search
Back to results

Multidisciplinary Approach to Reduce Injury and Substance Abuse

Primary Purpose

Drug Abuse

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Brief advice
Brief Intervention plus Booster
Brief Intervention
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Drug Abuse focused on measuring Drug abuse, injury, trauma, screening, brief intervention.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Study participants must be 18 years or older
  • Speak English or Spanish
  • Been admitted to the level 1 Trauma Department
  • Test positive for illegal drugs or admit to illegal drug use

Exclusion Criteria:

  • Other penetrating trauma not related to motor vehicle collisions, violence or falls, such as poisoning and, bites
  • Patients with traumatic brain injury, or a Glasgow Coma Scale score of less than 15
  • Patients who do not pass the Mini-Mental Status Exam are excluded

Sites / Locations

  • University Medical Center Brackenridge

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Brief Intervention

Brief advice

Brief Intervention plus Booster

Arm Description

30-45 minute motivational interviewing based intervention with feedback addressing drug use, injury prevention and HIV risk.

This condition of the experiment acts a control and will be a short session in which the therapist will provide brief advice about drug use and give the patient a pamphlet.

30-45 minute motivational interviewing based intervention with feedback addressing drug use, injury prevention and HIV risk plus a brief phone booster session at 1 month post-intake to review feedback, 2) assess progress, 2) renew motivation to change, and 3) evaluate and affirm commitment to change.

Outcomes

Primary Outcome Measures

The primary outcome of interest will be patients' subsequent drug use.

Secondary Outcome Measures

HIV risk-behaviors, improved health, increased employment, decreased illegal behavior, increased substance treatment, enhanced quality of life, use of Transtheoretical model of change, organization implementation, and intervention cost-effectiveness.

Full Information

First Posted
January 11, 2010
Last Updated
November 23, 2015
Sponsor
University of Texas at Austin
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT01048359
Brief Title
Multidisciplinary Approach to Reduce Injury and Substance Abuse
Official Title
Multidisciplinary Approach to Reduce Injury and Substance Abuse
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary purpose of the project entitled: Multidisciplinary Approach to Reduce Injury and Substance Abuse, which is funded by the National Institute on Drug Abuse (5R01DA026088-02), is to compare the effectiveness of brief intervention, brief intervention plus a booster, and brief advice for adult patients who abuse drugs and present to a trauma department for treatment of an injury.
Detailed Description
Multidisciplinary Approach to Reduce Injury and Substance Abuse is a randomized clinical trial evaluating the effectiveness of brief advice (BA), brief motivational intervention with feedback (BMI), and brief motivational intervention with feedback and booster (BMI+B) in injured patients with drug problems. The setting is a level 1 Trauma Department, which serves a large and diverse patient population. Injured patients are screened for eligibility in the project based on a positive toxicology screen or self reported drug use in the past 90 days. The primary outcome of interest will be patients' subsequent drug use. Other outcomes of interest include: HIV-related risk behaviors, improved health outcomes (including injury reduction), increased employment, decreased engagement in illegal behavior, increased substance abuse treatment utilization, and enhanced quality of life at three, six, and twelve month follow-ups. This study will also examine the potential moderating and mediating effects of patient readiness to change, use of experiential and behavioral processes of change and decisional balance considerations. In addition, this project will examine implementation factors at the organizational level and the cost effectiveness of BA, BMI, and BMI+B. Study participants and their related identifying information will be collected during the time they are admitted to the recruitment hospital trauma department. Study participants must be 18 years or older, speak English or Spanish, have been admitted to the recruitment hospital trauma department, and test positive for illegal drugs or admit to illegal drug use when verbally screened. Additional information will be collected from participants in the in-person assessment interviews at three, six, and 12 month follow-up periods.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Abuse
Keywords
Drug abuse, injury, trauma, screening, brief intervention.

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
417 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief Intervention
Arm Type
Experimental
Arm Description
30-45 minute motivational interviewing based intervention with feedback addressing drug use, injury prevention and HIV risk.
Arm Title
Brief advice
Arm Type
Active Comparator
Arm Description
This condition of the experiment acts a control and will be a short session in which the therapist will provide brief advice about drug use and give the patient a pamphlet.
Arm Title
Brief Intervention plus Booster
Arm Type
Experimental
Arm Description
30-45 minute motivational interviewing based intervention with feedback addressing drug use, injury prevention and HIV risk plus a brief phone booster session at 1 month post-intake to review feedback, 2) assess progress, 2) renew motivation to change, and 3) evaluate and affirm commitment to change.
Intervention Type
Behavioral
Intervention Name(s)
Brief advice
Intervention Description
The American College of Surgeons (ACS) recently mandated standards of care for all level I trauma centers and currently defined standards of care at the collaborating institution requires that assessment and referral are included in treatment as usual. Therefore, our treatment as usual, or BA, consists of an initial interview conducted by study staff, a recommendation to abstain from drug use, provision of educational material supporting that recommendation, referral to hospital or community treatment resources most likely to be beneficial to the patient and information about relevant community health care agencies.
Intervention Type
Behavioral
Intervention Name(s)
Brief Intervention plus Booster
Intervention Description
A brief drug use intervention based on motivational interviewing is provided to participants at baseline and a booster session incorporating personalized feedback is provided at one month
Intervention Type
Behavioral
Intervention Name(s)
Brief Intervention
Intervention Description
A brief drug use intervention based on motivational interviewing is provided to participants at baseline
Primary Outcome Measure Information:
Title
The primary outcome of interest will be patients' subsequent drug use.
Time Frame
3, 6, and 12 months after intervention
Secondary Outcome Measure Information:
Title
HIV risk-behaviors, improved health, increased employment, decreased illegal behavior, increased substance treatment, enhanced quality of life, use of Transtheoretical model of change, organization implementation, and intervention cost-effectiveness.
Time Frame
3, 6, and 12 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Study participants must be 18 years or older Speak English or Spanish Been admitted to the level 1 Trauma Department Test positive for illegal drugs or admit to illegal drug use Exclusion Criteria: Other penetrating trauma not related to motor vehicle collisions, violence or falls, such as poisoning and, bites Patients with traumatic brain injury, or a Glasgow Coma Scale score of less than 15 Patients who do not pass the Mini-Mental Status Exam are excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary M Velasquez, PhD
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Craig A Field, PhD
Organizational Affiliation
University of Texas, El Paso
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Brackenridge
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Multidisciplinary Approach to Reduce Injury and Substance Abuse

We'll reach out to this number within 24 hrs