Pharmacy-led Intervention to Increase the Adoption of Fixed-dose Single Pill Blood Pressure Lowering Medications: A Pragmatic RCT

Not Applicable

Not yet recruiting

• Conditions: Hypertension; Primary Care

• Registration Number: NCT07228065
• Lead Sponsor: Brigham and Women's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-11
• Study First Submitted: 2025-11-12
• Study First Submitted QC: 2025-11-12
• Last Update Submitted: 2025-11-12
• Study First Posted: 2025-11-13
• Last Update Posted: 2025-11-13
• Study Start: 2026-01-15
• Primary Completion: 2026-08-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 746

Inclusion Criteria

• patients with documented hypertension diagnosis
• had an elevated ambulatory blood pressure reading during the baseline 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

• in nursing homes
• already on a fixed-dose combination medication
• heart or renal failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in systolic blood pressure	3 months	Data for this outcome will be extracted from electronic health records. The primary effectiveness outcome will be a change in ambulatory systolic blood pressure at 3 months. For patients who do not return within 3 months, their index visit reading will be carried forward.

Secondary Outcome Measures

Name	Time	Method
Provider adoption	3 months	Data for this outcome will be extracted from electronic health records. Adoption will be definted as the proportion of patients whose providers prescribe FDC wtihin 3 months
Patient adoption	3 months	Data for this outcome will be extracted from prescription fill data that is merged with electronic health records. Adoption is defined as the proportion of patients who fill their first FDC prescription within 3 months.