← Back to searchRecruitingRecruiting
Improving Hypertension Control in Safety-Net Settings: The Boston Hypertension Equity Alliance in Treatment
NCT06948838 · Boston Medical Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Comparative Effectiveness of Interventions to Improve Hypertension Control in Safety-Net Settings: The Boston Hypertension Equity Alliance in Treatment
About this study
A hybrid type 1 effectiveness-implementation study will be implemented to evaluate the comparative impact of each intervention on clinical outcomes while also assessing implementation at each site. The multi-site cluster randomized stepped-wedge design allows for feasible resource allocation and sequential roll out of the interventions for comparison, ensuring each site has the opportunity to benefit from both approaches. Data will be collected for multiple patient reported outcomes (PROs) to understand the range of impacts of the interventions from the patient perspective.
The specific aims are to:
* Assess comparative effectiveness of remote BP monitoring (RBPM) versus RBPM + multilevel intensification intervention (MII) on HTN control and quality of care. Prior research has demonstrated the effectiveness of each of these interventions yet the optimal approach to achieve equity in HTN control in safety net practices remains unknown.
* Use mixed methods, guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, to assess implementation of the two comparators as measured by reach, adoption, implementation (fidelity) and maintenance. Using a convergent parallel design, the investigators will use concurrent quantitative and qualitative data to obtain perspectives across multiple levels to understand the reasons for success or failure of implementation of each comparator. By merging these data, integration can be achieved by using qualitative themes related to implementation to support or refute quantitative findings of reach and fidelity.
* Evaluate the comparative impacts of each intervention on PROs assessed with validated measures of patient activation, medication adherence, and trust in medical settings. The study intervention approaches were informed by direct feedback from the targeted diverse patients and clinical providers to address patient-reported barriers to HTN control: lack of activation, adherence to medications, and trust in their care providers.
Eligibility 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
Study design
Enrollment target: 16895 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-09-08
Estimated completion: 2029-09
Last updated: 2025-10-14
Interventions
Behavioral: RBPMOther: MII
Primary outcomes
- • Systolic blood pressure (SBP) improvement (Baseline, every 3 months up to 54 months)
- • Interventions received (Baseline, 54 months)
- • Patient activation (Baseline, 18 months, 30 months, 36 months, 42 months, 54 months)
Sponsor
Boston Medical Center · other
With: Patient-Centered Outcomes Research Institute, Boston Healthcare for the Homeless Program (BHCHP), Boston Medical Center General Internal Medicine primary care (BMC GIM), Boston Medical Center Family Medicine Primary Care (BMC FM), NeighborHealth Center Family Medicine at Maverick Street (NH FM), NeighborHealth Center Internal Medicine at Gove Street (NH IM), NeighborHealth South End (NH South End), Manet Community Health Center (Maner CHC), Mattapan Community Health Center (Mattapan), Greater Roslindale Medical and Dental Center (GRMDC), Boston University School of Public Health (BUSPH), BUSPH Biostatistics and Epidemiology Data Analytics Center (BEDAC)
Contacts & investigators
ContactMichael Fischer, MD MS · contact · Michael.Fischer@bmc.org · (617) 414-7288
ContactJustine Scott, MPH · contact · Justine.Scott@bmc.org · (617) 414-7288
InvestigatorMichael Fischer, MD MS · principal_investigator, Boston Medical Center, Internal Medicine
InvestigatorCheryl Clark, MD ScD · principal_investigator, Institute for Health Equity Research, Evaluation & Policy, MA League of CHCs
All locations (7)
Boston Healthcare for the Homeless (BHCHP)Recruiting
Boston, Massachusetts, United States
Boston Medical Center Family MedicineRecruiting
Boston, Massachusetts, United States
Boston Medical Center, General Internal Medicine primary careRecruiting
Boston, Massachusetts, United States
Neighborhood HealthRecruiting
Boston, Massachusetts, United States
Mattapan Community Health CenterRecruiting
Boston, Massachusetts, United States
Manet Community Health CenterRecruiting
Quincy, Massachusetts, United States
Greater Roslindale Medical and Dental Center (GRMDC)Recruiting
Roslindale, Massachusetts, United States