Improving blood pressure control for patients in safety-net primary care
Comparative Effectiveness of Interventions to Improve Hypertension Control in Safety-Net Settings: The Boston Hypertension Equity Alliance in Treatment
This project will test remote blood pressure monitoring alone versus remote monitoring plus extra treatment support for adults with uncontrolled high blood pressure who receive care at safety-net primary care clinics.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16895 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston Medical Center Academic / other |
| Locations | 7 sites (Boston, Massachusetts and 6 other locations) |
| Trial ID | NCT06948838 on ClinicalTrials.gov |
What this trial studies
This multi-site, hybrid effectiveness-implementation project uses a cluster randomized stepped-wedge design to roll out and compare two approaches: remote blood pressure monitoring (RBPM) alone and RBPM plus a multilevel intensification intervention (MII). The study will collect clinical outcomes and patient-reported outcomes while using mixed quantitative and qualitative methods guided by the RE-AIM framework to evaluate reach, adoption, fidelity, and maintenance. Each participating clinic will sequentially implement both approaches so sites can be compared within the pragmatic care setting. The design emphasizes real-world implementation in diverse, urban safety-net primary care populations.
Who should consider this trial
Good fit: Adults over 18 who receive primary care at one of the participating Boston safety-net clinics, have hypertension with recent primary care contact, and have uncontrolled systolic blood pressure above 140 are ideal candidates.
Not a fit: People who already have controlled blood pressure, do not receive care at the participating clinics, or are unable or unwilling to participate in remote blood pressure monitoring may not receive benefit from this project.
Why it matters
Potential benefit: If successful, the interventions could help more patients achieve controlled blood pressure and reduce risks of stroke, heart attack, and kidney disease by improving monitoring and treatment in safety-net clinics.
How similar studies have performed: Previous studies have shown that remote blood pressure monitoring and treatment intensification can improve blood pressure control, but their comparative effectiveness and implementation in safety-net settings remains unclear.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (age\>18) patients receiving primary care at one of the 9 participating sites, with primary care provider (PCP) visit in the preceding year * Presence of HTN defined by one or more of: 1) diagnosis included on active problem list, 2) active HTN medications in prior year, 3) 3 separate elevated BP measurements * Uncontrolled HTN defined as systolic blood pressure (SBP)\>140 Exclusion Criteria: * Not meeting the inclusion criteria
Where this trial is running
Boston, Massachusetts and 6 other locations
- Boston Healthcare for the Homeless (BHCHP) — Boston, Massachusetts, United States (Recruiting)
- Boston Medical Center Family Medicine — Boston, Massachusetts, United States (Recruiting)
- Boston Medical Center, General Internal Medicine primary care — Boston, Massachusetts, United States (Recruiting)
- Neighborhood Health — Boston, Massachusetts, United States (Recruiting)
- Mattapan Community Health Center — Boston, Massachusetts, United States (Recruiting)
- Manet Community Health Center — Quincy, Massachusetts, United States (Recruiting)
- Greater Roslindale Medical and Dental Center (GRMDC) — Roslindale, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Michael Fischer, MD MS — Boston Medical Center, Internal Medicine
- Study coordinator: Michael Fischer, MD MS
- Email: Michael.Fischer@bmc.org
- Phone: (617) 414-7288
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.