Evaluation of an Interactive Opioid Risk Education Program (STOMP) for Parents (STOMP)

Scenario-tailored Opioid Messaging Program (STOMP): An Interactive Intervention to Prevent Opioid-related Adverse Drug Events in Children and Adolescents

Millions of children and adolescents are prescribed opioid pain relievers each year, placing them at risk for serious adverse events and misuse in the home setting. Parents who manage these medicines, therefore, need to recognize opioid-related risks and make decisions that will both reduce these risks yet ensure effective pain relief for their children. The proposed research will evaluate new strategies to help parents learn about opioid risks, make safe and effective analgesic decisions, and develop and demonstrate safe drug management behaviors. 840 parents and their children who are undergoing an elective surgical procedure will be recruited. Parents will be randomized to receive the new educational and practical behavioral strategy or routine information. Parents' knowledge and perceptions will be evaluated at baseline and at critical times after surgery. Parents' opioid handling and administration will also be assessed.

The overarching goal of this research is to improve opioid analgesic safety and efficacy by optimizing opioid risk recognition, informed analgesic decision-making, and drug storage/disposal behaviors among parents of youth who are prescribed these agents for home use. The study aims are to determine whether the Scenario-Tailored Opioid Messaging Program (STOMP) will: 1) Improve parents' opioid risk understanding and their analgesic decision-making; 2) Enhance parents' analgesic self-efficacy, analgesic use, storage behaviors and their children's pain outcomes, and 3) To demonstrate that the STOMP plus provision of a simple method to get rid of left-over opioids will effectively nudge parents to safely dispose of left-over opioid analgesics. Parents whose children are prescribed opioids for acute, short-lived pain after surgery will be randomly assigned to receive our interventions or a routine provider informational interaction at the time of opioid prescribing. Parents will be surveyed about their opioid familiarity, knowledge, risk perceptions and common analgesic decision-making at baseline and after hospital discharge. Parents will also record their child's pain medication use and symptoms after discharge. Data will be analyzed to determine whether the STOMP educational intervention with or without the behavioral nudge intervention will enhance parents' risk perceptions, their decision-making skills and their opioid handling behaviors.

Pain, Postoperative, Medication Adherence, Opioid Use, Knowledge, Attitudes, Practice, Risk Reduction Behavior

Group assignment will be coded for parents and data collectors. Parents will be blinded to whether the information they receive is the Intervention vs. Control. Group assignment will coded on data entry and unblinded after analyses.

This group will receive BOTH the scenario-tailored STOMP educational feedback AND the behavioral Nudge intervention

This group will receive scenario-tailored opioid message (STOMP) feedback and NO behavioral nudge intervention.

This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.

Behavioral Nudge in this study is a simple, take-home kit (ziplock baggy of used coffee grounds) to be used to dispose of left-over prescription opioids

Number of parent participants who became aware (binary) of serious opioid-related adverse effect (over sedation)

Change in parent's perceived risk of keeping/sharing opioids (misuse) (Risk perceptions measured on scale from -4 to +4 where higher number reflects higher perception of riskiness; the outcome is measured as change in risk perception - positive change indicates that risk perception became greater)

The Parents PROMIS Pain Interference measure was used to capture pain interference with functioning (score range 0-30 with higher number indicating worse pain interference)

Survey measures how confident the parent is in managing pain and opioid-related adverse events (score range 0-35; higher = more efficacy)

Number of participants who made the scenario-based decision to administer opioid to excessively sedated child

Inclusion Criteria: Parent (>=21yr) and child (5-17 yr) (dyad) who lives in the home and is prescribed an opioid for postoperative pain management English speaking Exclusion Criteria: Child is undergoing a non-elective procedure Child cannot self-report pain levels (i.e., is cognitively impaired) Child has a hematologic/oncologic condition Child has a kidney or liver conditions that precludes the usual analgesic prescription pattern (opioid plus a non-opioid) Child has been taking opioids for prolonged pain pre-operatively (>2 weeks)

Voepel-Lewis T, Boyd CJ, Tait AR, McCabe SE, Zikmund-Fisher BJ. A Risk Education Program Decreases Leftover Prescription Opioid Retention: An RCT. Am J Prev Med. 2022 Oct;63(4):564-573. doi: 10.1016/j.amepre.2022.04.035. Epub 2022 Jul 28.

Voepel-Lewis T, Farley FA, Grant J, Tait AR, Boyd CJ, McCabe SE, Weber M, Harbagh CM, Zikmund-Fisher BJ. Behavioral Intervention and Disposal of Leftover Opioids: A Randomized Trial. Pediatrics. 2020 Jan;145(1):e20191431. doi: 10.1542/peds.2019-1431.