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

Pain, Postoperative Clinical Trial

— STOMP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03287622
• Other study ID #: 00127009
• Secondary ID: 1R01DA044245-01A
• Status: Completed
• Phase: N/A
• Start date: October 24, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 712
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Educational Intervention
This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.
• 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

Locations

Country	Name	City	State
United States	University of Michigan, C.S. Mott Children's Hospital	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid-related Risk Knowledge	Number of parent participants who became aware (binary) of serious opioid-related adverse effect (over sedation)	Day 3 follow-up assessment
Primary	Opioid Risk Perception	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)	Mean difference in score from baseline to follow-up assessments (Days 3 & 14)
Secondary	Opioid Disposal Behavior	Number of parents (and percentage) who disposed of left-over opioids after use	Day 14 (or after course completion)
Secondary	Pain Interference (PROMIS)	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)	Day 14
Secondary	Analgesic Self-Efficacy	Survey measures how confident the parent is in managing pain and opioid-related adverse events (score range 0-35; higher = more efficacy)	Efficacy scores Day 14
Secondary	Analgesic Use / Adherence	Total number of opioid doses administered	Day 14
Secondary	Analgesic Decision Competency	Number of participants who made the scenario-based decision to administer opioid to excessively sedated child	Day 3