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

Mass General Brigham

Status: Not yet enrolling

Conditions: Hypertension; Primary Care

Treatments: Behavioral: Pharmacist Collaborative Practice Agreement (CPA); Behavioral: Provider nudge; Behavioral: Patient nudge

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07228065

2P30AG064199 (U.S. NIH Grant/Contract)

2025P002849

Details and patient eligibility

About

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.

Enrollment: 746 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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746 participants in 3 patient groups

Provider nudge only

Active Comparator group

Description:

Pharmacists will deliver targeted nudges to providers through clinical decision support integrated into the EHR.

Treatment:

Behavioral: Provider nudge

Provider nudge + Patient nudge

Experimental group

Description:

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.

Treatment:

Behavioral: Patient nudge

Behavioral: Provider nudge

Provider nudge + Pharmacist collaborative practice agreement (CPA)

Experimental group

Description:

In addition to provider nudges (Provider nudge only arm), patients will receive pharmacist counseling and prescribing delivered via virtual encounters after the visit.

Treatment:

Behavioral: Provider nudge

Behavioral: Pharmacist Collaborative Practice Agreement (CPA)