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Project Health Link: Connecting Patients With Services

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00234221
First Posted: October 6, 2005
Last Update Posted: April 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Frederic C. Blow, University of Michigan
  Purpose
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.

Condition Intervention
Alcohol Abuse Behavioral: Strengths Based Case Management Behavioral: Motivational Enhancement Therapy Behavioral: Brief Informational Feedback

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Services Interventions for Injured ED Problem Drinkers

Further study details as provided by Frederic C. Blow, University of Michigan:

Primary Outcome Measures:
  • receipt of assessment [ Time Frame: 3 and 6 months post-baseline ]
  • treatment entry [ Time Frame: 3 and 6 months post-baseline ]

Enrollment: 686
Study Start Date: November 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Strengths Based Case Management Model (SBCM)
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
Active Comparator: Motivational Enhancement Therapy (MET)
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
Active Comparator: Brief Informational Feedback (BIF) session
Subjects will receive brief informational feedback on the results of their alcohol screening and assessment and encouragement to seek treatment.
Behavioral: Brief Informational Feedback

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (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).

Exclusion Criteria:

  • (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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00234221


Locations
United States, Michigan
Hurley Medical Center
Flint, Michigan, United States, 48503
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Frederic C Blow, PhD University of Michigan
  More Information

Responsible Party: Frederic C. Blow, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00234221     History of Changes
Other Study ID Numbers: 1R01AA014665-01A1 ( U.S. NIH Grant/Contract )
First Submitted: October 4, 2005
First Posted: October 6, 2005
Last Update Posted: April 13, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders