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Clinical Trials/NCT04677387
NCT04677387
Completed
N/A

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

University of North Carolina, Chapel Hill1 site in 1 country48 target enrollmentJuly 1, 2021
ConditionsNaloxone

Overview

Phase
N/A
Intervention
Not specified
Conditions
Naloxone
Sponsor
University of North Carolina, Chapel Hill
Enrollment
48
Locations
1
Primary Endpoint
Change in Naloxone Dispensing Rate Over a 6-month Period
Status
Completed
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
July 1, 2021
End Date
July 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Mean Willingness to Dispense Naloxone Score(up to 3-month Follow-up Survey)
  • Mean Naloxone Counselling Self-Efficacy Score(up to 3-month Follow-up Survey)
  • Mean Pharmacist Quality of Non-verbal Communication Score(up to 1-month post-training)

Study Sites (1)

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