Implementing a Home Blood Pressure Monitoring Program in Primary Care

NCT05885997 | Active Not Recruiting

• 2 other identifiers: AAAS5544R01HL152699
• Study Type: interventional
• Target: 23,928
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypertension

Keywords

home blood pressure monitoring; remote patient monitoring; self-measured blood pressure monitoring; implementation science

Outcome Measures

Primary Outcomes (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

  12 months

Secondary Outcomes (4)

• Office diastolic blood pressure (DBP)

  12 months

• Change in patient's antihypertensive medication regimen intensity

  12 months

• Antihypertensive medication adherence

  12 months

• Uncontrolled hypertension

  12 months

Study Arms (4)

Intervention Clinics, Pre-Implementation Period

EXPERIMENTAL

Usual care

Other: Usual care

Intervention Clinics, Post-Implementation Period

EXPERIMENTAL

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

Control Clinics, Pre-Implementation Period

OTHER

Usual care

Other: Usual care

Control Clinics, Post-Implementation Period

OTHER

Usual care

Other: Usual care

Interventions

Supported HBPM program plus multifaceted implementation strategy BEHAVIORAL

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

Intervention Clinics, Post-Implementation Period

Usual care OTHER

Usual care

Control Clinics, Post-Implementation Period; Control Clinics, Pre-Implementation Period; Intervention Clinics, Pre-Implementation Period

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead
• New York Presbyterian Hospital: collaborator
• Weill Medical College of Cornell University: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Weill Medical College of Cornell University

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ian Kronish, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analysts will be blinded to group assignment when analyzing electronic health record data to determine the effectiveness of the program.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine at CUIMC, Associate Director of the Center for Behavioral Cardiovascular Health

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 2, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After completion of major study activities.
• Access Criteria: Access to the data archive will be provided upon request

Locations

US (2)