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Enrolling by Invitation

NCT Number: NCT07460219

Veterans Affairs Pharmacist Heart Failure Medication Titration Project 2

Nurse or pharmacist led GDMT management programs have been shown to effectively increase GDMT rates. The Veterans Healthcare Administration (VHA) has a pharmacist-based HF remote management program that uses an online, real-time, patient dashboard to optimize HF therapy. However, only a minority of VHA patients with recent-onset HF received HF care from pharmacists, with many of the encounters being limited to monitoring and education. Expanding the pharmacist program is a goal, but how to successfully implement this is unclear.

The PHARM-HF-2 Project is a multi-site pragmatic randomized quality improvement project that evaluates two different interventions. First, the project evaluates if education and feedback messages increase the frequency of pharmacist HF medication management compared with education alone. Second, the project evaluates if primary care nudges to refer patients with heart failure to pharmacy care increase the frequency of pharmacist HF medication management compared with usual care.

PHARM-HF-2 is a cluster randomized project at the level of the clinical site in a stepped wedge design. A total of 22 VHA sites will be randomized to different time points at which they begin receiving the intervention. In the initial phase, all sites will receive education only. At intervals of 2 months, 4 sites will transition from education only to audit and feedback with education in a randomized order. By the end of the project, all sites will be receiving the monthly audit and feedback intervention.

The second implementation strategy is nested within the primary strategy among sites randomized to education and feedback. Primary care referral nudges will studied with a two-arm parallel design with randomization at the level of the primary care team (PACT team) with 1:1 allocation stratified by site. This nested evaluation will start four months into the study.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Palo Alto Veterans Affairs Healthcare System

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Primary care pharmacist within one of three VA regions (6, 10, and 19)

Exclusion criteria

  • Site declined

Treatment and study plan

Education only

Other

Pharmacists will be informed regarding the educational material on a VHA Sharepoint site. The educational information will include suggested titration protocols, education about heart failure medications, a frequently asked questions document, guideline documents, patient educational material, and recordings of Teams webinars on heart failure management. The pharmacists will be invited to a regular webinar regarding heart failure medication management.

Education and Feedback (E+F)

Other

Primary care pharmacists with a heart failure action within the last year will receive a monthly Teams message. The monthly Teams message will contain information including their heart failure medication actions over the prior 3 month period. This data will be obtained from VHA pharmacy data. The message will also include reminders regarding the monthly educational sessions and access to the educational sharepoint. They will also receive a Teams calendar hold for the monthly educational meeting.

Primary Care Referral Nudges

Other

Primary care clinicians will receive a weekly email that lists potential patients with HF with reduced ejection fraction with upcoming clinic visits that are not on optimal medication therapy. The message will suggest referral to PACT pharmacists for medication optimization.

Primary outcomes

  1. Monthly heart failure medication adjustment encounters

    Time frame: Up to 12 months

    Number of encounters in which pharmacist adjusted heart failure medications

Secondary outcomes

  1. Pharmacist Heart Failure Encounters

    Time frame: Up to 12 months

    Number of encounters in which pharmacist documented heart failure care

  2. Guideline medical therapy score

    Time frame: At 12 months follow-up

    Composite score of heart failure medical therapy among patients with heart failure for patients within each pharmacists panel (Score range 0-18 with higher scores indicating higher amounts of medical therapy)

  3. Beta-blocker therapy

    Time frame: At 12 months follow-up

    Percentage of patients with heart failure with reduced ejection fraction in each pharmacist panel that are treated with beta-blocker therapy

  4. Renin-angiotensin system inhibitor (RASI) therapy

    Time frame: At 12 months follow-up

    Percentage of patients with heart failure with reduced ejection fraction in each pharmacist panel that are treated with RASI therapy

  5. Angiotensin receptor neprilysin inhibitor (ARNI) therapy

    Time frame: At 12 months follow-up

    Percentage of patients with heart failure with reduced ejection fraction in each pharmacist panel that are treated with ARNI therapy

  6. Mineralocorticoid receptor antagonist (MRA) therapy

    Time frame: At 12 months follow-up

    Percentage of patients with heart failure in each pharmacist panel that are treated with MRA therapy

  7. Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2i) therapy

    Time frame: At 12 months follow-up

    Percentage of patients with heart failure in each pharmacist panel that are treated with SGLT2i therapy

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Acronym: PHARM-HF-2

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2026
Registry last updated
Mar 10, 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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