Preventing Opioid Overdose Deaths by Empowering Pharmacists to Dispense Naloxone

Not Applicable

Completed

• Conditions: Opioid Overdose
• Interventions: Behavioral: Educational Webinar; Behavioral: Resources; Behavioral: Reminders

• Registration Number: NCT05093309
• Lead Sponsor: Auburn University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-18
• Primary Completion: 2019-09-18
• Study Completion: 2019-09-18
• Status Verified: 2021-10
• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-10-13
• Last Update Submitted: 2021-10-13
• Study First Posted: 2021-10-26
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Resources	The intervention group received naloxone resources + monthly reminders + educational webinar.
Intervention	Reminders	The intervention group received naloxone resources + monthly reminders + educational webinar.
Intervention	Educational Webinar	The intervention group received naloxone resources + monthly reminders + educational webinar.

Primary Outcome Measures

Name	Time	Method
Change in naloxone knowledge from baseline to immediately post-intervention and 3 months post-intervention	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	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	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	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	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Auburn University Harrison School of Pharmacy; 🇺🇸 Auburn, Alabama, United States