Team-Based Home Blood Pressure Monitoring

Study Overview
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Brief Summary
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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
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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

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

Conditions
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High Blood Pressure, Hypertension

Intervention / Treatment
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* Behavioral: Team-Based Home Blood Pressure Monitoring


Participation Criteria
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Eligibility Criteria
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ELIGIBILITY CRITERIA Clinicians and Staff Eligibility Criteria Practice employees (practice leaders, administrators, clinicians, or staff) that work with hypertensive patients during the study period (scheduling appointments, coordinating care, measuring blood pressure, responding to questions, and/or treating their blood pressure) Patient 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. Patient Exclusion Criteria Not current patient in the participating practices Diagnosis of dementia, end-stage renal disease, and/or in hospice Currently pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Suite TB-HBPM pre intervention<br>Each suite/cluster throughout the institution will begin in the baseline usual care phase in the first year. | Behavioral: Team-Based Home Blood Pressure Monitoring<br>* Implementation of best practices for hypertension control using a practice wide team-based home blood pressure monitoring intervention<br>|
| Other: Suite TB-HBPM throughout intervention implementation<br>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. | Behavioral: Team-Based Home Blood Pressure Monitoring<br>* Implementation of best practices for hypertension control using a practice wide team-based home blood pressure monitoring intervention<br>|
| Other: Suite TB-HBPM post intervention implementation<br>Post implementation phase of the suites 2 years after introduction of intervention. | Behavioral: Team-Based Home Blood Pressure Monitoring<br>* Implementation of best practices for hypertension control using a practice wide team-based home blood pressure monitoring intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure control | 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. | Up to 48 months participation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure control by race and ethnicity | 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. | Up to 48 months participation | 
| Blood pressure control by insurance | Change in percent of participants with blood pressure controlled defined as <140/90 mm Hg by insurance (Commercial, Medicaid, Medicare, Other and None) | Up to 48 months participation | 
| Participation in Home Blood Pressure Monitoring (HBPM) | Percentage of participants eligible for home blood pressure monitoring (HBPM) who agree to participate in HBPM based on EHR documentation | Beginning of the intervention for the relevant wedge up to 48 months participation | 
| Transmission of home blood pressure readings | Percentage of participants who participate in HPBM who transmit a least 10 BP readings per month | First three months following each participant's enrollment in HBPM | 
| Chronic disease self-management capacity (QICA) | Change in Quality Improvement Capacity Assessment QICA scores, scale range 20-200 with higher indicating better outcomes. | Pre-intervention and six months post-intervention | 
| Sustained blood pressure control | Change in percent of participants with blood pressure in control (<140/90 mm Hg) post-intervention | Beginning with the 6-month intervention period and up to 48 months participation | 
| Cost Analysis | 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 | Up to 48 months participation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Home blood pressure monitoring, Hypertension control, Primary Care Teams, Implementation Research, Health Equity, Clinical Trial