Project IMPACT: CHW Intervention

NCT03159533 | Completed

• 1 other identifier: 16-00969
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 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

Study Arms (2)

CHW Intervention

ACTIVE COMPARATOR

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

Control Group

PLACEBO COMPARATOR

Wait-list

Behavioral: Wait List Control Group

Interventions

CHW Intervention BEHAVIORAL

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.).

CHW Intervention

Wait List Control Group BEHAVIORAL

4 education sessions beginning 6-12 months later.

Control Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (2)

• Islam NS, Wyatt LC, Ali SH, Zanowiak JM, Mohaimin S, Goldfeld K, Lopez P, Kumar R, Beane S, Thorpe LE, Trinh-Shevrin C. Integrating Community Health Workers into Community-Based Primary Care Practice Settings to Improve Blood Pressure Control Among South Asian Immigrants in New York City: Results from a Randomized Control Trial. Circ Cardiovasc Qual Outcomes. 2023 Mar;16(3):e009321. doi: 10.1161/CIRCOUTCOMES.122.009321. Epub 2023 Feb 23.

  PMID: 36815464 DERIVED

• 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.

  PMID: 29207983 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nadia Islam

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: May 18, 2017
• Study Start: March 9, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: May 18, 2020

Record last verified: 2020-05

Locations

US (1)