monthly

random chart

reviews to monitor

for RIOSORD use

and associated

patient outcomes.

• PI RIOSORD use continued on all

patients prescribed opioid pain

medication and updated yearly.

Data collected on an ongoing

process utilizing an Excel

document to store data.

Clinical

provider/nursing

staff time

• Monthly for

random chart

reviews

• Weekly for

data collection

10. Monitor provider

satisfaction.

• PI Provider satisfaction surveys

administered yearly.

Clinical

provider/nursing

staff time

• Yearly

Note. COT = chronic opioid therapy; EMR = electronic medical record; MED = morphine

equivalent dose; OIRD = Overdose or Serious Opioid-Induced Depression; PI = Project

Investigator; RIOSORD = Risk Index for Overdose or Serious Opioid-Induced Depression.

Plans for dissemination include poster presentations, sharing knowledge of the

RIOSORD tool and Naloxotel software with affiliate clinics (i.e., VCU-CMH practices), and

other local primary care offices. An application will be submitted for a poster presentation of the

literature review findings at the Virginia Council for Nurse Practitioner’s (VCNP) annual

conference in March 2017. Once the project is completed, a poster presentation at the 2018

VCNP annual conference would be appropriate in addition to a pain management conference

such as the International Conference on Opioids held in Boston, Massachusetts annually.


Publication will be considered; relevant peer-reviewed publications include the Practical Pain

Management, which is a comprehensive journal for information on chronic pain and/or The

Journal of Pain, which publishes original articles related to all aspects of pain. Dr. Jeffrey Fudin

is a member of the editorial board of Practical Pain Management and will be instrumental in

providing assistance from a publication perspective.


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Development of a risk index for serious prescription opioid-induced respiratory


depression or overdose in veterans’ health administration patients. Pain Medicine 16(8),

1566-1579. Doi:10.1111/pme.12777

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login.aspx?direct=true&AuthType=ip,url,cookie,uid&db=s3h&AN=99620845&site=eho

st-live&scope=site


Appendix A

Flow Diagram of the Search Process

Iden

tifi

cati

on

Scr

eenin

gE

ligib

ilit

yIn

cluded

Articles identified through

database searching

(n = 613)

Additional articles identified

through other sources

(n = 0)

Articles after duplicates removed

(n = 520)

Abstracts screened

(n = 520)

Abstracts excluded

(n = 391)

Full-text articles assessed for

eligibility

(n = 129)

Full-text articles excluded,

with reasons

(n = 112)

Studies included

(n = 17)


Appendix B

RIOSORD Tool used in the Veterans’ Health Administration

Source: Fudin, J. (2015, December 18). Risk tool helps pharmacists qualify patients for

take-home naloxone. Pharmacy Times, 12. Retrieved from

http://www.pharmacytimes.com/contributor/jeffrey-fudin/2015/12/risk-tool-helps-

pharmacists-qualify-patients-for-take-home-naloxone


Appendix C

RIOSORD Tool used in the Commercial Insurance Population

Source: Zedler, B., Saunders, W., Joyce, A., Vick, C., & Murrelle, L. (2015). Validation of a screening risk index

for overdose or serious prescription opioid-induced respiratory depression. Poster session presented at the 2015

American Academy of Pain Medicine Annual Meeting, National Harbor, MD.


Appendix D

Proposed DNP Project Budget

Budget period: February 2017 – August 2017

Direct Costs

Category Calculations Final Costs

I. Materials/Supplies/

Educational Handouts

a. Paper 30 pt/d x 3d/wk = 90 pt/wk

90 pt/wk x 16 wks = 1440 pts

(1 case, 5000 sheets) x 2

cases

111.98

c. Toner Black, yields 11,000 pages 43.99

II. Naloxotel (electronic

RIOSORD tool)

0

III. Other

a. Educational videos 0

Total Direct Costs = $ 155.97

Indirect Costs

Category Calculations Final Costs

I. Staffing salary/wages

a. MD (1) $ 216/hr x 120 hr 25,920.00

b. NP (1) $ 49/hr x 120 hr 5,880.00

a. Nurses (2 LPNs) $ 18/hr x 120 hr (x 2) 4,320.00

b. Clerical (1) $ 12/hr x 60 hr 720.00

II. Equipment

a. Computers, copiers,

printer, scanner

0

III. Information Technology

a. EMR system $ 1300/mo x 6 mo 7,800.00

b. E-prescribing (included in EMR cost)

IV. Facilities

a. Office rental $ 2,500/mo x 6 mo 15,000.00

b. Office utilities $ 366/mo x 6 mo 2,196.00

c. Office maintenance $ 17/mo x 6 mo 102.00

Total Indirect Costs = $ 61,938.00

Notes. Indirect costs are already part of the established practice setting. COT = chronic

opioid therapy; d = days; DNP = Doctor of Nursing Practice; EMR = electronic medical

record; hr = hours; LPN = licensed practical nurse; MD = medical doctor; mo = months; NP =

nurse practitioner; pt = patients; RIOSORD = Risk Index for Overdose or Serious Opioid-

Induced Respiratory Depression; wk = weeks.


Appendix E

The Stetler Model of Research Utilization

Source: Stetler, C. (2001). Updating the Stetler Model of research utilization to facilitate evidence-based practice. Nursing

Outlook, 49(6), 272-279.


Appendix F

Example of a Naloxotel Comprehensive Progress Note

Documented: 09/11/16

Provider: Dr. Joe Payne, Physician

Patient: Jane Doe, 00/00/0000, ID 123456 Prescribed drugs:

hydrocodone 20 mg/day

methadone 30 mg/day

Total Morphine Dose:

288mg/day

The following parameters were evaluated and identified to elevate risk for opioid-induced

respiratory depression in this patient:

Within the past 6 months the patient had a healthcare visit (outpatient, inpatient, or ED) involving any

the following health conditions:

- Chronic kidney disease with clinically significant renal impairment

- Chronic pulmonary disease (e.g., emphysema, chronic bronchitis, asthma, pneumoconiosis,

asbestosis)

- Chronic headache (e.g., migraine)

Prescribed Drugs or Drug Classes Identified by RIOSORD:

Methadone

An extended-release or long-acting (ER/LA) formulation of any prescription opioid, including the

above A prescription antidepressant (e.g., fluoxetine, citalopram, venlafaxine, amitriptyline)

The following parameters were evaluated and identified to elevate risk for opioid-induced respiratory

depression to this patient above that which is calculated for the validated RIOSORD: carisopridol,

hydoxazine

Predicted Opioid Risk Assessment - 83%

This patient was evaluated for percent risk of opioid-induced respiratory depression using the

validated RIOSORD [1, 2] analysis tool. This patient was determined to have a(n) 83% risk based on

the unique criteria outlined herein.

357 Delaware Avenue, #214, Delmar, NY 12054 E [email protected] P 781-472-4637 www.naloxotel.com


Appendix G

Example of a Naloxotel Prior Authorization Letter

Documented: 09/11/16

Provider: Dr. Joe Payne, Physician

Patient: Jane Doe, 00/00/0000, ID 123456 Prescribed drugs:

hydrocodone 20 mg/day

methadone 30 mg/day

Total Morphine Dose:

288mg/day

This patient was evaluated for percent risk of opioid-induced respiratory depression using the

validated RIOSORD [1, 2] analysis tool. This patient was determined to have a(n) 83% risk based on

the unique criteria outlined herein.

For this reason, naloxone for in-home use is recommended for this patient. This recommendation is

consistent with AMA, ASAM, FDA, CDC, SAMHSA and other professional organization

recommendations or guidelines to provide in-home naloxone for patients receiving opioids that are at

risk for opioid induced respiratory depression.

This patient is on hydrocodone 20mg/day which is metabolized by CPY 2D6 to a more active

metabolite and by 3A4 to an inactive metabolite. For this reason, a medication inducer or inhibitor

may increase or decrease these levels and place the patient at higher risk

Patient and caregiver was/were counseled on opioid risk factors, how to minimize such risks, and

offered naloxone for in-home use. Based on the overall assessment and understanding of patient

and/or caregiver, it is determined that the best option for this patient is: Evzio Auto-Injector. This is

due to the following reason(s): Patient's caregiver lacks the manual dexterity or strength to manipulate

intranasal dosage form, Patient has medically documented physical or pathological issue to one or

both naris.

Patient agrees to fill prescription for naloxone as outlined above. Education about overdose

prevention and instructions for use of Evzio Auto-Injector for OPIOID OVERDOSE reversal were

provided to this patient and/or caregiver. Method of contact was In-person. Length of the session was

40 minutes.

1. Zedler, Barbara, et al. "Development of a Risk Index for Serious Prescription Opioid-Induced Respiratory Depression or

Overdose in Veterans' Health Administration Patients." Pain Medicine 16.8 (2015): 1566-1579.

2. Zedler BK, Saunders W, Joyce A, Vick C, Murrelle L. Validation of a screening risk index for serious prescription opioid-

induced respiratory depression or overdose in a national commercial insurance claims database. Pain Medicine, 2015.

357 Delaware Avenue, #214, Delmar, NY 12054 E [email protected] P 781-472-4637 www.naloxotel.com


Appendix H

Opioid Overdose Symptoms and Resuscitation Instructions


Appendix I

Nurse Checklist for Naloxone Training

_____

1. Determine need for naloxone training based on type of naloxone delivery system

prescribed.

_____ 2. Play appropriate video to provide an overview and demonstration of the prescribed

method of naloxone delivery.

_____ 3. Demonstrate use of the Evzio Auto-Injector using the trainer device (if this is the

prescribed naloxone delivery system).

_____ 4. Provide patient with a copy of the Naloxotel Comprehensive Progress Note, which

explains the patient’s opioid risk assessment and probability of opioid-induced

respiratory depression.

_____ 5. Provide patient education handouts on opioid overdose resuscitation, naloxone

resources, and overdose prevention tips.

_____ 6. Provide written instructions for the prescribed naloxone delivery device.

_____ 7. Ask patient if there are any questions and provide answers if able. If not able, have

the visit provider talk to patient regarding concerns prior to discharge from clinic.

_____ 8. Submit Naloxotel prior authorization letter if needed for insurance coverage

determination for the prescribed naloxone delivery system.

_____ 9. Follow-up with patient via phone call one week after appointment date to inquire if

the prescription for naloxone was filled and if there are any further questions.


Appendix J

Overdose Prevention Tips and Naloxone Resources

How to Avoid Overdose:

Only take medication that is prescribed for you

Do not take more than prescribed

Call if your pain worsens

Never mix pain medication with alcoholic beverages

Avoid taking pain medication at the same time as sleep medications

Store pain medication in a secure location

Bring any unused medication to the office for disposal

Learn how to use naloxone

Teach family/friends how to respond to an overdose

Learn how to use naloxone:

Naloxone is a medication that can be given as an injection into the thigh muscle or

sprayed up the nose to reverse the effects of an opioid pain medication and save lives.

Call 911 for help; even after giving naloxone. More than one dose of naloxone may

be required to fully reverse an overdose.

Follow Opioid Overdose Resuscitation instructions to provide rescue breathing until

help arrives.

Be sure that family/friends know where naloxone is stored and how to use it.

There are various ways to give naloxone to someone. It is important to become

familiar with the delivery method that is prescribed.

Visit PrescribeToPrevent.com to view educational videos on how to respond to an

overdose and how to use naloxone. Use the Patient Education tab to gain access to

the educational videos that are available for viewing.

Other sources:

Evzio.com to learn how to use the Evzio AutoInjector.

Narcan.com to learn how to use the Narcan nasal spray.


Appendix K

Proposed DNP Project Timeline

Project Implementation

Project starts

Start data collection

Start retrospective chart reviews

Project Implementation

Project ends

Complete data collection

Complete retrospective chart reviews

Project

Planning Begins

October 2016 December 2016 January 2017 February 2017 August 2017 September 2017 December 2017

Project

Proposal

Project Evaluation

Finalize all data collection

Begin data analysis

PDSA Cycles Project Evaluation

Finalize data analysis


Appendix L

RIOSORD Provider Satisfaction Survey

Please respond to the following questions using a scale of 1 to 10.

(1 = the lowest rating and 10 = the highest rating)

1. How would you rate ease of use of the RIOSORD during patient visits?

1 2 3 4 5 6 7 8 9 10

2. How would you rate the perceived benefit of using the RIOSORD tool in clinical practice?

1 2 3 4 5 6 7 8 9 10

3. How would you rate the overall usefulness of the RIOSORD tool?

1 2 3 4 5 6 7 8 9 10

4. How would you rate your overall satisfaction with use of the RIOSORD?

1 2 3 4 5 6 7 8 9 10

5. Would you recommend other clinicians to use the RIOSORD tool in clinical practice?

(1 = would not recommend…10 = highly recommend)

1 2 3 4 5 6 7 8 9 10

6. How would you rate the amount of time required to administer the RIOSORD?

(1 = it did not take a long time/did not significantly add to the patient visit time…10

= took too long/added significantly to the patient visit time)

1 2 3 4 5 6 7 8 9 10

7. How would you rate your likelihood of continuing to use the RIOSORD questionnaire?

(1 = would not continue to use…10 = will continue to use)

1 2 3 4 5 6 7 8 9 10


Appendix M

Relationship of the DNP Essentials to the DNP Project

DNP Essential DNP Project

I. Scientific Underpinnings

for Practice

The project demonstrates integration of nursing science with

knowledge gained from ethical, biophysical, psychosocial,

analytical, and organizational sciences. This knowledge

translates into the highest level of nursing practice as

evidenced by evaluation and synthesis of evidence obtained

from review of the literature in regards to COT and opioid-

related overdose, use of a theoretical model to guide the

DNP project, and implementation of a new practice

approach to increase access to naloxone.

II. Organizational and

Systems Leadership for

Quality Improvement and

Systems Thinking

The project implements and evaluates a care delivery

approach to meet the current and future needs of patients on

COT. Use of the Stetler model of research utilization will

guide the decision-making processes for the delivery of

quality healthcare and provision of patient safety for those

on COT. The project investigator acts as the project

champion or leader through this process.

III. Clinical Scholarship and

Analytical Methods for

Evidence-Based Practice

The project designs and implements a quality improvement

plan and processes to evaluation outcomes to promote safe,

timely, effective, and patient-centered care. The RIOSORD

tool is a validated risk assessment tool used to obtain an

individualized score for the probability of overdose that the

clinician can use to determine need for in-home naloxone.

Data collection will help to identify naloxone-prescribing

patterns to improve practice and the practice environment.

Dissemination of findings via poster presentations at various

nurse practitioner and/or pain management conferences will

help to improve patient outcomes beyond the local level.

IV. Information

Systems/Technology and

Patient Care Technology

for the Improvement and

Transformation of Health

Care

The project demonstrates the selection of a software

application (i.e., Naloxotel) that evaluates and monitors

patient outcomes in relation to healthcare delivery and

quality improvement in patient outcomes. The project

investigator analyzes and communicates critical elements in

the selection, use, and evaluation of patient care technology

with the project team and clinical project setting.

V. Health Care Policy for

Advocacy in Health Care

The project investigator critically analyzes health policies

for recommendations to reduce opioid-related overdose


deaths and increasing access to naloxone. The project

investigator also demonstrates the ability to educate others

such as stakeholders and staff on the importance of

improving healthcare outcomes and promoting safe opioid

use through use of evidence-based practice guidelines such

as the CDC opioid prescribing guidelines.

VI. Interprofessional

Collaboration for

Improving Patient and

Population Health

Outcomes

The DNP project involves use of effective communication

skills to build interprofessional collaborative relationships

in the development of a quality improvement, patient safety

scholarly project. The project investigator employs

consultative skills at workshops and conferences to establish

collaborative relationships and contacts. The project

investigator also provides leadership to the project team

from conception to completion of the project in addition to

planning for sustainability.

VII. Clinical Prevention and

Population Health for

Improving the Nation’s

Health

The DNP project analyzes epidemiological, biostatistical,

and other appropriate scientific data related to the

population health of persons suffering from CNCP as well

as the prevalence of opioid-related overdose. The project

investigator synthesizes information related to clinical

prevention of opioid-related overdose deaths and promotes

improvement of patient outcomes/patient safety through

implementation of interventions to address access to

naloxone in addition to safer opioid prescribing practices.

The project investigator will also evaluate the effectiveness

of strategies to reduce opioid-related morbidity and

mortality.

VIII. Advanced Nursing

Practice

The DNP project conducts a systematic assessment of

physical and mental health and illness parameters in patients

on COT that contribute to risk for overdose. Utilization of

the RIOSORD tool provides a comprehensive risk

evaluation in which to guide clinical judgement and systems

thinking in regards to naloxone prescribing. The project

investigator and/or clinician(s) use this information to

educate and guide patients on appropriate risk reduction

strategies. The sharing of knowledge gleaned from the

review of the literature, synthesis of information, and

conception of this project contributes to the development

and sustainment of therapeutic relationships with patients,

staff, colleagues, and other professionals in relation to the

delivery of optimal healthcare, improvement of patient

outcomes, and promotion of safe opioid use. The project

investigator also acts as a mentor and provides guidance and


Notes. CDC = Centers for Disease Control and Prevention; CNCP = chronic noncancer pain;

COT = chronic opioid therapy; DNP = Doctor of Nursing Practice; RIOSORD = risk index for

overdose or opioid-induced respiratory depression.

Source: American Association of Colleges of Nursing. (2006, October). The essentials of

doctoral education for advanced nursing practice. Retrieved from

http://www.aacn.nche.edu/publications/position/DNPEssentials.pdf

support for other nurses to achieve excellence in nursing

practice.

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