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临床试验/NCT01048359
NCT01048359已完成3 期

Multidisciplinary Approach to Reduce Injury and Substance Abuse

University of Texas at Austin2 个研究点 分布在 1 个国家目标入组 417 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
417
试验地点
2
主要终点
The primary outcome of interest will be patients' subsequent drug use.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 3, 6, and 12 months after intervention

次要结局

  • 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.(3, 6, and 12 months after intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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