NCT03337100

The Impact of Co-Dispensing Naloxone to Patients Prescribed Chronic Opioid Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In the setting of naloxone standing orders, this study will assess if co-dispensing naloxone with opioids to patients prescribed chronic opioid therapy changes opioid risk behaviors, increases naloxone uptake, and increases knowledge about overdose and naloxone.

Detailed description

This is a pragmatic, pharmacy-based, cluster randomized controlled trial of a naloxone co-dispensing program for adults prescribed chronic opioid therapy. Pharmacies (target N=6) will be randomized to the order in which they are encouraged to implement a naloxone co-dispensing program for patients prescribed chronic opioid therapy. The intent of this program is to provide patients prescribed chronic opioid therapy naloxone for potential opioid overdose reversal under the terms of a standing order. Participants prescribed chronic opioid therapy who use randomized pharmacies will be recruited to receive knowledge and risk surveys at baseline and over the follow-up. The primary outcome is opioid risk behaviors (target enrollment is 200 patients). Secondary outcomes include knowledge about overdose and naloxone, substance use, and pain intensity. Patients who use randomized pharmacies (anticipated n=550 patients) will also be followed in the electronic health record for secondary outcomes: naloxone dispensings, changes in opioid dose, aberrant urine toxicology results, and overdose events.

Conditions

• Overdose
• Risk Behavior

Interventions

Type	Name	Description
BEHAVIORAL	Co-Dispensing	Implementation of a naloxone co-dispensing pharmacy program. The intent of this program is to provide patients prescribed chronic opioid therapy naloxone under the terms of a standing order for potential opioid overdose reversal. Prior to implementing the program, a naloxone standing order will be implemented and pharmacy operational staff will provide training to pharmacy staff about the standing order and a naloxone co-dispensing protocol. Under a co-dispensing protocol, pharmacy staff members will identify opioid prescriptions meeting criteria for co-dispensing, prepare naloxone fills, offer patients naloxone, and provide counseling on its use.

Timeline

• Start date: 2017-11-27
• Primary completion: 2021-04-30
• Completion: 2022-09-30
• First posted: 2017-11-08
• Last updated: 2023-03-03

Locations

1 site across 1 country: United States