Clinical trial NCT03159533: Project IMPACT: CHW Intervention
Official title: Project IMPACT: Community Health Care Worker (CHW) Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-05-18
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Step wedge design, whereby 5 groups of 3 practices will implement the intervention in phases.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent of current diagnosed hypertensive patients with BP <140/90 (or BP<130/80 for patients with diabetes) at 6 Months
timeFrame: 6 Months
measure: Percent of current diagnosed hypertensive patients with BP <140/90 (or BP<130/80 for patients with diabetes) at 12 months
timeFrame: 12 months
measure: Percent of patients with HbA1c <7 (for patients with hypertension + diabetes) at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Percent of patients with diagnosis of hypertension with a BP measure taken in the past 6 months
timeFrame: 6 months
measure: Percent of patients without hypertension having valid BP measurement, last 12 months
timeFrame: 12 months
measure: Percent of current hypertensive patients screened for diabetes in last year
timeFrame: 12 months
measure: Percent of current hypertensive patients receiving counseling on BMI, diet and physical activity
timeFrame: 12 months
measure: Percent of current diagnosed hypertensive patients referred to a nutritionist in the past year
timeFrame: 12 months
measure: Percent of current diagnosed hypertensive patients who smoke who have been referred for smoking cessation
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Nadia Islam
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lopez PM, Zanowiak J, Goldfeld K, Wyka K, Masoud A, Beane S, Kumar R, Laughlin P, Trinh-Shevrin C, Thorpe L, Islam N. Protocol for project IMPACT (improving millions hearts for provider and community transformation): a quasi-experimental evaluation of an integrated electronic health record and community health worker intervention study to improve hypertension management among South Asian patients. BMC Health Serv Res. 2017 Dec 6;17(1):810. doi: 10.1186/s12913-017-2767-1.