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临床试验/NCT03538860
NCT03538860已完成不适用

A Clinical Trial to Validate an Automated Online Language Interpreting Tool With Hispanic Patients Who Have Limited English Proficiency - Phase Two.

University of California, Davis2 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2017年11月14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
114
试验地点
2
主要终点
Diagnostic Inter-rater reliability

研究概览

简要总结

There is a pressing national need to provide higher-quality, more effectively accessible language interpretation services to improve the health outcomes of Americans who have limited English proficiency (LEP). This project addresses a critical component of this problem: The need to improve access to high quality, mental health services for diverse populations by improving the flow of clinical work across care settings (primary care and specialty care) through the use of innovative online asynchronous methods of language interpretation and clinical communication. The investigators are conducting a two phase study. The first phase is completed and involved developing and testing the interpreting tool. The second phase of the research is a clinical trial to compare two methods of cross-language psychiatric assessment.

详细描述

The investigators propose to develop and test a novel automated asynchronous interpretation tool. The proposed project builds on previous research, piloting the automated asynchronous interpretation tool. This 5-year project will be conducted in two phases. In Phase 1 the investigators iteratively evaluate and refine the automated asynchronous interpretation tool already developed in prior studies. In Phase 2, the investigators evaluate this tool using a two-group randomized cross-over trial. Investigators compare:

  • Method A (current gold standard of in-person real-time interpreting practice). A Spanish-speaking patient is diagnostically assessed in-person by an English-speaking psychiatrist through a Spanish-speaking interpreter.
  • Method B (comparative practice - ATP). A Spanish-speaking patient is interviewed in Spanish by a trained mental health interviewer. The interview is recorded in real time, translated into English using the automatic interpretation tool and adding sub-titles to the video file, and sent to an English-speaking psychiatrist to asynchronously - that is, at a later time - review the video and make a diagnosis.

All patients will undergo evaluation by both methods. Half of the patients will be randomized to be assessed by Method A first, followed by Method B and half to be assessed by Method B first, followed by Method A. The specific aims of the study are :

  • Aim 1: To iteratively evaluate and refine the automated asynchronous interpretation tool already developed in prior studies.
  • Aim 2: To compare patient satisfaction of Method A vs. Method B.
  • Aim 3: To compare the diagnostic accuracy and psychiatrist inter-rater reliability of Method A vs. Method B and demonstrate psychiatrist inter-rater reliability for Method B.
  • Aim 4: To compare the interview and language interpretation quality and accuracy of Method A vs. Method B.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
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

  • Inclusion Criteria: Hispanic patients with significant Limited English proficiency (LEP)
  • aged 18 or older
  • diagnosis of a mood disorder, anxiety disorder, or substance/alcohol abuse disorder(s)
  • Diagnosis of a chronic medical condition
  • referred by PCP or self-referral with PCP informed

排除标准

  • less than 18 years
  • imminent suicidal ideation and/or plans
  • immediate violent intentions or plans
  • significant cognitive deficits
  • patient who's PCP recommends not participating.

结局指标

主要结局

Diagnostic Inter-rater reliability

时间窗: Measured at one time point by each psychiatrist, once both methods of interviews are completed in one day

Using independent assessments from four psychiatrists for each of the 100 method B interviews the investigators will also examine inter-rater reliability of Method B diagnosis.

Diagnostic accuracy

时间窗: Measured at one time point by each psychiatrist, once both methods of interviews are completed in one day

Diagnosis accuracy with respect to gold standard SCID for Method B will be evaluated against Method A.

次要结局

  • Interview and language interpretation accuracy(Measured at one time point by each psychiatrist, once both methods of interviews are completed in one day)
  • Satisfaction ratings(Measured at one time point by each psychiatrist, once both methods of interviews are completed in one day)
  • Interview and language interpretation quality(Measured at one time point by each psychiatrist, once both methods of interviews are completed in one day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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