NCT05091710

Haiti Community Health Workers (CHW) Adaptation

Pilot Trial of a Community Health Worker Intervention to Improve Heart Failure Care in Rural Haiti

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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.
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.

Timeline

• Start date: 2023-02-23
• Primary completion: 2025-08-31
• Completion: 2025-08-31
• First posted: 2021-10-25
• Last updated: 2025-11-10

Locations

1 site across 1 country: Haiti