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临床试验/NCT01113190
NCT01113190已完成不适用

Optimizing SBIRT for Drug-Using Patients in an Inner-City Emergency Department

University of Michigan1 个研究点 分布在 1 个国家目标入组 878 人开始时间: 2011年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
878
试验地点
1
主要终点
drug use - number of days used

研究概览

简要总结

Screening, brief interventions, and referral to treatment (SBIRT) for drug use/abuse offers opportunities for early detection, brief intervention/treatment, and substance use treatment referrals for patients in medical settings. Although SBIRT components, particularly screening and brief interventions, have been shown to be effective strategies for addressing alcohol misuse in primary care, data are limited on using all of the components of SBIRT for drug-using patients, particularly in the Emergency Department (ED). Further, because of the often chaotic environment of EDs, many logistical and practical impediments exist for the adoption of the entire SBIRT model in this setting.

详细描述

The proposed study will use computerized screening using touch screen computer tablets with audio (~4,900 patients) and will test intervention strategies in a two-factorial design (3x2). Specifically, 900 patients aged 18-60 in an inner-city ED who screen positive for drug use in the past 3 months will be randomized to the combinations of three ED-based conditions (computer brief intervention-CBI; intervener brief intervention-IBI; enhanced usual care-EUC), and two follow-up conditions (adapted motivational enhancement therapy-AMET; enhanced usual care-EUC) that will take place 3 months post-ED. All individuals who meet criteria for a drug use disorder will additionally receive the "referral to treatment" or "RT" component of SBIRT. Stratified random assignment [by gender and diagnosis of a drug use disorder (yes/no)] will take place at baseline for all ED based and follow-up conditions. All participants will receive written information including substance abuse and other community resources, and HIV prevention materials. Recognizing that brief interventions are important, but not necessarily sufficient, for change in all patients who use drugs, the primary specific aims of the proposed study will determine the independent effectiveness of immediate "on-the-spot" ED-based brief intervention conditions, 3-month followup brief treatment conditions, and combinations of conditions, for decreasing drug use and improving health-related outcomes (including physical and mental health, and HIV risk behavior) at 6 and 12 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •patients age 18-60 years presenting to the HMC for medical care (except exclusions as noted below)
  • •ability to provide informed consent. Additional inclusion criteria for intervention: past 3-month use of illicit drugs or misuse of psychoactive prescription drugs

排除标准

  • •patients who do not understand English (less than 1% in our prior work) -
  • •prisoners
  • •patients classified by medical staff as "Level 1 trauma" (e.g., unconscious, intubated on respirators, in need of immediate lifesaving procedures such as surgery)
  • •patients deemed unable to provide informed consent as stated above (e.g., intoxication, mental incompetence)
  • •patients treated in the ED for suicide attempts or sexual assault

研究组 & 干预措施

CBI in ED with AMET at 3 months

Active Comparator

computer-delivered brief intervention (CBI) at baseline with adapted motivational enhancement therapy-AMET at 3 months

干预措施: Computer-delivered Brief Intervention (CBI) (Behavioral)

CBI in ED with AMET at 3 months

Active Comparator

computer-delivered brief intervention (CBI) at baseline with adapted motivational enhancement therapy-AMET at 3 months

干预措施: Adapted Motivational Enhancement Therapy (AMET) (Behavioral)

CBI in ED with EUC at 3 months

Active Comparator

computer-delivered brief intervention (CBI) at baseline with enhanced usual care-EUC at 3 months

干预措施: Computer-delivered Brief Intervention (CBI) (Behavioral)

CBI in ED with EUC at 3 months

Active Comparator

computer-delivered brief intervention (CBI) at baseline with enhanced usual care-EUC at 3 months

干预措施: Enhanced Usual Care (EUC) (Behavioral)

IBI in ED with AMET at 3 months

Active Comparator

intervener-delivered brief intervention (IBI) at baseline with adapted motivational enhancement therapy-AMET at 3 months

干预措施: Intervener-delivered Brief Intervention (IBI) (Behavioral)

IBI in ED with AMET at 3 months

Active Comparator

intervener-delivered brief intervention (IBI) at baseline with adapted motivational enhancement therapy-AMET at 3 months

干预措施: Adapted Motivational Enhancement Therapy (AMET) (Behavioral)

IBI in ED with EUC at 3 months

Active Comparator

intervener-delivered brief intervention (IBI) at baseline with enhanced usual care-EUC at 3 months

干预措施: Intervener-delivered Brief Intervention (IBI) (Behavioral)

IBI in ED with EUC at 3 months

Active Comparator

intervener-delivered brief intervention (IBI) at baseline with enhanced usual care-EUC at 3 months

干预措施: Enhanced Usual Care (EUC) (Behavioral)

EUC in ED with AMET at 3 months

Active Comparator

enhanced usual care (EUC) at baseline with adapted motivational enhancement therapy-AMET at 3 months

干预措施: Adapted Motivational Enhancement Therapy (AMET) (Behavioral)

EUC in ED with AMET at 3 months

Active Comparator

enhanced usual care (EUC) at baseline with adapted motivational enhancement therapy-AMET at 3 months

干预措施: Enhanced Usual Care (EUC) (Behavioral)

EUC in ED with EUC at 3 months

Active Comparator

enhanced usual care (EUC) at baseline with EUC at 3 months

干预措施: Enhanced Usual Care (EUC) (Behavioral)

结局指标

主要结局

drug use - number of days used

时间窗: change over time (3, 6 and 12 months post-baseline)

drug use

时间窗: change over time (3, 6 and 12 months post-baseline)

Drug use is measured using the NIDA-Modified ASSIST (Alcohol, Smoking and Substance Involvement Screening Test).

次要结局

  • health related outcomes (mental health)(change over time (3, 6 and 12 months post-baseline))
  • health related outcomes (physical health)(change over time (3, 6 and 12 months post-baseline))
  • HIV risk behaviors(change over time (3, 6 and 12 months post-baseline))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Frederic C. Blow

Principal Investigator

University of Michigan

研究点 (1)

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