Project Health Link: Connecting Patients With Services
April 7, 2016 updated by: Frederic C. Blow, University of Michigan
Services Interventions for Injured ED Substance Abusers
The proposed study will compare three alternative interventions in the emergency department (ED) to promote linkage to substance abuse assessment, referral and treatment entry for those who meet abuse/dependence criteria for stimulants, cannabis, and/or non-injected opioids: (1) a 5-session Strengths-Based Case Management (SBCM) model; (2) a 2-session Brief Motivational Enhancement (BME); or (3) a one-time Brief Informational Feedback (BIF) session.
The primary outcome variables for this trial include receiving an assessment and referral and treatment entry.
Other outcomes include degree of treatment completion, substance-related measures, health service utilization, health status changes, and psychosocial factors.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
755
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Flint, Michigan, United States, 48503
- Hurley Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- (1) adults age 19-60 presenting to the Hurley Medical Center ED within 24 hours of an injury; (2) ability to provide informed consent.
Additional inclusion criteria for intervention study: meets criteria for substance abuse or dependence for stimulants (cocaine powder, crack cocaine, methamphetamine, amphetamine), cannabis (marijuana, hashish), and or opioids (noninjected heroin, other opioids such as hydrocodone and oxycodone) in the previous year.
Exclusion Criteria:
- (1) adult patients who do not understand English; (2) prisoners; (3) adults classified by medical staff as "Level 1 trauma"; (4) adults deemed unable to provide informed consent as stated above (e.g., intoxication, mental incompetence); (5) patients treated in the ED for suicide attempts and sexual assaults; (6) patients who have been in treatment for substance abuse in the past six months; (7) patients who are triaged to psychiatric emergency services; and (8) patients who report injecting heroin or other opiates in the past year.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
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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 substance use/abuse with the goal of negotiating a 'contract' to: 1) link to services, with the eventual goal of seeking and receiving specialized substance treatment; or 2) provide a strategy to self-monitor substance use, consider consequences, and later seek assessment.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
receipt of assessment
Time Frame: 3 and 6 months post-baseline
|
3 and 6 months post-baseline
|
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treatment entry
Time Frame: 3 and 6 months post-baseline
|
3 and 6 months post-baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (ACTUAL)
December 1, 2009
Study Completion (ACTUAL)
December 1, 2009
Study Registration Dates
First Submitted
November 7, 2005
First Submitted That Met QC Criteria
November 7, 2005
First Posted (ESTIMATE)
November 9, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
April 8, 2016
Last Update Submitted That Met QC Criteria
April 7, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01DA016591-01A1 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.