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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Overdose, Risk Behavior

Intervention / Treatment
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* Behavioral: Co-Dispensing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Co-Dispensing<br>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<br>* 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.<br>|
| No Intervention: Usual Care<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Opioid-Related Risk Behavior | 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 | 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 | 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 | Among survey participants, surveys will be used to identify naloxone dispensings in the outpatient setting. | Baseline up to 10 months | 
| Changes in opioid dose | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioids, Naloxone, Co-dispensing, Cluster randomized trial, Opioid antagonist