Routine Clinical Screening for Substance Use Disorders in... | NCT01661465

Studies
Routine Clinical Screening for Substance Use Disorders in the Emergency Room Setting

NCT01661465

Sponsor

University of Alabama at Birmingham

Status

Terminated

Last Update Posted

Mar 31, 2023Actual

Enrollment

9,212Actual

Phase

Not provided

Conditions

Substance Use

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The Principal Investigator left the site.

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Aug 7, 2012

First Submission Date that Met QC Criteria

Aug 7, 2012

First Posted Date

Aug 9, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2023

Last Update Posted Date

Mar 31, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Cheryl McCullumsmith, Division Director, Hospital Psychiatry, University of Alabama at BirminghamPrincipal Investigator

Lead Sponsor

University of Alabama at BirminghamOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To ensure consistent documentation of alcohol and substance use, the emergency medicine is initiating a new standard of care for substance use screening: the use of a brief self-evaluation questionnaire on alcohol, tobacco and illicit substance use to be completed in triage. This questionnaire will allow emergency medicine patients presenting to the emergency room. This study will also review medical records after one year of the index emergency room visit to establish rates or re-presentation and hospitalization correlated with different substance use.

Detailed Description

Screening for alcohol use and substances of abuse in the emergency and trauma settings is critical for both effective current treatment of the presenting clinical issue and prevention of future incidents. Identification, engagement and treatment of substance use disorders decreased trauma and emergency department visits and medical comorbidities (Bertholet et al., 2005; Kaner et al., 2007). To ensure consistent documentation of alcohol and substance use, the emergency medicine is initiating a new standard of care for substance use screening: the use of a brief self-evaluation questionnaire on alcohol, tobacco and illicit substance use to be completed in triage. This questionnaire will allow emergency medicine patients presenting to the emergency room. This research study will perform a chart review on all self-evaluation questionnaires on alcohol, tobacco and substance use to determine the prevalence of use of specific substances in this patient population and associated demographic predictors and medical comorbidities. This study will also review medical records after one year of the index emergency room visit to establish rates or re-presentation and hospitalization correlated with different substance use.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9,212Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent of subjects with re-presentation of drug or alcohol abuse 1 year after initial presentation to Emergency Department		baseline to 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Able to complete a questionnaire

Exclusion Criteria:

Younger than 19 Unable or unwilling to complete a self-assessment form written in English Prisoners

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients presenting to University Hospital Emergency Department

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama Birmingham		Birmingham	Alabama	35294	United States

Condition Browse Module

MeSH Terms

ID	Term
D019966	Substance-Related Disorders

Ancestor Terms

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided