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Completed

NCT Number: NCT04677387

Nalox-Comm: Naloxone Communication Training for Pharmacists

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.

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Key information

Conditions

Naloxone Behavior Communication

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill (Asheville campus)

Asheville, North Carolina, 28804, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • currently work at a pharmacy that stocks naloxone;
  • currently work at a rural community pharmacy;
  • 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.

Treatment and study plan

Nalox-comm Training Module

Behavioral

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.

Prescribe to Prevent: Overdose Prevention and Naloxone Rescue Kits for Prescribers and Pharmacists

Behavioral

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.

Primary outcomes

  1. Change in Naloxone Dispensing Rate Over a 6-month Period

    Time frame: 3-month period before intervention and 3-month follow-up dispensing data

    Pharmacy records indicated the number of times each pharmacy dispensed naloxone and opioid prescriptions over the RCT period. These data were aggregated into the total number of naloxone and opioid prescriptions dispensed in the 3 months pre-intervention and the 3 months post-intervention.

    The change in naloxone dispensing rates was measured by comparing pharmacy records of the number of naloxone products dispensed in the three months prior to study participation to the number of naloxone products dispensed in the three months after study completion. The rate was defined as the number of naloxone products dispensed divided by the number of opioid prescriptions dispensed in each 3-month period.

Secondary outcomes

  1. Mean Willingness to Dispense Naloxone Score

    Time frame: up to 3-month Follow-up Survey

    An online survey including 6 self-reported Likert-scale items will assess pharmacists' willingness to dispense naloxone. 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 were averaged to create a mean willingness score (range = 1-4), with higher scores indicating more willingness to dispense naloxone.

  2. Mean Naloxone Counselling Self-Efficacy Score

    Time frame: up to 3-month Follow-up Survey

    An online survey including 6 self-reported Likert-scale items assessed pharmacists' self-efficacy to counsel about naloxone. Pharmacists rated 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 ranged from 1= "not at all confident" to 4= "very confident." Items were averaged to create a mean self-efficacy score (range = 1-4), with higher scores indicating greater self-efficacy to dispense naloxone.

  3. Mean Pharmacist Quality of Non-verbal Communication Score

    Time frame: up to 1-month post-training

    Simulated patients (SPs) called pharmacists and used a validated observation guide that has been adapted for use for telephone interactions to rate the pharmacists' quality of non-verbal communication. The guide included 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Addressing the Opioid Epidemic Through Community Pharmacy Engagement: Randomized Controlled Trial (Aim 2)

Acronym: Nalox-Comm

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 21, 2020
Registry last updated
Jun 26, 2024

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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