Mood DisorderNCT03538860
Validation of an Automated Online Language Interpreting Tool - Phase Two.
A study testing Active comparator: Human interpreter and Intervention: Asynchronous Telepsychiatry in people with Mood Disorder and Anxiety Disorder, run by University of California, Davis at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mood Disorder, Anxiety Disorder, Substance Use Disorder
- What is being tested?
- Active comparator: Human interpreter and Intervention: Asynchronous Telepsychiatry
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2017to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
Official title: A Clinical Trial to Validate an Automated Online Language Interpreting Tool With Hispanic Patients Who Have Limited English Proficiency - Phase Two.
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.
Read the detailed 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.
- Being tested
- Active comparator: Human interpreter, Intervention: Asynchronous Telepsychiatry
- Keywords
- Telepsychiatry, AsynchronousTelepsychiatry, Automated Translation
- Medical subject headings
- Mood Disorders, Anxiety Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active comparator: Human interpreterBehavioural
A Spanish-speaking patient is diagnostically assessed in-person by an English-speaking psychiatrist through a Spanish-speaking interpreter.
Intervention: Asynchronous TelepsychiatryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Method A first then Method B | Other | Conventional in-person interview with a psychiatrist with a live human interpreter with crossover to asynchronous telepsychiatry Receives: Behavioral: Active comparator: Human interpreter; Behavioral: Intervention: Asynchronous Telepsychiatry |
| Method B first then Method A | Other | Asynchronous telepsychiatry - that is, video-recorded interviews that are subsequently processed with automated speech recognition and machine translation technologies, with crossover to conventional in-person interview with a psychiatrist with a live human interpreter Receives: Behavioral: Active comparator: Human interpreter; Behavioral: Intervention: Asynchronous Telepsychiatry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
Diagnosis accuracy with respect to gold standard SCID for Method B will be evaluated against Method A.
Measured: Measured at one time point by each psychiatrist, once both methods of interviews are completed in one day
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: Measured at one time point by each psychiatrist, once both methods of interviews are completed in one day
Secondary outcomes (3)
Satisfaction ratings
Satisfaction ratings from patients' questionnaires
Measured: Measured at one time point by each psychiatrist, once both methods of interviews are completed in one day
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: Measured at one time point by each psychiatrist, once both methods of interviews are completed in one day
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: Measured at one time point by each psychiatrist, once both methods of interviews are completed in one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start14 Nov 2017
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mood DisorderStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538860
- Sponsor's protocol ID
- 1131922
- Other IDs
- R01HS024949
- Status last verified
- Oct 2021
- First submitted
- 1 Mar 2018
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tougas H, Chan S, Shahrvini T, Gonzalez A, Chun Reyes R, Burke Parish M, Yellowlees P. The Use of Automated Machine Translation to Translate Figurative Language in a Clinical Setting: Analysis of a Convenience Sample of Patients Drawn From a Randomized Controlled Trial. JMIR Ment Health. 2022 Sep 6;9(9):e39556. doi: 10.2196/39556.
PubMed 36066959Parish MB, Gonzalez A, Hilty D, Chan S, Xiong G, Scher L, Liu D, Sciolla A, Shore J, McCarron R, Kahn D, Iosif AM, Yellowlees P. Asynchronous Telepsychiatry Interviewer Training Recommendations: A Model for Interdisciplinary, Integrated Behavioral Health Care. Telemed J E Health. 2021 Sep;27(9):982-988. doi: 10.1089/tmj.2020.0076. Epub 2021 Jan 12.
PubMed 33434453
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Validate an Automated Online Language Interpreting Tool With Hispanic Patients Who Have Limited English Proficiency - Phase Two.
- ClinicalTrials.gov ID
- NCT03538860
- Acronym / sponsor ID
- 1131922
- Keywords
- Telepsychiatry, AsynchronousTelepsychiatry, Automated Translation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Method A first then Method B | Other | Behavioral: Active comparator: Human interpreter, Behavioral: Intervention: Asynchronous TelepsychiatryConventional in-person interview with a psychiatrist with a live human interpreter with crossover to asynchronous telepsychiatry |
| Method B first then Method A | Other | Behavioral: Active comparator: Human interpreter, Behavioral: Intervention: Asynchronous TelepsychiatryAsynchronous telepsychiatry - that is, video-recorded interviews that are subsequently processed with automated speech recognition and machine translation technologies, with crossover to conventional in-person interview with a psychiatrist with a live human interpreter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active comparator: Human interpreterA Spanish-speaking patient is diagnostically assessed in-person by an English-speaking psychiatrist through a Spanish-speaking interpreter. | Behavioural | Method A first then Method B, Method B first then Method A |
| Intervention: Asynchronous TelepsychiatryA 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. | Behavioural | Method A first then Method B, Method B first then Method A |
Primary outcome
Diagnostic accuracy
Time frame: 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.
Diagnostic Inter-rater reliability
Time frame: 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.
3 secondary outcomes
Satisfaction ratings
Time frame: Measured at one time point by each psychiatrist, once both methods of interviews are completed in one day
Interview and language interpretation quality
Time frame: Measured at one time point by each psychiatrist, once both methods of interviews are completed in one day
Interview and language interpretation accuracy
Time frame: Measured at one time point by each psychiatrist, once both methods of interviews are completed in one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Derived from this study: PubMed 36066959Tougas H, Chan S, Shahrvini T, Gonzalez A, Chun Reyes R, Burke Parish M, Yellowlees P. The Use of Automated Machine Translation to Translate Figurative Language in a Clinical Setting: Analysis of a Convenience Sample of Patients Drawn From a Randomized Controlled Trial. JMIR Ment Health. 2022 Sep 6;9(9):e39556. doi: 10.2196/39556.
- Derived from this study: PubMed 33434453Parish MB, Gonzalez A, Hilty D, Chan S, Xiong G, Scher L, Liu D, Sciolla A, Shore J, McCarron R, Kahn D, Iosif AM, Yellowlees P. Asynchronous Telepsychiatry Interviewer Training Recommendations: A Model for Interdisciplinary, Integrated Behavioral Health Care. Telemed J E Health. 2021 Sep;27(9):982-988. doi: 10.1089/tmj.2020.0076. Epub 2021 Jan 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active comparator: Human interpreter and Intervention: Asynchronous Telepsychiatry in people with Mood Disorder and Anxiety Disorder, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (time frame: Measured at one time point by each psychiatrist, once both methods of interviews are completed in one day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03538860, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.