Team-based Care to Improve Hypertension

NCT ID: NCT05413252

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2027-12-31

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.

Conditions

Hypertension; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Current Practice

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Practice Facilitation

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

team-based care implementation

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

New York City Department of Health and Mental Hygiene

OTHER_GOV

Sponsor Role: collaborator

New York University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donna Shelley, MD

Role: PRINCIPAL_INVESTIGATOR

NYU School of Global Public Health

Locations

New York University

New York, New York, United States

New York University School of Global Public Health

New York, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 37259081 (View on PubMed)

Other Identifiers

IRB-FY2022-6555

Identifier Type: -

Identifier Source: org_study_id