Palo Alto Veterans Affairs Healthcare System
Palo Alto, California, 94304, United States
NCT Number: NCT07460219
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Palo Alto, California, 94304, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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 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.
Time frame: Up to 12 months
Number of encounters in which pharmacist adjusted heart failure medications
Time frame: Up to 12 months
Number of encounters in which pharmacist documented heart failure care
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)
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
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
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
Time frame: At 12 months follow-up
Percentage of patients with heart failure in each pharmacist panel that are treated with MRA therapy
Time frame: At 12 months follow-up
Percentage of patients with heart failure in each pharmacist panel that are treated with SGLT2i therapy
Stanford University
Other
Acronym: PHARM-HF-2
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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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