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Preventing Opioid Overdose Deaths by Empowering Pharmacists to Dispense Naloxone

Primary Purpose

Opioid Overdose

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Webinar
Resources
Reminders
Sponsored by
Auburn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Opioid Overdose focused on measuring naloxone, community pharmacy, implementation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Auburn University Harrison School of Pharmacy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
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).

Secondary Outcome Measures

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.

Full Information

First Posted
October 4, 2021
Last Updated
October 13, 2021
Sponsor
Auburn University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT05093309
Brief Title
Preventing Opioid Overdose Deaths by Empowering Pharmacists to Dispense Naloxone
Official Title
Preventing Opioid Overdose Deaths by Empowering Pharmacists to Dispense Naloxone
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 18, 2018 (Actual)
Primary Completion Date
September 18, 2019 (Actual)
Study Completion Date
September 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Auburn University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Overdose
Keywords
naloxone, community pharmacy, implementation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention group received naloxone resources + monthly reminders + educational webinar.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group received naloxone resources + monthly reminders + delayed educational webinar (after the 3-month study period).
Intervention Type
Behavioral
Intervention Name(s)
Educational Webinar
Other Intervention Name(s)
Empowering Community Pharmacists Webinar
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Resources
Other Intervention Name(s)
Flyers
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Reminders
Other Intervention Name(s)
Nudge
Intervention Description
Reminders consisted of monthly emails from investigators for the purpose of retaining study engagement.
Primary Outcome Measure Information:
Title
Change in naloxone knowledge from baseline to immediately post-intervention and 3 months post-intervention
Description
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).
Time Frame
3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
Title
Change in perceived barriers from baseline to immediately post-intervention and 3 months post-intervention
Description
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).
Time Frame
3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
Title
Change in attitudes from baseline to immediately post-intervention and 3 months post-intervention
Description
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).
Time Frame
3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
Title
Change in confidence from baseline to immediately post-intervention and 3 months post-intervention
Description
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).
Time Frame
3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
Title
Change in intention from baseline to immediately post-intervention and 3 months post-intervention
Description
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).
Time Frame
3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
Secondary Outcome Measure Information:
Title
Change in number of naloxone prescriptions dispensed from baseline to 3 months post-intervention
Description
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.
Time Frame
3 months: baseline (T1) and 3 months post-intervention (T3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsey Hohmann, PharmD, PhD
Organizational Affiliation
Auburn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Auburn University Harrison School of Pharmacy
City
Auburn
State/Province
Alabama
ZIP/Postal Code
36849
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
In order to protect confidentiality of participants, data will not be shared.
Citations:
PubMed Identifier
36047381
Citation
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.
Results Reference
derived

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Preventing Opioid Overdose Deaths by Empowering Pharmacists to Dispense Naloxone

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