- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02861976
Screening in Trauma for Opioid Misuse Prevention (STOMP)
June 16, 2020 updated by: University of Wisconsin, Madison
Screening in Trauma for Opioid Misuse Prevention (STOMP): Screen Development and Pilot Implementation Study
The current study seeks to begin the crucial work of creating effective protocols to prevent opioid misuse, addiction, and related complications by developing and pilot testing an opioid risk screening protocol at Wisconsin trauma centers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
346
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
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Wisconsin
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Madison, Wisconsin, United States, 53715
- University Of Wisconsin - Madison
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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
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients of UW Trauma Inpatient Service with expected need for post discharge with outpatient opioid analgesia.
Description
Inclusion Criteria:
- Inpatient victim of traumatic injury
- Expected need for post-discharge outpatient opioid analgesia
- English speaking
- Disposition to short-term rehabilitation facility is allowed
Exclusion Criteria:
- Disposition to a skilled nursing or long-term acute care facility
- Current active opioid use disorder or current active participation in a program of recovery for another substance use disorder
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opioid use disorder (CIDI-SAM) or opioid misuse (COMM) Opioid Use Disorder in 6 Months Post Traumatic Injury
Time Frame: 6 months subject participation
|
This data will be analyzed in tandem with patient demographics, physical and mental health, and hypothesized risk factors for opioid misuse.
|
6 months subject participation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Randall Brown, MD, PhD, University of Wisconsin, Madison
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.
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)
July 15, 2016
Primary Completion (Actual)
May 23, 2019
Study Completion (Actual)
June 1, 2020
Study Registration Dates
First Submitted
February 9, 2016
First Submitted That Met QC Criteria
August 5, 2016
First Posted (Estimate)
August 10, 2016
Study Record Updates
Last Update Posted (Actual)
June 17, 2020
Last Update Submitted That Met QC Criteria
June 16, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-0430 (Other Identifier: M D Anderson Cancer Center)
- A532050 (Other Identifier: UW Madison)
- 3152 (Other Identifier: Study Team)
- SMPH/FAMILY MEDICINE/CL-WINGRA (Other Identifier: UW Madison)
- Protocol Version 9/5/2019 (Other Identifier: UW Madison)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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