Team-Based Home Blood Pressure Monitoring
- Conditions
- HypertensionHigh Blood Pressure
- Interventions
- Behavioral: Team-Based Home Blood Pressure Monitoring
- Registration Number
- NCT05488795
- Lead Sponsor
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5760
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Suite TB-HBPM post intervention implementation Team-Based Home Blood Pressure Monitoring Post implementation phase of the suites 2 years after introduction of intervention. Suite TB-HBPM pre intervention Team-Based Home Blood Pressure Monitoring Each suite/cluster throughout the institution will begin in the baseline usual care phase in the first year. Suite TB-HBPM throughout intervention implementation Team-Based Home Blood Pressure Monitoring 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.
- Primary Outcome Measures
Name Time Method Blood pressure control Up to 48 months participation Change in percent of participants whose BP is controlled (defined as \<140/90 mm Hg) among all eligible patients diagnosed with hypertension based on the last BP reading during the control period and the last BP reading during the follow-up period.
- Secondary Outcome Measures
Name Time Method Participation in Home Blood Pressure Monitoring (HBPM) Beginning of the intervention for the relevant wedge up to 48 months participation Percentage of participants eligible for home blood pressure monitoring (HBPM) who agree to participate in HBPM based on EHR documentation
Blood pressure control by race and ethnicity Up to 48 months participation Change in percent of participants with blood pressure controlled defined as \<140/90 mm Hg by race/ethnicity: among eligible Non-Hispanic White patients, non-Hispanic Black patients, and Hispanic patients.
Blood pressure control by insurance Up to 48 months participation Change in percent of participants with blood pressure controlled defined as \<140/90 mm Hg by insurance (Commercial, Medicaid, Medicare, Other and None)
Chronic disease self-management capacity (QICA) Pre-intervention and six months post-intervention Change in Quality Improvement Capacity Assessment QICA scores, scale range 20-200 with higher indicating better outcomes.
Sustained blood pressure control Beginning with the 6-month intervention period and up to 48 months participation Change in percent of participants with blood pressure in control (\<140/90 mm Hg) post-intervention
Transmission of home blood pressure readings First three months following each participant's enrollment in HBPM Percentage of participants who participate in HPBM who transmit a least 10 BP readings per month
Cost Analysis Up to 48 months participation Marginal changes in net revenue (marginal billing and bonus revenue) and marginal changes in costs related to time for training, staffing costs, and BP monitor
Trial Locations
- Locations (1)
Highland Family Medicine
🇺🇸Rochester, New York, United States