Clinical trial NCT05093309: Preventing Opioid Overdose Deaths by Empowering Pharmacists to Dispense Naloxone
Official title: Preventing Opioid Overdose Deaths by Empowering Pharmacists to Dispense Naloxone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Overdose
Keywords: naloxone
community pharmacy
implementation
Lead sponsor: Auburn University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2021-10-26
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


Eligibility criteria: 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).

Primary outcomes:
measure: Change in naloxone knowledge from baseline to immediately post-intervention and 3 months post-intervention
timeFrame: 3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
measure: Change in perceived barriers from baseline to immediately post-intervention and 3 months post-intervention
timeFrame: 3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
measure: Change in attitudes from baseline to immediately post-intervention and 3 months post-intervention
timeFrame: 3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
measure: Change in confidence from baseline to immediately post-intervention and 3 months post-intervention
timeFrame: 3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
measure: Change in intention from baseline to immediately post-intervention and 3 months post-intervention
timeFrame: 3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
Secondary outcomes:
measure: Change in number of naloxone prescriptions dispensed from baseline to 3 months post-intervention
timeFrame: 3 months: baseline (T1) and 3 months post-intervention (T3)
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University Harrison School of Pharmacy
state: Alabama
Study officials:
affiliation: Auburn University
name: Lindsey Hohmann, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hohmann LA, Fox BI, Garza KB, Wang CH, Correia C, Curran GM, Westrick SC. Impact of a Multicomponent Educational Intervention on Community Pharmacy-Based Naloxone Services Implementation: A Pragmatic Randomized Controlled Trial. Ann Pharmacother. 2023 Jun;57(6):677-695. doi: 10.1177/10600280221120405. Epub 2022 Sep 1.