Clinical trial NCT05885997: Implementing a Home Blood Pressure Monitoring Program in Primary Care
Official title: Implementing a Home Blood Pressure Monitoring Program to Improve Hypertension Control in a Primary Care Network: the MonitorBP Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: home blood pressure monitoring
remote patient monitoring
self-measured blood pressure monitoring
implementation science
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
name: New York Presbyterian Hospital
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-06-02
Enrollment: 23928
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in patient's office systolic blood pressure (SBP)
timeFrame: 12 months
Secondary outcomes:
measure: Office diastolic blood pressure (DBP)
timeFrame: 12 months
measure: Change in patient's antihypertensive medication regimen intensity
timeFrame: 12 months
measure: Antihypertensive medication adherence
timeFrame: 12 months
measure: Uncontrolled hypertension
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Columbia University
name: Ian Kronish, MD
role: PRINCIPAL_INVESTIGATOR
References: