Team-Based Home Blood Pressure Monitoring (TB-HBPM)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; High Blood Pressure
• Intervention / Treatment: Behavioral: Team-Based Home Blood Pressure Monitoring

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

• Study Type: Interventional
• Enrollment (Estimated): 5760
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kevin Fiscella; Phone Number: 585-324-4563; Email: Kevin_Fiscella@urmc.rochester.edu
• Study Contact Backup: Name: Emma Strujo; Phone Number: 585-324-4553; Email: Emma_Strujo@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14620
      • Recruiting
      • Highland Family Medicine
      • Contact: Jennifer Maguire, MD; Phone Number: 585-279-4800; Email: jennifer_maguire@urmc.rochester.eduU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Suite TB-HBPM pre intervention; 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; Implementation of best practices for hypertension control using a practice wide team-based home blood pressure monitoring intervention
Other: Suite TB-HBPM throughout intervention implementation; 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; Implementation of best practices for hypertension control using a practice wide team-based home blood pressure monitoring intervention
Other: Suite TB-HBPM post intervention implementation; Post implementation phase of the suites 2 years after introduction of intervention.	Behavioral: Team-Based Home Blood Pressure Monitoring; Implementation of best practices for hypertension control using a practice wide team-based home blood pressure monitoring intervention

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician mean blood pressure (BP) goal (mm Hg) for patients	We will calculate the mean BP goal for each clinician based on the specified BP goal listed in EHR smartphrase for each of the clinician's patients. The mean goal is calculated by the sum of all systolic (SBP) and diastolic BP (DBP) goals divided by the number of patients with goals for each participating clinician. A reasonable range of mean BP goals are: SBP: 120-150 mm Hg and DBP: 80-100 mm Hg for different clinicians	Up to 48 months participation
Anti-hypertensive medication intensification	Frequency of anti-hypertensive medication intensification (e.g., the number of additions/deletions of anti-hypertensive medication and/or number of changes in dose of anti-hypertensive medication)	Up to 48 months participation
The percentage of participants who are managed by a clinical pharmacist	The percentage of HBPM participants who are managed by a clinical pharmacist based on EHR data	Up to 48 months participation
Team function	Change in team function score based on the score on the TEAMS Tool scale at pre-intervention and post-intervention periods for that wedge. Scale range 14-70 with higher scores indicating better outcomes.	Up to 48 months participation
Exploratory outcomes- LDL control levels	Change in LDL-cholesterol level (mg/dl) based on lipid blood testing in the EHR over 48 months.	Up to 48 months participation
Exploratory outcomes- Smoking status	Change in percent of current smokers among eligible participants based on EHR documentation over 48 months.	Up to 48 months participation
Exploratory outcomes- Hypertension-related Emergency department visits	Change in emergency department visits (number) involving a primary diagnosis of hypertension diagnosis among eligible patients recorded on the emergency department discharge summary from the EHR over 48 months.	Up to 48 months participation
Exploratory outcomes- Hypertension-related Hospitalizations	Change in hospitalization (number) involving a primary diagnosis of hypertension diagnosis among eligible patients recorded on the hospital discharge summary from the EHR over 48 months.	Up to 48 months participation

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Kevin Fiscella, MD, MPH, URMC

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Clinical Trial; Implementation Research; Health Equity; Home blood pressure monitoring; Hypertension control; Primary Care Teams
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: RSRB 6036; R33HL157643 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Data Quality and Management

a. Description of Plan for Data Quality and Management - The PI will review all data collection forms on an ongoing basis for data completeness and accuracy as well as protocol compliance. A statement reflecting the results of the review will be sent to the NIH in the annual report. The EHR is the primary data source. EHR data quality will be assessed using extreme outlier data, missing data for outcome variables (i.e. office or transmitted blood pressure readings, dates of visits, participant ID), and loss to follow-up (no data for the participant appears in EHR, e.g. due to relocation, left practice etc). Note: clinical staff will conduct outreach to all participants as part of sound clinical practice. Regular data checks and data cleaning will be deployed to optimize data quality. Multiple imputation methods will be used as necessary to address missing data as described in the statistical analysis.

• IPD Sharing Time Frame: No personally identifiable information will be transcribed. The de-identified data will be stored in a password-protected file on a secure URMC shared drive housed in the Department of Family Medicine. Only the research team will have access to the de-identified data. 7 years after the completion of the study, the audio recordings will destroyed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No