Clinical trial NCT05413252: Team-based Care to Improve Hypertension
Official title: Facilitation of Team-based Care to Improve HTN Management and Outcomes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Cardiovascular Diseases
Keywords: team-based care
practice facilitation
implementation
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: New York City Department of Health and Mental Hygiene
First posted: 2022-06-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of with a diagnosis of hypertension who have a BP <140/90 (JNC Guidelines) as assessed through EHRs reports.
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University
state: New York
city: New York
country: United States
facility: New York University School of Global Public Health
state: New York
Study officials:
affiliation: NYU School of Global Public Health
name: Donna Shelley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.