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

NCT ID: NCT03287622

Last Updated: 2020-11-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

712 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-24

Study Completion Date

2019-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Four-armed, randomized, control, factorial design
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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Education Intervention + Nudge

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

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type BEHAVIORAL

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

Nudge

Intervention Type 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

Standard of Care + Nudge

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

Group Type EXPERIMENTAL

Nudge

Intervention Type 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

Educational Intervention no Nudge

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

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type BEHAVIORAL

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

Standard of Care no Nudge

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Educational Intervention

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

Intervention Type 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

Intervention Type BEHAVIORAL

Other Intervention Names

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STOMP Intervention

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Terri Voepel-Lewis

Associate Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Terri Voepel-Lewis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35909029 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31871245 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1R01DA044245-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00127009

Identifier Type: -

Identifier Source: org_study_id