MedTrace Logo

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

NCT03287622 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 712

Last updated 2020-11-19

Study results available
· View outcomes & findings →

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.

Conditions

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

Interventions

BEHAVIORAL

Educational Intervention

This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.

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

Sponsors & Collaborators

Principal Investigators

  • Terri Voepel-Lewis, PhD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-24
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03287622 on ClinicalTrials.gov