Project IMPACT: CHW Intervention

Study Overview
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Brief Summary
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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
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The Goal of this study is that: EHR-based decision support and performance feedback interventions will be more effective in improving hypertension control for South Asian patients than standard care; 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.

Official Title
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Project IMPACT: Community Health Care Worker (CHW) Intervention

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: CHW Intervention
* Behavioral: Wait List Control Group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Step wedge design, whereby 5 groups of 3 practices will implement the intervention in phases.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CHW Intervention<br>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 | Behavioral: CHW Intervention<br>* Patients randomized to Group A will be invited to attend 4 more group educational sessions on self-management immediately.CHWs will follow up with participants by phone or in person through a home or clinic visit. At these follow-up meetings, CHWs will engage in goal-setting activities regarding changes to health behaviors, medication adherence, or other issues related to hypertension control as identified jointly by the patient and CHW. CHWs will also collect height, weight, and blood pressure measurements at initial and in-person follow-up visits. The CHW will make necessary referrals to other services available in the community (i.e. exercise classes, social services, mental health, tobacco cessation, etc.).<br>|
| Placebo Comparator: Control Group<br>Wait-list | Behavioral: Wait List Control Group<br>* 4 education sessions beginning 6-12 months later.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Percent of patients with HbA1c <7 (for patients with hypertension + diabetes) at 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients with diagnosis of hypertension with a BP measure taken in the past 6 months |  | 6 months | 
| Percent of patients without hypertension having valid BP measurement, last 12 months |  | 12 months | 
| Percent of current hypertensive patients screened for diabetes in last year |  | 12 months | 
| Percent of current hypertensive patients receiving counseling on BMI, diet and physical activity |  | 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 |