Ruth Carrico PhD RN FSHEA CIC Associate Professor Division of Infectious Diseases

Ruth Carrico PhD RN FSHEA CICRuth Carrico PhD RN FSHEA CICAssociate Professor Associate Professor

Division of Infectious Diseases Division of Infectious Diseases

University of Louisville University of Louisville

Clinical & Translational Research Clinical & Translational Research Step by Step from Idea to PublicationStep by Step from Idea to Publication

Planning Your Study: Implementation Planning Your Study: Implementation StudiesStudies

Step by Step from Idea to Publication Step by Step from Idea to Publication Step by Step from Idea to Publication Step by Step from Idea to Publication

4. Performing the Study4. Performing the Study

5. Analyzing the Data5. Analyzing the Data

3. Planning the Study 3. Planning the Study

1. Clinical & Translational Research: Definitions1. Clinical & Translational Research: Definitions

6. Disseminating Study Findings: Scientific Writing 6. Disseminating Study Findings: Scientific Writing

7. Clinical Research: Elements for Success7. Clinical Research: Elements for Success

2. Developing the Research Question 2. Developing the Research Question

Clinical & Translational Research Clinical & Translational Research

ObjectivesObjectives ObjectivesObjectives

Describe the elements of study design in Describe the elements of study design in implementation studiesimplementation studies

Explore conceptual basis of implementation science Explore conceptual basis of implementation science and its application to clinical and translational and its application to clinical and translational researchresearch


Basic Research

ClinicalResearch

ClinicalPractice

PatientOutcomes

Translation Translation

T1 T2


Patients inPatients in the universethe universe

http://nihroadmap.nih.gov/

From Research to Practice: Lost in TranslationFrom Research to Practice: Lost in Translation

Basic Research

ClinicalResearch

ClinicalPractice

PatientOutcomes

Translation Translation

T1 T2


Patients inPatients in the universethe universe

http://nihroadmap.nih.gov/

Implementation Research

*Demonstration Research*Dissemination Research*Translating Research Into Practice: TRIP

From Research to Practice: Lost in TranslationFrom Research to Practice: Lost in Translation

The Science Behind Implementation StudiesThe Science Behind Implementation Studies The Science Behind Implementation StudiesThe Science Behind Implementation Studies

A. True A. True


Implementation studies, although Implementation studies, although newly recognized as important, rely newly recognized as important, rely largely on qualitative research and largely on qualitative research and

as such are of lesser quality as such are of lesser quality compared to interventional studiescompared to interventional studies

B. FalseB. False


The study of effectiveness, efficiency, and equity of The study of effectiveness, efficiency, and equity of health program selection, delivery, and uptakehealth program selection, delivery, and uptake



Research has indicated that provision of a peanut butter sandwich to all patients will result in an improved nutritional status.

The new guideline states that a peanut butter sandwich should be provided daily to all targeted patient populations.

You are responsible for implementation.

Make a peanut butter sandwich for your patient.

Research

Performance Improvement

Teaching

Application

People Skills

Variation in Knowledge and Skills


The idea is to bridge the gap between proven The idea is to bridge the gap between proven interventions and clinical/community practices in real-interventions and clinical/community practices in real-world settingsworld settings




The overall goal of implementation science is to The overall goal of implementation science is to advance the adoption and integration of evidence-advance the adoption and integration of evidence-based interventions and change practice patternsbased interventions and change practice patterns

The idea is to bridge the gap between proven The idea is to bridge the gap between proven interventions and clinical/community practices in real-interventions and clinical/community practices in real-world settings world settings




The overall goal of implementation science is to The overall goal of implementation science is to advance the adoption and integration of evidence-advance the adoption and integration of evidence-based interventions and change practice patterns.based interventions and change practice patterns.

The idea is to bridge the gap between proven The idea is to bridge the gap between proven interventions and clinical/community practices in real-interventions and clinical/community practices in real-world settings. world settings.


Implementation science examines all points on the Implementation science examines all points on the causal pathway from program to impactcausal pathway from program to impact


Implementation Research GoalsImplementation Research Goals Implementation Research GoalsImplementation Research Goals

Produce generalizable knowledge and increased Produce generalizable knowledge and increased understanding of implementation processes, barriers, understanding of implementation processes, barriers, facilitators, and strategiesfacilitators, and strategies

Develop reliable strategies for increasing use of Develop reliable strategies for increasing use of evidence-based/effective services to improve outcomes; evidence-based/effective services to improve outcomes; facilitate widespread adoption of those strategiesfacilitate widespread adoption of those strategies

Develop, test and refine implementation theories and Develop, test and refine implementation theories and hypotheses as the methods and measures used to hypotheses as the methods and measures used to accomplish themaccomplish them



Implementation Research: systematic study of how specific Implementation Research: systematic study of how specific activities and strategies are used to successfully integrate activities and strategies are used to successfully integrate

Implementation: use of strategies to adopt and integrate evidence-based interventions and change practice patterns

Dissemination Research: systematic study of how the distribution can be successful executed

Translation Research: comprised of dissemination, implementation and diffusion research

Dissemination: targeted distribution of information and intervention materials to a specific audience

TerminologyTerminology

D. Schillinger. A Resource Manual for Community-Engaged Research 2010


Basic Research

ClinicalResearch

Clinical Practice

T2T1

Guideline DevelopmentMeta-analyses

Systemic reviews

Dissemination researchImplementation research

NIH: Clinical & Translational ScienceNIH: Clinical & Translational Science

Translation to Patients Translation to Practice


Basic Research

ClinicalResearch


T2T1

Changing public health practice to improve

“prevention”

Changing clinical practice to improve

“treatment”

Patients in the UniversePatients in the Universe



Components of Implementation ScienceComponents of Implementation Science


Basic Research

ClinicalResearch Implementation

Research

Changing public health practice to improve

“prevention”

Changing clinical practice to improve

“treatment”



PopulationResearch

T1 T2



Population-based Research


T1

Basic Research

ClinicalResearch

T2


““Cross-Disciplinary Communication”Cross-Disciplinary Communication”

Evolution of Attitudes Toward Evidence Evolution of Attitudes Toward Evidence Evolution of Attitudes Toward Evidence Evolution of Attitudes Toward Evidence


Belief in passive perfusion of scientific evidence into practice



Demonstration that much of clinical practice not evidence based and even if it were, the magnitude makes it impossible for clinicians to keep up with



Passive dissemination does not work. “Quality Chasm” requires aggressive action including performance measurement and accountability



It is insufficient to focus on the individual. Rather, the redesign of service delivery systems is necessary. Behavior change.

EV

IDE

NC

E

PRACTICE HEALTH

COMMUNITYHealth Care Delivery

Systems

Providers

Patients

Public

GovernmentPayors

Public HealthProf. Societies

Academia

System-Centered Implementation

Strategies

Translating Practice Into Evidence: Community Engagement Strategies

Advocacy & Policy Strategies

Individual-Centered

Implementation Strategies

Introduction to Translating Evidence into Practice:

Theory, Evidence & Design

STAKEHOLDERS

Translating Evidence Into Practice, Policy and Public Health

UCSF Model

Steps in Implementation ResearchSteps in Implementation Research Steps in Implementation ResearchSteps in Implementation Research

4. 4. Tailor or develop interventions to improve performanceTailor or develop interventions to improve performance

5. Implement intervention5. Implement intervention

3. Review evidence on implementation interventions3. Review evidence on implementation interventions

1. Identify care gaps and need for change1. Identify care gaps and need for change

6. Evaluate the process of implementation6. Evaluate the process of implementation

7. Evaluate outcomes of the intervention7. Evaluate outcomes of the intervention

2. Identify barriers to consistent use of guidelines2. Identify barriers to consistent use of guidelines


PerformancePerformance

InterventionIntervention

Uncontrolled before-afterUncontrolled before-after Uncontrolled before-afterUncontrolled before-after

PerformancePerformance


Measures performance before and after the intervention in uncontrolled group. Differences in performance assumed to be due to intervention.

Performance in non-randomized or controlled groupPerformance in non-randomized or controlled group

Interrupted time seriesInterrupted time series Interrupted time seriesInterrupted time series

Intervention (e.g., Intervention (e.g., dissemination ofdissemination of

national guideline)national guideline)


Attempts to detect whether intervention had an effect significantly greater than the underlying trend.

Control groupControl groupperformanceperformance

InterventionIntervention

Controlled before-afterControlled before-after Controlled before-afterControlled before-after

Control group Control group performanceperformance


Measures performance before and after the intervention in controlled population with similar characteristics. Compares post-intervention performance in study and control groups

Study groupStudy groupperformanceperformance

Study groupStudy groupperformanceperformance

difference difference

Randomized/cluster-randomized controlled trialRandomized/cluster-randomized controlled trialRandomized/cluster-randomized controlled trialRandomized/cluster-randomized controlled trial

Study Subjects

Planning The StudyPlanning The Study

None or an alternative intervention

Interventional Designs

1. Non-Randomized

2. Randomized

Intervention

Types of Implementation InterventionsTypes of Implementation Interventions Types of Implementation InterventionsTypes of Implementation Interventions

4. 4. Educational outreach visitsEducational outreach visits

5. Use of local opinion leaders5. Use of local opinion leaders

3. Local consensus processes3. Local consensus processes

1. Distribution of educational materials1. Distribution of educational materials

6. Patient-mediated interventions6. Patient-mediated interventions

7. Audit and feedback7. Audit and feedback

2. Educational meetings2. Educational meetings



10. Mass media10. Mass media

8. Reminders8. Reminders

9. Marketing9. Marketing



11. 11. Patient/HCP stories and experiencesPatient/HCP stories and experiences

12. Checklists12. Checklists

10. Mass media10. Mass media

8. Reminders8. Reminders

13. Community engagement13. Community engagement

14. Simulation14. Simulation

9. Marketing9. Marketing


Implementation Research ChallengesImplementation Research ChallengesImplementation Research ChallengesImplementation Research Challenges

Develop more sophisticated study designs to address key Develop more sophisticated study designs to address key implementation questionsimplementation questions

Develop a better understanding of interventions and their Develop a better understanding of interventions and their mechanisms of actionmechanisms of action

Understand the impact of context of practice on Understand the impact of context of practice on effectivenesseffectiveness


So What?So What?So What?So What?

How do I take credit for making happen what needs to How do I take credit for making happen what needs to happenhappen

How do I make happen what needs to happenHow do I make happen what needs to happen

Implementation studies represent the basis for Implementation studies represent the basis for understanding the impact of best practicesunderstanding the impact of best practices


How do I lead change to ensure that what happens needs How do I lead change to ensure that what happens needs to happen; and what needs to happen happensto happen; and what needs to happen happens

Hope is not a plan. Plan needs to be evidence-basedHope is not a plan. Plan needs to be evidence-based


Pay for Reporting

Pay for Performance

Financial reward for practitioners in healthcare facilities for collecting and submitting performance data to a quality measurement program (CMS via NHSN)

Financial reward for scoring well on performance measures

A. True A. True


Pay for Performance and Pay for Performance and Accountable Care Act Performance Accountable Care Act Performance Measures apply only to hospitals at Measures apply only to hospitals at

this time (2012)this time (2012)

B. FalseB. False


Value-Based PurchasingValue-Based PurchasingValue-Based PurchasingValue-Based Purchasing

• Notion that standardized care processes reduce error and help to “perfect” the system by identifying and reducing defect

• Data inconclusive as to degree of bundle adherence and outcomes

• Reporting generally all or none


Care BundlesCare BundlesCare BundlesCare Bundles

• Use of chlorhexidine-alcohol skin preparation– Maximum sterile barriers– Full size body drape

• Complete surgical garb • Insertion site selection• Hand hygiene• Daily evaluation of need• Feedback (performance and outcomes)


Central Line BundleCentral Line BundleCentral Line BundleCentral Line Bundle

• Antimicrobial selection, timing, redosing and duration

• Skin preparation

• Hair removal

• Glucose control

• Temperature control (normothermia)

• Instrument sterilization


Surgical Care BundleSurgical Care BundleSurgical Care BundleSurgical Care Bundle

• Head of bed elevation

• Oral care

• Closed suction

• Care of ventilator

• Hand hygiene

• Sedation vacation

• Rapid extubation/discontinuation of ventilator


Ventilator BundleVentilator BundleVentilator BundleVentilator Bundle

The Future of Implementation ResearchThe Future of Implementation Research The Future of Implementation ResearchThe Future of Implementation Research

Theory development (limited empiric evidence)Theory development (limited empiric evidence)

Understand applicability of studies conducted in one Understand applicability of studies conducted in one setting to another/different contextsetting to another/different context

Understand interactions between provider, patient, Understand interactions between provider, patient, practice environment and broader system of carepractice environment and broader system of care


Ruth Carrico PhD RN FSHEA CIC Associate Professor Division of Infectious Diseases

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