Preventing Opioid Overdose Deaths by Empowering Pharmacists to Dispense Naloxone

Opioid Overdose Clinical Trial

Official title:

Preventing Opioid Overdose Deaths by Empowering Pharmacists to Dispense Naloxone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05093309
• Other study ID #: R36HS026669-01A1
• Status: Completed
• Phase: N/A
• Start date: September 18, 2018
• Est. completion date: September 18, 2019

Study information

• Verified date: October 2021
• Source: Auburn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 18, 2019
• Est. primary completion date: September 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Drug Overdose
• Opiate Overdose
• Opioid Overdose

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Auburn University Harrison School of Pharmacy	Auburn	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
Auburn University	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in naloxone knowledge from baseline to immediately post-intervention and 3 months post-intervention	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).	3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
Primary	Change in perceived barriers from baseline to immediately post-intervention and 3 months post-intervention	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).	3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
Primary	Change in attitudes from baseline to immediately post-intervention and 3 months post-intervention	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).	3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
Primary	Change in confidence from baseline to immediately post-intervention and 3 months post-intervention	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).	3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
Primary	Change in intention from baseline to immediately post-intervention and 3 months post-intervention	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).	3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
Secondary	Change in number of naloxone prescriptions dispensed from baseline to 3 months post-intervention	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.	3 months: baseline (T1) and 3 months post-intervention (T3)