Veterans Affairs Pharmacist Heart Failure Medication Titration Project 2

Overview

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

• 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.
• 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.

Primary outcome measures

• Monthly heart failure medication adjustment encounters [Time frame: Up to 12 months]

Secondary outcome measures (7)

• Pharmacist Heart Failure Encounters [Time frame: Up to 12 months]
• Guideline medical therapy score [Time frame: At 12 months follow-up]
• Beta-blocker therapy [Time frame: At 12 months follow-up]
• Renin-angiotensin system inhibitor (RASI) therapy [Time frame: At 12 months follow-up]
• Angiotensin receptor neprilysin inhibitor (ARNI) therapy [Time frame: At 12 months follow-up]
• Mineralocorticoid receptor antagonist (MRA) therapy [Time frame: At 12 months follow-up]
• Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2i) therapy [Time frame: At 12 months follow-up]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• Site declined

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 1 center

• Palo Alto Veterans Affairs Healthcare System — Palo Alto

Identifiers

NCT: NCT07460219 · 67031

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗