Trial Outcomes & Findings for Nalox-Comm: Naloxone Communication Training for Pharmacists (NCT NCT04677387)

Last Updated: 2024-06-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

48 participants

Primary outcome timeframe

3-month period before intervention and 3-month follow-up dispensing data

Results posted on

2024-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	Prescribe to Prevent Naloxone Training Module This is a 55-minute online module that covers basic information about naloxone that is relevant to community pharmacists. 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.	Nalox-Comm This is a newly developed 30-60 minute online module focused on teaching pharmacists how to overcome naloxone communication barriers. 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.
Overall Study STARTED	25	23
Overall Study Baseline Survey	25	23
Overall Study Immediate Post-training Survey	18	19
Overall Study 1-month Follow-up Simulated Patient Data	17	16
Overall Study 3-month Follow-up Survey	17	18
Overall Study 3-month Follow-up Dispensing Data	19	20
Overall Study COMPLETED	17	18
Overall Study NOT COMPLETED	8	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nalox-Comm: Naloxone Communication Training for Pharmacists

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prescribe to Prevent Naloxone Training Module n=25 Participants This is a 55-minute online module that covers basic information about naloxone that is relevant to community pharmacists. 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.	Nalox-Comm n=23 Participants This is a newly developed 30-60 minute online module focused on teaching pharmacists how to overcome naloxone communication barriers. 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.	Total n=48 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants	22 Participants n=7 Participants	46 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex/Gender, Customized Sex/Gender · Female	16 Participants n=5 Participants	11 Participants n=7 Participants	27 Participants n=5 Participants
Sex/Gender, Customized Sex/Gender · Male	8 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants
Sex/Gender, Customized Sex/Gender · Prefer not to answer	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants	23 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Prescribe to Prevent Naloxone Training Module n=19 Participants This is a 55-minute online module that covers basic information about naloxone that is relevant to community pharmacists. 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.	Nalox-Comm n=20 Participants This is a newly developed 30-60 minute online module focused on teaching pharmacists how to overcome naloxone communication barriers. 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.
Change in Naloxone Dispensing Rate Over a 6-month Period	.0073 number of naloxone products dispensed Standard Deviation .015	.0041 number of naloxone products dispensed Standard Deviation .0139

SECONDARY outcome

Timeframe: up to 3-month Follow-up Survey

Population: Only participants who completed Baseline and 3-month Follow-up Survey were analyzed.

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.

Outcome measures

Outcome measures
Measure	Prescribe to Prevent Naloxone Training Module n=17 Participants This is a 55-minute online module that covers basic information about naloxone that is relevant to community pharmacists. 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.	Nalox-Comm n=18 Participants This is a newly developed 30-60 minute online module focused on teaching pharmacists how to overcome naloxone communication barriers. 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.
Mean Willingness to Dispense Naloxone Score Baseline Survey	3.72 score on a scale Standard Error 0.07	3.57 score on a scale Standard Error 0.117
Mean Willingness to Dispense Naloxone Score Immediate Post-training Survey	3.64 score on a scale Standard Error 0.096	3.84 score on a scale Standard Error 0.07
Mean Willingness to Dispense Naloxone Score 3-month Follow-up Survey	3.47 score on a scale Standard Error 0.14	3.69 score on a scale Standard Error 0.107

SECONDARY outcome

Timeframe: up to 3-month Follow-up Survey

Population: Only participants who completed Baseline and 3-month Follow-up Survey were analyzed.

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.

Outcome measures

Outcome measures
Measure	Prescribe to Prevent Naloxone Training Module n=17 Participants This is a 55-minute online module that covers basic information about naloxone that is relevant to community pharmacists. 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.	Nalox-Comm n=18 Participants This is a newly developed 30-60 minute online module focused on teaching pharmacists how to overcome naloxone communication barriers. 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.
Mean Naloxone Counselling Self-Efficacy Score Baseline Survey	3.08 score on a scale Standard Error .012	2.74 score on a scale Standard Error 0.112
Mean Naloxone Counselling Self-Efficacy Score Immediate Post-training Survey	3.19 score on a scale Standard Error 0.116	3.4 score on a scale Standard Error 0.107
Mean Naloxone Counselling Self-Efficacy Score 3-month Follow-up Survey	3.28 score on a scale Standard Error 0.105	3.51 score on a scale Standard Error 0.098

SECONDARY outcome

Timeframe: up to 1-month post-training

Population: All available data are reported and include pharmacists whose communication behavior was possible to be observed.

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.

Outcome measures

Outcome measures
Measure	Prescribe to Prevent Naloxone Training Module n=17 Participants This is a 55-minute online module that covers basic information about naloxone that is relevant to community pharmacists. 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.	Nalox-Comm n=16 Participants This is a newly developed 30-60 minute online module focused on teaching pharmacists how to overcome naloxone communication barriers. 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.
Mean Pharmacist Quality of Non-verbal Communication Score baseline	3.31 score on a scale Standard Error 0.141	3.5 score on a scale Standard Error 0.149
Mean Pharmacist Quality of Non-verbal Communication Score 1-month follow-up	3.62 score on a scale Standard Error 0.182	4.11 score on a scale Standard Error 0.123

Adverse Events

Prescribe to Prevent Naloxone Training Module

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nalox-Comm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Delesha Carpenter, PhD, MSPH

University of North Carollina at Chapel Hill

Phone: 828-250-3916

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place