Veterans Affairs Pharmacist Heart Failure Medication Titration Project 2

NCT07460219 | Enrolling By Invitation

• 1 other identifier: 67031
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality Improvement; Pharmacotherapy; Heart Failure

Outcome Measures

Primary Outcomes (1)

• Monthly heart failure medication adjustment encounters

  Number of encounters in which pharmacist adjusted heart failure medications

  Up to 12 months

Secondary Outcomes (7)

• Pharmacist Heart Failure Encounters

  Up to 12 months

• Guideline medical therapy score

  At 12 months follow-up

• Beta-blocker therapy

  At 12 months follow-up

• Renin-angiotensin system inhibitor (RASI) therapy

  At 12 months follow-up

• Angiotensin receptor neprilysin inhibitor (ARNI) therapy

  At 12 months follow-up

Study Arms (3)

Education Only

ACTIVE COMPARATOR

Pharmacists practicing at sites randomized to Education Only

Other: Education Only

Education and Feedback (E+F) without Primary Care Referral Nudges

EXPERIMENTAL

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)

Education and Feedback (E+F) with Primary Care Referral Nudges

EXPERIMENTAL

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); Other: Primary Care Referral Nudges

Interventions

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 Only

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.

Education and Feedback (E+F) with Primary Care Referral Nudges; Education and Feedback (E+F) without Primary Care Referral Nudges

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.

Education and Feedback (E+F) with Primary Care Referral Nudges

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Site declined

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Palo Alto Veterans Affairs Healthcare System

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

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

Model Details: 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

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: March 10, 2026
• Study Start: July 16, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)