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HypertensionMonitorBPNCT05885997

Implementing a Home Blood Pressure Monitoring Program in Primary Care

A study testing Supported HBPM program plus multifaceted implementation strategy in people with Hypertension, run by Columbia University at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Hypertension
What is being tested?
Supported HBPM program plus multifaceted implementation strategy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23,928 participants
Where
2 sitesUnited States
Study dates
1 Nov 2023to 31 Dec 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 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

Who cannot join

  • 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
  • Medical director declines participation in the trial
  • Site for pilot testing the supported HBPM program or its implementation strategy

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Columbia University Irving Medical Center

    New York, New York, 10032

  • Weill Medical College of Cornell University

    New York, New York, 10065

Other trials in United States

About this study

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

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.

Read the detailed 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.

Conditions
Hypertension
Being tested
Supported HBPM program plus multifaceted implementation strategy, Usual care
Keywords
home blood pressure monitoring, remote patient monitoring, self-measured blood pressure monitoring, implementation science
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supported HBPM program plus multifaceted implementation strategyBehavioural

    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
  • Usual careOther

    Usual care

Study groups in NCT05885997
Study groupRoleWhat they receive
Intervention Clinics, Pre-Implementation PeriodExperimentalUsual care
Receives: Other: Usual care
Intervention Clinics, Post-Implementation PeriodExperimentalAccess to Supported HBPM program plus a multifaceted implementation strategy designed to increase uptake of the program by primary care patients with uncontrolled hypertension
Receives: Behavioral: Supported HBPM program plus multifaceted implementation strategy
Control Clinics, Pre-Implementation PeriodOtherUsual care
Receives: Other: Usual care
Control Clinics, Post-Implementation PeriodOtherUsual care
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 months

Secondary outcomes (4)
  1. 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

    Measured: 12 months

  2. 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

    Measured: 12 months

  3. Antihypertensive medication adherence

    Change in the proportion of days covered by antihypertensive medications from the 6 months prior to the index visit to 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.

    Measured: 12 months

  4. 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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2023
  2. Study start1 Nov 2023
  3. Primary completion20 Oct 2026
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
23,928 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05885997
Sponsor's protocol ID
AAAS5544
Other IDs
R01HL152699
Acronym
MonitorBP
Status last verified
Oct 2026
First submitted
23 May 2023
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: A de-identified data archive that contains raw study data will be posted on an open science platform.

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