NCT07228065

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
720

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
13mo left

Started May 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
May 2026May 2027

First Submitted

Initial submission to the registry

November 12, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

March 27, 2026

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

November 12, 2025

Last Update Submit

March 24, 2026

Conditions

HypertensionPrimary Care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in diastolic blood pressure

    6 months

  • Percentage of patients with well-controlled blood pressure

    6 months

  • PCP level adoption: FDC prescribing; FDC discussion in EHR notes

    6 months

  • Patient level adoption: FDC adherence (fill)

    6 months

Study Arms (3)

Provider nudge only

ACTIVE COMPARATOR

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

Behavioral: Provider nudge

Provider nudge + Patient nudge

EXPERIMENTAL

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 nudgeBehavioral: Patient nudge

Provider nudge + Pharmacist Virtual Visit

EXPERIMENTAL

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 nudgeBehavioral: Pharmacist Virtual Visit

Interventions

Patient nudgeBEHAVIORAL

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

Provider nudge + Patient nudge
Provider nudgeBEHAVIORAL

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

Provider nudge + Patient nudgeProvider nudge + Pharmacist Virtual VisitProvider nudge only
Pharmacist Virtual VisitBEHAVIORAL

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

Provider nudge + Pharmacist Virtual Visit

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Julie Lauffenburger, PharmD, PhD

CONTACT

617-525-8865jlauffenburger@bwh.harvard.edu

Rasha Khatib, PhD, MHS

CONTACT

rasha.alkhatib@aah.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 12, 2025

First Posted

November 13, 2025

Study Start

May 1, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

March 27, 2026

Record last verified: 2025-12