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

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • University of Wisconsin - Madison

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

University of Wisconsin, Madison

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.

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)

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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