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Haiti Community Health Workers (CHW) Adaptation

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Haiti
Study Type
Interventional
Intervention
HF follow up care
HF Standard of Care (SOC)
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure focused on measuring Community health worker (CHW), ADAPT-ITT, Haiti

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria for patient participant:

  • Adult HF patients
  • Hospitalized >48 hours at Hôpital-Universitaire de Mirebalais (HUM)
  • Anticipated discharge from HUM within 1-3 days
  • Living in Mirebalais Commune, Haiti Inclusion criteria for historical patient reference group
  • Adult HF patients
  • Hospitalized >48 hours at HUM
  • Discharged from HUM within the 12 months preceding the intervention
  • Living in Mirebalais Commune

Exclusion Criteria for patient participant and historical patient reference group:

  • None

Inclusion Criteria for CHW

  • Adult
  • Provide inpatient or outpatient care to HF patients
  • Working in in Mirebalais

Exclusion Criteria for CHW

  • None

Inclusion criteria for healthcare staff (provider/administrator)

  • Hospital leadership involved in supervision of clinical care programs (i.e. Chief Executive Officer, Chief Medical Officer, Chief Operations Officer, Chief Nursing Officer, etc.)
  • Leaders of the Community Health Department - including the nurse Director of Community Health, and Community Health Worker Supervisors.
  • Healthcare providers at HUM involved in the care of patients with heart failure (i.e. internal medicine physicians, inpatient hospital nurses, outpatient clinic physicians, outpatient clinic nurses, etc.)

Exclusion criteria for healthcare staff (provider/administrator)

  • None

Sites / Locations

  • Zanmi Lasante/Hôpital Universitaire de MirebalaisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Follow up care program for HF patients

Standard of care

Arm Description

Discharged HF patients in rural Haiti will be receive a follow-up care program delivered by trained community health workers (CHWs).

Historical reference group who received standard of care for HF identified prior to CHW training.

Outcomes

Primary Outcome Measures

Acceptability of HF follow up program to patients
Acceptability of the HF follow up program to patients will be assessed using a 5-point Likert scale response to the question "Was it acceptable to have a CHW come to your home to educate you in your heart failure care and encourage clinic follow-up?" where 1=not acceptable, 5=very acceptable.
Acceptability of HF follow up program to Community Health Workers (CHWs)
Acceptability of the HF follow up program to CHWs will be assessed using a 5-point Likert scale response to the question "Was it acceptable to have a CHW come to your home to educate you in your heart failure care and encourage clinic follow-up?" where 1=not acceptable, 5=very acceptable.
Acceptability of HF follow up program to nurses/doctors
Acceptability of the HF follow up program to nurses/doctors will be assessed using a 5-point Likert scale response to the question "Was it acceptable to have a CHW come to your home to educate you in your heart failure care and encourage clinic follow-up?" where 1=not acceptable, 5=very acceptable.
Appropriateness of HF follow up program to patients
Appropriateness of HF follow up program to patients will be assessed using a 5-point Likert scale response to the question "Were you satisfied with the CHWs interactions with you?" where 1=not acceptable, 5=very acceptable.
Appropriateness of HF follow up program to CHWs
Appropriateness of HF follow up program to CHWs will be assessed using a 5-point Likert scale response to the question "Were you satisfied with the CHWs interactions with you?" where 1=not acceptable, 5=very acceptable.
Appropriateness of HF follow up program to nurses/doctors
Appropriateness of HF follow up program to nurses/doctors will be assessed using a 5-point Likert scale response to the question "Were you satisfied with the CHWs interactions with you?" where 1=not acceptable, 5=very acceptable.
Feasibility of HF follow up program to patients
Feasibility of HF follow up program to patients will be assessed by the percent of invited eligible patients who consent to participate. The higher the percentage of consenting patients, the more feasible the program.
Feasibility of HF follow up program to CHWs
Feasibility of HF follow up program to CHWs will be assessed by the percent of invited CHWs who complete the training. The higher the percentage, the more feasible the program.
Fidelity of HF follow up program
Fidelity of HF follow up program will be assessed by the percent of home visit checklist items completed by CHWs. The higher the percentage, the greater the fidelity.
HF follow up program intervention components delivered
Assessed by the number of interventions delivered based abstracted from the home visit checklist completed by the CHWs.
Completion of scheduled visits
Assessed by the percent of scheduled visits that were completed from the CHW records.
Percent of visits with all home visit checklist items completed
Assessed by dividing the number of visits with all home visit checklist items completed by the total number of visits.

Secondary Outcome Measures

Linkage of HF patients
Percent of patients that complete 30 day follow up visit
Retention of HF patients
Percent of patients that complete 90 day follow up visit
Hospital readmission rate
Percent of patients that are readmitted to the hospital abstracted from the medical charts
Patient symptoms based on the New York Heart Association (NYHA) Classification
A New York Heart Association (NHYA) class from 1 to 4 will be assigned to each patient. The higher the classification the more serious the symptoms NYHA Classification - The Stages of Heart Failure: Class 1 - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class 2 - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class 3 - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest. Class 4 - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
Patient quality of life assessed European Quality of Life 5D (EuroQol 5D)
Quality of life of patients will be assessed with the European Quality of Life 5D (EuroQol 5D) level. ThevEuropean Quality (EQ)-5D descriptive system is a preference-based Health-related quality of life (HRQL) measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers given to EQ-5D permit to find 243 unique health states or can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
Symptoms and quality of life based on the Kansas City Cardiomyopathy Questionnaire (KCCQ)
The KCCQ will be used to assess symptoms, physical and social limitations, and quality of life in HF patients. Scores are scaled from 0 to 100 and will be summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Mortality rate in HF patients
The number of HF patients who die within 90 days following discharge will be calculated.

Full Information

First Posted
September 15, 2021
Last Updated
January 30, 2023
Sponsor
Boston Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05091710
Brief Title
Haiti Community Health Workers (CHW) Adaptation
Official Title
Pilot Trial of a Community Health Worker Intervention to Improve Heart Failure Care in Rural Haiti
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Evidence-based interventions to improve linkage and outcomes for heart failure (HF) patients requires input from stakeholders: patients, community health workers (CHWs), healthcare staff, and health system administrators. In this research the investigators will assess a CHW intervention designed to improve linkage to care for HF patients. This intervention was systematically adapted for use in rural Haiti in a prior study using the Assessment, Decisions, Administration, Production, Topical Experts, Integration, Training staff, Testing (ADAPT-ITT) framework. The ADAPT-ITT framework provides 8 sequential phases to adapt interventions and programs to new target audiences. It has been applied successfully to the adaptation of several interventions for HIV among under-resourced communities leading to randomized clinical trials. With the first 6 steps of the ADAPT-ITT framework completed in a prior study, this protocol outlines the training and testing of the adapted CHW intervention. In addition to assessing the feasibility, appropriateness, and acceptability of the adapted intervention through participants' feedback, the investigators will assess its efficacy in improving HF outcomes. The proposed intervention is targeted at both the patient domain - through improved peer support - and health system domain - by improving health system navigation.
Detailed Description
This is a clinical trial involving the training of 6 CHWs in a linkage-to-care intervention and the testing of the intervention on 30 HF patients. In a prior study, the ADAPT-ITT framework was used to adapt a CHW-based intervention for post-discharge HF patients in Haiti. This study represents the last two phases of the ADAPT-ITT framework: Training and Testing. The study population will include adult HF patients (> 18 years of age), hospitalized for more than 48 hours, discharged from Hôpital-Universitaire de Mirebalais (HUM), without a prior clinic visit, living in Mirebalais Commune. Patients will be recruited for study participation shortly before discharge. A comparison group of 30 HF patients will be recruited and will not participate in the follow up care intervention. Those patients will be retrospectively identified from the medical record. The comparison group and will not receive any intervention. Six experienced CHWs will be trained to conduct the linkage to care intervention. The intervention will include study visits in the form of home visits and phone calls performed by CHWs during which they will remind patients about upcoming visits, ensure patient has sufficient medications, review medication schedule and provide education as needed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Community health worker (CHW), ADAPT-ITT, Haiti

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Follow up care program for HF patients
Arm Type
Experimental
Arm Description
Discharged HF patients in rural Haiti will be receive a follow-up care program delivered by trained community health workers (CHWs).
Arm Title
Standard of care
Arm Type
Other
Arm Description
Historical reference group who received standard of care for HF identified prior to CHW training.
Intervention Type
Other
Intervention Name(s)
HF follow up care
Intervention Description
The intervention will consist of follow up phone calls and visits during which the CHWs will remind patients about upcoming visits, ensure patient has sufficient medications, review medication schedule and provide education as needed.
Intervention Type
Other
Intervention Name(s)
HF Standard of Care (SOC)
Intervention Description
SOC after discharge for HF is to notify patients of a follow-up visit at the hospital/clinic - about 7 days after discharge and provide patients about 30 days of medications at discharge. If a patient does not return for a follow-up appointment, there are no systems to track this missed visit, or to trigger active attempts to contact patients. For patients who come back to their scheduled 7-day visit, there is generally a 14-day visit followed by a 28-day visit.
Primary Outcome Measure Information:
Title
Acceptability of HF follow up program to patients
Description
Acceptability of the HF follow up program to patients will be assessed using a 5-point Likert scale response to the question "Was it acceptable to have a CHW come to your home to educate you in your heart failure care and encourage clinic follow-up?" where 1=not acceptable, 5=very acceptable.
Time Frame
90 days
Title
Acceptability of HF follow up program to Community Health Workers (CHWs)
Description
Acceptability of the HF follow up program to CHWs will be assessed using a 5-point Likert scale response to the question "Was it acceptable to have a CHW come to your home to educate you in your heart failure care and encourage clinic follow-up?" where 1=not acceptable, 5=very acceptable.
Time Frame
12 months
Title
Acceptability of HF follow up program to nurses/doctors
Description
Acceptability of the HF follow up program to nurses/doctors will be assessed using a 5-point Likert scale response to the question "Was it acceptable to have a CHW come to your home to educate you in your heart failure care and encourage clinic follow-up?" where 1=not acceptable, 5=very acceptable.
Time Frame
12 months
Title
Appropriateness of HF follow up program to patients
Description
Appropriateness of HF follow up program to patients will be assessed using a 5-point Likert scale response to the question "Were you satisfied with the CHWs interactions with you?" where 1=not acceptable, 5=very acceptable.
Time Frame
90 days
Title
Appropriateness of HF follow up program to CHWs
Description
Appropriateness of HF follow up program to CHWs will be assessed using a 5-point Likert scale response to the question "Were you satisfied with the CHWs interactions with you?" where 1=not acceptable, 5=very acceptable.
Time Frame
12 months
Title
Appropriateness of HF follow up program to nurses/doctors
Description
Appropriateness of HF follow up program to nurses/doctors will be assessed using a 5-point Likert scale response to the question "Were you satisfied with the CHWs interactions with you?" where 1=not acceptable, 5=very acceptable.
Time Frame
12 months
Title
Feasibility of HF follow up program to patients
Description
Feasibility of HF follow up program to patients will be assessed by the percent of invited eligible patients who consent to participate. The higher the percentage of consenting patients, the more feasible the program.
Time Frame
90 days
Title
Feasibility of HF follow up program to CHWs
Description
Feasibility of HF follow up program to CHWs will be assessed by the percent of invited CHWs who complete the training. The higher the percentage, the more feasible the program.
Time Frame
90 days
Title
Fidelity of HF follow up program
Description
Fidelity of HF follow up program will be assessed by the percent of home visit checklist items completed by CHWs. The higher the percentage, the greater the fidelity.
Time Frame
90 days
Title
HF follow up program intervention components delivered
Description
Assessed by the number of interventions delivered based abstracted from the home visit checklist completed by the CHWs.
Time Frame
90 days
Title
Completion of scheduled visits
Description
Assessed by the percent of scheduled visits that were completed from the CHW records.
Time Frame
90 days
Title
Percent of visits with all home visit checklist items completed
Description
Assessed by dividing the number of visits with all home visit checklist items completed by the total number of visits.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Linkage of HF patients
Description
Percent of patients that complete 30 day follow up visit
Time Frame
30 days
Title
Retention of HF patients
Description
Percent of patients that complete 90 day follow up visit
Time Frame
90 days
Title
Hospital readmission rate
Description
Percent of patients that are readmitted to the hospital abstracted from the medical charts
Time Frame
90 days
Title
Patient symptoms based on the New York Heart Association (NYHA) Classification
Description
A New York Heart Association (NHYA) class from 1 to 4 will be assigned to each patient. The higher the classification the more serious the symptoms NYHA Classification - The Stages of Heart Failure: Class 1 - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class 2 - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class 3 - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest. Class 4 - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
Time Frame
90 days
Title
Patient quality of life assessed European Quality of Life 5D (EuroQol 5D)
Description
Quality of life of patients will be assessed with the European Quality of Life 5D (EuroQol 5D) level. ThevEuropean Quality (EQ)-5D descriptive system is a preference-based Health-related quality of life (HRQL) measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers given to EQ-5D permit to find 243 unique health states or can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
Time Frame
30 days, 90 days
Title
Symptoms and quality of life based on the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
The KCCQ will be used to assess symptoms, physical and social limitations, and quality of life in HF patients. Scores are scaled from 0 to 100 and will be summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Time Frame
30 days, 90 days
Title
Mortality rate in HF patients
Description
The number of HF patients who die within 90 days following discharge will be calculated.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for patient participant: Adult HF patients Hospitalized >48 hours at Hôpital-Universitaire de Mirebalais (HUM) Anticipated discharge from HUM within 1-3 days Living in Mirebalais Commune, Haiti Inclusion criteria for historical patient reference group Adult HF patients Hospitalized >48 hours at HUM Discharged from HUM within the 12 months preceding the intervention Living in Mirebalais Commune Exclusion Criteria for patient participant and historical patient reference group: None Inclusion Criteria for CHW Adult Provide inpatient or outpatient care to HF patients Working in in Mirebalais Exclusion Criteria for CHW None Inclusion criteria for healthcare staff (provider/administrator) Hospital leadership involved in supervision of clinical care programs (i.e. Chief Executive Officer, Chief Medical Officer, Chief Operations Officer, Chief Nursing Officer, etc.) Leaders of the Community Health Department - including the nurse Director of Community Health, and Community Health Worker Supervisors. Healthcare providers at HUM involved in the care of patients with heart failure (i.e. internal medicine physicians, inpatient hospital nurses, outpatient clinic physicians, outpatient clinic nurses, etc.) Exclusion criteria for healthcare staff (provider/administrator) None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gene F Kwan, MD MPH
Phone
617-638-8786
Email
gene.kwan@bmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gene F Kwan, MD MPH
Organizational Affiliation
Boston Medical Center, Cardiovascular Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zanmi Lasante/Hôpital Universitaire de Mirebalais
City
Mirebalais
Country
Haiti
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darius Fenelon

12. IPD Sharing Statement

Plan to Share IPD
No

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Haiti Community Health Workers (CHW) Adaptation

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