Project Health Link: Connecting Patients With Services

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Frederic C. Blow, University of Michigan
ClinicalTrials.gov Identifier:
NCT00251173
First received: November 7, 2005
Last updated: April 7, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention
Drug Abuse
Behavioral: Strengths Based Case Management (SBCM)
Behavioral: Motivational Enhancement Therapy (MET)
Behavioral: Brief Informational Feedback (BIF) session

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Services Interventions for Injured ED Substance Abusers

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • receipt of assessment [ Time Frame: 3 and 6 months post-baseline ] [ Designated as safety issue: No ]
  • treatment entry [ Time Frame: 3 and 6 months post-baseline ] [ Designated as safety issue: No ]

Enrollment: 755
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 (SBCM)
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.
Behavioral: Motivational Enhancement Therapy (MET)
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 (BIF) session

  Eligibility

Ages Eligible for Study:   19 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00251173

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: NCT00251173     History of Changes
Other Study ID Numbers: 1R01DA016591-01A1 
Study First Received: November 7, 2005
Last Updated: April 7, 2016
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 24, 2016