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Team-based Care to Improve Hypertension

New York University (NYU) logo

New York University (NYU)

Status

Active, not recruiting

Conditions

Hypertension
Cardiovascular Diseases

Treatments

Other: Practice Facilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT05413252
IRB-FY2022-6555

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

90 participants in 2 patient groups

Current Practice
No Intervention group
Description:
Practices will deliver care as usual and patients at these sites receive standard HTN care delivered.
Practice Facilitation
Active Comparator group
Description:
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.
Treatment:
Other: Practice Facilitation

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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