跳至主要内容
临床试验/NCT00607620
NCT00607620已完成不适用

Disseminating Organizational SBI Services (DO-SBIS) at Trauma Centers

University of Washington2 个研究点 分布在 1 个国家目标入组 878 人开始时间: 2008年9月最近更新:
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
2
主要终点
Number of Participants With Hazardous Drinking

研究概览

简要总结

The goal of the Disseminating Organizational Screening and Brief Interventions Services (DO-SBIS) investigation is to capitalize on the unique opportunity afforded by the American College of Surgeons' mandate by taking early steps to insure high quality, evidence-based SBI services are implemented and outcomes are assessed. In the first phase of the investigation, SBI services will be assessed for all 190 level I trauma centers in the United States. In the second phase of the investigation, 20 level I trauma centers will be selected for randomization to intervention or control conditions.

详细描述

Each year in the United States approximately 2.5 million individuals are so severely injured that they require inpatient hospital admission. The integration of screening and brief interventions (SBI) into acute injury care has the potential to markedly increase the number of patients who receive needed services and has been a longstanding public health objective. In January of 2005 the American College of Surgeons, the primary agency responsible for developing trauma center requirements, passed a landmark resolution mandating that level I trauma centers must screen injured patients for an alcohol use disorder, and provide an intervention to those who screen positive. Preliminary studies suggest that there is a substantial risk that the SBI mandate will be implemented with marked variability and that low quality SBI procedures could become the default standard of trauma center care.

Providers at each intervention trauma center will receive workshop training and ongoing telephone coaching in the delivery of evidence-based motivational interviewing (MI) intervention; MI training will be embedded within evidence-based organizational development activities that aim to facilitate the integration of SBI services into routine trauma center care. Control trauma centers will implement SBI care as usual. The investigation hypothesizes that intervention trauma centers, when compared to control trauma centers, will demonstrate higher quality SBI, as evidenced by greater provider proficiency in SBI delivery, significant reductions in 6- and 12-month post-injury alcohol use in patients receiving SBI, and enhanced organizational acceptance of SBI services. Without DO-SBIS baseline data on SBI services and follow-up RCT data on patient, provider, and organizational outcomes, a critical opportunity to provide empiric support of a historic policy decision to require alcohol services at level I trauma centers could be lost. The DO-SBIS interdisciplinary research group includes trauma surgery opinion leaders who are dedicated to implementing future policy mandates that derive from the DO-SBIS research program. Future mandates will aim to strengthen and refine trauma center delivery of evidence-based SBI services. The dissemination of high quality SBI services at level I trauma centers has the potential to influence alcohol policy in other health care settings nationwide.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

  • For provider subjects: staff at trauma centers selected by study
  • For patient subjects: admitted to trauma centers selected by study, positive blood alcohol levels, able to provide two follow-up contacts

排除标准

  • For Providers: Once a trauma center is selected for participation, providers will be selected from existing hospital staff.
  • For Patients: Patients so severely injured that they cannot participate in study procedures will be excluded;
  • Patients who are admitted after self-inflicted injury, or are psychotic and therefore require more intensive acute interventions, will not be included in the study;
  • Injured hospitalized prisoners are excluded.
  • Children under the age of 18 are excluded.

研究组 & 干预措施

Usual Care

No Intervention

Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate

Intervention

Experimental

Providers receive training in alcohol screening and brief interventions from study staff in compliance with American College of Surgeons' Alcohol Screening and Brief Intervention Mandate

干预措施: Brief Intervention (Behavioral)

结局指标

主要结局

Number of Participants With Hazardous Drinking

时间窗: The investigators will assess at baseline, 6-month and 12-month.

The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a dichotomous measure. AUDIT Scores of ≥8 for men and ≥5 for women indicate hazardous drinking.

Alcohol Use Problems

时间窗: The investigators will assess at baseline, 6-month and 12-month.

The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome.

次要结局

  • Number of Abstinent Days(The investigators will assess at 6- and 12-month.)
  • Number of Binge Drinking Days(The investigators will assess at 6-month and 12-month.)
  • Alcohol Use Problems(The investigators will assess at 6-month and 12-month.)

研究者

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

Douglas Zatzick

Professor, Psychiatry & Behavioral Sciences

University of Washington

研究点 (2)

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