MedDataX Logo

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

NCT ID: NCT07228065

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

746 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-15

Study Completion Date

2026-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension Primary Care

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Provider nudge only

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

Group Type ACTIVE_COMPARATOR

Provider nudge

Intervention Type BEHAVIORAL

Pharmacists will deliver targeted nudges to providers through clinical decision support integrated into the electronic health record (EHR)

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.

Group Type EXPERIMENTAL

Provider nudge

Intervention Type BEHAVIORAL

Pharmacists will deliver targeted nudges to providers through clinical decision support integrated into the electronic health record (EHR)

Patient nudge

Intervention Type BEHAVIORAL

Patients will receive pharmacist-delivered nudges (e.g., text messages) 1-7 days before their visit to encourage fixed-dosed combinations

Provider nudge + Pharmacist collaborative practice agreement (CPA)

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

Group Type EXPERIMENTAL

Provider nudge

Intervention Type BEHAVIORAL

Pharmacists will deliver targeted nudges to providers through clinical decision support integrated into the electronic health record (EHR)

Pharmacist Collaborative Practice Agreement (CPA)

Intervention Type BEHAVIORAL

Patients will receive pharmacist counseling and prescribing delivered via virtual encounters after their visit

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Provider nudge

Pharmacists will deliver targeted nudges to providers through clinical decision support integrated into the electronic health record (EHR)

Intervention Type BEHAVIORAL

Patient nudge

Patients will receive pharmacist-delivered nudges (e.g., text messages) 1-7 days before their visit to encourage fixed-dosed combinations

Intervention Type BEHAVIORAL

Pharmacist Collaborative Practice Agreement (CPA)

Patients will receive pharmacist counseling and prescribing delivered via virtual encounters after their visit

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Julie Lauffenburger

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Julie Lauffenburger, PharmD, PhD

Role: CONTACT

Phone: 617-525-8865

Email: [email protected]

Rasha Khatib, PhD, MHS

Role: CONTACT

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2P30AG064199

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2025P002849

Identifier Type: -

Identifier Source: org_study_id