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NCT Number: NCT07228065

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Primary Care Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Provider nudge

Behavioral

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

Patient Nudge

Behavioral

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

Pharmacist Virtual Visit

Behavioral

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

Primary outcomes

  1. Change in systolic blood pressure

    Time frame: 6 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 outcomes

  1. Change in diastolic blood pressure

    Time frame: 6 months

    Change in diastolic blood pressure from qualifying visit blood pressure reading to the end of the 6-month follow-up, using EHR data

  2. Percentage of patients with well-controlled blood pressure

    Time frame: 6 months

    Percentage of patients who reach blood pressure control defined as <140/90mmHg

  3. PCP level adoption: FDC prescribing; FDC discussion in EHR notes

    Time frame: 6 months

    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

  4. Patient level adoption: FDC adherence (fill)

    Time frame: 6 months

    Percentage of patients who fill their first FDC prescription within 6 months; filling any intensified prescription within 6 months will also be explored.

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Lauffenburger, PharmD, PhD

CONTACT

[email protected]

617-525-8865

Rasha Khatib, PhD, MHS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Institute on Aging (NIA)
  • Wake Forest University Health Sciences

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 13, 2025
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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