MonitorBP: Implementing a Home Blood Pressure Monitoring Program in Primary Care
Study Details
Study Description
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 comprised of navigator support and wireless home BP monitoring as well as to determine the effectiveness of this evidence-based practice when implemented across multiple practices serving a diverse patient population.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 HBPM program with navigator and nursing support.
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 wireless, 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 a supported, wireless home BP device, electronic health record (EHR)-integrated HBPM program, and will accelerate a change in the paradigm of hypertension management from the office to the home.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Clinics, Pre-Implementation Period Usual care |
Other: Usual care
Usual care
|
| Experimental: Intervention Clinics, Post-Implementation Period Access to supported HBPM program plus a multifaceted implementation strategy designed to increase uptake of the program by primary care patients with uncontrolled hypertension |
Behavioral: Supported HBPM program plus multifaceted implementation strategy
Supported HBPM Progam:
Wireless home BP devices
Navigator support for onboarding and engaging patients in HBPM
Nursing support for monitoring home BP data for extreme readings
Multifaceted implementation strategy:
EHR integration of HBPM order and data
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
Problem-solving meetings to tailor implementation for individual practices
|
| Other: Control Clinics, Pre-Implementation Period Usual care |
Other: Usual care
Usual care
|
| Other: Control Clinics, Post-Implementation Period Usual care |
Other: Usual care
Usual care
|
Outcome Measures
Primary Outcome Measures
- Change in patient's office systolic blood pressure (SBP) [12 months]
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
Secondary Outcome Measures
- Office diastolic blood pressure (DBP) [12 months]
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
- Change in patient's antihypertensive medication regimen intensity [12 months]
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
- Antihypertensive medication adherence [12 months]
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.
- Uncontrolled hypertension [12 months]
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
Eligibility Criteria
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)
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Terminal illness/in hospice care (as per ICD-10 codes)
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Do not reside in New York City
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Columbia University Irving Medical Center | New York | New York | United States | 10032 |
Sponsors and Collaborators
- Columbia University
- Weill Medical College of Cornell University
- New York Presbyterian Hospital
Investigators
- Principal Investigator: Ian Kronish, MD, Columbia University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AAAS5544