Project Health Link: Connecting Patients With Services

Alcohol Abuse Clinical Trial

Official title:

Services Interventions for Injured ED Problem Drinkers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234221
• Other study ID #: 1R01AA014665-01A1
• Status: Completed
• Phase: N/A
• First received: October 4, 2005
• Last updated: April 11, 2016
• Start date: November 2005
• Est. completion date: December 2009

Study information

• Verified date: April 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 686
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Alcohol Abuse

Intervention

Behavioral:
• Strengths Based Case Management

• Motivational Enhancement Therapy

• Brief Informational Feedback

Locations

Country	Name	City	State
United States	Hurley Medical Center	Flint	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	receipt of assessment		3 and 6 months post-baseline	No
Primary	treatment entry		3 and 6 months post-baseline	No