Validation of an Automated Online Language Interpreting Tool - Phase Two.

Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03538860
• Other study ID #: 1131922
• Secondary ID: R01HS024949
• Status: Completed
• Phase: N/A
• Start date: November 14, 2017
• Est. completion date: July 31, 2021

Study information

• Verified date: October 2021
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: 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

Exclusion Criteria: Criteria:

• 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.

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Chronic Medical Condition
• Disease
• Mood Disorder
• Mood Disorders
• Substance Use Disorder
• Substance-Related Disorders

Intervention

Behavioral:
• Active comparator: Human interpreter
A Spanish-speaking patient is diagnostically assessed in-person by an English-speaking psychiatrist through a Spanish-speaking interpreter.
• Intervention: Asynchronous Telepsychiatry
A Spanish-speaking patient is interviewed in Spanish by a trained mental health interviewer. The interview is video-recorded in real-time, automatically translated into English with sub-titles added to the video file, and sent to a psychiatrist and to 3 English-speaking psychiatrists to asynchronously review the video and make a diagnosis.

Locations

Country	Name	City	State
United States	UC Davis Medical Center	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy	Diagnosis accuracy with respect to gold standard SCID for Method B will be evaluated against Method A.	Measured at one time point by each psychiatrist, once both methods of interviews are completed in one day
Primary	Diagnostic Inter-rater reliability	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.	Measured at one time point by each psychiatrist, once both methods of interviews are completed in one day
Secondary	Satisfaction ratings	Satisfaction ratings from patients' questionnaires	Measured at one time point by each psychiatrist, once both methods of interviews are completed in one day
Secondary	Interview and language interpretation quality	All 200 interviews in both methods will be video recorded and the audio transcribed. The investigators will measure and compare the two interview methods interpretation quality through perception of interpretation quality	Measured at one time point by each psychiatrist, once both methods of interviews are completed in one day
Secondary	Interview and language interpretation accuracy	All 200 interviews in both methods will be video recorded and the audio transcribed. The investigators will measure and compare the two interview methods accuracy through the presence of medical errors, and the presence of language errors	Measured at one time point by each psychiatrist, once both methods of interviews are completed in one day