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Veterans Affairs Pharmacist Heart Failure Medication Titration Project 2

Veterans Affairs Pharmacist Heart Failure Medication Titration Project 2

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07460219
Acronym
PHARM-HF-2
Enrollment
400
Registered
2026-03-10
Start date
2025-07-16
Completion date
2026-12-15
Last updated
2026-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality Improvement, Pharmacotherapy, Heart Failure

Brief summary

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.

Interventions

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.

OTHEREducation and Feedback (E+F)

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.

OTHERPrimary Care Referral Nudges

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.

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

This is a multisite randomized quality improvement project. The project evaluates two separate interventions to increase pharmacist HF medication adjustment. In a stepped wedge randomized design, the study will compare education and feedback versus education alone. The education and feedback intervention will be randomized at the level of the clinical site. 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 education and feedback in a randomized order. By the end of the project, all sites will be receiving the monthly education and feedback intervention. The second component of the project will be a parallel randomized project comparing primary care pharmacist referral nudges with usual care. This second project will be nested within sites randomized to education an

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Site declined

Design outcomes

Primary

MeasureTime frameDescription
Monthly heart failure medication adjustment encountersUp to 12 monthsNumber of encounters in which pharmacist adjusted heart failure medications

Secondary

MeasureTime frameDescription
Pharmacist Heart Failure EncountersUp to 12 monthsNumber of encounters in which pharmacist documented heart failure care
Guideline medical therapy scoreAt 12 months follow-upComposite 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)
Beta-blocker therapyAt 12 months follow-upPercentage of patients with heart failure with reduced ejection fraction in each pharmacist panel that are treated with beta-blocker therapy
Renin-angiotensin system inhibitor (RASI) therapyAt 12 months follow-upPercentage of patients with heart failure with reduced ejection fraction in each pharmacist panel that are treated with RASI therapy
Angiotensin receptor neprilysin inhibitor (ARNI) therapyAt 12 months follow-upPercentage of patients with heart failure with reduced ejection fraction in each pharmacist panel that are treated with ARNI therapy
Mineralocorticoid receptor antagonist (MRA) therapyAt 12 months follow-upPercentage of patients with heart failure in each pharmacist panel that are treated with MRA therapy
Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2i) therapyAt 12 months follow-upPercentage of patients with heart failure in each pharmacist panel that are treated with SGLT2i therapy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026