NCT00234221

Brief Summary

This study will compare three alternative interventions in the emergency department (ED) to promote substance abuse assessment, referral, and treatment entry: 1) a 5 session strengths-based case management model (SBCM); 2) a 2-session motivational enhancement therapy (MET); or 3) a one-time brief informational feedback (BIF) session. The primary outcome variables for this trial include follow-through on receiving an assessment and referral, and treatment engagement. Additional outcomes include degree of treatment completion, alcohol-related measures, health service utilization, health status changes, and psychosocial factors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
686

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2005

Longer than P75 for not_applicable

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

October 4, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2005

Completed
26 days until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

April 13, 2016

Status Verified

April 1, 2016

Enrollment Period

4.1 years

First QC Date

October 4, 2005

Last Update Submit

April 11, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • receipt of assessment

    3 and 6 months post-baseline

  • treatment entry

    3 and 6 months post-baseline

Study Arms (3)

Strengths Based Case Management Model (SBCM)

ACTIVE COMPARATOR

The Strengths Based Case Management Model (SBCM) consists of 5 case-management sessions designed to promote linkage and engagement in assessment and treatment services, while assisting with the patient's perceived needs, as well as personal strengths and barriers to linkage and engagement.

Behavioral: Strengths Based Case Management

Motivational Enhancement Therapy (MET)

ACTIVE COMPARATOR

The MET therapist will conduct 2 motivational enhancement sessions to work through the content of an educational workbook targeting the participant's alcohol use/abuse with the goal of negotiating a 'contract' to: 1) link to services, with the eventual goal of seeking and receiving specialized alcohol treatment; or 2) provide a strategy to self-monitor alcohol use, consider consequences, and later seek assessment.

Behavioral: Motivational Enhancement Therapy

Brief Informational Feedback (BIF) session

ACTIVE COMPARATOR

Subjects will receive brief informational feedback on the results of their alcohol screening and assessment and encouragement to seek treatment.

Behavioral: Brief Informational Feedback

Interventions

Strengths Based Case Management Model (SBCM)
Motivational Enhancement Therapy (MET)
Brief Informational Feedback (BIF) session

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • (1) adults age 19 - 60 presenting to the Emergency Department at Hurley Medical Center within 24 hours of an injury; (2) ability to provide informed consent.
  • For intervention portion of the project: (1) meets DSM-IV criteria for alcohol abuse or dependence in the following year. (Patients who meet abuse/dependence criteria for alcohol may also be using other drugs. They will be included in the study only if they do not meet criteria for past year drug abuse/dependence).

You may not qualify if:

  • (1) adult patients who do not understand English; (2) prisoners; (3) pregnant women; (4) institutionalized patients (e.g. nursing home residents); (5) adults classified by medical staff as "Level 1 trauma"; (6) adults deemed unable to provide informed consent (e.g. intoxication, mental incompetence, under guardianship); (7) patients treated in the ED for suicide attempts and sexual assault; (8) patients meeting past year drug abuse/dependence criteria; and (9) patients who have been in treatment for alcohol or other drug abuse/dependence in the previous year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Frederic C Blow, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 4, 2005

First Posted

October 6, 2005

Study Start

November 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

April 13, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations