Veterans Affairs Pharmacist Heart Failure Medication Titration Project 2 (PHARM-HF-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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Heart Failure; Quality Improvement; Pharmacotherapy
• Intervention / Treatment: Other: Education Only; Other: Education and Feedback (E+F); Other: Primary Care Referral Nudges

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Palo Alto Veterans Affairs Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Site declined

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Education Only; Pharmacists practicing at sites randomized to Education Only	Other: Education Only; 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.
Experimental: Education and Feedback (E+F) without Primary Care Referral Nudges; Pharmacists practicing at sites randomized to education and feedback but not primary care referral nudges in the nested implementation strategy.	Other: Education 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.
Experimental: Education and Feedback (E+F) with Primary Care Referral Nudges; Pharmacists practicing at sites randomized to education and feedback and the primary care referral nudges in the nested implementation strategy.	Other: Education 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.; Other: Primary 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monthly heart failure medication adjustment encounters	Number of encounters in which pharmacist adjusted heart failure medications	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacist Heart Failure Encounters	Number of encounters in which pharmacist documented heart failure care	Up to 12 months
Guideline medical therapy score	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)	At 12 months follow-up
Beta-blocker therapy	Percentage of patients with heart failure with reduced ejection fraction in each pharmacist panel that are treated with beta-blocker therapy	At 12 months follow-up
Renin-angiotensin system inhibitor (RASI) therapy	Percentage of patients with heart failure with reduced ejection fraction in each pharmacist panel that are treated with RASI therapy	At 12 months follow-up
Angiotensin receptor neprilysin inhibitor (ARNI) therapy	Percentage of patients with heart failure with reduced ejection fraction in each pharmacist panel that are treated with ARNI therapy	At 12 months follow-up
Mineralocorticoid receptor antagonist (MRA) therapy	Percentage of patients with heart failure in each pharmacist panel that are treated with MRA therapy	At 12 months follow-up
Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2i) therapy	Percentage of patients with heart failure in each pharmacist panel that are treated with SGLT2i therapy	At 12 months follow-up

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: September 1, 2025
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: 67031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No