Haiti Community Health Workers (CHW) Adaptation

NCT05091710 | Completed

• 2 other identifiers: H-417581K23HL140133-01A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Community health worker (CHW); ADAPT-ITT; Haiti

Outcome Measures

Primary Outcomes (12)

• 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.

  90 days

• 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.

  12 months

• 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.

  12 months

• 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.

  90 days

• 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.

  12 months

• 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.

  12 months

• 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.

  90 days

• 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.

  90 days

• 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.

  90 days

• 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.

  90 days

• Completion of scheduled visits

  Assessed by the percent of scheduled visits that were completed from the CHW records.

  90 days

• 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.

  90 days

Secondary Outcomes (7)

• Linkage of HF patients

  30 days

• Retention of HF patients

  90 days

• Hospital readmission rate

  90 days

• Patient symptoms based on the New York Heart Association (NYHA) Classification

  90 days

• Patient quality of life assessed European Quality of Life 5D (EuroQol 5D)

  30 days, 90 days

Study Arms (2)

Follow up care program for HF patients

EXPERIMENTAL

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

Other: HF follow up care

Standard of care

OTHER

Historical reference group who received standard of care for HF identified prior to CHW training.

Other: HF Standard of Care (SOC)

Interventions

HF follow up care OTHER

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.

Follow up care program for HF patients

HF Standard of Care (SOC) OTHER

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.

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult HF patients
• Hospitalized \>48 hours at Hôpital-Universitaire de Mirebalais (HUM)
• Anticipated discharge from HUM within 1-3 days
• Adult HF patients
• Hospitalized \>48 hours at HUM
• Discharged from HUM within the 12 months preceding the intervention
• Living in Mirebalais Commune

You may not qualify if:

• None
• Adult
• Provide inpatient or outpatient care to HF patients
• Working in in Mirebalais
• None
• 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.)
• None

Sponsors & Collaborators

• Boston Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Zanmi Lasante/Hôpital Universitaire de Mirebalais

Mirebalais, Haiti

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Gene F Kwan, MD MPH

  Boston Medical Center, Cardiovascular Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 25, 2021
• Study Start: February 23, 2023
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

HA (1)