Team-based Care to Improve Hypertension

Not Applicable

Active, not recruiting

• Conditions: Cardiovascular Diseases; Hypertension
• Interventions: Other: Practice Facilitation

• Registration Number: NCT05413252
• Lead Sponsor: New York University

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.

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 Timeline

• Study First Submitted: 2022-06-03
• Study First Submitted QC: 2022-06-07
• Study First Posted: 2022-06-09
• Study Start: 2023-01-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-05
• Primary Completion: 2025-09-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• One to 5 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Practice Facilitation	Practice Facilitation	Practices review coaching and support from a trained practice facilitator. This includes 24 site visits in which facilitators meet with staff to work on implementing system changes to improve hypertension management.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

New York University; 🇺🇸 New York, New York, United States

New York University School of Global Public Health; 🇺🇸 New York, New York, United States