Haiti Community Health Workers (CHW) Adaptation

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05091710
• Other study ID #: H-41758
• Secondary ID: 1K23HL140133-01A
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2023
• Est. completion date: August 2025

Study information

• Verified date: March 2024
• Source: Boston Medical Center
• Contact: Gene F Kwan, MD MPH
• Phone: 617-638-8786
• Email: gene.kwan[@]bmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.
• 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.

Locations

Country	Name	City	State
Haiti	Zanmi Lasante/Hôpital Universitaire de Mirebalais	Mirebalais

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

Haiti, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Completion of scheduled visits	Assessed by the percent of scheduled visits that were completed from the CHW records.	90 days
Primary	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	Linkage of HF patients	Percent of patients that complete 30 day follow up visit	30 days
Secondary	Retention of HF patients	Percent of patients that complete 90 day follow up visit	90 days
Secondary	Hospital readmission rate	Percent of patients that are readmitted to the hospital abstracted from the medical charts	90 days
Secondary	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.	90 days
Secondary	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).	30 days, 90 days
Secondary	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.	30 days, 90 days
Secondary	Mortality rate in HF patients	The number of HF patients who die within 90 days following discharge will be calculated.	90 days