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NCT06098950 · ClinicalTrials.gov registry record · NA

Human Algorithm Interactions for Acute Respiratory Failure Diagnosis

A NA study, sponsored by University of Michigan.

Completed
Registry status
NA
Development phase
457
Enrollment target

NCT06098950: Completed NA study, sponsored by University of Michigan.

NCT06098950 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 457 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06098950, a NA study, has completed, sponsored by University of Michigan.

COMPLETED
Registry status
NA
Development phase
457 participants
Enrollment target

Study 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

Primary Outcome

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 assessm

Interventions

  • OTHER Artificial Intelligence model predictions without explanation
  • OTHER Artificial intelligence model predictions with explanation
  • OTHER AI model biased against heart failure
  • OTHER AI model biased against pneumonia
  • OTHER AI model biased against COPD

Trial Details

FieldValue
Enrollment Target 457 participants
Start Date 2022-04-01
Est. Completion 2023-01-31
Phase NA
University of Michigan

1,327 total trials

What the finished NCT06098950 record still lists

NCT06098950 is an interventional study that assigns participants to a tested intervention. The registered 457 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 5 interventions - of which Artificial Intelligence model predictions without explanation is the first listed.

NCT06098950 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06098950 about?

NCT06098950 is a clinical study titled "Human Algorithm Interactions for Acute Respiratory Failure Diagnosis". 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, cli...

What is the current status of trial NCT06098950?

This trial is currently completed. It is a NA study. The enrollment target is 457 participants. The study started on 2022-04-01. Estimated completion is 2023-01-31.

What interventions are being tested in trial NCT06098950?

The interventions under investigation include: Artificial Intelligence model predictions without explanation (OTHER), Artificial intelligence model predictions with explanation (OTHER), AI model biased against heart failure (OTHER), AI model biased against pneumonia (OTHER), AI model biased against COPD (OTHER).

Who is sponsoring clinical trial NCT06098950?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06098950's enrollment target sits among peer trials

457 224th of 2000 higher than 1,777 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06098950, the US trial registry maintained by the National Library of Medicine. NCT06098950 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.