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

NCT03287622 | Completed Results DMC

• 2 other identifiers: 001270091R01DA044245-01A1
• Study Type: interventional
• Target: 712
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Opioid Disposal Behavior

  Day 14 (or after course completion)

• Pain Interference (PROMIS)

  Day 14

• Analgesic Self-Efficacy

  Efficacy scores Day 14

• Analgesic Use / Adherence

  Day 14

• Analgesic Decision Competency

  Day 3

Study Arms (4)

Education Intervention + Nudge

EXPERIMENTAL

This group will receive BOTH the scenario-tailored STOMP educational feedback AND the behavioral Nudge intervention

Behavioral: Educational Intervention; Behavioral: Nudge

Standard of Care + Nudge

EXPERIMENTAL

This group will receive routine, standard of care information AND the behavioral Nudge intervention

Behavioral: Nudge

Educational Intervention no Nudge

EXPERIMENTAL

This group will receive scenario-tailored opioid message (STOMP) feedback and NO behavioral nudge intervention.

Behavioral: Educational Intervention

Standard of Care no Nudge

NO INTERVENTION

This group will receive only standard of care information and NO behavioral nudge intervention.

Interventions

Educational Intervention BEHAVIORAL

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

Also known as: STOMP Intervention

Education Intervention + Nudge; Educational Intervention no Nudge

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

Education Intervention + Nudge; Standard of Care + Nudge

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parent (\>=21yr) and child (5-17 yr) (dyad) who lives in the home and is prescribed an opioid for postoperative pain management
• English speaking

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

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

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (2)

• Voepel-Lewis T, Boyd CJ, Tait AR, McCabe SE, Zikmund-Fisher BJ. A Risk Education Program Decreases Leftover Prescription Opioid Retention: An RCT. Am J Prev Med. 2022 Oct;63(4):564-573. doi: 10.1016/j.amepre.2022.04.035. Epub 2022 Jul 28.

  PMID: 35909029 DERIVED

• Voepel-Lewis T, Farley FA, Grant J, Tait AR, Boyd CJ, McCabe SE, Weber M, Harbagh CM, Zikmund-Fisher BJ. Behavioral Intervention and Disposal of Leftover Opioids: A Randomized Trial. Pediatrics. 2020 Jan;145(1):e20191431. doi: 10.1542/peds.2019-1431.

  PMID: 31871245 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Medication Adherence; Behavior; Risk Reduction Behavior

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Results Point of Contact

• Title: Dr. Terri Voepel-Lewis
• Organization: University of Michigan

terriv@umich.edu

734-646-6803

Study Officials

• Terri Voepel-Lewis, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Group assignment will be coded for parents and data collectors. Parents will be blinded to whether the information they receive is the Intervention vs. Control. Group assignment will coded on data entry and unblinded after analyses.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Scientist

Model Details: Four-armed, randomized, control, factorial design

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 19, 2017
• Study Start: October 24, 2017
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: November 19, 2020
• Results First Posted: November 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)