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Effectiveness of an artificial intelligence clinical decision support system for early detection of sepsis

Effectiveness of an artificial intelligence-clinical decision support system for early detection of sepsis: a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN83789437
Enrollment
400
Registered
2024-07-12
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Sepsis Infections and Infestations

Interventions

Randomized Comparison of Artificial Intelligence-Clinical Decision Support System (AI-CDSS) Use with Standard Sepsis Diagnostic Practices This randomized controlled trial compares two groups: one usi

Sponsors

Tri-Service General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Professional Status: Must be a licensed health professional authorized to diagnose and manage sepsis, including postgraduate year residents, residents, fellows, or attending physicians in relevant departments such as emergency medicine, intensive care, and infectious diseases. 2. Clinical Experience: Must have a minimum of one year of clinical experience, ensuring familiarity with sepsis diagnosis and management protocols. 3. Access to Technology: Must have regular access to the necessary technological infrastructure to use the AI-CDSS, including computers or tablets with internet connectivity. This infrastructure should also be integrated into the hospital’s electronic health record system where feasible. 4. Training Willingness: Must be willing to undergo a brief training session on the use of the AI-CDSS to ensure proper understanding and effective utilization of the system, focusing on how it integrates with sepsis diagnostic and management protocols.

Exclusion criteria

Exclusion criteria: 1. Non-Diagnostic Roles: Health professionals who are not directly involved in diagnosing or managing patient care, such as administrative staff, nurses without diagnostic responsibilities, or medical students who do not participate in clinical decision-making. 2. Inexperience in Sepsis Management: Health professionals with less than one year of clinical experience in departments relevant to sepsis care, ensuring that all participants have adequate exposure to sepsis management practices.

Design outcomes

Primary

MeasureTime frame
Physician confidence in their sepsis diagnosis measured using a questionnaire on days on day 1, 2, 4, and 7 after the initial diagnosis or risk identification

Secondary

MeasureTime frame
The following secondary outcome measures will be assessed using a questionnaire administered on days 1, 2, 4, and 7 after the initial sepsis diagnosis: 1. Satisfaction with the Diagnostic Process to evaluate factors influencing physician satisfaction, including decision-making efficiency (time required and ease of accessing necessary information) and overall satisfaction with the diagnostic process as used in their clinical practice 2. Effectiveness of Sepsis Management Decisions. This involves assessing the effectiveness of the decisions made following the sepsis diagnosis in managing patient care and improving health outcomes, such as recovery rates and prevention of sepsis progression.

Countries

Taiwan

Contacts

Public ContactHung-Sheng Shang
iamkeith@mail.ndmctsgh.edu.tw+886 920713130

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026