Multidisciplinary Approach to Reduce Injury and Substance Abuse
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...
Brief Summary
Official Title: “Multidisciplinary Approach to Reduce Injury and Substance Abuse”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
- Study Primary Completion Date: September 2012
Detailed Clinical Trial 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 UMC Brackenridge Hospital Trauma Department, which serves a large and diverse patient population. Injured patients are screened for eligibility in the project based on a positive tox 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 UMC Brackenridge Hospital Trauma Department. Study participants must be 18 years or older, speak English or Spanish, have been admitted to the UMC Brackenridge 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 appointments at UMC Brackenridge at three, six, and 12 month follow-up periods.
Intervention(s) in this Clinical Trial
- Behavioral: Brief advice
- 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 educationalmaterial 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.
- Behavioral: Brief Intervention plus Booster Session (BMI+B)
- 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
- Behavioral: Brief Intervention
- A brief drug use intervention based on motivational interviewing is provided to participants at baseline
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: Brief Intervention
- Active Comparator: Brief advice
- 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.
- Experimental: Brief Intervention plus Booster
Outcome Measures for this Clinical Trial
Primary Measures
- The primary outcome of interest will be patients' subsequent drug use.
- Time Frame: 3, 6, and 12 months after intervention
Safety Issue?: No
- Time Frame: 3, 6, and 12 months after intervention
Secondary 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.
- Time Frame: 3, 6, and 12 months after intervention
Safety Issue?: No
- Time Frame: 3, 6, and 12 months after intervention
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Study participants must be 18 years or older
- Speak English or Spanish
- Been admitted to the UMC Brackenridge Hospital 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 Scalescore of less than 15
- Patients who do not pass the Mini-Mental Status Exam are excluded
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: National Institute on Drug Abuse (NIDA) NIH
Overall Clinical Trial Officials and Contacts
Mary M Velasquez, PhD Principal Investigator University of Texas at Austin
Overall Contact: Mary M Velasquez, PhD (512) 471-7019 velasquez@austin.utexas.edu
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01048359
Study ID Number: DESPR DA026088
ClinicalTrials.gov Identifier: NCT01048359
Health Authority: United States: Federal Government
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01048359
