Fixed-Dose Combinations Pragmatic Randomized Implementation Trial for Blood Pressure Control
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBrigham and Women's Hospital
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Provider nudge
- Patient nudge
- Pharmacist Virtual Visit
Treatment groups
720 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Brigham and Women's Hospital
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Wake Forest University Health Sciences
Collaborator
Source ClinicalTrials.gov