Team-based Care to Improve Hypertension

Hypertension Clinical Trial

Official title:

Facilitation of Team-based Care to Improve HTN Management and Outcomes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05413252
• Other study ID #: IRB-FY2022-6555
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 31, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2022
• Source: New York University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 81
• Est. completion date: December 31, 2027
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension

Intervention

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.

Locations

Country	Name	City	State
United States	New York University School of Global Public Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University	New York City Department of Health and Mental Hygiene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	12 months
Secondary	Percentage of with a diagnosis of hypertension who have a BP <140/90 (JNC Guidelines) as assessed through EHRs reports.	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.	12 months