Preventing Opioid Overdose Deaths by Empowering Pharmacists to Dispense Naloxone
NCT ID: NCT05093309
Last Updated: 2021-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2018-09-18
2019-09-18
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Intervention
The intervention group received naloxone resources + monthly reminders + educational webinar.
Educational Webinar
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.
Resources
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.
Reminders
Reminders consisted of monthly emails from investigators for the purpose of retaining study engagement.
Control
The control group received naloxone resources + monthly reminders + delayed educational webinar (after the 3-month study period).
No interventions assigned to this group
Interventions
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Educational Webinar
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.
Resources
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.
Reminders
Reminders consisted of monthly emails from investigators for the purpose of retaining study engagement.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Members of the stakeholder panel (from the formative phase of the study).
18 Years
ALL
Yes
Sponsors
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Agency for Healthcare Research and Quality (AHRQ)
FED
Auburn University
OTHER
Responsible Party
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Lindsey Hohmann
Assistant Professor
Principal Investigators
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Lindsey Hohmann, PharmD, PhD
Role: PRINCIPAL_INVESTIGATOR
Auburn University
Locations
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Auburn University Harrison School of Pharmacy
Auburn, Alabama, United States
Countries
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References
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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.
Other Identifiers
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