Implementing a Home Blood Pressure Monitoring Program in Primary Care

Hypertension Clinical Trial

— MonitorBP  

Official title:

Implementing a Home Blood Pressure Monitoring Program to Improve Hypertension Control in a Primary Care Network: the MonitorBP Cluster Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05885997
• Other study ID #: AAAS5544
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: November 1, 2027

Study information

• Verified date: November 2023
• Source: Columbia University
• Contact: Maria-Jose Lopez-Sanchez, MPH
• Phone: 212-342-1335
• Email: ml4419[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this research is to determine whether a theory-informed implementation strategy is successful at increasing the uptake of a supported home blood pressure monitoring (HBPM) program as well as to determine the effectiveness of this evidence-based practice when implemented across multiple practices serving a diverse patient population.

Description:

Hypertension guidelines now strongly recommend that patients with hypertension monitor their blood pressure (BP) at home (i.e., home BP monitoring; HBPM) as an approach to improving BP control so long as HBPM is conducted with clinical support (i.e., supported HBPM). Yet, few health systems have systematically implemented HBPM programs, and less than 20% of hypertensive patients routinely measure their BP at home, resulting in a gap in the translation of evidence-based recommendations into practice.

While there is strong evidence for Supported HBPM from pragmatic randomized controlled trials (RCTs), the evidence has been generated from the subgroup of patients and clinicians who volunteered to participate in trials, and the sample sizes have been in the hundreds of patients. There remains a gap in assessing the effectiveness of a scaled-up HBPM program that seeks to maximize the enrollment of primary care patients with uncontrolled hypertension.

Accordingly, in partnership with health system leaders at New York-Presbyterian Hospital (NYP), Columbia University Irving Medical Center, and Weill Cornell Medicine, the study investigator leveraged a system-wide investment in telemedicine to develop a telemonitoring-enabled Supported HBPM program. The Supported HBPM program consists of two options for obtaining electronic health record (EHR)-integrated home BP data. The low resource intensity option is designed for patients that can obtain valid home BP devices and are comfortable using the patient portal. It includes digital support to prompt patients to track their home BP readings in the patient portal using their own BP devices with automated triage support for extreme readings. The high resource intensity option is designed for patients that need additional support with HBPM. It involves navigator support with obtaining and using loaned home BP devices that wirelessly transmit data into the EHR and nursing support to triage extreme readings. Both programs can be ordered by clinicians in the EHR and both provide clinicians with weekly summaries of home BP readings with average home BP already calculated.

The study investigator concurrently followed a theory-driven process (the Behavior Change Wheel) to develop an implementation strategy aimed at increasing uptake of the Supported HBPM program. The study investigator now plans to implement and evaluate the Supported HBPM program across practices in the NYP, Weill Cornell Medicine, and ColumbiaDoctors primary care network which is comprised of a socioeconomically diverse patient population.

The study will evaluate the program by conducting a parallel-group cluster randomized trial in which 15 practices will be matched and then randomly assigned to early implementation of the Supported HBPM program (intervention) versus usual care with delayed implementation (i.e., wait-list control). Data will be retrospectively collected from a 12 month period before implementation (pre-implementation periods) as well as from a 12 month period after implementation (post-implementation period) to assess outcomes.

If successful, this project will provide a roadmap for widely implementing an EHR-integrated Supported HBPM program, and will accelerate a change in the paradigm of hypertension management from the office to the home.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16000
• Est. completion date: November 1, 2027
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Patient-level

Inclusion Criteria:

• Hypertension (as per International Statistical Classification of Diseases and Related Health Problems (ICD)-10 codes)

• At least one completed primary care office visit during relevant 6-month pre implementation or post-implementation study time period

• Age 18-85 years old

Exclusion Criteria:

• Advanced dementia or other measure of frailty (as per ICD-10 codes)

• Pregnancy during measurement period (as per ICD-10 codes)

• Stage 5 or end-stage kidney disease (as per ICD-10 codes)

• Terminal illness/in hospice care (as per ICD-10 codes)

Practice-level

Inclusion Criteria:

• Primary care practice that provides care to adult patients affiliated with New York Presbyterian's Ambulatory Care Network, ColumbiaDoctors, or Weill Cornell Medicine, including practices that specialize in HIV medicine

Exclusion Criteria:

• Medical director declines participation in the trial

• Site for pilot testing the supported HBPM program or its implementation strategy

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Supported HBPM program plus multifaceted implementation strategy
Supported HBPM Program: Patients are loaned a wireless home BP device or use their own device Navigator or app support for onboarding and engaging patients in HBPM Nursing or app support for monitoring and triaging home BP data for extreme readings EHR integration of order for program and home BP data, with weekly feedback of home BP results to clinicians within the EHR Multifaceted implementation strategy: Clinician education about the benefits of the program as well as training in how to refer and manage patients who are enrolled Prompts and reminders to increase clinician referrals Instructional materials for patients and clinicians Problem-solving meetings to tailor implementation for individual practices

Other:
• Usual care
Usual care

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	New York Presbyterian Hospital, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in patient's office systolic blood pressure (SBP)	Change in patient's office systolic blood pressure (SBP) from index visit to last visit during the subsequent 12 months, among patients with uncontrolled hypertension at the index visit	12 months
Secondary	Office diastolic blood pressure (DBP)	Change in patient's office diastolic blood pressure (DBP) from index visit to last visit during the subsequent 12 months, among patients with uncontrolled hypertension at the index visit	12 months
Secondary	Change in patient's antihypertensive medication regimen intensity	Change in patient's antihypertensive medication regimen intensity as calculated by the Therapeutic Intensity Score from index visit to last visit during the subsequent 12 months, among patients with uncontrolled hypertension at the index visit	12 months
Secondary	Antihypertensive medication adherence	Proportion of days covered by antihypertensive medications during the last 6 months of the 12-month follow-up period, among patients with uncontrolled hypertension at the index visit. Antihypertensive medication adherence will be calculated for each prescribed class of medication and then averaged across all classes.	12 months
Secondary	Uncontrolled hypertension	Percentage of patients whose last office BP during the 12-month follow-up period was SBP>= 140 mmHg or DBP >= 90 mmHg, among all eligible patients	12 months