Prevention Interventions for Opioid Misuse

Study Overview
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Brief Summary
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The purpose of the study is to develop and test innovative interventions to prevent the development of opioid misuse and opioid use disorders among older adolescents and young adults (AYA; ages 16-30) who use opioids, which will be initiated from a health care visit in the emergency department and extended post discharge via a telehealth approach. This study will have significant impact by identifying optimal, cost-effective opioid prevention strategies to sustain outcomes among AYAs.

Official Title
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Optimized Interventions to Prevent Opioid Use Disorder Among Adolescents and Young Adults in the Emergency Department

Conditions
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Opioid Use

Intervention / Treatment
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* Behavioral: Brief intervention (BI)
* Behavioral: Portal
* Behavioral: Enhanced Usual Care (EUC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 16-30 years Seeking care in Michigan Medicine emergency department (ED) Ability to read/comprehend and communicate in English Medically & cognitively able to provide consent or assent Prescription opioid use plus >=1 other risk factor (misuse positive for marijuana, other illicit drugs, other prescription drug misuse; binge drinking; depression or suicidality) or opioid misuse [prescription opioid misuse or illicit opioid use (e.g., heroin, fentanyl)] Exclusion Criteria: Presenting with acute sexual assault, acute suicidality or a current cancer diagnosis/are currently receiving cancer treatment Current pregnancy at baseline History of injection drug use within last 12 months High risk for opioid use disorder Enrolled in Aim 1

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 30 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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief intervention (BI) then Portal<br>The BI will be delivered at intake and the portal will occur for 4 weeks starting at intake. | Behavioral: Brief intervention (BI)<br>* A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors.<br>Behavioral: Portal<br>* Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks.<br>|
| Experimental: Brief intervention (BI) then Enhanced Usual Care (EUC)<br>The BI will be delivered at intake and EUC will be added 4 weeks later. | Behavioral: Brief intervention (BI)<br>* A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors.<br>Behavioral: Enhanced Usual Care (EUC)<br>* The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.<br>|
| Experimental: Enhanced Usual Care (EUC) then Portal<br>EUC will be delivered at intake and the portal will occur for 4 weeks starting at intake. | Behavioral: Portal<br>* Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks.<br>Behavioral: Enhanced Usual Care (EUC)<br>* The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.<br>|
| Active Comparator: Enhanced Usual Care (EUC) then EUC<br>EUC will be delivered at intake and delivered again 4 weeks later. | Behavioral: Enhanced Usual Care (EUC)<br>* The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in opioid misuse | Alcohol Smoking and Substance Involvement Screening Test severity score (prescription opioids/heroin, scores range 0-27 per subscale, higher score indicates worse outcomes) | 3, 6, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in days of opioid misuse | Addiction Severity Index (modified; score ranges from 0-30, higher score indicates worse outcomes) | 3, 6, and 12 months | 
| Change in overdose risk behaviors | Opioid-related risk behaviors (score ranges from 0-32, higher score indicates worse outcomes) | 3, 6, and 12 months | 
| Change in other drug and alcohol use | Substance use index (based on frequency measures, higher scores indicate worse outcome) | 3, 6, and 12 months | 
| Change in substance use consequences | Adapted alcohol, cannabis, and/or opioid-related consequences (total, higher score indicates worse outcomes) | 3, 6, and 12 months | 
| Change in impaired driving | Adapted items from Young Adult Driving Questionnaire (5 items; score ranges from 0-30; higher score indicates worse outcome) | 3, 6, and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid misuse