An analysis of the gap between available healthcare services and deficiencies in care and treatment...

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Mireille Levy-Culminating Experience Page 1 Boston University School of Public Health Department of Global Health and Development Culminating Experience Cover Page Name: Mireille Levy CE Advisor: James Wolff Culminating Experience Paper Title: An analysis of the gap between available healthcare services and deficiencies in care and treatment among patients with Chronic Kidney Disease in Chinandega and León, Nicaragua Abstract Currently, there is an epidemic of Chronic Disease of unknown causes (CKDu) in the farming communities of Chinandega and León, Nicaragua. An increase in the incidence rate of CKDu over the past decade have resulted in increases in patient demand for specific services and treatment beyond what the government is able to sufficiently provide. El Ministerio de Salud (MINSA) in Nicaragua has responded by developing the Norma y Protocolo Para El Abordaje De La Enfermedad Renal Crónica, a medical provider protocol guideline for early detection, treatment and management of patients with CKD/u 1 and by building sub-clinics that specializes in CKD/u in high impact areas. However, quality and access to care and treatment for CKD/u is compromised by a set of systemic issues arising from resource shortages, lack of programming and poor implementation of key initiatives by MINSA and sub agencies. This paper discusses systemic issues that undermine the quality of patient care, the economic impact of CKDu on Nicaragua’s healthcare system, medical resource shortages and patient barriers to care in areas most affected. To address these issues, I suggest that MINSA create a CKDu Task Force that collaboratively provides recommendations to improve dissemination, training and provider education on the CKD protocol guideline and to address areas of unmet needs and service gaps that improve the quality of care and health outcomes among patients with CKD/u. 1 CKD/u is used in instances where the context applies to both CKD and CKDu patients.

Transcript of An analysis of the gap between available healthcare services and deficiencies in care and treatment...

Page 1: An analysis of the gap between available healthcare services and deficiencies in care and treatment among patients with Chronic Kidney Disease in Chinandega and León, Nicaragua

Mireille Levy-Culminating Experience Page 1

Boston University School of Public Health

Department of Global Health and Development

Culminating Experience Cover Page

Name: Mireille Levy

CE Advisor: James Wolff

Culminating Experience Paper Title: An analysis of the gap between available healthcare services and

deficiencies in care and treatment among patients with Chronic Kidney Disease in Chinandega and León,

Nicaragua

Abstract

Currently, there is an epidemic of Chronic Disease of unknown causes (CKDu) in the farming

communities of Chinandega and León, Nicaragua. An increase in the incidence rate of CKDu over the past decade

have resulted in increases in patient demand for specific services and treatment beyond what the government is

able to sufficiently provide. El Ministerio de Salud (MINSA) in Nicaragua has responded by developing the

Norma y Protocolo Para El Abordaje De La Enfermedad Renal Crónica, a medical provider protocol guideline

for early detection, treatment and management of patients with CKD/u1 and by building sub-clinics that

specializes in CKD/u in high impact areas. However, quality and access to care and treatment for CKD/u is

compromised by a set of systemic issues arising from resource shortages, lack of programming and poor

implementation of key initiatives by MINSA and sub agencies. This paper discusses systemic issues that

undermine the quality of patient care, the economic impact of CKDu on Nicaragua’s healthcare system, medical

resource shortages and patient barriers to care in areas most affected.

To address these issues, I suggest that MINSA create a CKDu Task Force that collaboratively provides

recommendations to improve dissemination, training and provider education on the CKD protocol guideline and

to address areas of unmet needs and service gaps that improve the quality of care and health outcomes among

patients with CKD/u.

1 CKD/u is used in instances where the context applies to both CKD and CKDu patients.

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TABLE OF CONTENTS

Section PAGE

Glossary ........................................................................................................................................................ 3

Introduction ................................................................................................................................................... 4

Chronic Kidney Disease (CKD ................................................................................................................. 4

Standard Methods of Diagnosis .................................................................................................................... 5

Blood Tests ....................................................................................................................................... 5

Urine Tests ....................................................................................................................................... 5

Epidemiology ................................................................................................................................................ 6

Identified Risk Factors for CKDu ................................................................................................................. 6

Occupational Risk Factors .............................................................................................................. 6

Environmental Risk Factors ............................................................................................................ 7

Pharmaceutical Risk Factors ........................................................................................................... 7

Behavioral Risk Factors .................................................................................................................. 8

Healthcare System Structure in Chichigalpa, Chinandega ........................................................................... 8

Systemic Issues That Compromise Quality of Patient Care ......................................................................... 9

Physician Protocols for CKD/u Diagnosis and Treatment .............................................................. 9

Absence of Provider Education: A departure from standard methods of diagnosis and patient education 10

Barriers to Patient Care ............................................................................................................................... 11

Transportation Barriers ................................................................................................................. 11

Renal Replacement Therapy Barriers ............................................................................................ 11

Medical Services Capacity at the JD Health Center ................................................................................... 13

Infrastructure ................................................................................................................................. 13

Organization of Health Service ..................................................................................................... 13

Equipment and Supplies ................................................................................................................. 15

The CKD Task Force .................................................................................................................................. 15

CKD Task Force Staff Support ...................................................................................................... 16

Task Force Members ...................................................................................................................... 16

The Division of General Health Services ....................................................................................... 17

The Division of Financial Administration ..................................................................................... 17

The Division of General Medical Supplies .................................................................................... 17

The Division of Procurement for Medicines .................................................................................. 18

The National Diagnostic and Reference Center ............................................................................ 18

The Division of Teaching and Research ........................................................................................ 18

Hospital Directors ......................................................................................................................... 18

Clinic Managers ............................................................................................................................ 19

SME’s ............................................................................................................................................. 19

Preliminary Planning ..................................................................................................................... 19

Initial Meeting and planning ......................................................................................................... 19

Moving Forward ............................................................................................................................ 20

Conclusion .................................................................................................................................................. 20

Bibliography ............................................................................................................................................... 21

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GLOSSARY

1. ADP - Automatic Peritoneal Dialysis

2. ANF - The American-Nicaraguan Foundation

3. CAPD - Continuous Ambulatory Peritoneal Dialysis

4. CAO - The Office of the Compliance Advisor/Ombudsman

5. CKD – Chronic Kidney Disease

6. CKDu – Chronic Kidney Disease of Unknown Causes

7. CKD/u – Chronic Kidney Disease and Chronic Kidney Disease of Unknown Causes2

8. DGFA - The Division of General Financial Administration

9. DGHS - The Division of General Health Services

10. DGMS - The Division of General Medical Supplies

11. DPM - The Division of Procurement for Medicines

12. DTR - The Division of Teaching and Research

13. GFR - Glomerular Filtration Rate

14. HD - Hemodialysis

15. HEODRA - Hospital Escuela Oscar Danilo Rosales Argüello

16. IFC - the International Financial Corporation

17. JD - The Julio Duran Health Center

18. MIGA - Multilateral Investment Guarantee Agency

19. MINSA – El Ministerio de Salud

20. MOH – Ministry of Health

21. NDRC - The National Diagnostic and Reference Center

22. NSAIDs - non-steroidal anti-inflammatory drugs

23. PD – Peritoneal Dialysis

24. SMEs – Subject Matter Experts

2 CKD/u is used in instances where the context applies to both CKD and CKDu patients.

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Date : November 28th, 2016

To :El Ministerio de Salud (MINSA), Nicaragua

From : Mireille Levy

Boston University School of Public Health MPH Candidate

RE : An analysis of the gap between available healthcare services and deficiencies in care and treatment

among patients with Chronic Kidney Disease in Chinandega and León, Nicaragua

Introduction

A rise in the incidence rate of Chronic Kidney Disease of unknown causes (CKDu) in Chinandega,

Nicaragua over the past decade have resulted in increases in patient demand for specific services and treatment

beyond what the government is able to sufficiently provide thus undermining the quality and accessibility to care

and treatment for patients with CKDu. Key initiatives by Nicaragua’s ministry of health (MOH), MINSA, to

address this issue, such as the development of the Norma y Protocolo Para El Abordaje De La Enfermedad Renal

Crónica, a medical provider protocol document for early detection, treatment and management for patients with

CKD/u and by building sub-clinics that specializes in CKD/u in high impact areas have fallen short of meeting

patient demand for care and treatment and ensuring that patients are receiving quality care in Chinandega and

León. Reasons for this is primarily due to resource shortages, lack of programming and poor implementation

strategies by MINSA and sub agencies.

The purpose of this paper is to discuss systemic issues that compromise the quality of patient care, the

economic impact of CKDu on Nicaragua’s healthcare system, medical resource shortages and patient barriers to

care in the most affected areas. Additionally, a policy recommendation is provided to offer an approach to address

these areas of concerns as a Public Health community in the departments of Chinandega and Léon, Nicaragua.

Information used to write this paper is from a literature review, an in-depth interview with a medical doctor

employed at the Hospital Escuela Oscar Danilo Rosales Argüello (HEODRA), multiple needs assessment reports,

and government documents published by the Nicaraguan Ministry of Health (MOH), MINSA.

Chronic Kidney Disease (CKD)

CKD is progressive loss of kidney function over time. The primary function of the kidneys are to remove

waste product from the blood. Urine created during this process is collected in the kidney, transported to the

bladder and excreted from the body [13]. Each kidney has several renal pyramids which contain a renal medulla

composed of about a million nephrons. Each nephron includes a glomerulus which is a microscopic blood filter.

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Damage to the glomerulus results in a lower filtration rate [15]. The National Kidney Disease Foundation defines

chronic kidney disease as either Glomerular Filtration Rate (GFR) <60 mL/min/1.73 m2 for ≥ 3 months [15].

Standard Methods of CKD Diagnosis

Bio-markers of kidney damage can be identified through blood tests, urine tests, diagnostic imaging or

kidney biopsy [13]. Calculating a patient’s GFR is the standard method for diagnosing a patient with CKD

however other tests should be conducted and compared to detect CKD.

Blood tests

A rapid creatinine test is normally conducted to determine kidney function because it is used to calculate

GFR. When damaged the kidneys cannot remove the body’s load of creatinine from the blood and the level in the

blood rises. Normal creatinine levels range from .5-1.21, this includes ranges for both males and females. A

creatinine test result higher than 1.21 may indicate kidney disease, acute kidney failure or other conditions such

as dehydration, low blood volume, or a meat heavy diet. Elevated creatinine levels should be confirmed either by

a repeated rapid test or a lab test. If results continue to show an elevated level of creatinine, then other tests should

be conducted to confirm the diagnosis of kidney disease.[16].

A BUN test is another way to check how well the kidneys are functioning by measuring the amount of

urea nitrogen in the blood. Healthy adults have a BUN result between 7-20 mg/dL, higher levels of urea nitrogen

in blood may suggest that the kidneys are not working properly [18].

Urine tests

Another efficient method for diagnosing individuals with kidney disease in a low resource setting, like

Nicaragua, is by a multi-reagent dipstick urine test to examine uric acid and albumin. Uric acid is produced from

broken-down cells and other purines and passes from the body during urination. Normal values range from 250

to 750 mg per 24 hours and low levels may indicate that the kidneys are unable to filter uric acid from the body

causing the substance to be retained in the blood stream.

Additionally, albumin can detect kidney disease. An excess amount of albumin in urine is called

albuminuria and indicates that the kidneys are leaking large molecules into urine, however albuminuria also

occurs in individuals with long-standing diabetes, usually type I, hypertension or a recent episode of high level

activity, such as labor intensive work common among young men in rural Nicaragua [22].

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Based on recommendations by the Clinic Reference Laboratory and the National Kidney Foundation, creatinine,

BUN, albumin and uric acid results should be compared and if each result is abnormal, then there is a high

probability that kidney function is impaired [14]. Additionally, it is recommended that an ultrasound be conducted

for differential diagnosis and to assess disease progression, if present, as a supplement to a patient’s GFR.

Epidemiology

Several case reports and published research studies over the past two decades indicate that an epidemic of

CKDu is occurring among agriculture communities in Nicaragua [1,3-11,23-24]. Information generated from

these studies suggest that patients share common demographic characteristics; this condition primarily affects

young males working in agriculture and who live along the pacific coast [1-5,7-9, 23-24] A community prevalence

study conducted among males working in pacific coastal areas in Nicaragua found an estimated CKDu prevalence

of 13.8% [5].

CKDu community prevalence studies have largely been focused in the department of Léon and Chinandega; the

areas with the highest CKDu prevalence in Nicaragua [3, 5-6]. The mortality rate among males age 35-55 years

in Chichigalpa, Chinandega is about five times as high as the national mortality rate [23]. La Isla Foundation, a

non-profit policy and research group reported that between 2002-2012, 75% of deaths among males age 35-55

years in Chichigalpa, Chinandega was due to CKDu [23]. In 2007, the mortality rate of CKD was 5.3 and 5.2 per

10,000 residents in Léon and Chinandega respectively [3]. Between 2004 and 2010 the total number of newly

registered CKD/u cases in the same community rose from 799 to 2,073 cases indicating an average increase of

212 new cases per year [3]. Among the 2,073 registered patients, 9% (183) are stage 0, 16% (332) are stage 1,

21% (428) are stage 2, 35% (726) are stage 3, 14% (291) are stage 4, and 4% (85) are in stage 5 [3].

Identified Risk Factors for CKDu

Several assessment studies conducted in Chinandega and Léon suggest an association between the

development of CKDu with behavioral, environmental, pharmaceutical and occupational exposures [1-4,6-13];

though the true cause of CKDu remains unknown there are several hypothesized risk factors by exposure category.

Occupational risk factors

Mortality data and community prevalence studies found that CKDu occurs primarily among young men

who work in farming. Prolonged exposure to heat and a heavy workload in combination with excess volume

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depletion and dehydration among agriculture workers are considered to be risk factors for CKDu [9]. Sugar cane

workers comprise the majority of patients with CKDu, although cases have been reported among miners,

construction workers and bricklayers [4, 9, 23-24].The departments of Chinandega and Léon, those with the

highest prevalence and mortality rate of CKDu, also host the country’s largest sugar cane plantation and are the

area’s largest employer [1,3,5-6, 23]. Individuals employed to either plant seeds or apply agrichemicals are also

at an increased risk for developing CKDu compared to workers who drive trucks or sort harvested crops on the

same farm [24]. One report found that nearly 70% of sugarcane workers in Chinandega developed CKDu [24]. A

study conducted by Raines et al. assessed potential risk factors associated with agricultural work. Age and sex

adjusted binomial logistic regression analysis of reduced GFR, measured as <60 mL/min/1.73 m2 found that the

odds of developing CKDu among men who indicated >365 lifetime days of harvesting crops were 431% more

than among men who reported less than 365 lifetime days of harvesting crops. (OR 4.31, 95% Cl 1.76-10.52).

Moreover, the odds of developing CKDu among men who reported any lifetime history cutting sugarcane during

the dry season were 586% higher than men who have never cut sugarcane during the dry season (OR 5.86, 95%

Cl 2.45-14.01).

Environmental risk factors

Exposure to heavy metals through contaminated surface dirt and drinking water, pesticides and

agrichemicals have been investigated in several studies. Exposure to pesticides when harvesting personal crops

for consumption and resale is also common among residents in rural communities [1, 8, 24]. A study conducted

by Raines et al assessed exposures to CKDu as potential causal mechanisms found that men who reported inhaling

pesticides from either work or personal use have a 331% higher odds of developing CKDu compared to men who

are not exposed to pesticides in the form of aerosols (OR 3.31, 95% Cl 1.32-8.31).

Pharmaceutical

Chronic and over prescribed use of non-steroidal anti-inflammatory drugs (NSAIDs) are included in the

list of hypothesized risk factors for CKDu [9, 11]. 19 Semi-structured interviews conducted with physicians and

retail pharmacies found that farm workers often suffer from chronic back and muscle pain. These workers

regularly visit their local pharmacy to purchase medications for pain relief. Prescriptions for NSAIDs are not

required in Nicaragua and these medicines are considered to be affordable by residents. A review of median

prices for two frequently consumed NSAIDs in Nicaragua from a WHO/HAI survey conducted in 2008 (adjusted

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for 2016 inflation) reported private sector consumer prices for both Ibuprofen 400mg cap/tab and Diclofenac

50mg cap/tab to be 0.11 USD. Even with a salary of 3-5 USD per day, NSAIDS to treat pain as a result of

strenuous working conditions is considered to be affordable to local residents and may be subject to abuse. In the

public sector, patients at health facilities receive NSAIDS at no charge.

Behavioral risk factors

Alcohol consumption and fructose intake are additional risk factors that have been investigated in multiple

research studies that relate to behavioral exposures [10, 11].A study conducted by Raines et al. assessed potential

risk factors associated with sugar consumption and traditional risk factors for renal failure among individuals with

an occupational history in agriculture. Age and sex adjusted binomial logistic regression analysis of reduced GFR,

measured as <60 mL/min/1.73 m2, found that participants who identified as being a male (OR 6.1, 95% Cl 2.34-

18.74), indicated current or past alcohol consumption (OR 3.25, 95% CI 1.36-7.85) and/or cane chewing (OR

3.24, 95% Cl 1.39-7.58 ), had a significantly higher odds of being diagnosed with CKDu compared to participants

who did not share these characteristics. CKDu is considered to be an unknown type of renal failure primarily

because it does not share the same etiological factors as patients with reduced GFR in developed countries such

as the United States.

In traditional CKD, males and females have similar odds of developing this disease and individuals are

more likely to be diagnosed as they grow older. Further, renal diseases tend to occur in patients who present with

hypertension and diabetes mellitus type II. However, Raines et al. measured hypertension and diabetes among

their participants as an independent variable and found both these characteristics to be an insignificant contributor

to CKDu among the participants in their study [8].

Healthcare System Structure in Chichigalpa, Chinandega

Primary and secondary services for care and treatment of CKD/u are provided free of charge to patients

by MINSA [3]. Chichigalpa is the largest town in Chinandega with a total population of about 46,455, of which

26% live in rural areas. A total of 10 health centers serve about 8,166 people while the rest are served at health

posts.

The Julio Duran (JD) Health Center in Chichigalpa provides primary care services for CKD patients while

secondary medical services are available at Hospital España in Chinandega and at HEODRA in Léon. Local

residents account for 90% of registered cases while the remaining resides in other departments.

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Systemic Issues that Compromise Quality of Patient Care

Physician Protocols for CKD/u Diagnosis and Treatment

A major issue that clinicians continue to face is a lack of protocols for evaluating, diagnosing, and

monitoring patients with CKD/u. Several reports and discussions with medical providers prior to 2009 mentioned

that until a set of treatment guidelines are published by MINSA, patients will continue to be managed based on

different criteria determined by individual general physicians [3]. In 2009, MINSA published their first rules and

protocol guidelines for clinicians on the prevention, collection, and management of patients with CKD. This

guideline essentially acknowledges CKD as a serious public health issue, outlines the epidemiology of this disease

in Nicaragua, and standardizes medical definitions, formulas for calculating GFR, and test result ranges related

to CKD/u. Also included are protocol compliance indicators for data collection, prevention and management of

CKD, standardized forms to record patient information and tests results, and formal protocols for diagnosing

patients with CKD/u. The guideline also provides guidance on determining disease stage, standardized follow-up

periods, including a detailed plan of action for each follow up appointment by disease stage, and CKD risk factors

depending on the patient’s health status [6].

Despite their criticism of a lack of coordinated effort to integrate a CKD protocol into their healthcare

system, providers are not using MINSA’s protocol guideline to diagnose, treat and monitor patients with CKD/u.

The main reasons for poor compliance among medical providers are due to a lack of awareness that a protocol is

available, deficiencies in education for medical providers about diagnostics methods, patient monitoring and care

coordination for patients with CKD, geographical displacement, poor compliance monitoring by MINSA, and a

primarily older physician population3.

Specifically, providers are not aware that a protocol has been published because the protocol guideline is

only available online and must be downloaded and printed in order to disseminate it around a health clinic and

MINSA has not distributed the protocols to medical providers at clinics that serve patients with CKD4. This is a

barrier to providing quality care because most healthcare centers do not have a computer and printer on site and

the number of people who have laptops or desktop computers at home remains low in Nicaragua; consequently,

access to electronic information continues to be an issue.

3 Results from an IDI conducted with a medical doctor employed at HEODRA in León, Nicaragua 4 Results from an IDI conducted with a medical doctor employed at HEODRA in León, Nicaragua

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In terms of geographical displacement, providers who care for CKD/u patients in rural areas don’t have

access to reliable or new information related to CKD5. One major reason is because medical doctors in rural areas

tend to be older and do not have the technical capacity to visit the protocol online and are unwilling to change the

processes that they have been using to diagnose and monitor patients with CKD/u in their respective health clinic6.

Absence of provider education: A departure from standard methods of diagnosis and patient education

Medical providers in the areas most affected, prevalence >10% in the Department of Chinandega, are not

receiving training specifically for CKD/u or on the protocol guideline resulting in a departure from standard

methods of diagnosing patients with CKD and deficiencies in patient education for personal care and treatment7.

In Nicaragua, blood and urine tests are primarily used to diagnose patients with CKD because it is less

costly than diagnostic imaging or a biopsy. Providers in primary care clinics containing a sub-clinic specifically

serving CKD patients are relying on two rapid creatinine tests taken at two points in time to determine if a patient

presents with CKD. Additionally, some providers are not measuring and comparing other indicators of CKD such

as BUN or Albumin nor calculating GFR8. Some medical providers are also unaware that they have to monitor

patients who either have an elevated creatinine level or a GFR between 60-90mL/min/1.73 m29. The major

problem with this type of diagnosing method is that creatinine levels may change for a variety of reasons other

than kidney failure, such as strenuous labor which is common among male farmers in Nicaragua. The standard

definition for CKD, including staging of the disease is based on a patient’s GFR. Therefore, patients who present

with elevated levels of creatinine may be misdiagnosed with CKD if their GFR is not calculated or/and if the

physician does not conduct other tests that indicate CKD. Additionally, without calculating a patient’s GFR or

using diagnostic imaging, it’s unlikely that a physician will know the stage of disease progression.

Additionally, the lack of CKD training to medical providers undermines the quality of care and treatment

education to their patients. Education provided to diagnosed patients generally consist of a few general tips such

as to reduce salt intake and to drink cool liquids.10 The absence of education specificity during consultation and

supplemental materials to take home contributes to a patient’s lack of awareness about their condition and

5 Rural clinics rarely have internet connection and therefore rely on MOH outreach and provider-to-provider updates on published information 6 Results from an IDI conducted with a medical doctor employed at HEODRA in León, Nicaragua 7 Results from an IDI conducted with a medical doctor employed at HEODRA in León, Nicaragua 8 Results from an IDI conducted with a medical doctor employed at HEODRA in León, Nicaragua 9 Results from an IDI conducted with a medical doctor employed at HEODRA in León, Nicaragua 10 Results from an IDI conducted with a medical doctor employed at HEODRA in León, Nicaragua

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compromises their ability to appropriately care for themselves to reduce disease staging. For instance, some

patients diagnosed with stage 5 renal failure do not enroll into dialysis because they are unaware of the severity

of their condition and do not perceive that their need for renal dialysis to be urgent11.

Barriers to patient care

Patients are only referred to a hospital when they are diagnosed with stage 5 kidney failure and require

dialysis therapy in order to survive. The cost of dialysis is covered entirely by MINSA 12[4], however patients

often do not receive dialysis treatment because of transportation barriers, medical supply shortages at the hospital,

and lack of information provided to them about their condition.

Transportation barriers

As of 2011, Hospital España has already reached their capacity to provide dialysis, so the remaining

patients must visit HEODRA in León [3]. Taxi services from Chichigalpa to HEODRA in León cost about $800

Córdoba or $26 USD round trip. By bus the trip requires four buses for a total of $70 Córdoba or $2.50 round

trip. Bearing in mind that an average daily income for a farmer in this area is between $2-$5 USD, cost of

transportation is a barrier to treatment, especially if they are required to receive dialysis 3 times a week13.

Renal replacement Therapy barriers

A medical needs assessment report of the Chichigalpa health center was conducted in 2010 that identified

poor and limited infrastructure, lack of trained personnel, shortage of dialysis supplies, lack of functioning

equipment, and insufficient funding sources from the government to pay for patient’s treatment costs to be the

primary barriers to patient access to dialysis. Peritoneal dialysis (PD) is the most common type of dialysis

treatment in Nicaragua because it is the least expensive option, though not necessarily affordable for the

government to cover.

For patients diagnosed with stage 5 renal failure, either a kidney transplant procedure or renal replacement

therapy, such as peritoneal or hemodialysis is required for the patient to survive.

11 Results from an IDI conducted with a medical doctor employed at HEODRA in León, Nicaragua 12Results from an IDI conducted with a medical doctor employed at HEODRA in León, Nicaragua 13This information was obtained from 2 farmers in Chinandega and the MD employed at HEODRA

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The cost of PD treatment is very costly for the government to cover [4]. In 2010, the initial cost of PD

catheters were US$600 plus US$900 a month per patient for treatment supplies and equipment totaling at about

$11,400 USD annually in a country that budgets to spend $445 on healthcare services and medication per capita

a year. Lastly, unpredictable shortages of essential supplies such as functioning equipment, dialysis fluid, and

other materials commonly occur within the Chichigalpa healthcare network, which contribute to patient barriers

to life saving treatment [3].

In contrast, HEODRA is able to provide nearly unlimited PD services to patients because they have a

contract with Baxter, a private international dialysis supply company. Moreover, Baxter trains nurses and doctors

at HEODRA on how to appropriately care for CKD patients and operate PD machines; this agreement is strictly

between Baxter and HEODRA, not with the Ministry of Health. Additionally, HEODRA also receives dialysis

supplies from The American-Nicaraguan Foundation (ANF). The problem is that these agreements do not service

the overall Public Health issue of CKDu, which are occurring among low-income and rural male farmers. For

instance, in 2010, HEODRA was providing PD treatment to 50 patients but only 10 were farmers while the

remaining were urban dwelling diabetic women [3]. Further, HEODRA is located in the city of Léon, about 1.5

hours from Chichigalpa by car and nearly twice as long by public transportation, further alienating those who

reside in Chinandega and need treatment the most.

Hemodialysis (HD) is another treatment option for individuals with stage 5 renal failure. It removes waste

products and free water from the blood and requires advance medical equipment, costly reagents, an outpatient

facility, specialized nursing and technical staff in order to provide quality treatment to patients and to ensure that

machines are calibrated. Patients with CKD stage 5 require 3-4 hour sessions 3 times a week. The cost of HD is

about $9,000 per patient annually in HEODRA and thus prohibitively costly for the government to cover based

on the national budget for health expenditure. Moreover in 2008 Hospital España, in Chichigalpa, received a

donation of 8 new HD machines but this health facility is not equipped with a cold storage room for supplies nor

an outpatient facility, therefore they are unable to provide any HD treatment to their patients [3].

Based on the results from a needs assessment report, it would make more sense from a financial

perspective for hospitals to cease PD dialysis and switch to HD dialysis therapy. The primary advantage, is that

Nicaragua’s healthcare system may save an average of $2,400 USD per patient annually when services with HD

dialysis compared to PD dialysis.

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Medical Services Capacity at the JD Health Center:

The Office of the Compliance Advisor/Ombudsman (CAO) is a group committed to responding and

resolving complaints by individuals, groups of people or organizations affected by projects conducted by the

International Financial Corporation (IFC) and Multilateral Investment Guarantee Agency (MIGA); essentially the

CAO promotes social and environmental accountability of IFC and MIGA. A medical needs assessment report

conducted by CAO evaluated the infrastructure, organization of health services, equipment and supplies related

to the ability to treat and monitor CKD/u patients in the department of Chinandega. The majority of CKD/u

patients in Chichigalpa receives their primary medical services form the Julio Duran Health Center; publically

funded by MINSA. As of 2010, the health center in Chichigalpa did not have sufficient amount of space, supplies,

equipment or personnel to meet the medical demands of their community residents including CKD/u patients.

Medical providers from this health center mentioned that a hygienic, comfortable, staffed and spacious

environment is necessary to deliver safe and quality medical care [1, 3].

Infrastructure

The JD health center consists of a small waiting room and two modest consultation rooms staffed by two

physicians. The waiting room was built to accommodate 15 patients, however there are usually about 40 patients

waiting to receive services at any point in time. The waiting room is not air conditioned, which may cause

discomfort for patients and pose additional risks for CKD/u patients. Patients, including those with CKD/u, are

examined and treated openly in front of other patients, compromising privacy and patient confidentiality. In

regards to unstable CKD/u patients, the JD health center has a small observation room but consists of only two

beds. Additionally, the clinic lacks a room to conduct care coordination services, health education discussions

for patients with chronic illnesses, and provider training and education sessions [4].

Organization of health service

CKD is a progressively fatal disease that requires early detection, monitoring, health education, and

medical treatment to prolong and improve the quality of life for a patient. In order to achieve this goal, the health

clinic needs to have a sufficient number of trained personnel, a feedback system for monitoring and evaluating

the quality of services, ancillary services, a stocked pharmacy, patient counseling services and other informational

resources [3].

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As of 2010, the JD consisted of a small CKD clinic staffed by a single nephrologist and an internal

medicine physician whom are responsible for providing treatment and monitoring services for about 2,073 known

registered CKD patients. The CKD clinic provides services from 8:00 am - 3:00 pm Monday-Friday which

includes 1 hour dedicated only to administrative responsibilities. Together these physicians consult about 700

CKD/u patients per month or 40-50 CKD/u patients per day [3]. Consequently, each patient only spends a few

minutes with a physician, an insufficient amount of time for a complex chronic disease that requires consultation

on medication and nutrition, blood and urine tests for monitoring disease progression, discussion of associated

signs and/or symptoms and a primary physical. Moreover, dietary and other type of counseling services such as

health education are necessary for CKD patients, especially for those who are in the later stages of the disease.

The JD Health Center does not have a nutritionist or a social workers on site; therefore CKD patients must seek

ancillary services at Hospital España in Chinandega. Patient appointments are scheduled based on creatinine

levels and care is limited after normal operating hours which is especially dangerous for CKD/u patients who are

either unstable or at the later stages of the disease. Some medical doctors disagree with this mechanism for

organizing medical appointments because several other factors can influence the result of a rapid creatinine test,

such as recent use of medication, high level activity or dehydration, which is common among residents of rural

communities [3].

Additionally, the availability of palliative services for CKD patients, especially those who are in stage 5,

is also concerning as the JD Health Center and most health facilities in Nicaragua completely lack a palliative

care program. Palliative programs are essential for the continuum of care as it providers physical and emotional

support to alleviate pain and suffering for both the patients and their families through the dying process. Currently,

the demand for palliative programs is low among patients and medical providers primarily because other priorities

have been set, lack of patient awareness about the disease and the meaning of palliative care remains low in

Nicaragua [3].

Another essential feature for evaluating the organization and quality of healthcare services are feedback

systems. Feedback systems monitor and evaluate the capacity of the healthcare facility, health staff availability

and quality of care provided to the patient by the provider. It can also identify problems in the delivery of care in

order to take effective corrective action. Feedback systems guided by a set of protocols, such as those produced

by MINSA in 2009, are useful to reduce medical complications, improve health outcomes, and increase the quality

of healthcare services while minimizing costs. In regards to CKD, a clinical feedback system can address

problems that patients have specifically mentioned such as scheduling availability, short appointment times,

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medication and reagent shortages, and low patient satisfaction based on the quality of care they receive. To the

knowledge of both the medical doctor that was interviewed and the assessment reports that were reviewed,

MINSA has not implemented a feedback system between rural clinics, community health centers and hospitals to

monitor and refer CKD/u patients to other health facilities.

Equipment and supplies

The JD Health Center medical needs assessment conducted by CAO also analyzed equipment and

materials required to properly treat CKD/u patients. Although the JD Health Center is sufficiently supplied with

staffing and administrative materials, the report indicated a serious shortage of medical supplies and equipment

required to monitor patients or test those that present with symptoms and characteristics of CKD/u. For instance,

diagnostic reagents and a small refrigerator to store urine and blood samples were missing. Reagents are a

component to diagnosing patients with CKD while blood and urine samples must be stored in a refrigerator unless

they are processed within an hour14, else the samples will be compromised and will likely yield incorrect test

results.

Another issue the health center faces is the inability to provide emergency treatment for CKD/u patients

if necessary. According to the needs assessment report, the health center needs an EKG machine, an oxygen

delivery system, respirator, manometer, and a separate stock of emergency medications to provide emergency

services to unstable patients. These supplies are not available at this clinic and the pharmacy closes at 4:00 pm

during the week and is closed on weekends [3]. Therefore, unstable CKD patients who require emergency

attention must travel to either Hospital España or HEODRA and may be charged for ambulance fuel expenses,

which is an additional barrier to care and illegal15.

The CKD Task Force

To improve provider compliance of the CKD protocol guideline and to recognize and work to address areas

of unmet healthcare need among patients with CKD/u, I recommend that MINSA create a stakeholder task force

to plan, organize and monitor the following initiatives in Chinandega and León:

14 Urine should be processed within an hour if not stored at 39o F. Time to process blood if not sored in a refrigerator depends on blood type. 15 Fuel expenses charged to the patient was mentioned in the needs assessment report and confirmed by MD that was interviewed for this paper.

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1. Disseminate, train and improve compliance of the protocol guideline Norma y Protocolo Para El

Abordaje De La Enfermedad Renal Crónica or the Rules and Protocols for Approaching Chronic Renal

Disease in Chinandega, the area with the highest prevalence, incidence and death rate of CKDu.

2. Identify areas of unmet need, such as those mentioned above, and provide recommendations that

addresses those needs to improve the quality of care among patients with CKD/u.

The CKD task force’s intended primary outcomes include an increase in early detection rates, a reduction

in death rates of CKD through improved patient monitoring methods, provider compliance on the CKD protocol

guideline to achieve standard diagnostic methods across providers in high prevalence areas, and recognition of

major and minor medical and non-medical areas of unmet needs among patients with CKD and CKDu. These

objectives should be executed through the provision of informed recommendations to MINSA by the Task Force

members, or stake holders, and subject matter experts (SMEs).

CKD Task Force Staff Support

Implementing the task force requires administrative staff support to organize meeting locations, manage

updates, audio record the meetings, draft meeting minute notes, and supply administrative materials to task force

members and SMEs (agendas, writing utensils, and reports). Reports from respective members should be given

to the Task Force Staff Support team to manage and send out to other members. Ultimately, the task force staff

support is responsible for coordinating and managing the task force meetings, administrative materials and

correspondences among members. This team is critical to ensuring that the Task Force is well organized and able

to properly operate under changing circumstances among several stakeholders. Failure to properly organize a task

force and manage its cohesiveness through logistical and administrative planning can cause the initiative to

collapse early on and waste valuable resources in an already low-resource setting like Nicaragua.

Task force members

I recommend that MINSA officials draft a preliminary list of task force members to represent stakeholders

of this epidemic and SMEs to provide expert knowledge or technical assistance that facilitates informed

recommendations by members in Chinandega and León.

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MINSA can draft a stakeholder and a SME member list to contact and invite them to be a member of the

task force. I recommend that the following agencies should have representation on the task force, but to not limit

the number of agencies on the taskforce. 16

The Division of General Health Services (DGHS)

The DGHS is responsible for conducting needs assessment reports, collecting and presenting data to

stake holders, and developing strategy reports and protocol guidelines for health clinics [25]. A member from

this division can serve to help strategize how the protocol guideline is implemented to both urban and rural

health clinics.

The Division of Financial Administration (DGFA)

The DGFA is responsible for developing Nicaragua’s annual healthcare budget, allocating funds to health

facilities and monitoring health expenditures, among other duties [25]. Representation from the DGFA will help

direct the type of recommendations made based on available funds and willingness to change budget allocations

where needed by the DGFA.

1. Lic. Sergio Guerrero – Director

The Division of General Medical Supplies (DGMS)

The DGMS is responsible for managing the supply chain system for medical supplies in Nicaragua.

Their primary responsibilities are managing logistics and overseeing rational use of medical supplies. They

gather supply consumption information from health units to analyze the prescription, dispensing and use of

medical supplies. Further, they work to identify opportunities for improvement to implement recommendations

that optimize the use of medical supplies [25]. This paper mentions dialysis and other medical supply shortages

at specific clinics in Chinandega as a gap in medical care for CKD patients. Representation from this division

raises awareness to this issue and members can provide directed input for recommendations made to address

this issue.

16 Task force member names were obtained from the official Nicaragua Ministry of Health website at http://www.minsa.gob.ni/index.php/directorio

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The Division of Procurement for Medicines (DPM)

MINSA works with the Division of General Procurements for Medicines who works with the Division

of Planning and Tracking Contracts and the Contracting Division to negotiate prices and purchase medicines

[25]. Medicine supply shortages data provided from medical needs assessment reports, health clinics and the

DGHS can be delivered to members of the DPM to encourage additional procurement of medicines for patients

with CKD as needed.

The National Diagnostic and Reference Center17 (NDRC)

The NDRC is responsible for handling confirmatory lab requests by smaller health clinics, to educate

health authorities, and guide laboratory directors and technicians to identify responsibilities and functions of

laboratory services. Further, they take into account priorities, needs and the local capacity of a health clinic to

conduct laboratory testing [25]. Representation by the NDRC will help to facilitate logistical planning and

implementing the portion of the CKD Protocol Guide that covers standardized diagnostic methods.

The Division of Teaching and Research (DTR)

The DTR is responsible for providing continuing education for providers, hospital management

education and social services for patients [25]. The division has published a series of continuing education

modules for providers but CKD is not among them. Representation from this division will assist in strategizing

how to implement continuing education on CKD for general physicians working at clinics in Chinandega and

León.

Hospital Directors

Patients who require dialysis services and treatment for disease complications are referred to a hospital for

care [3]. Needs assessment and other reports have indicated a dialysis supply shortage, a treatment necessary for

survival among patients with stage 5 CKD [3]. Hospital directors or their representatives are an important

stakeholder in regards to addressing treatment shortages as a care gap for patients with CKD. Their presence

will help the task force committee plan recommendations to address these issues that incorporate the needs and

perspectives of hospital directors or managers who have the authority to implement recommendations. Further,

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buy-in from hospital directors will be crucial for implementing a continuous training program on the CKD

protocol guidelines for providers in large hospitals. Below is the list of hospital directors.

1. Gaviota Sandoval Rodríguez - Hospital España

2. Dr. Ricardo Cuadra Solórzano – Oscar Danilo Rosales

3. Dra. Vera Mercedes Orozco Iglesias – Rosario Lacayo

Clinic Managers

Clinic administrators or managers from clinics that serve a large number of CKD patients in Chinandega

and León should be members of the task force as they are the front line care givers for patients with CKD. Input

from this group will facilitate the development of realistic recommendations and improve the likelihood that a

recommendation is successfully implemented in their respective clinics.

SME’s

SMEs serve the role of providing technical assistance and help inform recommendations to the task

force. An Epidemiologist specializing in kidney or Chronic diseases, a Nephrologist, and a health educator

should be included in the task force, but additional SMEs can be included depending on the need of the task

force. These members can be appointed by MINSA and asked to present at the first meeting.

Preliminary Planning

MINSA members should meet to discuss task force objectives and to develop a flexible timeline for the

taskforce (i.e. beginning to approx. end date). Task force member selection from each stakeholder group to be

the representative to the task force should also take place during this planning phase. Ideally, several members

from each stakeholder group are given the task force’s purpose, objectives and a formal invitation to participate

with the understanding that a number of invitees will decline the request.

Initial Meeting and Planning

Ideally, The CKD Task Force’s initial meeting should be attended by influential members of MINSA to

encourage awareness about the task force and demonstrate a sense of urgency towards the CKD epidemic in

Chinandega and León. Additionally, it would be ideal to have all meetings open to the public including a brief Q

& A session to allow members of the affected community or other individuals to softly participate. The initial

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meeting can be an introduction to the purpose and objectives of the task force and include presentations from

SMEs and MINSA about the epidemic to further familiarize stakeholders about the issue at hand and where they

fit in terms of addressing those objectives. Additionally, documents outlining specific objectives by MINSA to

address the two major objectives should be given to members of the task force.

Moving Forward

The remaining taskforce meetings should primarily be recommendation and implementation meetings.

Stakeholders should discuss their role and level of contribution to either or both objectives of the Task Force.

Planning meetings between staff support and MINSA should be conducted between The CKD Task Force

member meetings to review meetings minutes, delegate data and other type of requests between members, and

handle other logistical aspects of the CKD Task Force to improve the efficiency of each member meeting.

Conclusion

Over the past 6 years, the MOH, INSS and other health organizations such as non-profits and academic

institutions have responded to the increasing epidemic of CKD, both known and unknown causes, along the

pacific coastal regions of Nicaragua. Nicaragua has nearly doubled their per capita health expenditure from $232

USD in 2010 to $455 USD in 2016 and they have developed and released protocol guidelines for the detection,

treatment and monitoring of chronic kidney disease. However, there continues to be areas of weakness regarding

protocol implementation and provider compliance, equipment and supply shortages, medical provider education,

and patient awareness about chronic kidney disease. Several non-profit organizations have donated medical

equipment and supplies to healthcare facilities, such as the 8 HD machines to Hospital España, but this facility

lacks additional materials needed to expand their capacity to deliver renal replacement treatment. Additionally,

health clinics in general often experience shortages in reagents, other supplies and fuel for transportation.

Academic institutions, such as Boston University, have worked with several other groups to conduct

epidemiological studies, both cross sectional and longitudinal, to better understand the development of this

particular type of kidney disease and to offer technical assistance to MINSA, CAO and other organizations in

Nicaragua.

Medical provider non-compliance to a CKD protocol guideline, gaps in medical need and health

disparities among CKD patients is largely a systemic problem coupled with resource shortages in Nicaragua’s

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healthcare system. Addressing these issues require a collaborative and organized effort among MINSA agencies,

SME’s and members of the affected community. A CKD Task Force comprised of MINSA sub agency members,

SMEs, and members of the affected community is likely to raise awareness to the issues at hand. Moreover,

concerted efforts by staff support, MINSA, members and SME’s may generate realistic recommendations on how

to disseminate, train and improve compliance of the CKD protocol guideline to providers and address identified

areas of unmet need among patients with CKD/u.

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