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Project Health Link: Connecting Patients With Services

Primary Purpose

Alcohol Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strengths Based Case Management
Motivational Enhancement Therapy
Brief Informational Feedback
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alcohol Abuse

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hurley Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Strengths Based Case Management Model (SBCM)

Motivational Enhancement Therapy (MET)

Brief Informational Feedback (BIF) session

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

receipt of assessment
treatment entry

Secondary Outcome Measures

Full Information

First Posted
October 4, 2005
Last Updated
April 11, 2016
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT00234221
Brief Title
Project Health Link: Connecting Patients With Services
Official Title
Services Interventions for Injured ED Problem Drinkers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
686 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strengths Based Case Management Model (SBCM)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Motivational Enhancement Therapy (MET)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Brief Informational Feedback (BIF) session
Arm Type
Active Comparator
Arm Description
Subjects will receive brief informational feedback on the results of their alcohol screening and assessment and encouragement to seek treatment.
Intervention Type
Behavioral
Intervention Name(s)
Strengths Based Case Management
Intervention Type
Behavioral
Intervention Name(s)
Motivational Enhancement Therapy
Intervention Type
Behavioral
Intervention Name(s)
Brief Informational Feedback
Primary Outcome Measure Information:
Title
receipt of assessment
Time Frame
3 and 6 months post-baseline
Title
treatment entry
Time Frame
3 and 6 months post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic C Blow, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Project Health Link: Connecting Patients With Services

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