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Enrolling By Invitation
NCT07228065
Fixed-Dose Combinations Pragmatic Randomized Implementation Trial for Blood Pressure Control
Conditions: Hypertension, Primary Care
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 720
Sponsor: Brigham and Women's Hospital
Location: Advocate Health Milwaukee Wisconsin
Summary
The proposed study is an effectiveness-implementation hybrid type II trial designed to evaluate the impact of provider- and patient-directed interventions on FDC use. The trial will test the effectiveness of theory-driven nudges tailored to address provider and patient barriers. All interventions will be pharmacist-driven, with pharmacists delivering information via nudges to providers and via nudges or more intensive interventions (i.e., CPA) to patients. Data to evaluate outcomes will be extracted from electronic health records.
Eligibility Criteria
Inclusion Criteria:
* patients with documented hypertension diagnosis
* had an elevated ambulatory blood pressure reading during the qualifying visit (systolic \>140 mmHg or diastolic \>90 mmHg
* have an upcoming scheduled visit
* have an active prescription for 1 blood pressure lowering medication with a fixed-dose combination (FDC) alternative
Exclusion Criteria:
* have received a prescription for a FDC in the preceding two years
* reside in a nursing home
* have a documented allergy to any FDC components
* are pregnant
* preferred language is not English or Spanish, defined as documentation in the EHR indicating a primary language other than English or Spanish, or a documented request for an interpreter in a language other than Spanish
* have a diagnosis of heart failure or renal failure, given that antihypertensive management in these populations typically requires disease-specific regimens and more frequent treatment adjustments
Source: ClinicalTrials.gov (NCT07228065). StuddyBuddy aggregates publicly available trial information.