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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

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

Intervention / Treatment
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* Behavioral: Educational Intervention
* Behavioral: Nudge


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 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
Interventional Model Description: Four-armed, randomized, control, factorial design
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Education Intervention + Nudge<br>This group will receive BOTH the scenario-tailored STOMP educational feedback AND the behavioral Nudge intervention | Behavioral: Educational Intervention<br>* This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.<br>* Other names: STOMP Intervention;Behavioral: Nudge<br>* 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<br>|
| Experimental: Standard of Care + Nudge<br>This group will receive routine, standard of care information AND the behavioral Nudge intervention | Behavioral: Nudge<br>* 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<br>|
| Experimental: Educational Intervention no Nudge<br>This group will receive scenario-tailored opioid message (STOMP) feedback and NO behavioral nudge intervention. | Behavioral: Educational Intervention<br>* This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.<br>* Other names: STOMP Intervention;|
| No Intervention: Standard of Care no Nudge<br>This group will receive only standard of care information and NO behavioral nudge intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid-related Risk Knowledge | Number of parent participants who became aware (binary) of serious opioid-related adverse effect (over sedation) | Day 3 follow-up assessment | 
| Opioid Risk Perception | 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) | Mean difference in score from baseline to follow-up assessments (Days 3 & 14) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Disposal Behavior | Number of parents (and percentage) who disposed of left-over opioids after use | Day 14 (or after course completion) | 
| Pain Interference (PROMIS) | 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) | Day 14 | 
| Analgesic Self-Efficacy | Survey measures how confident the parent is in managing pain and opioid-related adverse events (score range 0-35; higher = more efficacy) | Efficacy scores Day 14 | 
| Analgesic Use / Adherence | Total number of opioid doses administered | Day 14 | 
| Analgesic Decision Competency | Number of participants who made the scenario-based decision to administer opioid to excessively sedated child | Day 3 |