N/A
N=712
Evaluation of an Interactive Opioid Risk Education Program (STOMP) for Parents
Pain, Postoperative · Medication Adherence · Opioid Use · Knowledge, Attitudes, Practice · Risk Reduction Behavior
Bottom Line
View on ClinicalTrials.gov: NCT03287622 ↗Enrolled (actual)
712
Serious AEs
1.2%
Results posted
Nov 2020
Primary outcome: Primary: Opioid-related Risk Knowledge — 287; 289 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Educational Intervention (Behavioral); Nudge (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid-related Risk Knowledge |
287; 289 | — |
| PRIMARY Opioid Risk Perception |
0.35; 0.12; 0.28; 0.14 | — |
| SECONDARY Opioid Disposal Behavior |
48; 44; 40; 25 | — |
| SECONDARY Pain Interference (PROMIS) |
8.63; 8.06 | — |
| SECONDARY Analgesic Self-Efficacy |
32.5; 32.2 | — |
| SECONDARY Analgesic Use / Adherence |
8.6; 7.9 | — |
| SECONDARY Analgesic Decision Competency |
43; 64 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT03287622). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.