Project IMPACT: CHW Intervention (IMPACT)

• ClinicalTrials.gov Identifier: NCT03159533
• Recruitment Status: Completed
• First Posted: May 18, 2017
• Last Update Posted: May 18, 2020
• Sponsor: NYU Langone Health
• Information provided by (Responsible Party): NYU Langone Health

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypertension	Behavioral: CHW Intervention; Behavioral: Wait List Control Group	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 305 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Step wedge design, whereby 5 groups of 3 practices will implement the intervention in phases.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Project IMPACT: Community Health Care Worker (CHW) Intervention
• Actual Study Start Date: March 9, 2017
• Actual Primary Completion Date: July 1, 2019
• Actual Study Completion Date: July 1, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: CHW Intervention; 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; 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.).
Placebo Comparator: Control Group; Wait-list	Behavioral: Wait List Control Group; 4 education sessions beginning 6-12 months later.

Outcome Measures

Primary Outcome Measures :

1. Percent of current diagnosed hypertensive patients with BP <140/90 (or BP<130/80 for patients with diabetes) at 6 Months [ Time Frame: 6 Months ]
2. Percent of current diagnosed hypertensive patients with BP <140/90 (or BP<130/80 for patients with diabetes) at 12 months [ Time Frame: 12 months ]
3. Percent of patients with HbA1c <7 (for patients with hypertension + diabetes) at 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures :

1. Percent of patients with diagnosis of hypertension with a BP measure taken in the past 6 months [ Time Frame: 6 months ]
2. Percent of patients without hypertension having valid BP measurement, last 12 months [ Time Frame: 12 months ]
3. Percent of current hypertensive patients screened for diabetes in last year [ Time Frame: 12 months ]
4. Percent of current hypertensive patients receiving counseling on BMI, diet and physical activity [ Time Frame: 12 months ]
5. Percent of current diagnosed hypertensive patients referred to a nutritionist in the past year [ Time Frame: 12 months ]
6. Percent of current diagnosed hypertensive patients who smoke who have been referred for smoking cessation [ Time Frame: 12 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, New York

New York University School of Medicine

New York, New York, United States, 10016

Sponsors and Collaborators

NYU Langone Health

Investigators

• Principal Investigator: Nadia Islam; NYU Langone Health

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03159533
• Other Study ID Numbers: 16-00969
• First Posted: May 18, 2017
• Last Update Posted: May 18, 2020
• Last Verified: May 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases