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临床试验/NCT03258632
NCT03258632已完成不适用

Improving Outcomes Among Medical/Surgical Inpatients With Alcohol Use Disorders

VA Office of Research and Development4 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
155
试验地点
4
主要终点
Time Line Follow Back

研究概览

简要总结

This project aims to help Veterans who are in medical treatment and have untreated alcohol problems. First, the investigators adapted a Decision Aid that explains alcohol-related treatment options and their risks and benefits. Then, the investigators are determining the effectiveness of an intervention called DO-MoST (for Drinking Options-Motivate, Shared Decisions, Telemonitor), whereby a Decision Coach helps Veterans make decisions about alcohol-related behaviors and treatments they prefer, and keeps in contact by phone to continue to help with drinking and treatment decisions. DO-MoST is designed to increase rates at which Veterans decide to reduce or quit drinking, and begin and remain in treatment, and to improve drinking- and medical-related outcomes over time. It may also decrease Veterans' use of expensive health services such as hospitalizations and emergency visits. Finally, the investigators will study how VA can use DO-MoST on an ongoing, more widespread basis. The project should increase patient-centered health care for Veterans with alcohol problems to benefit their recovery.

详细描述

In fiscal year 2014, over 57,000 Veterans with diagnosed alcohol use disorders (AUDs) received VHA inpatient medical-surgical services. This likely underrepresents the prevalence of AUDs among Veteran inpatients, because these conditions often go undiagnosed during hospital stays. The high prevalence of AUDs among VHA medical and surgical patients is of critical concern because AUDs and medical conditions exacerbate one another, and their co-occurrence increases the use of costly health services. Yet, there are no evidence-based strategies that improve outcomes in this patient population by means of increased utilization (initiation, engagement) of AUD treatment services. The investigators have identified Drinking Options: Motivate, Shared Decisions, Telemonitor (DO-MoST) as a potential solution to the critical need for evidence-based strategies.

This project is evaluating DO-MoST as a new and innovative intervention to facilitate the transition from medical-surgical care to AUD treatment in primary and specialty care settings, thereby improving Veterans' AUD and medical outcomes. DO-MoST entails use of motivational interviewing and a decision aid during the inpatient stay to facilitate informed choices about drinking options and resources for help to change drinking, if desired, followed by telephone calls with the patient to continue to motivate and support decisions. In addition to determining the effectiveness of DO-MoST, this project includes a process evaluation - that is, will gather information from providers and patients on DO-MoST's implementation at the two project sites - to inform VA's potential widespread implementation of DO-MoST with medical-surgical patients with AUDs.

Using an effectiveness/implementation Hybrid Type 1 design, incorporating a randomized controlled trial (RCT) and process evaluation to facilitate future implementation, this project has three Specific Aims.

Aim 1: Adapt a decision aid being implemented with AUD patients in non-VA primary care settings to be appropriate for Veterans with AUDs in medical-surgical treatment settings. With this prototype, the investigators will conduct alpha testing with patients and providers, and adapt and pilot the decision aid to finalize it for use in the RCT.

Aim 2: Conduct DO-MoST at two VA facilities (Ann Arbor and Palo Alto) and evaluate its effectiveness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (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

  • Medical-surgical inpatients with alcohol use disorder at the Ann Arbor or Palo Alto VA. Specifically:
  • in a current episode of medical-surgical care,
  • meet DSM 5 criteria for an AUD
  • no specialty addiction treatment or weekly mutual-help group attendance within 60 days prior to the inpatient episode,
  • no restricted access due to infection control requirements (e.g., TB, MRSA, C. diff),
  • no significant cognitive impairment,
  • ongoing access to a cell or land line telephone,
  • at least one contact who will continue to know the patient's contact information, and (8) not having participated in an interview for Aim 1 of this project.

排除标准

  • See inclusion criteria.

结局指标

主要结局

Time Line Follow Back

时间窗: Alcohol use in the past 30 days, assessed at 12-month follow-up

The investigators will use the Timeline Follow-Back (TLFB) to assess abstinence from alcohol use during the 30 days preceding assessment. The TLFB is a widely used, standardized, calendar-based retrospective self-report assessment to quantify daily alcohol use. The investigators will examine the primary outcome of abstinence from alcohol use at 12-month follow-up.

次要结局

  • Utilization of Substance Use-related Care(12 months)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (4)

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