Improving Hypertension Control in Safety-Net Settings: The Boston Hypertension Equity Alliance in Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RBPM, MII.
- Who it may be relevant to
- Registry conditions: Hypertension, Hypertension Complicated. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparative Effectiveness of Interventions to Improve Hypertension Control in Safety-Net Settings: The Boston Hypertension Equity Alliance in Treatment
Overview
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.
Interventions
- 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.
Primary outcome measures
- Systolic blood pressure (SBP) improvement [Time frame: Baseline, every 3 months up to 54 months]
- Interventions received [Time frame: Baseline, 54 months]
- Patient activation [Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months]
Secondary outcome measures (6)
- Blood pressure control [Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months]
- Medication intensification [Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months]
- BP monitoring [Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months]
- Fidelity of interventions [Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months]
- Medication adherence [Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months]
- Trust in primary care [Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 7 centers
- Boston Healthcare for the Homeless (BHCHP) — Boston
- Boston Medical Center Family Medicine — Boston
- Boston Medical Center, General Internal Medicine primary care — Boston
- Neighborhood Health — Boston
- Mattapan Community Health Center — Boston
- Manet Community Health Center — Quincy
- Greater Roslindale Medical and Dental Center (GRMDC) — Roslindale
Identifiers
NCT: NCT06948838 · H-45398 · HMC-2023C2-33345