By InvitationNot Applicable

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

United States350 participantsStarted 2025-12-05

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Accuracy of Predicting the Source of Treatment Recommendation

Timeframe: From enrollment to the end of the survey, an average of 45 minutes

Trial details

NCT IDNCT07025096

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

View on ClinicalTrials.gov More Sepsis trials