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

NCT ID: NCT03337100

Last Updated: 2023-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-27
• Study Completion Date: 2022-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Co-Dispensing

Early implementation of a naloxone co-dispensing pharmacy program. Pharmacies in the phase 1 (early) naloxone co-dispensing arm will be assigned to implement the pharmacy based naloxone co-dispensing program first relative to the phase 2 arm.

Group Type: EXPERIMENTAL

Co-Dispensing

Intervention Type: BEHAVIORAL

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.

Usual Care

Usual care/Phase 2 naloxone co-dispensing:

Pharmacies in the usual care/phase 2 naloxone co-dispensing arm will provide usual pharmacy services to patients receiving chronic opioid therapy (no naloxone co-dispensing). After 10 months, they may implement the pharmacy-based naloxone co-dispensing program.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients prescribed chronic opioid therapy

• Stock naloxone for outpatient dispensing.
• Pharmacy leadership willing to provide naloxone under a co-dispensing protocol.
• Pharmacy leadership willing to be randomized to order of implementation.
• Have or can implement a naloxone standing order.

• Prescribed chronic opioid therapy and meet criteria for the pharmacy co-dispensing protocol
• Receive medications at participating pharmacies
• Have a health plan which covers the formulation of naloxone available at the pharmacy they received their opioid prescriptions from.
• (for surveys)18 years of age or greater

Exclusion Criteria

• None

• (for surveys) Non-English speaking, hospice enrollment, do-not-resuscitate order

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Denver Health and Hospital Authority

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Glanz, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Ingrid Binswanger, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Denver Health

Denver, Colorado, United States

Countries

United States

References

Binswanger IA, Rinehart D, Mueller SR, Narwaney KJ, Stowell M, Wagner N, Xu S, Hanratty R, Blum J, McVaney K, Glanz JM. Naloxone Co-Dispensing with Opioids: a Cluster Randomized Pragmatic Trial. J Gen Intern Med. 2022 Aug;37(11):2624-2633. doi: 10.1007/s11606-021-07356-6. Epub 2022 Feb 7.

Reference Type: DERIVED

PMID: 35132556 (View on PubMed)

Other Identifiers

1R01DA042059

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CO-16-2405-02

Identifier Type: -

Identifier Source: org_study_id