Team-Based Home Blood Pressure Monitoring

Identifying Successful Strategies for Implementing Team-Based Home Blood Pressure Monitoring in Primary Care

Sponsors

Lead Sponsor: University of Rochester

Collaborator: National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)

Source University of Rochester
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

Overall Status Recruiting
Start Date 2022-08-01
Completion Date 2026-07-01
Primary Completion Date 2025-07-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Blood pressure control Up to 48 months participation
Secondary Outcome
Measure Time Frame
Blood pressure control by race and ethnicity Up to 48 months participation
Blood pressure control by insurance Up to 48 months participation
Participation in Home Blood Pressure Monitoring (HBPM) Beginning of the intervention for the relevant wedge up to 48 months participation
Transmission of home blood pressure readings First three months following each participant's enrollment in HBPM
Chronic disease self-management capacity (QICA) Pre-intervention and six months post-intervention
Sustained blood pressure control Beginning with the 6-month intervention period and up to 48 months participation
Cost Analysis Up to 48 months participation
Enrollment 5760
Condition
Intervention

Intervention Type: Device

Intervention Name: At home Blood Pressure Monitoring Cuff

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

Eligibility

Criteria:

Inclusion Criteria: - HFM employee (practice leaders, administrators, clinicians, or staff) that works with hypertensive patients during the study period (scheduling appointments, coordinating care, measuring blood pressure, responding to questions, and/or treating their blood pressure) - 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: - <18 years of age - >85 years of age - Not current HFM patient - No hypertension diagnosis - HFM patients with co-morbidities - HFM patients with dementia, end-stage renal disease, and/or in hospice - Pregnant patients

Gender:

All

Minimum Age:

18 Years

Maximum Age:

85 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Kevin Fiscella, MD, MPH Principal Investigator URMC
Overall Contact

Last Name: Kevin Fiscella

Phone: 585-324-4563

Email: [email protected]

Location
Facility: Status: Contact: Highland Family Medicine Matthew Devine, MD 585-279-4800
Location Countries

United States

Verification Date

2022-08-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Rochester

Investigator Full Name: Kevin Fiscella

Investigator Title: Professor, Family Medicine

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Suite TB-HBPM pre intervention

Type: Other

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

Label: Suite TB-HBPM throughout intervention implementation

Type: Other

Description: 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.

Label: Suite TB-HBPM post intervention implementation

Type: Other

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

Acronym TB-HBPM
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Intervention Model Description: Stepped Wedge Cluster Randomized Design. Each practice suite represents a cluster. All eight suites begin in the control group and then cross over (one-way) to the intervention group at one of three randomly assigned time periods, ensuring that all suites eventually receive implementation of TB-HBPM.

Primary Purpose: Health Services Research

Masking: None (Open Label)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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