Skip to main content
OpenTrials
Completed

NCT Number: NCT03287622

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain, Postoperative Behavior Health Behavior Knowledge, Attitudes, Practice Medication Adherence Neurologic Manifestations Opioid Use Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Postoperative Complications Risk Reduction Behavior Signs and Symptoms Treatment Adherence and Compliance

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, C.S. Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Educational intervention

Behavioral

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

Other names: STOMP Intervention

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

  1. Opioid-related Risk Knowledge

    Time frame: Day 3 follow-up assessment

    Number of parent participants who became aware (binary) of serious opioid-related adverse effect (over sedation)

  2. Opioid Risk Perception

    Time frame: 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

  1. Opioid Disposal Behavior

    Time frame: Day 14 (or after course completion)

    Number of parents (and percentage) who disposed of left-over opioids after use

  2. Pain Interference (PROMIS)

    Time frame: 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)

  3. Analgesic Self-Efficacy

    Time frame: 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)

  4. Analgesic Use / Adherence

    Time frame: Day 14

    Total number of opioid doses administered

  5. Analgesic Decision Competency

    Time frame: Day 3

    Number of participants who made the scenario-based decision to administer opioid to excessively sedated child

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Scenario-tailored Opioid Messaging Program (STOMP): An Interactive Intervention to Prevent Opioid-related Adverse Drug Events in Children and Adolescents

Acronym: STOMP

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 19, 2017
Registry last updated
Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.