Clinical trial NCT04677387: Nalox-Comm: Naloxone Communication Training for Pharmacists
Official title: Addressing the Opioid Epidemic Through Community Pharmacy Engagement: Randomized Controlled Trial (Aim 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Naloxone
Keywords: community pharmacy
communication
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-12-21
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Naloxone Dispensing Rate Over a 6-month Period
timeFrame: 3-month period before intervention and 3-month follow-up dispensing data
Secondary outcomes:
measure: Mean Willingness to Dispense Naloxone Score
timeFrame: up to 3-month Follow-up Survey
measure: Mean Naloxone Counselling Self-Efficacy Score
timeFrame: up to 3-month Follow-up Survey
measure: Mean Pharmacist Quality of Non-verbal Communication Score
timeFrame: up to 1-month post-training
Other outcomes:
Locations:
city: Asheville
country: United States
facility: University of North Carolina at Chapel Hill (Asheville campus)
state: North Carolina
Study officials:
affiliation: UNC Eshelman School of Pharmacy
name: Delesha Carpenter, PhD, MSPH
role: PRINCIPAL_INVESTIGATOR
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