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Preventing Opioid Overdose Deaths by Empowering Pharmacists to Dispense Naloxone

Preventing Opioid Overdose Deaths by Empowering Pharmacists to Dispense Naloxone

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05093309
Enrollment
55
Registered
2021-10-26
Start date
2018-09-18
Completion date
2019-09-18
Last updated
2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Overdose

Keywords

naloxone, community pharmacy, implementation

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).

Interventions

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.

BEHAVIORALResources

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.

BEHAVIORALReminders

Reminders consisted of monthly emails from investigators for the purpose of retaining study engagement.

Sponsors

Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
Auburn University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Change in naloxone knowledge from baseline to immediately post-intervention and 3 months post-intervention3 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 perceived barriers from baseline to immediately post-intervention and 3 months post-intervention3 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-intervention3 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).
Change in confidence from baseline to immediately post-intervention and 3 months post-intervention3 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-intervention3 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).

Secondary

MeasureTime frameDescription
Change in number of naloxone prescriptions dispensed from baseline to 3 months post-intervention3 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026