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

NCT06948838 | Recruiting

• 2 other identifiers: H-45398HMC-2023C2-33345
• Study Type: interventional
• Target: 16,895
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Hypertension; Hypertension Complicated

Keywords

Remote blood pressure monitoring (RBPM); HTN management; HTN-related outcomes; Evidence-based health system strategies; Hybrid effectiveness-implementation study; PROs; Diverse urban area; Disparities

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Blood pressure control

  Baseline, 18 months, 30 months, 36 months, 42 months, 54 months

• Medication intensification

  Baseline, 18 months, 30 months, 36 months, 42 months, 54 months

• BP monitoring

  Baseline, 18 months, 30 months, 36 months, 42 months, 54 months

• Fidelity of interventions

  Baseline, 18 months, 30 months, 36 months, 42 months, 54 months

• Medication adherence

  Baseline, 18 months, 30 months, 36 months, 42 months, 54 months

Study Arms (2)

Remote Blood Pressure Monitoring (RBPM)

EXPERIMENTAL

Individual level interventions fo monitor blood pressure.

Behavioral: RBPM

Multilevel Intensification interventions (MII)

EXPERIMENTAL

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; Other: MII

Interventions

RBPM BEHAVIORAL

Standardized blood pressure measurement and treatment protocols in clinical practice.

Multilevel Intensification interventions (MII); Remote Blood Pressure Monitoring (RBPM)

MII OTHER

Team-based interventions including multiple evidence-proven interventions such as clinician decision support, monitoring medication non-adherence, use of combination pills, and formulary modifications.

Multilevel Intensification interventions (MII)

Eligibility Criteria

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

You may qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Boston Healthcare for the Homeless Program (BHCHP): collaborator
• Boston Medical Center General Internal Medicine primary care (BMC GIM): collaborator
• Boston Medical Center Family Medicine Primary Care (BMC FM): collaborator
• NeighborHealth Center Family Medicine at Maverick Street (NH FM): collaborator
• NeighborHealth Center Internal Medicine at Gove Street (NH IM): collaborator
• NeighborHealth South End (NH South End): collaborator
• Manet Community Health Center (Maner CHC): collaborator
• Mattapan Community Health Center (Mattapan): collaborator
• Greater Roslindale Medical and Dental Center (GRMDC): collaborator
• Boston University School of Public Health (BUSPH): collaborator
• BUSPH Biostatistics and Epidemiology Data Analytics Center (BEDAC): collaborator

Study Sites (7)

Boston Healthcare for the Homeless (BHCHP)

Boston, Massachusetts, 02118, United States

RECRUITING

Boston Medical Center Family Medicine

Boston, Massachusetts, 02118, United States

RECRUITING

Boston Medical Center, General Internal Medicine primary care

Boston, Massachusetts, 02118, United States

RECRUITING

Neighborhood Health

Boston, Massachusetts, 02118, United States

RECRUITING

Mattapan Community Health Center

Boston, Massachusetts, 02126, United States

RECRUITING

Manet Community Health Center

Quincy, Massachusetts, 02169, United States

RECRUITING

Greater Roslindale Medical and Dental Center (GRMDC)

Roslindale, Massachusetts, 02131, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Fischer, MD MS

CONTACT

(617) 414-7288; Michael.Fischer@bmc.org

Justine Scott, MPH

CONTACT

(617) 414-7288; Justine.Scott@bmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A hybrid type 1 effectiveness-implementation study with a cluster randomized stepped wedge study design will be used. This will be a longitudinal repeated measures design. RBPM will begin for all clusters in September, 2025. At the end of month 12, MII implementation will begin for the group in the first wedge, with the second and third groups implementing at 6-month intervals thereafter. All sites will continue interventions as part of ongoing operations, with final long-term follow-up assessment at the end of month 54.

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 29, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)