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Human Algorithm Interactions for Acute Respiratory Failure Diagnosis

Primary Purpose

Acute Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Artificial Intelligence model predictions without explanation
Artificial intelligence model predictions with explanation
AI model biased against heart failure
AI model biased against pneumonia
AI model biased against COPD
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acute Respiratory Failure focused on measuring Artificial Intelligence, Diagnostic Accuracy, Computer Assisted Diagnosis, Biased Model

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Physicians, nurse practitioners, and physician assistants that care for patients with acute respiratory failure as part of their clinical practice Exclusion Criteria: Physicians, nurse practitioners, and physician assistants that only provide patient care in outpatient settings

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

AI model biased for heart failure, no AI explanation

AI model biased for pneumonia, no AI explanation

AI model biased for COPD, no AI explanation

AI model biased for heart failure, Image-based AI explanation presented

AI model biased for pneumonia, Image-based AI explanation presented

AI model biased for COPD, Image-based AI explanation presented

Arm Description

Participants in this arm will be shown standard AI model predictions during 3 patient clinical vignettes within the survey and systematically biased AI model predictions during 3 clinical vignettes. When shown systematically biased AI model predictions, the model will be biased against heart failure, always predicting that heart failure is present with high likelihood in patients with a body mass index (BMI) at or above 30. Standard predictions will be shown for the other 2 diagnoses. Participants in this arm will not be shown an AI explanation when shown AI model predictions.

Participants in this arm will be shown standard AI model predictions during 3 patient clinical vignettes within the survey and systematically biased AI model predictions during 3 clinical vignettes. When shown systematically biased AI model predictions, the model will be biased against pneumonia, always predicting that pneumonia is present with high likelihood in patients 80 years or older. Standard predictions will be shown for the other 2 diagnoses. Participants in this arm will not be shown an AI explanation when shown AI model predictions.

Participants in this arm will be shown standard AI model predictions during 3 patient clinical vignettes within the survey and systematically biased AI model predictions during 3 clinical vignettes. When shown systematically biased AI model predictions, the model will be biased against COPD, always predicting that COPD is present with high likelihood when a pre-processing filter was applied to the patient's X-ray. Standard predictions will be shown for the other 2 diagnoses. Participants in this arm will not be shown an AI explanation when shown AI model predictions.

Participants in this arm will be shown standard AI model predictions during 3 patient clinical vignettes within the survey and systematically biased AI model predictions during 3 clinical vignettes. When shown systematically biased AI model predictions, the model will be biased against heart failure, always predicting that heart failure is present with high likelihood in patients with a body mass index (BMI) at or above 30. Standard predictions will be shown for the other 2 diagnoses. Participants in this arm will also be shown AI explanation when shown AI model predictions.

Participants in this arm will be shown standard AI model predictions during 3 patient clinical vignettes within the survey and systematically biased AI model predictions during 3 clinical vignettes. When shown systematically biased AI model predictions, the model will be biased against pneumonia, always predicting that pneumonia is present with high likelihood in patients 80 years or older. Standard predictions will be shown for the other 2 diagnoses. Participants in this arm will also be shown AI explanation when shown AI model predictions.

Participants in this arm will be shown standard AI model predictions during 3 patient clinical vignettes within the survey and systematically biased AI model predictions during 3 clinical vignettes. When shown systematically biased AI model predictions, the model will be biased against COPD, always predicting that COPD is present with high likelihood when a pre-processing filter was applied to the patient's X-ray. Standard predictions will be shown for the other 2 diagnoses. Participants in this arm will also be shown AI explanation when shown AI model predictions.

Outcomes

Primary Outcome Measures

Participant diagnostic accuracy across clinical vignette settings
Diagnostic accuracy is defined as the number of correct diagnostic assessments over the total number of diagnostic assessments. After reviewing each individual patient clinical vignette within the survey, participants will be asked to make three separate diagnostic assessments for each clinical vignette, one for heart failure, pneumonia, and COPD. If the participant's assessment agrees with the reference label for each vignette, the diagnostic assessment is considered correct. Diagnostic assessments will be performed while participants are completing the survey (day 0), immediately after the participant reviews the clinical vignette. Participant diagnostic accuracy will be compared across vignette settings (no AI model, standard AI model, standard AI model with explanation, biased AI model, biased AI model with explanation).

Secondary Outcome Measures

Treatment Selection Accuracy across clinical vignette settings
Treatment selection accuracy is defined as whether the participant choose the correct treatment for the patient in the clinical vignette, and could choose any combination of steroids, antibiotics, Intravenous (IV) diuretics, or none of these treatments for the patient. Treatment selection assessments will be performed while participants are completing the survey (day 0), immediately after the participant reviews the clinical vignette. Participant treatment selection accuracy will be compared across vignette settings (no AI model, standard AI model, standard AI model with explanation, biased AI model, biased AI model with explanation).
Diagnosis specific diagnostic accuracy across clinical vignette settings
Diagnostic accuracy specific to heart failure, pneumonia, and COPD across vignette settings

Full Information

First Posted
October 17, 2023
Last Updated
October 17, 2023
Sponsor
University of Michigan
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT06098950
Brief Title
Human Algorithm Interactions for Acute Respiratory Failure Diagnosis
Official Title
Measuring the Impact of AI in the Diagnosis of Hospitalized Patients: A Randomized Survey Vignette Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Artificial intelligence (AI) shows promising in identifying abnormalities in clinical images. However, systematically biased AI models, where a model makes inaccurate predictions for entire subpopulations, can lead to errors and potential harms. When shown incorrect predictions from an AI model, clinician diagnostic accuracy can be harmed. This study aims to study the effectiveness of providing clinicians with image-based AI model explanations when provided AI model predictions to help clinicians better understand the logic of an AI model's prediction. It will evaluate whether providing clinicians with AI model explanations can improve diagnostic accuracy and help clinicians catch when models are making incorrect decisions. As a test case, the study will focus on the diagnosis of acute respiratory failure because determining the underlying causes of acute respiratory failure is critically important for guiding treatment decisions but can be clinically challenging. To determine if providing AI explanations can improve clinician diagnostic accuracy and alleviate the potential impact of showing clinicians a systematically biased AI model, a randomized clinical vignette survey study will be conducted. During the survey, study participants will be shown clinical vignettes of patients hospitalized with acute respiratory failure, including the patient's presenting symptoms, physical exam, laboratory results, and chest X-ray. Study participants will then be asked to assess the likelihood that heart failure, pneumonia and/or Chronic Obstructive Pulmonary Disease (COPD) is the underlying diagnosis. During specific vignettes in the survey, participants will also be shown standard or systematically biased AI models that provide an estimate the likelihood that heart failure, pneumonia and/or COPD is the underlying diagnosis. Clinicians will be randomized see AI predictions alone or AI predictions with explanations when shown AI models. This survey design will allow for testing the hypothesis that systematically biased models would harm clinician diagnostic accuracy, but commonly used image-based explanations would help clinicians partially recover their performance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure
Keywords
Artificial Intelligence, Diagnostic Accuracy, Computer Assisted Diagnosis, Biased Model

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
While participating in a survey, participants are randomized to see different hypothetical patient clinical vignettes, AI model predictions, and then ask questions about the patient's likely diagnosis and treatment.
Masking
Participant
Masking Description
Participants are not aware of what type of AI model predictions are shown during the clinical vignettes within the survey.
Allocation
Randomized
Enrollment
457 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AI model biased for heart failure, no AI explanation
Arm Type
Experimental
Arm Description
Participants in this arm will be shown standard AI model predictions during 3 patient clinical vignettes within the survey and systematically biased AI model predictions during 3 clinical vignettes. When shown systematically biased AI model predictions, the model will be biased against heart failure, always predicting that heart failure is present with high likelihood in patients with a body mass index (BMI) at or above 30. Standard predictions will be shown for the other 2 diagnoses. Participants in this arm will not be shown an AI explanation when shown AI model predictions.
Arm Title
AI model biased for pneumonia, no AI explanation
Arm Type
Experimental
Arm Description
Participants in this arm will be shown standard AI model predictions during 3 patient clinical vignettes within the survey and systematically biased AI model predictions during 3 clinical vignettes. When shown systematically biased AI model predictions, the model will be biased against pneumonia, always predicting that pneumonia is present with high likelihood in patients 80 years or older. Standard predictions will be shown for the other 2 diagnoses. Participants in this arm will not be shown an AI explanation when shown AI model predictions.
Arm Title
AI model biased for COPD, no AI explanation
Arm Type
Experimental
Arm Description
Participants in this arm will be shown standard AI model predictions during 3 patient clinical vignettes within the survey and systematically biased AI model predictions during 3 clinical vignettes. When shown systematically biased AI model predictions, the model will be biased against COPD, always predicting that COPD is present with high likelihood when a pre-processing filter was applied to the patient's X-ray. Standard predictions will be shown for the other 2 diagnoses. Participants in this arm will not be shown an AI explanation when shown AI model predictions.
Arm Title
AI model biased for heart failure, Image-based AI explanation presented
Arm Type
Experimental
Arm Description
Participants in this arm will be shown standard AI model predictions during 3 patient clinical vignettes within the survey and systematically biased AI model predictions during 3 clinical vignettes. When shown systematically biased AI model predictions, the model will be biased against heart failure, always predicting that heart failure is present with high likelihood in patients with a body mass index (BMI) at or above 30. Standard predictions will be shown for the other 2 diagnoses. Participants in this arm will also be shown AI explanation when shown AI model predictions.
Arm Title
AI model biased for pneumonia, Image-based AI explanation presented
Arm Type
Experimental
Arm Description
Participants in this arm will be shown standard AI model predictions during 3 patient clinical vignettes within the survey and systematically biased AI model predictions during 3 clinical vignettes. When shown systematically biased AI model predictions, the model will be biased against pneumonia, always predicting that pneumonia is present with high likelihood in patients 80 years or older. Standard predictions will be shown for the other 2 diagnoses. Participants in this arm will also be shown AI explanation when shown AI model predictions.
Arm Title
AI model biased for COPD, Image-based AI explanation presented
Arm Type
Experimental
Arm Description
Participants in this arm will be shown standard AI model predictions during 3 patient clinical vignettes within the survey and systematically biased AI model predictions during 3 clinical vignettes. When shown systematically biased AI model predictions, the model will be biased against COPD, always predicting that COPD is present with high likelihood when a pre-processing filter was applied to the patient's X-ray. Standard predictions will be shown for the other 2 diagnoses. Participants in this arm will also be shown AI explanation when shown AI model predictions.
Intervention Type
Other
Intervention Name(s)
Artificial Intelligence model predictions without explanation
Intervention Description
During 6 clinical vignettes, participants will see AI model predictions without a corresponding AI explanation. The AI model will provide a score for each diagnosis (heart failure, pneumonia, COPD) on a scale of 0-100 estimating how likely the patient's presentation was due to each of these diagnoses. In 3 of the clinical vignettes, participants will be shown standard AI model predictions and 3 vignettes they will be shown systematically biased AI model predictions, with the model specifically biased against one of the three diagnoses.
Intervention Type
Other
Intervention Name(s)
Artificial intelligence model predictions with explanation
Intervention Description
During 6 clinical vignettes, participants will see AI model predictions with explanation. The AI model will provide a score for each diagnosis on a scale of 0-100. In 3 clinical vignettes, participants will be shown standard AI model predictions and 3 vignettes they will be shown systematically biased AI model predictions with the model specifically biased against one of the three diagnoses. If the AI model provides a score above 50 an AI model explanation will be shown as gradient-weighted class activation mapping (Grad-CAM) heatmaps overlaid on the chest X-ray that highlighted which regions of the image most affecting the AI model's prediction.
Intervention Type
Other
Intervention Name(s)
AI model biased against heart failure
Intervention Description
In 3 clinical vignettes, participants will be shown systematically biased AI model predictions with the model specifically biased against heart failure, always predicting that heart failure is present with high likelihood in survey vignette patients with a body mass index (BMI) at or above 30. Standard predictions will be shown for the other 2 diagnoses (pneumonia, COPD).
Intervention Type
Other
Intervention Name(s)
AI model biased against pneumonia
Intervention Description
In 3 clinical vignettes, participants will be shown systematically biased AI model predictions with the model specifically biased against pneumonia, always predicting that pneumonia is present with high likelihood in survey vignette patients 80 years or older. Standard predictions will be shown for the other 2 diagnoses (heart failure, COPD).
Intervention Type
Other
Intervention Name(s)
AI model biased against COPD
Intervention Description
In 3 clinical vignettes, participants will be shown systematically biased AI model predictions with the model specifically biased against COPD, always predicting that COPD is present with high likelihood in survey vignette patients where a pre-processing filter was applied to the patient's X-ray. Standard predictions will be shown for the other 2 diagnoses (heart failure, pneumonia).
Primary Outcome Measure Information:
Title
Participant diagnostic accuracy across clinical vignette settings
Description
Diagnostic accuracy is defined as the number of correct diagnostic assessments over the total number of diagnostic assessments. After reviewing each individual patient clinical vignette within the survey, participants will be asked to make three separate diagnostic assessments for each clinical vignette, one for heart failure, pneumonia, and COPD. If the participant's assessment agrees with the reference label for each vignette, the diagnostic assessment is considered correct. Diagnostic assessments will be performed while participants are completing the survey (day 0), immediately after the participant reviews the clinical vignette. Participant diagnostic accuracy will be compared across vignette settings (no AI model, standard AI model, standard AI model with explanation, biased AI model, biased AI model with explanation).
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Treatment Selection Accuracy across clinical vignette settings
Description
Treatment selection accuracy is defined as whether the participant choose the correct treatment for the patient in the clinical vignette, and could choose any combination of steroids, antibiotics, Intravenous (IV) diuretics, or none of these treatments for the patient. Treatment selection assessments will be performed while participants are completing the survey (day 0), immediately after the participant reviews the clinical vignette. Participant treatment selection accuracy will be compared across vignette settings (no AI model, standard AI model, standard AI model with explanation, biased AI model, biased AI model with explanation).
Time Frame
Day 0
Title
Diagnosis specific diagnostic accuracy across clinical vignette settings
Description
Diagnostic accuracy specific to heart failure, pneumonia, and COPD across vignette settings
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Physicians, nurse practitioners, and physician assistants that care for patients with acute respiratory failure as part of their clinical practice Exclusion Criteria: Physicians, nurse practitioners, and physician assistants that only provide patient care in outpatient settings
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Sjoding, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data could be made available to other researchers from accredited research institutions after entering into a data use agreement with the University of Michigan
IPD Sharing Time Frame
Data will be shared indefinitely once the study is published
IPD Sharing Access Criteria
This information will be published as supplements with the study manuscript.

Learn more about this trial

Human Algorithm Interactions for Acute Respiratory Failure Diagnosis

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