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Clinical Trials/NCT05488795
NCT05488795
Active, not recruiting
Not Applicable

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

University of Rochester1 site in 1 country5,760 target enrollmentOctober 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
High Blood Pressure
Sponsor
University of Rochester
Enrollment
5760
Locations
1
Primary Endpoint
Blood pressure control
Status
Active, not recruiting
Last Updated
3 months ago

Overview

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

Registry
clinicaltrials.gov
Start Date
October 1, 2022
End Date
August 31, 2026
Last Updated
3 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kevin Fiscella

Professor, Family Medicine

University of Rochester

Eligibility Criteria

Inclusion 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/

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

Time Frame: 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 Outcomes

  • Participation in Home Blood Pressure Monitoring (HBPM)(Beginning of the intervention for the relevant wedge up to 48 months participation)
  • Blood pressure control by race and ethnicity(Up to 48 months participation)
  • Blood pressure control by insurance(Up to 48 months participation)
  • 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)
  • Transmission of home blood pressure readings(First three months following each participant's enrollment in HBPM)
  • Cost Analysis(Up to 48 months participation)

Study Sites (1)

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