Nalox-Comm: Naloxone Communication Training for Pharmacists

Not Applicable

Completed

• Conditions: Naloxone
• Interventions: Behavioral: Nalox-comm Training Module

• Registration Number: NCT04677387
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

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 Timeline

• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-15
• Study First Posted: 2020-12-21
• Study Start: 2021-07-01
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31
• Status Verified: 2023-10
• Results First Submitted: 2024-06-04
• Results First Submitted QC: 2024-06-04
• Last Update Submitted: 2024-06-04
• Results First Posted: 2024-06-26
• Last Update Posted: 2024-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nalox-Comm	Nalox-comm Training Module	This is a newly developed 30-60 minute online module focused on teaching pharmacists how to overcome naloxone communication barriers.

Primary Outcome Measures

Name	Time	Method
Change in Naloxone Dispensing Rate Over a 6-month Period	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 Outcome Measures

Name	Time	Method
Mean Willingness to Dispense Naloxone Score	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.
Mean Naloxone Counselling Self-Efficacy Score	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.
Mean Pharmacist Quality of Non-verbal Communication Score	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.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill (Asheville campus); 🇺🇸 Asheville, North Carolina, United States