Nalox-Comm: Naloxone Communication Training for Pharmacists (Nalox-Comm)

June 4, 2024 updated by: University of North Carolina, Chapel Hill

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Asheville, North Carolina, United States, 28804
        • University of North Carolina at Chapel Hill (Asheville campus)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3-month period before intervention and 3-month follow-up dispensing data

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 3-month Follow-up Survey
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.
up to 3-month Follow-up Survey
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.
up to 1-month post-training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

December 15, 2020

First Submitted That Met QC Criteria

December 15, 2020

First Posted (Actual)

December 21, 2020

Study Record Updates

Last Update Posted (Actual)

June 26, 2024

Last Update Submitted That Met QC Criteria

June 4, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-2192
  • R34DA046598 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

IPD Sharing Time Frame

9-36 months following publication

IPD Sharing Access Criteria

The investigator who proposes to use the data must have IRB, IEC, or REB approval, as applicable, and an executed data use/sharing agreement with UNC.

IPD Sharing Supporting Information Type

  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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