Optimizing scalable, technology-supported behavioral interventions to prevent opioid misuse among adolescents and young adults in the emergency department: A randomized controlled trial protocol

Abstract

Preventing opioid misuse and opioid use disorder is critical among at-risk adolescents and young adults (AYAs). An Emergency Department (ED) visit provides an opportunity for delivering interventions during a rapidly changing opioid landscape. This paper describes pilot data and the protocol for a 2 × 2 factorial randomized controlled trial testing efficacy of early interventions to reduce escalation of opioid (prescription or illicit) misuse among at-risk AYAs. Interventions are delivered using technology by health coaches. AYAs ages 16-30 in the ED screening positive for prescription opioid use (+ ≥ 1 risk factor) or opioid misuse will be stratified by risk severity, sex, and age group. Participants will be randomly assigned to a condition at intake, either a live video health coach-delivered single session or a control condition of an enhanced usual care (EUC) community resource brochure. They are also randomly assigned to one of two post-intake conditions: health coach-delivered portal-like messaging via web portal over 30 days or EUC delivered at 30 days post-intake. Thus, the trial has four groups: health coach-delivered session+portal, health coach-delivered session+EUC, EUC + portal, and EUC + EUC. Outcomes will be measured at 3-, 6-, and 12-months. The primary outcome is opioid misuse based on a modified Alcohol Smoking and Substance Involvement Screening Test. Secondary outcomes include other opioid outcomes (e.g., days of opioid misuse, overdose risk behaviors), other substance misuse and consequences, and impaired driving. This study is innovative by testing the efficacy of feasible and scalable technology-enabled interventions to reduce and prevent opioid misuse and opioid use disorder. Trial Registration:ClinicalTrials.gov University of Michigan HUM00177625 NCT Registration: NCT04550715.

Keywords: Adolescents; Emerging adults; Intervention; Opioids; Prevention.

Conflict of interest statement

Conflict of Interests:

The authors do not have any personal financial interests related to the subject matters discussed in this manuscript.

Dr. Glantz’s role on this study is through his involvement as a Science Officer on UG3/UH3 DA050173. He had no involvement in the other cited grants.

Declaration of interests

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Copyright © 2021 Elsevier Inc. All rights reserved.

Figures

Figure 1.

Flow Chart for Randomized Control Trial Comparing Four Intervention Groups Aiming to Prevent and Reduce Opioid Misuse

Figure 2.

SPIRIT Diagram for Randomized Control Trial Comparing Four Intervention Groups Aiming to Prevent and Reduce Opioid Misuse