An interventional study of RBPM and MII in Hypertension and Hypertension Complicated, sponsored by Boston Medical Center. Recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Boston Medical Center · Not applicable, Interventional, and Health services research
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.
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:
Exclusion Criteria:
Individual level interventions fo monitor blood pressure.
Behavioral: RBPM
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
Standardized blood pressure measurement and treatment protocols in clinical practice.
Team-based interventions including multiple evidence-proven interventions such as clinician decision support, monitoring medication non-adherence, use of combination pills, and formulary modifications.
Systolic blood pressure (SBP) improvement
Change in BP abstracted from the electronic health record (EHR).
Time frame: Baseline, every 3 months up to 54 months
Interventions received
The number and proportion of individuals who receive each intervention.
Time frame: 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.
Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
Blood pressure control
Assessed as Yes/No from EHR records for Systolic BP\<140 mmHg and Systolic BP\<130 mmHg.
Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
Medication intensification
Assessed from EHR and claims data.
Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
BP monitoring
Assessed by EHR data on the frequency of BP monitoring.
Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
Fidelity of interventions
The number and proportion of individuals who receive all key elements of the interventions based on EHR data.
Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
Medication adherence
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.
Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
Trust in primary care
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.
Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
Plan to share: No
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Boston Medical Center