Fixed-Dose Combinations Pragmatic Randomized Implementation Trial for Blood Pressure Control (FIX-BP)

Pharmacy-led Intervention to Increase the Adoption of Fixed-dose Single Pill Blood Pressure Lowering Medications: Hybrid Effectiveness-Implementation 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Primary Care
• Intervention / Treatment: Behavioral: Provider nudge; Behavioral: Patient nudge; Behavioral: Pharmacist Virtual Visit

• Study Type: Interventional
• Enrollment (Estimated): 720
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie Lauffenburger, PharmD, PhD; Phone Number: 617-525-8865; Email: jlauffenburger@bwh.harvard.edu
• Study Contact Backup: Name: Rasha Khatib, PhD, MHS; Email: rasha.alkhatib@aah.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Provider nudge only; Pharmacists will deliver targeted nudges to providers through clinical decision support integrated into the EHR.	Behavioral: Provider nudge; Pharmacists will deliver targeted nudges to providers through clinical decision support integrated into the electronic health record (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.	Behavioral: Provider nudge; Pharmacists will deliver targeted nudges to providers through clinical decision support integrated into the electronic health record (EHR); Behavioral: Patient nudge; Patients will receive pharmacist-delivered nudges (e.g., text messages) 1-7 days before their visit to encourage fixed-dosed combinations
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.	Behavioral: Provider nudge; Pharmacists will deliver targeted nudges to providers through clinical decision support integrated into the electronic health record (EHR); Behavioral: Pharmacist Virtual Visit; Patients will receive pharmacist counseling and prescribing delivered via virtual encounters after their visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in systolic blood pressure	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in diastolic blood pressure	Change in diastolic blood pressure from qualifying visit blood pressure reading to the end of the 6-month follow-up, using EHR data	6 months
Percentage of patients with well-controlled blood pressure	Percentage of patients who reach blood pressure control defined as <140/90mmHg	6 months
PCP level adoption: FDC prescribing; FDC discussion in EHR notes	Percentage of patients whose PCPs prescribe FDC within 6 months; any intensification at 6 months will also be explored; any FDC documentation in the notes	6 months
Patient level adoption: FDC adherence (fill)	Percentage of patients who fill their first FDC prescription within 6 months; filling any intensified prescription within 6 months will also be explored.	6 months

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Institute on Aging (NIA); Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: November 12, 2025
• First Submitted That Met QC Criteria: November 12, 2025
• First Posted (Actual): November 13, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: 2025P002849; 2P30AG064199 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No