Preventing Opioid Overdose Deaths by Empowering Pharmacists to Dispense Naloxone

NCT05093309 | Completed

• 1 other identifier: R36HS026669-01A1
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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).

Conditions

Opioid Overdose

Keywords

naloxone; community pharmacy; implementation

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (1)

• Change in number of naloxone prescriptions dispensed from baseline to 3 months post-intervention

  3 months: baseline (T1) and 3 months post-intervention (T3)

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group received naloxone resources + monthly reminders + educational webinar.

Behavioral: Educational Webinar; Behavioral: Resources; Behavioral: Reminders

Control

NO INTERVENTION

The control group received naloxone resources + monthly reminders + delayed educational webinar (after the 3-month study period).

Interventions

Educational Webinar BEHAVIORAL

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.

Also known as: Empowering Community Pharmacists Webinar

Intervention

Resources BEHAVIORAL

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.

Also known as: Flyers

Intervention

Reminders BEHAVIORAL

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

Also known as: Nudge

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Multiple pharmacists from the same pharmacy site.
• Members of the stakeholder panel (from the formative phase of the study).

Sponsors & Collaborators

• Auburn University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Auburn University Harrison School of Pharmacy

Auburn, Alabama, 36849, United States

Location

Related Publications (1)

• 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.

  PMID: 36047381 DERIVED

MeSH Terms

Conditions

Opiate Overdose

Interventions

Health Resources

Condition Hierarchy (Ancestors)

Drug Overdose; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Lindsey Hohmann, PharmD, PhD

  Auburn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 26, 2021
• Study Start: September 18, 2018
• Primary Completion: September 18, 2019
• Study Completion: September 18, 2019
• Last Updated: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)