- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07406269
Clinical Evaluation of AI Decision Support for Early Rehabilitation After Surgery (DESIRE)
Evaluation of Clinical Effectiveness and Implementation of an Artificial Intelligence Based Decision Support Tool That Guides Early Rehabilitation After Gastrointestinal and Oncology Surgery
After gastrointestinal or oncology surgery, it can be difficult to determine when a patient is ready to safely begin early rehabilitation or move toward discharge. Delays may prolong hospital stay, while premature decisions may increase risks.
This study evaluates an artificial intelligence (AI)-based decision support tool that analyzes routinely collected hospital data to identify patients who are likely ready for early rehabilitation and discharge planning after surgery. The tool provides a simple yes/no output to support clinicians in their decision-making.
The AI tool does not replace clinical judgment. Treating physicians remain fully responsible for all care decisions.
The purpose of this study is to examine how well this tool performs in clinical practice and how it can be safely and effectively implemented to support postoperative care.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients who undergo gastrointestinal or oncology surgery often require careful monitoring after their operation. During the days following surgery, healthcare professionals assess many factors, such as vital signs, laboratory results, recovery progress, and the need for hospital-based treatments. Based on this information, decisions are made about when patients can safely start early rehabilitation or move toward discharge planning.
In this study, researchers are evaluating an artificial intelligence (AI)-based decision support tool designed to assist clinicians with these decisions. The tool analyzes routinely collected information from the electronic patient record, including demographic data, type of surgery, vital signs, laboratory values, and medication information. Using these data, the system provides a simple yes/no output indicating whether a patient is likely ready for early rehabilitation and discharge planning on the second day after surgery.
The AI tool is advisory only. It does not make treatment decisions and cannot initiate any actions. The treating physician always reviews the patient's condition independently and makes the final decision about care, rehabilitation, and discharge planning.
The study focuses on two main aspects:
- How accurately the AI tool identifies patients who are ready for early rehabilitation and discharge planning.
- How the tool can be safely and practically integrated into everyday clinical workflows.
Participation in this study does not change the standard of care. All patients continue to receive routine postoperative care according to existing hospital protocols. The AI tool serves solely as an additional source of information for clinicians.
Patient data used by the AI system are processed within secure hospital systems and handled in accordance with data protection regulations. No additional tests or procedures are required specifically for this study.
The results of this study may help improve postoperative care by supporting timely rehabilitation and discharge planning, potentially reducing unnecessary hospital stays while maintaining patient safety.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Denise Hilling, MD, PhD
- Phone Number: +31 10 704 19 02
- Email: d.hilling@erasmusmc.nl
Study Locations
-
-
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Rotterdam, Netherlands
- Erasmus MC, University Medical Center Rotterdam
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Contact:
- Denise Hilling, MD PhD
- Phone Number: +31 10 704 19 02
- Email: d.hilling@erasmusmc.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 years or older
- Undergoing gastrointestinal or oncological surgery
- Postoperatively admitted to the surgical ward
- Expected to remain admitted for at least 2 days after surgery
Exclusion Criteria:
- Admitted to the intensive care unit (ICU) at the time of prediction on postoperative day 2
- Inability to provide informed consent in Dutch or English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cohort of 103 patients undergoing GE/oncological surgery and admitted >2 days after surgery
|
The intervention consists of the clinical use of a locked, non-adaptive artificial intelligence (AI)-based clinical decision support system (DESIRE) that analyzes routinely collected electronic health record data to predict, on postoperative day 2, the risk that a patient will require hospital-specific interventions after gastrointestinal or oncological surgery. The system automatically extracts demographic, perioperative, vital sign, laboratory, and medication-related variables and generates a binary (yes/no) output indicating whether the patient is likely to be at low risk for requiring additional hospital care. A predefined conservative threshold is used to identify patients eligible for early rehabilitation. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of patients requiring unplanned escalation of hospital-specific care within 30 days after early transfer to rehabilitation area.
Time Frame: From postoperative day 2 (time of AI prediction and potential transfer to rehabilitation area) through 30 days after surgery
|
This is a composite outcome, consisting of any of the following events: ICU admission Re-operation Radiological intervention Administration of intravenous antibiotics Respiratory failure (new need for supplemental oxygen) 30-day mortality 30-day emergency readmission |
From postoperative day 2 (time of AI prediction and potential transfer to rehabilitation area) through 30 days after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DESIRE implementation
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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