Team-Based Home Blood Pressure Monitoring

NCT ID: NCT05488795

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5760 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2026-08-31

Brief Summary

The overall goal of this study is to identify and rigorously evaluate strategies for implementing and sustaining team-based home blood pressure monitoring (TB-HBPM) within primary care.

The TB-HBPM intervention is a multifaceted program involving patient transmission of blood readings to EHR and clinical decision support. Implementation strategies include group-based education on hypertension measurement, target blood pressure goals, drug and lifestyle management, referral to community resources, and team training designed to optimize the coordination of hypertension care, and monthly audit and feedback reports to teams and clinicians.

Hypertension control rates are suboptimal in many primary care practices with persistent racial disparities in control. Team-based home blood pressure monitoring (TB-HPBM) involving patient transmission of their home blood pressure readings in real-time to their clinical team has been shown to improve blood pressure control. There is an urgent need to implement TB-HBPM into practice. The overall objective of this research is to assess implementation strategies that mitigate barriers and leverage facilitators to TB-HBHM on hypertension control and disparities between Black and White patients. The study team and investigators will use mixed methods to assess the process and generate knowledge to facilitate broader uptake of TB-HBPM.

Detailed Description

Aim 2: Deploy theorized implementation strategies using a type-2 hybrid stepped-wedge randomized cluster trial The department of family medicine will roll out the clinical intervention (TBHBPM).

To improve rigor in evaluation, the study biostatistician will use computer-generated numbers to randomly assign each of the eight suites to when they will begin the intervention during one of three wedges (Figure 1). The study team and investigators will randomize two suites in the first wedge and three each to the second and third wedge.

Aim 3: Assess the impact of implementation strategies using specific metrics based on RE-AIM

Aim 4: Test theoretical assumptions underlying the implementation strategies

Conditions

High Blood Pressure; Hypertension

Study Design

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

Study Groups

Suite TB-HBPM pre intervention

Each suite/cluster throughout the institution will begin in the baseline usual care phase in the first year.

Group Type: OTHER

Team-Based Home Blood Pressure Monitoring

Intervention Type: BEHAVIORAL

Implementation of best practices for hypertension control using a practice wide team-based home blood pressure monitoring intervention

Suite TB-HBPM throughout intervention implementation

Each suite will be randomized to implement the TB-HBPM program during one of three wedges separated by six months between each, 1.5 years later.

Group Type: OTHER

Team-Based Home Blood Pressure Monitoring

Intervention Type: BEHAVIORAL

Implementation of best practices for hypertension control using a practice wide team-based home blood pressure monitoring intervention

Suite TB-HBPM post intervention implementation

Post implementation phase of the suites 2 years after introduction of intervention.

Group Type: OTHER

Team-Based Home Blood Pressure Monitoring

Intervention Type: BEHAVIORAL

Implementation of best practices for hypertension control using a practice wide team-based home blood pressure monitoring intervention

Interventions

Team-Based Home Blood Pressure Monitoring

Implementation of best practices for hypertension control using a practice wide team-based home blood pressure monitoring intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Current HFM patient 18-85 years of age with hypertension diagnosis
• Diagnosis of hypertension based on ICD-10 codes of I10-I14
• at least one HFM health visit and hypertension diagnosis beginning no later than 7/1/2021.

Exclusion Criteria

• Not current patient in the participating practices
• Diagnosis of dementia, end-stage renal disease, and/or in hospice
• Currently pregnant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Kevin Fiscella

Professor, Family Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevin Fiscella, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

URMC

Locations

Highland Family Medicine

Rochester, New York, United States

Countries

United States

References

Fiscella KA, Sass E, Sridhar SB, Maguire JA, Lashway K, Wong G, Thien A, Thomas M, Bisognano JD, Rosenberg T, Sanders MR, Johnson BA, Polgreen LA. Team-based home blood pressure monitoring for blood pressure equity a protocol for a stepped wedge cluster randomized trial. Contemp Clin Trials. 2023 Nov;134:107332. doi: 10.1016/j.cct.2023.107332. Epub 2023 Sep 16.

Reference Type: DERIVED

PMID: 37722482 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R33HL157643

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RSRB 6036

Identifier Type: -

Identifier Source: org_study_id