Nalox-Comm: Naloxone Communication Training for Pharmacists

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Naloxone

Intervention / Treatment
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* Behavioral: Nalox-comm Training Module
* Behavioral: Prescribe to Prevent: Overdose Prevention and Naloxone Rescue Kits for Prescribers and Pharmacists


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Prescribe to Prevent Naloxone Training Module<br>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<br>* 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.<br>|
| Experimental: Nalox-Comm<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the number of times Naloxone is dispensed over a 6 month period | 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. | 3-month period before and 3-month period after pharmacist completes intervention training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Willingness to Dispense Naloxone Score at 3 months | 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. | Baseline, 3-months post-intervention | 
| Change from Baseline in Naloxone Counselling Self-Efficacy Score at 3 months | 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. | Baseline, 3-months post-intervention | 
| Change from Baseline in Pharmacist Quality of Non-verbal Communication score up to 1 month post-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. | Baseline, 1-month period after pharmacist completes intervention training | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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communication, community pharmacy