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临床试验/NCT00278447
NCT00278447已完成3 期

Linkage of Alcohol Abusers to Primary Care

Boston Medical Center2 个研究点 分布在 1 个国家目标入组 569 人开始时间: 2006年4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
569
试验地点
2
主要终点
Alcohol and drug use

研究概览

简要总结

The objective of this study is to test whether a chronic disease management (CDM) program for substance abusers in primary care leads to improved alcohol and drug-related outcomes (such as reduced consumption and health problems) and health care utilization patterns.

详细描述

Chronic disease management (CDM) is a collaborative, longitudinal, proven effective approach to the treatment of chronic medical illnesses that addresses individual patient and health systems barriers to receipt of needed treatment. The objective of this Addiction Health Evaluation And Disease management (AHEAD) Study is to test the effectiveness of CDM for substance dependence in primary care. The study will enroll and randomize subjects to attend a substance dependence CDM program (the AHEAD Unit) integrated into a real-world primary care clinic or to referral to usual primary care. All subjects will be assessed regarding alcohol and/or drug diagnosis, consumption and problems, readiness to change, health-related quality of life, and medical and substance abuse treatment utilization. Primary outcomes are alcohol and drug use, alcohol and drug-related problems, emergency department visits, and hospitalizations. Additional outcomes are health-related quality of life, readiness to change, medical and psychiatric comorbidity, HIV risk behaviors, and treatment utilization and costs. The hypothesis is that compared with standard care, a health services intervention -- chronic disease management for alcohol and drug dependence integrated in primary care -- will decrease alcohol and drug use and related problems, and improve health care utilization patterns.

This study contains two studies (and study populations):

    1. 320 alcohol dependent subjects with current risky drinking, and
    1. 320 drug dependent subjects with current drug use.

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
None

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

  • 18 years of age or older
  • Fluent in English or Spanish
  • Alcohol or drug dependent
  • Heavy drinking in the past 30 days or recent drug use
  • Provide 2 contacts to assist with follow-up
  • Have no plans to move from the local area within a year of screening
  • Score >21 on Mini-Mental State Examination (no serious cognitive impairment)

排除标准

  • Pregnant (self-report)
  • Breath alcohol >100 mg/dL
  • Inability to provide informed consent determined by trained research associates

结局指标

主要结局

Alcohol and drug use

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

Alcohol and drug-related problems

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

Nights Hospitalized

时间窗: 3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled

Emergency department visits

时间窗: 3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled

次要结局

  • Health-related quality of life(3, 6, and 12 months after baseline)
  • Readiness to change(3, 6, and 12 months after baseline)
  • Medical comorbidity(3, 6, and 12 months after baseline)
  • Psychiatric comorbidity(3, 6, and 12 months after baseline)
  • Treatment utilization and costs(3, 6, and 12 months after baseline, and up to 2 years after the last subject is enrolled)
  • HIV risk behaviors(3, 6, and 12 months after baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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