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临床试验/NCT07460219
NCT07460219Enrolling By Invitation不适用

Veterans Affairs Pharmacist Heart Failure Medication Titration Project 2

Stanford University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年7月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
400
试验地点
1
主要终点
Monthly heart failure medication adjustment encounters

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Site declined

研究组 & 干预措施

Education Only

Active Comparator

Pharmacists practicing at sites randomized to Education Only

干预措施: Education Only (Other)

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.

干预措施: Education and Feedback (E+F) (Other)

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.

干预措施: Education and Feedback (E+F) (Other)

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.

干预措施: Primary Care Referral Nudges (Other)

结局指标

主要结局

Monthly heart failure medication adjustment encounters

时间窗: Up to 12 months

Number of encounters in which pharmacist adjusted heart failure medications

次要结局

  • 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)
  • Mineralocorticoid receptor antagonist (MRA) therapy(At 12 months follow-up)
  • Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2i) therapy(At 12 months follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexander Sandhu

Assistant Professor

Stanford University

研究点 (1)

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