The Impact of a Web-Based Naloxone Intervention Under Standing Orders 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 the impact of a targeted, web-based overdose prevention and naloxone intervention for patients prescribed chronic opioid therapy. Outcomes are changes in opioid risk behaviors, naloxone uptake, and knowledge about overdose and naloxone.

Detailed Description
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This is a patient level randomized study of a targeted, web-based overdose prevention and naloxone intervention for patients prescribed chronic opioid therapy. This study will be conducted in a health system which has implemented naloxone standing orders. Adults prescribed chronic opioid therapy will be identified in the electronic health record, outreached, and recruited for participation. Once enrolled, participants will be randomized to usual care or the intervention. The web-based intervention is an animated video which provides education on what is an opioid overdose, how to prevent and recognize an opioid overdose, and how to respond with naloxone. This video also encourages patients to pick up naloxone from a pharmacy under standing orders. Participants will be given knowledge and risk surveys over the follow-up. The primary outcome is opioid risk behavior. Secondary outcomes include knowledge about overdose and naloxone, substance use, and pain intensity. Patients will also be followed in the electronic health record for naloxone dispensings, changes in opioid dose, aberrant urine toxicology results, and overdose events.

Official Title
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The Impact of a Web-Based Naloxone Intervention Under Standing Orders to Patients Prescribed Chronic Opioid Therapy

Conditions
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Overdose, Risk Behavior

Intervention / Treatment
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* Behavioral: Naloxone Navigator (NN)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or greater Prescribed chronic opioid therapy Have a health plan which covers the formulation of naloxone available at the pharmacy they received their opioid prescriptions from. Exclusion Criteria: Non-English speaking, hospice enrollment, do-not-resuscitate order, no internet access

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naloxone Navigator<br>Targeted, web-based animated video (Naloxone Navigator [NN]): This arm is a web-based intervention targeted to patients receiving chronic opioid therapy identified in the electronic health record. Participants in this arm have access to naloxone under standing orders from the pharmacy or with a prescription from their providers. | Behavioral: Naloxone Navigator (NN)<br>* Patients prescribed chronic opioid therapy will be identified and recruited to enroll in the study. Patients randomized to receive the web-based animated video (Naloxone Navigator) will be sent a link to the video after enrollment. The web-based, animated video provides education on what is an opioid overdose, how to prevent it, how to recognize an overdose, and how to respond with naloxone. This video also encourages patients to pick up naloxone from a pharmacy under a standing order.<br>|
| No Intervention: Usual Care<br>Participants in the usual care arm will receive usual care from their health plan, pharmacy and clinicians. As part of usual care, participants can access naloxone through physician prescription or standing orders. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Opioid-Related Risk Behavior | 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 8-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overdose and Naloxone Knowledge | Patient 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. | Baseline post-intervention and sustained effects at 4-6 and 8-12 months | 
| Rate of Naloxone Dispensings | Pharmacy or insurance claims databases will be used to identify naloxone dispensings in the outpatient setting. | Baseline to 12 months | 
| Patient reported naloxone pick-up | Patient surveys will be used to identify naloxone dispensings in the outpatient setting. | Baseline to 12 months | 
| Change in opioid dose | Using pharmacy or insurance claims data, the investigators will calculate changes in the milligrams morphine equivalent dose. | Baseline to 12 months | 
| Change in Drug Use Risk Behavior | 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. Scores on the single scale range from 0-60, with lower values representing less drug use risk behavior. | Change from baseline to 4-6 months, and 8-12 months | 
| Change in Hazardous Drinking and Alcohol Use Disorders | Alcohol Use Risk Behavior will be assessed using the validated Alcohol Use Disorders Identification Test--Consumption (AUDIT-C) scale. 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 8-12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid antagonist, Naloxone, Opioids, Web-based intervention