Team-based Care to Improve Hypertension

NCT05413252 | Active Not Recruiting DMC

• 1 other identifier: IRB-FY2022-6555
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypertension; Cardiovascular Diseases

Keywords

team-based care; practice facilitation; implementation

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (1)

• Percentage of with a diagnosis of hypertension who have a BP <140/90 (JNC Guidelines) as assessed through EHRs reports.

  12 months

Study Arms (2)

Current Practice

NO INTERVENTION

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

Practice Facilitation

ACTIVE COMPARATOR

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.

Other: Practice Facilitation

Interventions

Practice Facilitation OTHER

Practices will be assigned a practice facilitator who will support practices in implementing all practice redesign components associated with TBC for HTN management.

Also known as: team-based care implementation

Practice Facilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York University: lead
• New York City Department of Health and Mental Hygiene: collaborator

Study Sites (2)

New York University

New York, New York, 10003, United States

Location

New York University School of Global Public Health

New York, New York, 10012, United States

Location

Related Publications (1)

• Shelley DR, Brown D, Cleland CM, Pham-Singer H, Zein D, Chang JE, Wu WY. Facilitation of team-based care to improve HTN management and outcomes: a protocol for a randomized stepped wedge trial. BMC Health Serv Res. 2023 May 31;23(1):560. doi: 10.1186/s12913-023-09533-1.

  PMID: 37259081 RESULT

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Donna Shelley, MD

  NYU School of Global Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is conducting a stepped-wedge design RCT trial. Practices will be randomized into the study into one of three waves.

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 9, 2022
• Study Start: January 31, 2023
• Primary Completion: September 30, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 5, 2024

Record last verified: 2024-07

Locations

US (2)