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

Not Applicable

Completed

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

Brief Summary: 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: 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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Standard of Care + Nudge	Nudge	This group will receive routine, standard of care information AND the behavioral Nudge intervention
Education Intervention + Nudge	Educational Intervention	This group will receive BOTH the scenario-tailored STOMP educational feedback AND the behavioral Nudge intervention
Educational Intervention no Nudge	Educational Intervention	This group will receive scenario-tailored opioid message (STOMP) feedback and NO behavioral nudge intervention.
Education Intervention + Nudge	Nudge	This group will receive BOTH the scenario-tailored STOMP educational feedback AND the behavioral Nudge intervention

Primary Outcome Measures

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

Secondary Outcome Measures

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

Locations (1): University of Michigan, C.S. Mott Children's Hospital
🇺🇸
Ann Arbor, Michigan, United States