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Project IMPACT: CHW Intervention (IMPACT)

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

Tracking Information
First Submitted Date  ICMJE April 13, 2017
First Posted Date  ICMJE May 18, 2017
Last Update Posted Date May 18, 2020
Actual Study Start Date  ICMJE March 9, 2017
Actual Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2017)
  • 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 ]
  • 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 ]
  • Percent of patients with HbA1c <7 (for patients with hypertension + diabetes) at 6 months [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2017)
  • Percent of patients with diagnosis of hypertension with a BP measure taken in the past 6 months [ Time Frame: 6 months ]
  • Percent of patients without hypertension having valid BP measurement, last 12 months [ Time Frame: 12 months ]
  • Percent of current hypertensive patients screened for diabetes in last year [ Time Frame: 12 months ]
  • Percent of current hypertensive patients receiving counseling on BMI, diet and physical activity [ Time Frame: 12 months ]
  • Percent of current diagnosed hypertensive patients referred to a nutritionist in the past year [ Time Frame: 12 months ]
  • Percent of current diagnosed hypertensive patients who smoke who have been referred for smoking cessation [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Project IMPACT: CHW Intervention
Official Title  ICMJE Project IMPACT: Community Health Care Worker (CHW) Intervention
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Hypertension
Intervention  ICMJE
  • 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.).
  • Behavioral: Wait List Control Group
    4 education sessions beginning 6-12 months later.
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: CHW Intervention
  • Placebo Comparator: Control Group
    Wait-list
    Intervention: Behavioral: Wait List Control Group
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 14, 2018)
305
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2017)
730
Actual Study Completion Date  ICMJE July 1, 2019
Actual Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03159533
Other Study ID Numbers  ICMJE 16-00969
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nadia Islam NYU Langone Health
PRS Account NYU Langone Health
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP