Project IMPACT: CHW Intervention

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: CHW Intervention; Behavioral: Wait List Control Group

• Registration Number: NCT03159533
• Lead Sponsor: NYU Langone Health

Brief Summary

The proposed study "Project IMPACT: CHW Intervention" is part of a larger study examining the efficacy, adoption, and impact of integrated EHR-based decision-support and physician feedback interventions with community health worker (CHW)-led self-management and coaching support for South Asian patients with uncontrolled hypertension. This is a randomized control intervention utilizing community health worker (CHW)-led self-management and coaching support for South Asian patients with uncontrolled hypertension at PCP clinics in New York City.

Detailed Description

The Goal of this study is that:

1. EHR-based decision support and performance feedback interventions will be more effective in improving hypertension control for South Asian patients than standard care;

2. A combined EHR-CHW intervention will be more effective in improving hypertension control for South Asian patients compared to standard care and the EHR-based intervention

Investigators hope to implement and assess the efficacy of CHW-led coaching through promotion of team-based care and use of culturally tailored education to improve hypertension control and mitigate risk factors related to CVD among South Asian patients with uncontrolled hypertension. Study findings can provide translatable and scalable models for other limited English proficient communities.

Study Timeline

• Study Start: 2017-03-09
• Study First Submitted: 2017-04-13
• Study First Submitted QC: 2017-05-17
• Study First Posted: 2017-05-18
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-15
• Last Update Posted: 2020-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 305

Inclusion Criteria

CHW Intervention

• Diagnosis of hypertension or at least two systolic blood pressure measurements of 140 mm Hg or greater, or at least two diastolic BP 90 mm Hg or greater in the past 12 months.

Focus Group

• Any clinical patients meeting the inclusion criteria for the CHW Intervention who participated in the CHW Intervention Pilot Round.

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Exclusion Criteria

• Pregnant patients are excluded.
• No children or vulnerable subjects will be enrolled in this study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHW Intervention	CHW Intervention	CHW lead Sessions Session1: BP and the Cardiovascular System Session 2: Nutrition and food labels Session 3: Physical Activity and Stress Management Session 4: CVD Risk factors: cholesterol, blood sugar, \& Smoking Session 5: Health Communication, Healthcare access \& Review
Control Group	Wait List Control Group	Wait-list

Primary Outcome Measures

Name	Time	Method
Percent of patients with HbA1c <7 (for patients with hypertension + diabetes) at 6 months	6 months
Percent of current diagnosed hypertensive patients with BP <140/90 (or BP<130/80 for patients with diabetes) at 6 Months	6 Months
Percent of current diagnosed hypertensive patients with BP <140/90 (or BP<130/80 for patients with diabetes) at 12 months	12 months

Secondary Outcome Measures

Name	Time	Method
Percent of patients with diagnosis of hypertension with a BP measure taken in the past 6 months	6 months
Percent of current hypertensive patients receiving counseling on BMI, diet and physical activity	12 months
Percent of patients without hypertension having valid BP measurement, last 12 months	12 months
Percent of current diagnosed hypertensive patients referred to a nutritionist in the past year	12 months
Percent of current diagnosed hypertensive patients who smoke who have been referred for smoking cessation	12 months
Percent of current hypertensive patients screened for diabetes in last year	12 months

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States