Haiti Community Health Workers (CHW) Adaptation

NCT ID: NCT05091710

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-23
• Study Completion Date: 2025-08-31

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.

Conditions

Heart Failure

Keywords

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Follow up care program for HF patients

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

Group Type: EXPERIMENTAL

HF follow up care

Intervention Type: 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.

Standard of care

Historical reference group who received standard of care for HF identified prior to CHW training.

Group Type: OTHER

HF Standard of Care (SOC)

Intervention Type: 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.

Interventions

HF follow up care

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

HF Standard of Care (SOC)

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

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

• 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

• None

• None

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gene F Kwan, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center, Cardiovascular Medicine

Locations

Zanmi Lasante/Hôpital Universitaire de Mirebalais

Mirebalais, , Haiti

Countries

Haiti

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1K23HL140133-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-41758

Identifier Type: -

Identifier Source: org_study_id