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

Kaiser Permanente

Status: Completed

Conditions: Risk Behavior; Overdose

Treatments: Behavioral: Co-Dispensing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03337100

CO-16-2405-02

1R01DA042059 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Study Population:

• Eligible pharmacies
• Patients prescribed chronic opioid therapy

Inclusion Criteria for pharmacies:

• 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.

Exclusion Criteria for pharmacies:

• None

Inclusion Criteria for patients:

• 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:

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Co-Dispensing

Experimental group

Description:

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.

Treatment:

Behavioral: Co-Dispensing

Usual Care

No Intervention group

Description:

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.