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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Medication Adherence; Opioid Use; Knowledge, Attitudes, Practice; Risk Reduction Behavior
• Intervention / Treatment: Behavioral: Educational Intervention; Behavioral: Nudge

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.

• Study Type: Interventional
• Enrollment (Actual): 712
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan, C.S. Mott Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Terri Voepel-Lewis, PhD, University of Michigan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2017
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: September 14, 2017
• First Submitted That Met QC Criteria: September 15, 2017
• First Posted (Actual): September 19, 2017

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: October 28, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 00127009; 1R01DA044245-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No