Artificial IntelligenceNCT05860777
Harnessing Health IT to Promote Equitable Care for Patients with Limited English Proficiency and Complex Care Needs
A study testing Complexity score and implementation in people with Artificial Intelligence, run by Mayo Clinic at 1 site in United States.
Trial summary
This is a pragmatic trial that will measure if the use of AI to identify patients with complex care needs and language barriers, as well as active reaching out to clinicians to offer the use of interpreter services will improve the frequency of interpreter use and reduce the time to first interpreter use Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Artificial Intelligence
- What is being tested?
- Complexity score and implementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,923 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 30 Sep 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with limited English proficiency and requiring an interpreter and having complex medical care needs (includes admitted to the ICU, prolonged hospital stay, requiring palliative care)
- Have research authorization
Who cannot join
- Do not require an interpreter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Harnessing Health Information Technology to Promote Equitable Care for Patients with Limited English Proficiency and Complex Care Needs
This is a pragmatic trial that will measure if the use of AI to identify patients with complex care needs and language barriers, as well as active reaching out to clinicians to offer the use of interpreter services will improve the frequency of interpreter use and reduce the time to first interpreter use
- Conditions
- Artificial Intelligence
- Being tested
- Complexity score and implementation
- Keywords
- Limited English Proficiency, Machine Learning, Language Barrier, Complex Medical Needs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complexity score and implementationOther
Also called AI machine learning model and implementation with reaching out to clinicians
AI machine learning model to identify patients with complex care needs and implementation with active reaching out to clinicians to offer interpreter services
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This is the control group who receive standard of care |
| Intervention | Experimental | This is the group in units who are identified via AI model and in which interpreter services are actively reaching out to clinicians Receives: Other: Complexity score and implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of interpreters
the number of interpreters used among patients with LEP and complex care needs
Measured: 12 months
Secondary outcomes (1)
Change in time to interpreter use
The time measured in hours and minutes for an interpreter to be used for patients with LEP
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start1 May 2023
- Primary completion21 Jun 2024
- Study completion30 Sep 2024
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 Artificial IntelligenceStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Model description
- This is a pragmatic clinical trial-a stepped wedge cluster randomized control trial
- Masking
- None (open label)
- Enrolment
- 1,923 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian W. Pickering, M.B., B.Ch., Mayo Clinic
- Investigators
- Brian Pickering, MB, B.Ch, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860777
- Sponsor's protocol ID
- 22-002926
- Status last verified
- Oct 2024
- First submitted
- 8 May 2023
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barwise A, Strechen I, Eltalhi T, Piche K, Wilson P, Tschida-Reuter D, Liu E, Herasevich S, Schulte PJ, Sutor B, Pickering B. Improving In-person Interpreter Utilization in Complex Care: Findings from a Stepped-Wedge Cluster Randomized Trial of Integrated Artificial Intelligence. J Gen Intern Med. 2026 Apr;41(5):1312-1321. doi: 10.1007/s11606-025-10104-9. Epub 2026 Jan 5.
PubMed 41491380Strechen I, Wilson P, Eltalhi T, Piche K, Tschida-Reuter D, Howard D, Sutor B, Tiong I, Herasevich S, Pickering B, Barwise A. Harnessing health information technology to promote equitable care for patients with limited English proficiency and complex care needs. Trials. 2024 Jul 4;25(1):450. doi: 10.1186/s13063-024-08254-y.
PubMed 38961501
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing Health Information Technology to Promote Equitable Care for Patients with Limited English Proficiency and Complex Care Needs
- ClinicalTrials.gov ID
- NCT05860777
- Acronym / sponsor ID
- 22-002926
- Conditions
- Artificial Intelligence
- Keywords
- Limited English Proficiency, Machine Learning, Language Barrier, Complex Medical Needs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,923 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 16 May 2023 (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.
This is a pragmatic trial that will measure if the use of AI to identify patients with complex care needs and language barriers, as well as active reaching out to clinicians to offer the use of interpreter services will improve the frequency of interpreter use and reduce the time to first interpreter use
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a pragmatic clinical trial-a stepped wedge cluster randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This is the control group who receive standard of care |
| Intervention | Experimental | Other: Complexity score and implementationThis is the group in units who are identified via AI model and in which interpreter services are actively reaching out to clinicians |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults with limited English proficiency and requiring an interpreter and having complex medical care needs (includes admitted to the ICU, prolonged hospital stay, requiring palliative care)
- Have research authorization
Key exclusion criteria (1 listed)
- Do not require an interpreter
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 |
|---|---|---|
| Complexity score and implementationAlso: AI machine learning model and implementation with reaching out to cliniciansAI machine learning model to identify patients with complex care needs and implementation with active reaching out to clinicians to offer interpreter services | Other | Intervention |
Primary outcome
Number of interpreters
Time frame: 12 months
the number of interpreters used among patients with LEP and complex care needs
1 secondary outcome
Change in time to interpreter use
Time frame: 12 months
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 3 Oct 2024.
- Derived from this study: PubMed 41491380Barwise A, Strechen I, Eltalhi T, Piche K, Wilson P, Tschida-Reuter D, Liu E, Herasevich S, Schulte PJ, Sutor B, Pickering B. Improving In-person Interpreter Utilization in Complex Care: Findings from a Stepped-Wedge Cluster Randomized Trial of Integrated Artificial Intelligence. J Gen Intern Med. 2026 Apr;41(5):1312-1321. doi: 10.1007/s11606-025-10104-9. Epub 2026 Jan 5.
- Derived from this study: PubMed 38961501Strechen I, Wilson P, Eltalhi T, Piche K, Tschida-Reuter D, Howard D, Sutor B, Tiong I, Herasevich S, Pickering B, Barwise A. Harnessing health information technology to promote equitable care for patients with limited English proficiency and complex care needs. Trials. 2024 Jul 4;25(1):450. doi: 10.1186/s13063-024-08254-y.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Brian Pickering, MB, B.Ch principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complexity score and implementation in people with Artificial Intelligence, run by Mayo Clinic 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 2 inclusion and 1 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 3 Oct 2024. 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?
Number of interpreters (time frame: 12 months). 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 NCT05860777, 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 3 Oct 2024.