Clinical trial NCT03287622: Evaluation of an Interactive Opioid Risk Education Program (STOMP) for Parents
Official title: Scenario-tailored Opioid Messaging Program (STOMP): An Interactive Intervention to Prevent Opioid-related Adverse Drug Events in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Medication Adherence
Opioid Use
Knowledge, Attitudes, Practice
Risk Reduction Behavior
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-09-19
Enrollment: 712
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Four-armed, randomized, control, factorial design
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Opioid-related Risk Knowledge
timeFrame: Day 3 follow-up assessment
measure: Opioid Risk Perception
timeFrame: Mean difference in score from baseline to follow-up assessments (Days 3 & 14)
Secondary outcomes:
measure: Opioid Disposal Behavior
timeFrame: Day 14 (or after course completion)
measure: Pain Interference (PROMIS)
timeFrame: Day 14
measure: Analgesic Self-Efficacy
timeFrame: Efficacy scores Day 14
measure: Analgesic Use / Adherence
timeFrame: Day 14
measure: Analgesic Decision Competency
timeFrame: Day 3
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan, C.S. Mott Children's Hospital
state: Michigan
Study officials:
affiliation: University of Michigan
name: Terri Voepel-Lewis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.