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临床试验/NCT00265512
NCT00265512已完成不适用

Improving Longterm SUD Outcomes With Telephone Case Monitoring

VA Office of Research and Development6 个研究点 分布在 1 个国家目标入组 667 人开始时间: 2006年11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
667
试验地点
6
主要终点
Rates of Substance Use

研究概览

简要总结

The prevalence of substance use disorders (SUD) in the VA is rising, making SUD(s) among the most commonly diagnosed disorders in the VA. A substantial body of data attests to the effectiveness of substance use disorder treatment; further the predictor most consistently associated with positive addiction treatment outcomes is duration. Despite the body of evidence supporting length of treatment as one of the stronger predictors of long-term SUD outcomes, only 36% of SUD treatment programs in the VA are meeting the continuing care performance criterion specified by the Office of Quality Performance. This randomized clinical trial investigates whether substance use disorder patients assigned to telephone case monitoring (TCM) for continuing care will do better than those attending face-to-face continuing care as usual (CCAU)(standard outpatient care).

详细描述

Background: The prevalence of substance use disorders (SUD) in the VA is rising, making SUD(s) among the most commonly diagnosed disorders in the VA. A substantial body of data attests to the effectiveness of substance use disorder treatment; further the predictor most consistently associated with positive addiction treatment outcomes is duration. Despite the body of evidence supporting length of treatment as one of the stronger predictors of long-term SUD outcomes, only 36% of SUD treatment programs in the VA are meeting the continuing care performance criterion specified by the Office of Quality Performance. The proposed randomized clinical trial investigates whether substance use disorder patients assigned to telephone case monitoring (TCM) for continuing care will do better than those attending face-to-face continuing care as usual (CCAU)(standard outpatient care).

Objectives: The objective of this research is to test, in a randomized clinical trial, whether in-person CCAU following intensive outpatient SUD treatment leads to better SUD outcomes when compared with TCM. In addition, we will investigate whether continuing care condition interacts with distance from providers such that telephone case monitoring (TCM) produces increasingly stronger results relative to continuing care as usual (CCAU) as distance from care increases. Should we find an interaction, we will test whether the interaction is due to TCM producing better proximal outcomes such as level of participation in continuing care and satisfaction with treatment. Finally, we will investigate the cost of providing telephone care relative to continuing care as usual.

Methods: The design of this study is a randomized controlled trial of telephone case monitoring versus face-to-face continuing care as usual with 2 sites and up to 500 patients per site recruited over 1.5 years for a total of up to 1000 patients. Patients will be involved in the intervention for up to 6 months and data collection will occur at baseline, 3, 6 and 12 months via mailed surveys. Data of interest include self-report of substance use, psychiatric symptoms, and quality of life. Data analyses will be conducted using hierarchical linear modeling.

Status: Patient recruitment has ended. Treatment and follow-up are on-going.

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

性别
All
接受健康志愿者

入选标准

  • Participants will be recruited from all patients who complete at least 14 days of intensive outpatient (IOP) substance use disorder treatment over an 18-month period in 2 VA IOP SUD programs.

排除标准

  • Completion of less than 14 days of IOP treatment.

研究组 & 干预措施

Telephone Case Monitoring Aftercare

Active Comparator

Telephone Case Monitoring Aftercare

干预措施: Telephone Case Monitoring (Behavioral)

Continuing Care as Usual

Active Comparator

Continuing Care as Usual

干预措施: Continuing Care as Usual (Behavioral)

结局指标

主要结局

Rates of Substance Use

时间窗: Rates of substance use measured at 3 months

Percentage of days abstinent from alcohol use. Each person is followed for 3 months. For each person, we then calculate the number of days they were abstinent and the percentage of days abstinent (days abstinent/ all days in 3 months).

次要结局

  • Psychiatric Symptoms(Psychiatric symptoms measured at 3 months, 6 months, 12 months post randomization)
  • Health Related Quality of Life(3 months, 6 months and 12 months after randomization)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (6)

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