Preventing Opioid Overdose Deaths by Empowering Pharmacists to Dispense Naloxone
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).
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Alabama
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Auburn、Alabama、アメリカ、36849
- Auburn University Harrison School of Pharmacy
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Multiple pharmacists from the same pharmacy site.
- Members of the stakeholder panel (from the formative phase of the study).
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:ヘルスサービス研究
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Intervention
The intervention group received naloxone resources + monthly reminders + educational webinar.
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At month 1 of the study period, the educational webinar was presented by expert speakers and consisted of 3 modules: 1) naloxone basics; 2) naloxone service implementation strategies; and 3) naloxone recommendation communication strategies.
Participants were mailed naloxone nasal spray and auto-injector training devices prior to attending the online webinar so that they could follow along during demonstrations.
他の名前:
After completing the baseline survey, both control and intervention groups were provided with a basic publicly available flyer about naloxone dosage forms in order to ensure all participants could provide adequate patient care.
他の名前:
Reminders consisted of monthly emails from investigators for the purpose of retaining study engagement.
他の名前:
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介入なし:Control
The control group received naloxone resources + monthly reminders + delayed educational webinar (after the 3-month study period).
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Change in naloxone knowledge from baseline to immediately post-intervention and 3 months post-intervention
時間枠:3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
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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).
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3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
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Change in perceived barriers from baseline to immediately post-intervention and 3 months post-intervention
時間枠:3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
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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).
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3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
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Change in attitudes from baseline to immediately post-intervention and 3 months post-intervention
時間枠:3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
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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).
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3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
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Change in confidence from baseline to immediately post-intervention and 3 months post-intervention
時間枠:3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
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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).
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3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
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Change in intention from baseline to immediately post-intervention and 3 months post-intervention
時間枠:3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
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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).
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3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Change in number of naloxone prescriptions dispensed from baseline to 3 months post-intervention
時間枠:3 months: baseline (T1) and 3 months post-intervention (T3)
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The number of naloxone prescriptions dispensed over 3 months before and after the intervention was assessed via self-report at T1 and T3.
Participants utilized national drug codes (NDCs) within their pharmacy dispensing software to identify naloxone dispensing information.
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3 months: baseline (T1) and 3 months post-intervention (T3)
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Lindsey Hohmann, PharmD, PhD、Auburn University
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- R36HS026669-01A1 (米国 AHRQ グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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