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

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.

• Educational Intervention (Behavioral), also known as STOMP Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.
• Nudge (Behavioral): 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

Primary outcomes

• 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 outcomes

• Opioid Disposal Behavior [Day 14 (or after course completion)]: Number of parents (and percentage) who disposed of left-over opioids after use
• 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)
• 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

Sex: All, ages: 21 Years to 99 Years

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)

Participant flow

Outcome results

• Opioid-related Risk Knowledge (Primary), Count of participants, Participants: Education Intervention 287; Standard of Care Education 289
• Opioid Risk Perception (Primary), Mean, units on a scale: Education Intervention 0.35 (0.07 to 0.63); Standard of Care 0.12 (-0.06 to 0.29)
• Opioid Disposal Behavior (Secondary), Count of participants, Participants: Nudge + Educational Intervention 48; Nudge + Standard of Care 44; Educational Intervention Only (No Nudge) 40; Standard of Care Only (No Nudge) 25
• Pain Interference (PROMIS) (Secondary), Mean, units on a scale: Education Intervention 8.63 +/- 8.39; Standard of Care 8.06 +/- 8.06
• Analgesic Self-Efficacy (Secondary), Mean, units on a scale: Education Intervention 32.5 +/- 3.22; Standard of Care 32.2 +/- 3.25
• Analgesic Use / Adherence (Secondary), Mean, Doses: Education Intervention 8.6 +/- 10.3; Standard of Care 7.9 +/- 8.6
• Analgesic Decision Competency (Secondary), Count of participants, Participants: Education Intervention 43; Standard of Care Only 64

Adverse events

Time frame: All adverse events within 30 days of enrollment were recorded.

Serious adverse events by term

• Results publication: 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. PMID 35909029
• Results publication: 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. PMID 31871245

• Informed Consent Form (PDF, 2018-10-22)
• Study Protocol and Statistical Analysis Plan (PDF, 2018-10-24)

• Terri Voepel-Lewis, PhD, Principal investigator, University of Michigan

NIH grants: R01DA044245