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NCT Number: NCT06948838

Improving 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Healthcare for the Homeless (BHCHP), Boston, Massachusetts, United States

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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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RBPM

Behavioral

Standardized blood pressure measurement and treatment protocols in clinical practice.

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.

Primary outcomes

  1. Systolic blood pressure (SBP) improvement

    Time frame: Baseline, every 3 months up to 54 months

    Change in BP abstracted from the electronic health record (EHR).

  2. Interventions received

    Time frame: Baseline, 54 months

    The number and proportion of individuals who receive each intervention.

  3. Patient activation

    Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months

    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.

Secondary outcomes

  1. Blood pressure control

    Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months

    Assessed as Yes/No from EHR records for Systolic BP<140 mmHg and Systolic BP<130 mmHg.

  2. Medication intensification

    Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months

    Assessed from EHR and claims data.

  3. BP monitoring

    Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months

    Assessed by EHR data on the frequency of BP monitoring.

  4. Fidelity of interventions

    Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months

    The number and proportion of individuals who receive all key elements of the interventions based on EHR data.

  5. Medication adherence

    Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months

    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.

  6. Trust in primary care

    Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Justine Scott, MPH

CONTACT

[email protected]

(617) 414-7288

Michael Fischer, MD MS

CONTACT

[email protected]

(617) 414-7288

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

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

Registry information

Official study title

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

Acronym: BHEAT

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Apr 29, 2025
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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