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Completed

NCT Number: NCT05093309

Preventing Opioid Overdose Deaths by Empowering Pharmacists to Dispense Naloxone

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Auburn University Harrison School of Pharmacy

Auburn, Alabama, 36849, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: Empowering Community Pharmacists Webinar

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.

Other names: Flyers

Reminders

Behavioral

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

Other names: Nudge

Primary outcomes

  1. Change in naloxone knowledge from baseline to immediately post-intervention and 3 months post-intervention

    Time frame: 3 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).

  2. Change in perceived barriers from baseline to immediately post-intervention and 3 months post-intervention

    Time frame: 3 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).

  3. Change in attitudes from baseline to immediately post-intervention and 3 months post-intervention

    Time frame: 3 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).

  4. Change in confidence from baseline to immediately post-intervention and 3 months post-intervention

    Time frame: 3 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).

  5. Change in intention from baseline to immediately post-intervention and 3 months post-intervention

    Time frame: 3 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 outcomes

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

    Time frame: 3 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.

Sponsors and collaborators

Lead sponsor

Auburn University

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 26, 2021
Registry last updated
Oct 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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