Project IMPACT: CHW Intervention

NYU Langone Health

Status: Completed

Conditions: Hypertension

Treatments: Behavioral: CHW Intervention; Behavioral: Wait List Control Group

Study type: Interventional

Funder types: Other

Identifiers

NCT03159533

16-00969

Details and patient eligibility

About

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.

Full 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.

Enrollment: 305 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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305 participants in 2 patient groups, including a placebo group

CHW Intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: CHW Intervention

Control Group

Placebo Comparator group

Description:

Wait-list

Treatment:

Behavioral: Wait List Control Group