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Project IMPACT: CHW Intervention

Project IMPACT: Community Health Care Worker (CHW) Intervention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03159533
Acronym
IMPACT
Enrollment
305
Registered
2017-05-18
Start date
2017-03-09
Completion date
2019-07-01
Last updated
2020-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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.

Interventions

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.).

4 education sessions beginning 6-12 months later.

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Step wedge design, whereby 5 groups of 3 practices will implement the intervention in phases.

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Percent of current diagnosed hypertensive patients with BP <140/90 (or BP<130/80 for patients with diabetes) at 6 Months6 Months
Percent of current diagnosed hypertensive patients with BP <140/90 (or BP<130/80 for patients with diabetes) at 12 months12 months
Percent of patients with HbA1c <7 (for patients with hypertension + diabetes) at 6 months6 months

Secondary

MeasureTime frame
Percent of current hypertensive patients receiving counseling on BMI, diet and physical activity12 months
Percent of patients with diagnosis of hypertension with a BP measure taken in the past 6 months6 months
Percent of current diagnosed hypertensive patients who smoke who have been referred for smoking cessation12 months
Percent of current diagnosed hypertensive patients referred to a nutritionist in the past year12 months
Percent of patients without hypertension having valid BP measurement, last 12 months12 months
Percent of current hypertensive patients screened for diabetes in last year12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026