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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03287622
Recruitment Status : Completed
First Posted : September 19, 2017
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Terri Voepel-Lewis, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Medication Adherence Opioid Use Knowledge, Attitudes, Practice Risk Reduction Behavior Behavioral: Educational Intervention Behavioral: Nudge Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 711 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Four-armed, randomized, control, factorial design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Prevention
Official Title: Scenario-tailored Opioid Messaging Program (STOMP): An Interactive Intervention to Prevent Opioid-related Adverse Drug Events in Children and Adolescents
Actual Study Start Date : October 24, 2017
Actual Primary Completion Date : April 19, 2019
Actual Study Completion Date : April 19, 2019

Arm Intervention/treatment
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 Name: 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 Name: STOMP Intervention

No Intervention: Standard of Care no Nudge
This group will receive only standard of care information and NO behavioral nudge intervention.



Primary Outcome Measures :
  1. Opioid risk knowledge and perception [ Time Frame: Change over time (through Day 14) ]
    Parent awareness (binary) and risk perceptions (scaled 1-6) of common and potentially serious opioid-related adverse effects

  2. Opioid disposal behavior [ Time Frame: Day 14 ]
    Measures disposal intention and action (binary)


Secondary Outcome Measures :
  1. Pain interference [ Time Frame: Day 14 ]
    The Parents Postoperative Pain Measure - Short Form will measure the degree to which pain interferes with function after surgery (0-10 scale)

  2. Analgesic Self-Efficacy [ Time Frame: Change over time (through Day 14) ]
    7 Item Survey measures how confident the parent is in managing pain and opioids (not at all to extremely)

  3. Opioid-related adverse events (OR-ADE) [ Time Frame: Day 21 ]
    Incidence of OR-ADEs experienced after surgery (summed)

  4. Analgesic use / adherence [ Time Frame: Day 21 ]
    Total morphine equivalents (mEq mg/kg) and total non-opioid mg/kg

  5. Analgesic decision competency [ Time Frame: Change over time (through Day 14) ]
    Measures parents' skill in making safe and effective opioid use decisions (binary outcome)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03287622


Locations
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United States, Michigan
University of Michigan, C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Terri Voepel-Lewis, PhD University of Michigan

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Responsible Party: Terri Voepel-Lewis, Associate Research Scientist, University of Michigan
ClinicalTrials.gov Identifier: NCT03287622    
Other Study ID Numbers: 00127009
1R01DA044245-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents