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临床试验/NCT05093309
NCT05093309已完成不适用

Preventing Opioid Overdose Deaths by Empowering Pharmacists to Dispense Naloxone

Auburn University2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2018年9月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
2
主要终点
Change in naloxone knowledge from baseline to immediately post-intervention and 3 months post-intervention

研究概览

简要总结

Objectives: The purpose of this study was to assess the impact of the Empowering Community Pharmacists program on pharmacists' knowledge, perceived barriers, attitudes, confidence, and intentions regarding naloxone services implementation, as well as change in number of naloxone prescriptions dispensed.

Methods: A 3-month pragmatic randomized controlled trial was conducted in 2018-2019. Alabama community pharmacists were recruited by email, phone, fax, and mailed postcards and randomized to intervention (monthly resources/reminders + educational webinar) or control (monthly resources/reminders + delayed educational webinar). Outcome measures were assessed via online surveys at baseline (T1), immediately post-intervention (T2), and 3-months post-intervention (T3), including: naloxone knowledge (percent correct); perceived barriers, attitudes, and confidence regarding naloxone services implementation (7-point Likert-type scale, 1=strongly disagree to 7=strongly agree); and number of naloxone prescriptions dispensed. Mean differences between control and intervention groups from T1-T3 were assessed using two-way mixed ANOVA and adjusted analyses were conducted using generalized estimating equations (GEE) with negative binomial distribution (alpha=0.05).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • Registered pharmacists.
  • Employed at least 30 hours per week at a community pharmacy.
  • Employed at a community pharmacy located in one of 20 Alabama priority counties with the highest opioid overdose mortality rates.

排除标准

  • Multiple pharmacists from the same pharmacy site.
  • Members of the stakeholder panel (from the formative phase of the study).

结局指标

主要结局

Change in naloxone knowledge from baseline to immediately post-intervention and 3 months post-intervention

时间窗: 3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)

Knowledge about naloxone was measured via online survey. Knowledge was measured as percent correct on a 7-item index adapted from Williams' (2013) Opioid Overdose Knowledge Scale (OOKS).

Change in confidence from baseline to immediately post-intervention and 3 months post-intervention

时间窗: 3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)

Confidence in performing naloxone dispensing behaviors was measured via online survey. Confidence (10-items) was measured using 7-point Likert-type scales (1=strongly disagree, 7=strongly agree) and informed by Nielsen et al (2016) and Williams' (2013) Opioid Overdose Attitude Scale (OOAS).

Change in intention from baseline to immediately post-intervention and 3 months post-intervention

时间窗: 3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)

Intention to dispense naloxone or perform naloxone services in the next three months was measured via online survey. The 5-item intention construct was measured using a 7-point Likert-type scale from 1=strongly disagree to 7=strongly agree and informed by an existing intention measure by Urmie et al (2007).

Change in perceived barriers from baseline to immediately post-intervention and 3 months post-intervention

时间窗: 3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)

Perceived barriers to adoption/implementation of pharmacy-based naloxone services was measured via online survey. Barriers (20-items) were measured using 7-point Likert-type scales (1=strongly disagree, 7=strongly agree) and informed by Nielsen et al (2016) and Williams' (2013) Opioid Overdose Attitude Scale (OOAS).

Change in attitudes from baseline to immediately post-intervention and 3 months post-intervention

时间窗: 3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)

Attitudes regarding pharmacy-based naloxone services was measured via online survey. Attitudes (15-items) were measured using 7-point Likert-type scales (1=strongly disagree, 7=strongly agree) and informed by Nielsen et al (2016) and Williams' (2013) Opioid Overdose Attitude Scale (OOAS).

次要结局

  • Change in number of naloxone prescriptions dispensed from baseline to 3 months post-intervention(3 months: baseline (T1) and 3 months post-intervention (T3))

研究者

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

Lindsey Hohmann

Assistant Professor

Auburn University

研究点 (2)

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