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Evaluating Artificial Intelligence-Based Clinical Decision Support for Sepsis and ARDS

Evaluating Artificial Intelligence-Based Comprehensive Clinical Decision Support for Sepsis and ARDS

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07025096
Enrollment
355
Registered
2025-06-17
Start date
2025-12-05
Completion date
2026-07-03
Last updated
2026-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome (ARDS), Sepsis

Keywords

Sepsis, Acute Respiratory Distress Syndrome, Clinical Decision Support, Clinical Decision Support System, Invasive Mechanical Ventilation, Artificial Intelligence

Brief summary

Sepsis and acute respiratory distress syndrome (ARDS) are common in intensive care units. Managing sepsis and ARDS is inherently complex and requires making numerous decisions under uncertainty. Artificial intelligence (AI) clinical decision support systems (CDSSs) offer a promising approach to support care management for sepsis and ARDS. The goal of this randomized, survey-based study is to compare treatment recommendations enacted by clinicians to those generated by an AI CDSS. The study will investigate whether an AI CDSS can generate treatment recommendations that are safe, appropriate, and indistinguishable to those provided by real clinicians. In this study, participants (i.e., critical care clinicians) will review a series of critical care cases (vignettes) in an electronic survey. Each vignette will contain a de-identified case of a patient with sepsis and ARDS as well as treatment recommendations for the case. Participants will assess the safety and appropriateness of each treatment recommendations and answer whether they think the treatment recommendations came from the clinician or an AI CDSS.

Interventions

OTHERArtifical Intelligence-Generated Treatment Recommendations

The clinical vignette will contain treatment recommendations which were generated by an artificial intelligence-based clinical decision support system.

Sponsors

University of Pennsylvania
Lead SponsorOTHER
National Institute of General Medical Sciences (NIGMS)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Intervention model description

Participants will review a series of clinical vignettes. Each vignette will be randomized to show a treatment recommendation either from an artificial intelligence-based clinical decision support system (AI CDSS) or from the clinician in the case, reflecting actual clinical practice. Vignettes will be randomized equally, and participants will see an equal number of vignettes from each arm.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Working as a physician (i.e., MD, DO) or an advanced practice provider (i.e., nurse practitioner, physician assistant) * Working at a hospital or medical center in medical critical care, anesthesia critical care, surgical critical care, or emergency medicine

Exclusion criteria

* Has not completed a residency training program (i.e., medical intern or resident)

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of Predicting the Source of Treatment RecommendationFrom enrollment to the end of the survey, an average of 45 minutesParticipants will answer if they think the treatment recommendations came from artificial intelligence (AI) or a clinician for each clinical vignette. Accuracy will be measured by participants correctly identifying the source of treatment recommendation.

Secondary

MeasureTime frameDescription
Confidence of Predicting the Source of Treatment RecommendationFrom enrollment to the end of the survey, an average of 45 minutesParticipants will respond to their confidence in their prediction in whether the treatment recommendations of a vignette came from artificial intelligence or from a clinician. Confidence will measured on a Likert scale ranging from 0 (Not at all confident) to 7 (Extremely confident).
Appropriateness of Treatment RecommendationsFrom enrollment to the end of the survey, an average of 45 minutesAppropriateness will be measured by participants' assessments of the clinical appropriateness of the treatment recommendations in the vignettes via Yes-No and free-text responses.
Safety of Treatment RecommendationsFrom enrollment to the end of the survey, an average of 45 minutesSafety will be measured by participants' assessments of the overall safety of the treatment recommendations in the vignettes via Yes-No and free-text responses.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORGary Weissman, MD, MSHP

University of Pennsylvania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 24, 2026