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

October 28, 2020 updated by: Terri Voepel-Lewis, University of Michigan

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
712

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan, C.S. Mott Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Education Intervention + Nudge
This group will receive BOTH the scenario-tailored STOMP educational feedback AND the behavioral Nudge intervention
Behavioral: Educational Intervention
This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.
Other Names:
  • STOMP Intervention
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
Experimental: Standard of Care + Nudge
This group will receive routine, standard of care information AND the behavioral Nudge intervention
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
Experimental: Educational Intervention no Nudge
This group will receive scenario-tailored opioid message (STOMP) feedback and NO behavioral nudge intervention.
Behavioral: Educational Intervention
This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.
Other Names:
  • STOMP Intervention
No Intervention: Standard of Care no Nudge
This group will receive only standard of care information and NO behavioral nudge intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Day 3 follow-up assessment
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)
Mean difference in score from baseline to follow-up assessments (Days 3 & 14)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Opioid Disposal Behavior
Time Frame: Day 14 (or after course completion)
Number of parents (and percentage) who disposed of left-over opioids after use
Day 14 (or after course completion)
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)
Day 14
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)
Efficacy scores Day 14
Analgesic Use / Adherence
Time Frame: Day 14
Total number of opioid doses administered
Day 14
Analgesic Decision Competency
Time Frame: Day 3
Number of participants who made the scenario-based decision to administer opioid to excessively sedated child
Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Terri Voepel-Lewis, PhD, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 24, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 00127009
  • 1R01DA044245-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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