Clinical trial NCT05091710: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Community health worker (CHW)
ADAPT-ITT
Haiti
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-10-25
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Acceptability of HF follow up program to patients
timeFrame: 90 days
measure: Acceptability of HF follow up program to Community Health Workers (CHWs)
timeFrame: 12 months
measure: Acceptability of HF follow up program to nurses/doctors
timeFrame: 12 months
measure: Appropriateness of HF follow up program to patients
timeFrame: 90 days
measure: Appropriateness of HF follow up program to CHWs
timeFrame: 12 months
measure: Appropriateness of HF follow up program to nurses/doctors
timeFrame: 12 months
measure: Feasibility of HF follow up program to patients
timeFrame: 90 days
measure: Feasibility of HF follow up program to CHWs
timeFrame: 90 days
measure: Fidelity of HF follow up program
timeFrame: 90 days
measure: HF follow up program intervention components delivered
timeFrame: 90 days
measure: Completion of scheduled visits
timeFrame: 90 days
measure: Percent of visits with all home visit checklist items completed
timeFrame: 90 days
Secondary outcomes:
measure: Linkage of HF patients
timeFrame: 30 days
measure: Retention of HF patients
timeFrame: 90 days
measure: Hospital readmission rate
timeFrame: 90 days
measure: Patient symptoms based on the New York Heart Association (NYHA) Classification
timeFrame: 90 days
measure: Patient quality of life assessed European Quality of Life 5D (EuroQol 5D)
timeFrame: 30 days, 90 days
measure: Symptoms and quality of life based on the Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 30 days, 90 days
measure: Mortality rate in HF patients
timeFrame: 90 days
Other outcomes:
Locations:
city: Mirebalais
country: Haiti
facility: Zanmi Lasante/Hôpital Universitaire de Mirebalais
Study officials:
affiliation: Boston Medical Center, Cardiovascular Medicine
name: Gene F Kwan, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: