Artificial Intelligence-augmented Perioperative Clinical Decision Support

Study Overview
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Brief Summary
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The study investigates a novel anaesthesiological clinical decision support (CDS) application, that integrates risk evaluation tools and updated clinical guidelines guided by artificial intelligence in the setting of preoperative anaesthesiological assessment. It will be compared to the current standard preoperative assessment workflow with participants being actual patients. 480 participants will be randomly assigned to either the CDS group (preoperative assessment using the CDS application) or the Control group (standard preoperative assessment workflow).

Official Title
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Artificial Intelligence-augmented Perioperative Clinical Decision Support

Conditions
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ASA Class III/IV Patients, Surgery, Clinical Decision Support Systems

Intervention / Treatment
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* Other: Electronic Clinical Decision Support Application
* Other: Standard procedures of the hospital and Sham Clinical Decision Support Application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA (American Society of Anaesthesiologists)-Class III and IV non-cardiac surgery Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clinical Decision Support Application guided Anaesthesiological Assessment<br>Preoperative anaesthesiological assessment and risk evaluation using a clinical decision support application. | Other: Electronic Clinical Decision Support Application<br>* Preoperative anaesthesiological assessment and risk evaluation using a clinical decision support application, that calculates perioperative risks for the patient and informs the anaesthesiologist on indicated diagnostics and procedures according to clinical guidelines in real-time.<br>|
| Sham Comparator: Standard Anaesthesiological Assessment<br>Preoperative anaesthesiological assessment using standard procedures of the hospital and a sham clinical decision support application. | Other: Standard procedures of the hospital and Sham Clinical Decision Support Application<br>* Preoperative anaesthesiological assessment using standard procedures of the hospital. In addition a sham clinical decision support application will be used. Information on perioperative risks and indicated diagnostic procedures according to clinical guidelines is not given to the physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of clinically not indicated preoperative diagnostic procedures ordered by the anaesthesiologist | Preoperative diagnostic procedures ordered by the anaesthesiologist are defined as ECG, echocardiography, carotid (Duplex) ultrasound, chest X-ray and functional non-invasive tests for coronary artery disease (e.g. stress echocardiography) | preoperative assessment until operative procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of documented items from a predefined set of relevant cardiovascular symptoms and conditions during the anaesthesiological assessment | Completeness of medical documentation will be measured by the number of documented items from a predefined list of relevant cardiovascular symptoms and conditions during the preoperative anaesthesiological asssessment. | preoperative assessment until operative procedure | 
| Incidence of intra- and postoperative complications |  | operative procedure until hospital discharge, assessed up to 4 weeks | 
| Incidence of 30-Day unplanned All-cause Hospital Readmission |  | hospital discharge until 30th postoperative day | 
| Length of Hospital Stay |  | hospital admission until hospital discharge, assessed up to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anaesthesiology, Clinical Decision Support, Artificial Intelligence, Perioperative Risk Assessment