NCT01683227

Brief Summary

Screening, Brief Intervention, and Referral to Treatment (SBIRT) is a comprehensive, integrated public health approach to identify and deliver a spectrum of early detection and intervention services for substance use in general medical care settings. These settings, such as emergency department visits, offer a potential "teachable moment" because patients may have perceptions of vulnerability about their health, and therefore be particularly receptive to screening and counseling. There is mounting scientific evidence suggesting SBIRT is effective in reducing alcohol use at varying levels of severity in a myriad of health care settings including primary care, emergency departments, and trauma centers. Although the SBIRT approach has shown promise for alcohol, relatively little is known about its effectiveness for adult illicit drug use specifically. This will be among the first studies to rigorously test the SBIRT approach for drug use. It will evaluate the effectiveness of SBIRT for drug use and related factors for 700 multi-ethnic ED patients using a two-group randomized repeated-measures design in which biologically-validated drug use abstinence and related outcomes of an intervention group are compared to those of an attention-placebo control group. Over a 14-month period, bilingual/bicultural Health Educators recruited participants who reported past 30-day illicit drug use in excess of risky alcohol use from the waiting areas of two large hospital's ED and trauma units. Following consent procedures and standardized baseline assessments, Health Educators randomly assigned participants to one of the two conditions. The intervention group received "Life Shift," an SBIRT drug use intervention matched to the participant's drug use risk level. The control group received the same type and quantity of intervention in an unrelated area-Driving and Traffic Safety ("Shift Gears" program), also matched to their driving/traffic risk level. A 6-month face-to-face follow-up visit by trained measurement technicians blind to the participant's assigned condition collected standardized self-report past 30-day drug use measures (ASI-Lite)and hair samples for validating self-reported abstinence. Additional outcome variables are changes in the frequency of drug use, functional status measures (i.e., medical problems, psychiatric problems, and alcohol use), and health care utilization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

April 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2012

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

1.2 years

First QC Date

September 7, 2012

Last Update Submit

April 18, 2016

Conditions

Keywords

drug use; emergency department; brief intervention

Outcome Measures

Primary Outcomes (1)

  • past 30 day drug use abstinence

    Based on the addiction severity index-Lite

    6 months post intervention

Secondary Outcomes (1)

  • Frequency of drug use

    6 months post intervention

Study Arms (2)

Screening/motivational drug intervention

EXPERIMENTAL

Screening and brief intervention counseling matched to patient's risk level delivered in the ER

Behavioral: Screening/motivational drug intervention

Motivational placebo intervention

PLACEBO COMPARATOR

Screening and brief intervention for driving and traffic safety

Behavioral: Motivational placebo intervention

Interventions

Screening and brief motivational intervention delivered in the ER to reduce drug use

Also known as: SBIRT
Screening/motivational drug intervention

Screening and brief motivational intervention delivered in the ER to reduce driving and traffic risk

Motivational placebo intervention

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • or over
  • speak English or Spanish
  • competent to give consent and interact
  • drug use risk higher than alcohol use risk

You may not qualify if:

  • under 18
  • non english or spanish speaker
  • no telephone where one can be reached
  • too injured/sick to participate
  • alcohol use risk higher than drug use risk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Scripps Mercy Emergency Department and Trauma Unit

San Diego, California, 92103, United States

Location

UCSD Emergency Department and Trauma Unit

San Diego, California, 92103, United States

Location

Related Publications (2)

  • Woodruff SI, Clapp JD, Eisenberg K, McCabe C, Hohman M, Shillington AM, Sise CB, Castillo EM, Chan TC, Sise MJ, Gareri J. Randomized clinical trial of the effects of screening and brief intervention for illicit drug use: the Life Shift/Shift Gears study. Addict Sci Clin Pract. 2014 May 22;9(1):8. doi: 10.1186/1940-0640-9-8.

  • Eisenberg K, Woodruff SI. Randomized controlled trial to evaluate screening and brief intervention for drug-using multiethnic emergency and trauma department patients. Addict Sci Clin Pract. 2013 Apr 8;8(1):8. doi: 10.1186/1940-0640-8-8.

MeSH Terms

Conditions

Substance-Related DisordersEmergencies

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Susan I Woodruff, PhD

    San Diego State University, School of Social Work

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 7, 2012

First Posted

September 11, 2012

Study Start

April 1, 2010

Primary Completion

June 1, 2011

Study Completion

August 1, 2012

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations