NCT02861976

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
346

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

July 15, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 10, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

2.9 years

First QC Date

February 9, 2016

Last Update Submit

June 16, 2020

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (1)

  • Opioid use disorder (CIDI-SAM) or opioid misuse (COMM) Opioid Use Disorder in 6 Months Post Traumatic Injury

    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

Interventions

Opioid risk screen development & implementationOTHER

Development of a screening tool for the risk of opioid misuse in patients with traumatic injury.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of UW Trauma Inpatient Service with expected need for post discharge with outpatient opioid analgesia.

You may qualify if:

  • Inpatient victim of traumatic injury
  • Expected need for post-discharge outpatient opioid analgesia
  • English speaking
  • Disposition to short-term rehabilitation facility is allowed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53715, United States

Location

Related Publications (1)

  • Brown R, Deyo B, Riley C, Quanbeck A, Glass JE, Turpin R, Hetzel S, Nicholas C, Cruz M, Agarwal S. Screening in Trauma for Opioid Misuse Prevention (STOMP): study protocol for the development of an opioid risk screening tool for victims of injury. Addict Sci Clin Pract. 2017 Dec 4;12(1):28. doi: 10.1186/s13722-017-0097-6.

    PMID: 29198186DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Randall Brown, MD, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2016

First Posted

August 10, 2016

Study Start

July 15, 2016

Primary Completion

May 23, 2019

Study Completion

June 1, 2020

Last Updated

June 17, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)