Team-Based Home Blood Pressure Monitoring

N/AActive Not RecruitingNCT05488795

University of Rochester5,760 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Up to 48 months participation

Secondary Outcomes

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.

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: Up to 48 months participation

Team-Based Home Blood Pressure Monitoring

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes