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NCT03287622 · ClinicalTrials.gov registry record · NA
Evaluation of an Interactive Opioid Risk Education Program (STOMP) for Parents
A NA study of Pain, Postoperative and Opioid Use, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 712
- Enrollment target
- 1
- Study location
NCT03287622: Completed NA study of Pain, Postoperative and Opioid Use, sponsored by University of Michigan.
NCT03287622 is a NA study of Pain, Postoperative and Opioid Use that has completed, run by University of Michigan. The registered enrollment target is 712 participants, above the 267-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (167% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03287622, a NA study of Pain, Postoperative and Opioid Use, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 712 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Number of parent participants who became aware (binary) of serious opioid-related adverse effect (over sedation)
Conditions Studied
Interventions
- BEHAVIORAL Educational Intervention
- BEHAVIORAL Nudge
Study Locations (1)
Michigan
- University of Michigan, C.S. Mott Children's Hospital - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 712 participants |
| Start Date | 2017-10-24 |
| Est. Completion | 2019-09-30 |
| Phase | NA |
What the finished NCT03287622 record still lists
NCT03287622 is an interventional study that assigns participants to a tested intervention. The registered 712 participants enrollment target is mid-sized for trials with a published cap, above the 267-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (167% higher).
The record links to 5 conditions, with Pain, Postoperative appearing as the primary indexed condition, and to 2 interventions - of which Educational Intervention is the first listed.
NCT03287622 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT03287622 about?
NCT03287622 is a clinical study titled "Evaluation of an Interactive Opioid Risk Education Program (STOMP) for Parents". 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 ri...
What is the current status of trial NCT03287622?
This trial is currently completed. It is a NA study. The enrollment target is 712 participants. The study started on 2017-10-24. Estimated completion is 2019-09-30.
What conditions does trial NCT03287622 study?
This clinical trial studies the following conditions: Pain, Postoperative, Opioid Use, Medication Adherence, Knowledge, Attitudes, Practice, Risk Reduction Behavior.
What interventions are being tested in trial NCT03287622?
The interventions under investigation include: Educational Intervention (BEHAVIORAL), Nudge (BEHAVIORAL).
Who is sponsoring clinical trial NCT03287622?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03287622 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03287622's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain, Postoperative trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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