Fixed-Dose Combinations Pragmatic Randomized Implementation Trial for Blood Pressure Control
Part of paid clinical trials in Milwaukee, Wisconsin.
- Sponsor
- Brigham and Women's Hospital
- Study ID
- NCT07228065
- Status
- Enrolling By Invitation
Conditions
- Hypertension
- Primary Care
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Provider nudge — BEHAVIORALPharmacists will deliver targeted nudges to providers through clinical decision support integrated into the electronic health record (EHR)
- Patient nudge — BEHAVIORALPatients will receive pharmacist-delivered nudges (e.g., text messages) 1-7 days before their visit to encourage fixed-dosed combinations
- Pharmacist Virtual Visit — BEHAVIORALPatients will receive pharmacist counseling and prescribing delivered via virtual encounters after their visit
Study Details
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.
Key Dates
- First listed
- Nov 13, 2025
- Start date
- Aug 7, 2026
- Status verified
- Aug 2026
- Primary completion
- Apr 30, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 720 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Active Comparator: Provider nudge onlyPharmacists will deliver targeted nudges to providers through clinical decision support integrated into the EHR.
- Experimental: Provider nudge + Patient nudgeIn addition to provider nudges (Provider nudge only arm), patients will receive pharmacist delivered nudges (e.g., text messages) 1-7 days before the visit to encourage fixed dose combination medications.
- Experimental: Provider nudge + Pharmacist Virtual VisitIn addition to provider nudges (Provider nudge only arm), patients will receive pharmacist counseling and prescribing delivered via virtual encounters after the visit.
Primary Outcome Measure
Change in systolic blood pressure [ Time Frame: 6 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Advocate Health | Milwaukee | Wisconsin | 53233 | - |
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