Improving Hypertension Control in Safety-Net Settings: The Boston Hypertension Equity Alliance in Treatment (BHEAT)

Comparative Effectiveness of Interventions to Improve Hypertension Control in Safety-Net Settings: The Boston Hypertension Equity Alliance in Treatment

High blood pressure (BP) or hypertension (HTN) affects over 100 million individuals in the US, increasing the risk of adverse outcomes, including stroke, myocardial infarction (MI), and chronic kidney disease (CKD). Effective therapies include non-pharmacologic approaches and multiple medication classes. Successful HTN management requires ongoing patient engagement for BP monitoring and treatment intensification. Reaching this goal is challenging, and many patients with HTN do not have controlled BP.

Using a collaborative partnership between patients, clinicians, health system and public health stakeholders, and the research team the investigators plan to overcome barriers to widespread implementation of evidence-based health system strategies to improve BP control in a large, urban, primary care-based safety-net setting for diverse populations experiencing disparities in HTN-related outcomes.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Hypertension Complicated
• Intervention / Treatment: Behavioral: RBPM; Other: MII

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 16895
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Fischer, MD MS; Phone Number: (617) 414-7288; Email: Michael.Fischer@bmc.org
• Study Contact Backup: Name: Justine Scott, MPH; Phone Number: (617) 414-7288; Email: Justine.Scott@bmc.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Boston Healthcare for the Homeless (BHCHP)
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Boston Medical Center Family Medicine
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Boston Medical Center, General Internal Medicine primary care
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Neighborhood Health
    • Boston, Massachusetts, United States, 02126
      • Recruiting
      • Mattapan Community Health Center
    • Quincy, Massachusetts, United States, 02169
      • Recruiting
      • Manet Community Health Center
    • Roslindale, Massachusetts, United States, 02131
      • Recruiting
      • Greater Roslindale Medical and Dental Center (GRMDC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote Blood Pressure Monitoring (RBPM); Individual level interventions fo monitor blood pressure.	Behavioral: RBPM; Standardized blood pressure measurement and treatment protocols in clinical practice.
Experimental: Multilevel Intensification interventions (MII); Team-based interventions to mitigate clinical inertia which is the lack of intensification of treatment despite inadequate disease control such as for HTN.	Behavioral: RBPM; Standardized blood pressure measurement and treatment protocols in clinical practice.; Other: MII; Team-based interventions including multiple evidence-proven interventions such as clinician decision support, monitoring medication non-adherence, use of combination pills, and formulary modifications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure (SBP) improvement	Change in BP abstracted from the electronic health record (EHR).	Baseline, every 3 months up to 54 months
Interventions received	The number and proportion of individuals who receive each intervention.	Baseline, 54 months
Patient activation	Patient activation will be assessed with the Consumer Health Activation index (CHAI), a 10 item validated instrument that generates a score of 0-100, with ≥80 indicating moderate/high activation.	Baseline, 18 months, 30 months, 36 months, 42 months, 54 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure control	Assessed as Yes/No from EHR records for Systolic BP<140 mmHg and Systolic BP<130 mmHg.	Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
Medication intensification	Assessed from EHR and claims data.	Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
BP monitoring	Assessed by EHR data on the frequency of BP monitoring.	Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
Fidelity of interventions	The number and proportion of individuals who receive all key elements of the interventions based on EHR data.	Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
Medication adherence	the 3-item self-report scale by Wilson will be used to assess this outcome. It queries patients about how many days they missed medications and overall consistency over the last 30 days. This measure has been standardized to a 0-100 scale, with good adherence defined as ≥80.	Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
Trust in primary care	Assessed with the 10 item Wake Forest Physician Trust Scale. The scale uses a 5-point Likert scale [1=strongly disagree to 5=strongly agree]. Total scores can range from 10 to 50, and higher scores represent greater trust.	Baseline, 18 months, 30 months, 36 months, 42 months, 54 months

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: 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)
• Investigators: Principal Investigator: Michael Fischer, MD MS, Boston Medical Center, Internal Medicine; Principal Investigator: Cheryl Clark, MD ScD, Institute for Health Equity Research, Evaluation & Policy, MA League of CHCs

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: April 15, 2025
• First Submitted That Met QC Criteria: April 21, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: October 9, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Disparities; PROs; Remote blood pressure monitoring (RBPM); HTN management; HTN-related outcomes; Evidence-based health system strategies; Hybrid effectiveness-implementation study; Diverse urban area
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: H-45398; HMC-2023C2-33345 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute (PCORI))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No