search
Back to results

Project Health Link: Connecting Patients With Services

Primary Purpose

Drug Abuse

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

About this trial

This is an interventional health services research trial for Drug Abuse

Eligibility Criteria

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

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.

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 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.

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
November 7, 2005
Last Updated
April 7, 2016
Sponsor
University of Michigan
search

1. Study Identification

Unique Protocol Identification Number
NCT00251173
Brief Title
Project Health Link: Connecting Patients With Services
Official Title
Services Interventions for Injured ED Substance Abusers
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug 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
755 (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 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.
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 (SBCM)
Intervention Type
Behavioral
Intervention Name(s)
Motivational Enhancement Therapy (MET)
Intervention Type
Behavioral
Intervention Name(s)
Brief Informational Feedback (BIF) session
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 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.
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

We'll reach out to this number within 24 hrs