Clinical trial NCT05488795: Team-Based Home Blood Pressure Monitoring
Official title: Identifying Successful Strategies for Implementing Team-Based Home Blood Pressure Monitoring in Primary Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High Blood Pressure
Hypertension
Keywords: Home blood pressure monitoring
Hypertension control
Primary Care Teams
Implementation Research
Health Equity
Clinical Trial
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-08-05
Enrollment: 5760
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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

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

Eligibility criteria: 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

Primary outcomes:
measure: Blood pressure control
timeFrame: Up to 48 months participation
Secondary outcomes:
measure: Blood pressure control by race and ethnicity
timeFrame: Up to 48 months participation
measure: Blood pressure control by insurance
timeFrame: Up to 48 months participation
measure: Participation in Home Blood Pressure Monitoring (HBPM)
timeFrame: Beginning of the intervention for the relevant wedge up to 48 months participation
measure: Transmission of home blood pressure readings
timeFrame: First three months following each participant's enrollment in HBPM
measure: Chronic disease self-management capacity (QICA)
timeFrame: Pre-intervention and six months post-intervention
measure: Sustained blood pressure control
timeFrame: Beginning with the 6-month intervention period and up to 48 months participation
measure: Cost Analysis
timeFrame: Up to 48 months participation
Other outcomes:
measure: Clinician mean blood pressure (BP) goal (mm Hg) for patients
timeFrame: Up to 48 months participation
measure: Anti-hypertensive medication intensification
timeFrame: Up to 48 months participation
measure: The percentage of participants who are managed by a clinical pharmacist
timeFrame: Up to 48 months participation
measure: Team function
timeFrame: Up to 48 months participation
measure: Exploratory outcomes- LDL control levels
timeFrame: Up to 48 months participation
measure: Exploratory outcomes- Smoking status
timeFrame: Up to 48 months participation
measure: Exploratory outcomes- Hypertension-related Emergency department visits
timeFrame: Up to 48 months participation
measure: Exploratory outcomes- Hypertension-related Hospitalizations
timeFrame: Up to 48 months participation
Locations:
city: Rochester
country: United States
facility: Highland Family Medicine
state: New York
Study officials:
affiliation: URMC
name: Kevin Fiscella, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: