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

Boston Medical Center (BMC)

Status: Begins enrollment in 1 month

Conditions: Hypertension; Hypertension Complicated

Treatments: Behavioral: RBPM; Other: MII

Study type: Interventional

Funder types: Other

Identifiers

NCT06948838

HMC-2023C2-33345 (Other Grant/Funding Number)

H-45398

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16,895 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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16,895 participants in 2 patient groups

Remote Blood Pressure Monitoring (RBPM)

Experimental group

Description:

Individual level interventions fo monitor blood pressure.

Treatment:

Behavioral: RBPM

Multilevel Intensification interventions (MII)

Experimental group

Description:

Team-based interventions to mitigate clinical inertia which is the lack of intensification of treatment despite inadequate disease control such as for HTN.

Treatment:

Other: MII

Behavioral: RBPM