Clinical trial NCT06948838: Improving Hypertension Control in Safety-Net Settings: The Boston Hypertension Equity Alliance in Treatment
Official title: Comparative Effectiveness of Interventions to Improve Hypertension Control in Safety-Net Settings: The Boston Hypertension Equity Alliance in Treatment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Boston Healthcare for the Homeless Program (BHCHP)
name: Boston Medical Center General Internal Medicine primary care (BMC GIM)
name: Boston Medical Center Family Medicine Primary Care (BMC FM)
name: NeighborHealth Center Family Medicine at Maverick Street (NH FM)
name: NeighborHealth Center Internal Medicine at Gove Street (NH IM)
name: NeighborHealth South End (NH South End)
name: Manet Community Health Center (Maner CHC)
name: Mattapan Community Health Center (Mattapan)
name: Greater Roslindale Medical and Dental Center (GRMDC)
name: Boston University School of Public Health (BUSPH)
name: BUSPH Biostatistics and Epidemiology Data Analytics Center (BEDAC)
First posted: 2025-04-29
Enrollment: 16895
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

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

Primary outcomes:
measure: Systolic blood pressure (SBP) improvement
timeFrame: Baseline, every 3 months up to 54 months
measure: Interventions received
timeFrame: Baseline, 54 months
measure: Patient activation
timeFrame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
Secondary outcomes:
measure: Blood pressure control
timeFrame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
measure: Medication intensification
timeFrame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
measure: BP monitoring
timeFrame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
measure: Fidelity of interventions
timeFrame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
measure: Medication adherence
timeFrame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
measure: Trust in primary care
timeFrame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
Other outcomes:
Locations:
Study officials:
affiliation: Boston Medical Center, Internal Medicine
name: Michael Fischer, MD MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Health Equity Research, Evaluation & Policy, MA League of CHCs
name: Cheryl Clark, MD ScD
role: PRINCIPAL_INVESTIGATOR
References: