Preventing Opioid Overdose Deaths by Empowering Pharmacists to Dispense Naloxone
13 octobre 2021 mis à jour par: Lindsey Hohmann, Auburn University
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).
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
55
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Alabama
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Auburn, Alabama, États-Unis, 36849
- Auburn University Harrison School of Pharmacy
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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).
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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.
Autres noms:
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.
Autres noms:
Reminders consisted of monthly emails from investigators for the purpose of retaining study engagement.
Autres noms:
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Aucune intervention: Control
The control group received naloxone resources + monthly reminders + delayed educational webinar (after the 3-month study period).
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in naloxone knowledge from baseline to immediately post-intervention and 3 months post-intervention
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in number of naloxone prescriptions dispensed from baseline to 3 months post-intervention
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Lindsey Hohmann, PharmD, PhD, Auburn University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
18 septembre 2018
Achèvement primaire (Réel)
18 septembre 2019
Achèvement de l'étude (Réel)
18 septembre 2019
Dates d'inscription aux études
Première soumission
4 octobre 2021
Première soumission répondant aux critères de contrôle qualité
13 octobre 2021
Première publication (Réel)
26 octobre 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 octobre 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 octobre 2021
Dernière vérification
1 octobre 2021
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R36HS026669-01A1 (Subvention/contrat AHRQ des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Non
Description du régime IPD
In order to protect confidentiality of participants, data will not be shared.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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