N/A N=503 Randomized Triple-blind Prevention

Scenario Tailored Opioid Messaging Program (STOMP) to Improve Risk Understanding in Young Adults

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

Bottom Line

View on ClinicalTrials.gov: NCT03863353 ↗

Enrolled (actual)

503

Serious AEs

3.3%

Results posted

Apr 2022

Primary outcome: Primary: Opioid Risk Perception — 31.4; 31.1; 32.8; 30.02 score on a scale — p=.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Educational Intervention (Behavioral)
Age: Pediatric, Adult · 15+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Dec 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Opioid Risk Perception	31.4; 31.1; 32.8; 30.02; 31.0; 29.8	.001 sig
SECONDARY Opioid Misuse Intention Decisions	47; 38; 18; 12	0.534

Summary

Legitimate prescription opioid use during adolescence has been associated with later prescription opioid misuse and substance use disorder symptoms during adulthood. Thus, primary prevention interventions for older adolescents and young adults (15-24 yrs) at the time of prescribing are imperative. The goal of our research is to improve opioid analgesic safety and efficacy by optimizing opioid risk recognition and informed decision-making among 15-24 year olds who are prescribed these agents for home use. Young adults and older adolescents who manage their own prescription pain medicines need to recognize opioid-related risks and make decisions that will both reduce these risks yet ensure effective pain relief. The proposed research will evaluate new strategies to help subjects learn about opioid risks and make safe and effective analgesic decisions. 355 subjects who are undergoing an elective surgical procedure will be recruited. Subjects will be randomized to receive the new educational routine information. Subjects' knowledge and perceptions will be evaluated at baseline and at critical times after surgery.

Eligibility Criteria

Inclusion Criteria

Undergoing an elective surgical procedure for which it is expected they will receive a prescription pain medicine for management of pain during recovery at home.

Exclusion Criteria

Undergoing non-elective procedure
Cognitive impairment precluding self-reporting of pain
Hematologic/oncologic condition
Liver of kidney conditions precluding usual analgesic prescription patters (opioid plus a non-opioid)
Use of opioids for prolonged pain pre-operatively (<2 weeks)

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Data sourced from ClinicalTrials.gov (NCT03863353). 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.