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

March 1, 2023 updated by: Kaiser Permanente
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Opioid-Related Risk Behavior
Time Frame: Change from baseline to 4-6 months and 8-10 months
Among survey participants, risk behavior will be assessed using the Opioid-Related Behaviors in Treatment (ORBIT) scale. The ORBIT is a scale used to identify recent risk behavior among patients receiving chronic opioid therapy. Scores on the single scale range from 0-40, with lower values representing less risk behavior.
Change from baseline to 4-6 months and 8-10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overdose and Naloxone Knowledge
Time Frame: Change from baseline to 4-6 months, and 8-10 months
Among survey participants, knowledge of overdose and naloxone will be measured using survey items adapted from the Opioid Overdose Knowledge Scale (OOKS). The OOKS is a scale measuring knowledge of overdose risks, warning signs, steps to address the overdose and appropriate use of naloxone. The investigators have adapted it to be specific to prescription opioids. The modified-OOKS is scored on a scale of 0-28, with higher values representing greater knowledge about overdose and naloxone.
Change from baseline to 4-6 months, and 8-10 months
Rate of Naloxone Dispensings
Time Frame: Baseline up to 2.5 years
Among survey participants and participants followed using automated data only, pharmacy and insurance claims databases will be used to identify naloxone dispensings.
Baseline up to 2.5 years
Patient reported naloxone pick-up
Time Frame: Baseline up to 10 months
Among survey participants, surveys will be used to identify naloxone dispensings in the outpatient setting.
Baseline up to 10 months
Changes in opioid dose
Time Frame: Baseline up to 2.5 years
Among survey participants and participants followed using automated data only, changes in the milligrams morphine equivalent dose will be calculated from pharmacy and insurance claims databases.
Baseline up to 2.5 years
Change in Drug Use Risk Behavior
Time Frame: Change from baseline to 4-6 months and 8-10 months
Among survey participants, drug use risk behavior will be assessed using question 2 of the validated National Institutes on Drug Abuse-Modified Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) scale version 2.0. The investigators added an item about tobacco use from the WHO ASSIST V3.0 to the NIDA-modified ASSIST V2.0 instrument, resulting in a scale of 0-66, with lower values representing less drug use risk behavior.
Change from baseline to 4-6 months and 8-10 months
Change in Hazardous Drinking or Alcohol Use Disorders
Time Frame: Change from baseline to 4-6 months and 8-10 months
Among survey participants, alcohol use risk behavior will be assessed using the validated Alcohol Use Disorders Identification Test--Consumption (AUDIT-C) scale. The AUDIT-C is a screener used to identify patients with alcohol use disorders or hazardous drinking behavior. The AUDIT-C is scored on a scale of 0-12. The higher the score, the more likely it is that the patient's drinking is affecting his or her safety.
Change from baseline to 4-6 months and 8-10 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity
Time Frame: Change from baseline to 4-6 months and 8-10 months
Among survey participants, pain intensity will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS). PROMIS Scale v1.0 - Pain Intensity 3a. The PROMIS Pain Intensity instrument is scored on a scale of 3-15. A higher score represents greater pain intensity.
Change from baseline to 4-6 months and 8-10 months
Rate of Opioid Overdose
Time Frame: Baseline up to 2.5 years
Among survey participants and participants followed using automated data only, overdoses will be assessed using electronic health record and insurance claims data and death records. Survey participants will be asked about non-fatal overdose events.
Baseline up to 2.5 years
Rate of Aberrant Urine Toxicology Screens
Time Frame: Baseline up to 2.5 years
Among survey participants and participants followed using automated data only, urine toxicology screen results found in laboratory databases will be used to measure opioid medication diversion and drug use.
Baseline up to 2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

National Institute on Drug Abuse (NIDA)
Denver Health and Hospital Authority

Investigators

  • Principal Investigator: Ingrid Binswanger, MD, Kaiser Permanente
  • Principal Investigator: Jason Glanz, PhD, Kaiser Permanente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2017

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

October 16, 2017

First Submitted That Met QC Criteria

November 6, 2017

First Posted (Actual)

November 8, 2017

Study Record Updates

Last Update Posted (Estimate)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CO-16-2405-02
  • 1R01DA042059 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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