RBPM
BehavioralStandardized blood pressure measurement and treatment protocols in clinical practice.
NCT Number: NCT06948838
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Boston Healthcare for the Homeless (BHCHP), Boston, Massachusetts, United States
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline, every 3 months up to 54 months
Change in BP abstracted from the electronic health record (EHR).
Time frame: Baseline, 54 months
The number and proportion of individuals who receive each intervention.
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.
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.
Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
Assessed from EHR and claims data.
Time frame: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
Assessed by EHR data on the frequency of BP monitoring.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Justine Scott, MPH
CONTACT
Michael Fischer, MD MS
CONTACT
Boston Medical Center
Other
Comparative Effectiveness of Interventions to Improve Hypertension Control in Safety-Net Settings: The Boston Hypertension Equity Alliance in Treatment
Acronym: BHEAT
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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