Fixed-Dose Combinations Pragmatic Randomized Implementation Trial for Blood Pressure Control

Sponsor
Brigham and Women's Hospital
Study ID
NCT07228065
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Provider nudge — BEHAVIORAL
    Pharmacists will deliver targeted nudges to providers through clinical decision support integrated into the electronic health record (EHR)
  • Patient nudge — BEHAVIORAL
    Patients will receive pharmacist-delivered nudges (e.g., text messages) 1-7 days before their visit to encourage fixed-dosed combinations
  • Pharmacist Virtual Visit — BEHAVIORAL
    Patients 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
Jul 31, 2026
Status verified
Jun 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 only
    Pharmacists will deliver targeted nudges to providers through clinical decision support integrated into the EHR.
  • Experimental: Provider nudge + Patient nudge
    In 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 Visit
    In 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 ]

Central Contacts

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