Team-based Care to Improve Hypertension

Sponsor
New York University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05413252
Collaborator
New York City Department of Health and Mental Hygiene (Other)
360
2
64

Study Details

Study Description

Brief Summary

The study is a stepped-wedge cluster randomized control trial to compare the effect of Practice Facilitation in 90 small-to-medium sized independent primary care practices on the adoption of team-based care.

Condition or Disease Intervention/Treatment Phase
  • Other: Practice Facilitation
N/A

Detailed Description

The study is designed to transform health care delivery by helping smaller independent practices to adopt team-based care. The study will use a stepped-wedge cluster randomized control trial to compare the effect of Practice Facilitation in small-to-medium sized independent primary care practices on the adoption of team-based care aimed at improving hypertension management and blood pressure control. The study will recruit approximately 90 practices which receive practice facilitation to support the adoption of team-based care. Sites are then randomly assigned to one of three waves in which they cross over to the intervention phase. Waves are separated by 6 months and the intervention period lasts 12 months. This is followed by a phase in which sustainability of TBC and BP control is assessed. Each practice will be assigned a practice facilitator and will be required to identify a site champion who will be a member of the team. PF activities will support practices in implementing all practice redesign components associated with TBC for HTN management through training, coaching, modeling TBC, and making changes to systems where necessary to support TBC. Data collection for the primary outcome (adoption of TBC) occurs immediately prior to the beginning of the next 6-month wave. BP outcome data is collected over the 6-month period prior to the next wave. Outcomes will be measured every 6 months in all clusters at every time period so that each cluster provides data points in both the control and intervention conditions.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
360 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
The study is conducting a stepped-wedge design RCT trial. Practices will be randomized into the study into one of three waves.The study is conducting a stepped-wedge design RCT trial. Practices will be randomized into the study into one of three waves.
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Facilitation of Team-based Care to Improve HTN Management and Outcomes
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Dec 31, 2027

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Current Practice

Practices will deliver care as usual and patients at these sites receive standard HTN care delivered.

Active Comparator: Practice Facilitation

Other: Practice Facilitation
Practices will be assigned a practice facilitator who will support practices in implementing all practice redesign components associated with TBC for HTN management.
Other Names:
  • team-based care implementation
  • Outcome Measures

    Primary Outcome Measures

    1. Number of practices that adopt team-based care as assessed by the Primary Care Team Dynamic Survey and Team Process - Monitoring Progress Toward Goals sub-scale. [12 months]

      Five core constructs of team-based care will be measured (clear roles, communication, mutual support, measurable processes and outcomes, and shared goals) by Primary Care Team Dynamic Survey and Team Process - Monitoring Progress Toward Goals sub-scale.

    Secondary Outcome Measures

    1. Percentage of with a diagnosis of hypertension who have a BP <140/90 (JNC Guidelines) as assessed through EHRs reports. [12 months]

      Percentage of patients 18 - 85 years of age who had a diagnosis of hypertension prior to and overlapping the measurement period and whose most recent blood pressure was adequately controlled (< 140/90 mmHg) during the measurement period.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • One to 4 healthcare providers

    • Minimum of 2 non-physician staff available at any time

    • Use an electronic health record (EHR) system to deliver care

    • Have no plans to participate in another CVD-related quality improvement initiative during the study

    • Willing to identify a "physician champion" or staff member to collaborate on all aspects of the intervention

    • Have a minimum of 200 patients on their practice panels that have hypertension that are managed by the practice

    • Agree to study terms including randomization, data sharing, participation in PF, and completion of surveys

    Exclusion Criteria:
    • Five or more healthcare providers

    • Do not have sufficient non-physician staff on board to adopt team-based care

    • Do not use an electronic health record (EHR) system to deliver care

    • Participation or planned participation in another CVD-related improvement initiative during the time of the study

    • Unwilling to identify a "physician champion" or staff member to collaborate on all aspects of the intervention

    • Less than 200 patients on their practice panel that have hypertension that are managed by the practice.

    • Failure to agree to study terms including randomization, data sharing, participation in PF, and completion of surveys

    • Primary care practices which are unable to provide patient level BP data for 6 months prior to enrolling into the study.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • New York University
    • New York City Department of Health and Mental Hygiene

    Investigators

    • Principal Investigator: Donna Shelley, MD, NYU School of Global Public Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    New York University
    ClinicalTrials.gov Identifier:
    NCT05413252
    Other Study ID Numbers:
    • IRB-FY2022-6555
    First Posted:
    Jun 9, 2022
    Last Update Posted:
    Jun 9, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by New York University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 9, 2022