Brief Intervention and Referral to Treatment With Substan... | NCT01661517

Studies
Brief Intervention and Referral to Treatment With Substance Use Disorders in the Emergency Room Setting

NCT01661517

Sponsor

University of Alabama at Birmingham

Status

Terminated

Last Update Posted

Oct 18, 2016Estimated

Enrollment

5,271Actual

Phase

Early Phase 1

Conditions

Substance Use

Interventions

Motivational interviewing and referral to treatment

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

Sep 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

incomplete data

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Sep 2013Actual

Completion Date

May 2015Actual

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

Oct 15, 2016

Last Update Posted Date

Oct 18, 2016Estimated

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

This study will be a quality improvement project to review the effectiveness and barriers to effectiveness of a new clinical program in the emergency room to provide substance use screening followed by brief motivational interviewing and referral to treatment for patients who meet criteria for problem substance use. This study will consist of a chart review of the results of the screens performed by substance use counselors and correlating them to institutional variables such as wait time in the emergency room and length of stay as well as to patient variables obtained by chart review such as medical diagnosis and sociodemographic variables.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5,271Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lifestyle Counseling	Experimental	motivational interviewer	Behavioral: Motivational interviewing and referral to treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Motivational interviewing and referral to treatment	Behavioral		Lifestyle Counseling

Measure	Description	Time Frame
substance use		2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 19 and older Presentation to UAB Emergency Department

Exclusion Criteria:

Younger than 19 Prisoners

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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	35205	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

Intervention Browse Module

MeSH Terms

ID	Term
D062405	Motivational Interviewing

Ancestor Terms

ID	Term
D037001	Directive Counseling
D003376	Counseling
D008605	Mental Health Services
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided