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Nalox-Comm: Naloxone Communication Training for Pharmacists

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04677387
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
120
Enrollment
1
Location
2
Arms
23
Anticipated Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a pilot Randomized Controlled Trial (RCT) in which 120 pharmacists will be randomized to an experimental or control group and data on naloxone dispensing and secondary outcomes will be collected over the course of the RCT.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Nalox-comm Training Module
  • Behavioral: Prescribe to Prevent: Overdose Prevention and Naloxone Rescue Kits for Prescribers and Pharmacists
 N/A

Detailed Description

This is a prospective pilot RCT that will evaluate the impact of naloxone communication training (Nalox-Comm) on 120 pharmacists' naloxone dispensing behaviors (primary outcome). Data will be collected at baseline, immediately after training is completed, and at 3-month follow up. Data sources include pharmacy records (for naloxone dispensing), simulated patient observations (to rate quality of communication), and survey data (for self-reports of knowledge and self-efficacy).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Addressing the Opioid Epidemic Through Community Pharmacy Engagement: Randomized Controlled Trial (Aim 2)
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Prescribe to Prevent Naloxone Training Module

This a 55-minute online module that covers basic information about naloxone that is relevant to community pharmacists.

Behavioral: Prescribe to Prevent: Overdose Prevention and Naloxone Rescue Kits for Prescribers and Pharmacists
A 55 minute long online module with videos, didactic content, and quizzes that covers the following topics: risk factors for overdose (OD), how to respond to OD, how naloxone works, types of naloxone, how to administer naloxone, medico-legal issues, how to bill for naloxone, and strategies to address overdose. Pharmacists can receive continuing education credit (0.125 CEUs) for completing the course.
Experimental: Nalox-Comm

This is a newly developed 30-60 minute online module focused on teaching pharmacists how to overcome naloxone communication barriers.

Behavioral: Nalox-comm Training Module
The online communication module will be 30-60 minutes. Content will include: 1) using non-judgmental language, 2) how to raise the topic of overdose (OD) and naloxone with patients in a non-threatening manner; 3) videos modeling how to initiate the conversation with patients and caregivers; 4) considerations in how to communicate differently with patients versus caregivers; and 5) addressing pharmacists' perceived barriers to naloxone counseling. Pharmacists can receive continuing education credit (0.1 CEU) for completing the course.

Outcome Measures

Primary Outcome Measures

  1. Change in the number of times Naloxone is dispensed over a 6 month period [3-month period before and 3-month period after pharmacist completes intervention training]

    Pharmacy records will indicate the number of times each pharmacy dispensed naloxone over the RCT period. These data will be aggregated into the total number of naloxone fills in the 3 months pre-intervention and the 3 months postintervention.

Secondary Outcome Measures

  1. Change from Baseline in Willingness to Dispense Naloxone Score at 3 months [Baseline, 3-months post-intervention]

    An online survey including 6 self-reported Likert-scale items will assess pharmacists' willingness to dispense naloxone. Four items from the Nielsen naloxone attitudes scale and 2 items from the Wilson Hospital-based Overdose Prevention and Education (HOPE) measure will be used. These items assess pharmacists' willingness to engage in naloxone counseling activities, including educating patients to recognize overdose and administer naloxone, proactively identify individuals for naloxone dispensation, and dispense naloxone. Response options will range from 1= "not at all willing" to 4= "very willing." Items will be averaged to create a mean willingness score (range = 1-4), with higher scores indicating more willingness to dispense naloxone. Mean willingness scores will be calculated at baseline and 3 months post-intervention.

  2. Change from Baseline in Naloxone Counselling Self-Efficacy Score at 3 months [Baseline, 3-months post-intervention]

    An online survey including 6 self-reported Likert-scale items will assess pharmacists' self-efficacy to counsel about naloxone. Four items from the Nielsen naloxone attitudes scale and 2 items from the Wilson HOPE measure will be used. Pharmacists will be asked to rate their confidence to engage in various naloxone communication tasks including: engage in naloxone counseling when the pharmacy is busy and discuss naloxone in a way that does not offend customers. Response options will range from 1= "not at all confident" to 4= "very confident." Items will be averaged to create a mean self-efficacy score (range = 1-4), with higher scores indicating greater self-efficacy to dispense naloxone. Mean self-efficacy scores will be calculated at baseline and 3 months post-intervention.

  3. Change from Baseline in Pharmacist Quality of Non-verbal Communication score up to 1 month post-training [Baseline, 1-month period after pharmacist completes intervention training]

    Simulated patients (SPs) will call pharmacists and use a validated observation guide that has been adapted for use for telephone interactions to rate the pharmacists' quality of non-verbal communication. The guide includes 4 items (i.e., explained things clearly, listened carefully, showed respect, and spent enough time with the SP) measured on a 5-point scale (1= not at all satisfied, 2= partly satisfied, 3= satisfied, 4= more than satisfied, 5= very satisfied). Higher scores (range = 1-5) indicate a more positive evaluation of the interaction.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

All Ingles pharmacist stock naloxone, and all 120 pharmacists at the participating pharmacies will be eligible because they:

  • work at one of the 60 rural Ingles Pharmacies in which the intervention is being conducted;

  • are at least 18 years of age; and

  • speak English.

Exclusion Criteria:
  • Non-staff pharmacists such as pharmacy "floaters" or fill-in pharmacists will not be eligible to participate.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of North Carolina at Chapel Hill (Asheville campus) Asheville North Carolina United States 28804

Sponsors and Collaborators

  • University of North Carolina, Chapel Hill
  • National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Delesha Carpenter, PhD, MSPH, UNC Eshelman School of Pharmacy

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT04677387
Other Study ID Numbers:
  • 20-2192
  • R34DA046598
First Posted:
Dec 21, 2020
Last Update Posted:
Aug 4, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of North Carolina, Chapel Hill
community pharmacy
communication
Additional relevant MeSH terms:
Naloxone

Study Results

No Results Posted as of Aug 4, 2022