Postoperative ComplicationsIDEALISTNCT02741986
Integrating Data, Algorithms and Clinical Reasoning for Surgical Risk Assessment
An observational study of Postoperative Complications, run by University of Florida at 2 sites in United States.
Trial summary
Brief Summary: The goal of this study is to implement and test an intelligent perioperative system (IPS) that in real-time predicts risk for postoperative complications using routine clinical data collected in electronic health records. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Risk estimation
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2016to Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All surgeons and anesthesiologists in the adult inpatient operative practices at the single-center academic tertiary center will be enrolled. Physicians in obstetric and pediatric practices will be excluded.
Who may be able to join
- Surgeons and anesthesiologists working in adult inpatient operative practices.
Who cannot join
- Surgeons and anesthesiologists working in obstetric and pediatric practices.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UF Health
Gainesville, Florida, 32610-3003
UF Health Jacksonville
Jacksonville, Florida, 32209
About this study
Official title: Integrating Data, Algorithms and Clinical Reasoning for Surgical Risk Assessment (IDEALIST)
Brief Summary: The goal of this study is to implement and test an intelligent perioperative system (IPS) that in real-time predicts risk for postoperative complications using routine clinical data collected in electronic health records. The accuracy of computer-generated risk scores will be compared to physician's risk scores for the same patients. Physicians will be also asked to provide the opinion regarding the computer-generated risk scores using interactive interface with the program. The information regarding the risk scores performance will be collected during the two 6-month periods. The accuracy of IPS and physicians will be compared at the end at those two time periods.
Read the detailed description
Postoperative complications significantly increase morbidity, mortality and cost after surgery. In the current clinical practice the prediction of the risk for developing complications after surgery is manly based on physicians' clinical judgment. The predictive accuracy of that judgment is limited and poorly studied. The investigators will design an intelligent perioperative system (IPS) as the set of computer software and algorithms that in real-time predict risk for postoperative complications using routine clinical data in electronic health records. The system is designed as the self-learning system with the ability to interact with physicians and solicit their feedback. This study will compare the clinical judgment of physicians with computer generated risk scores for patients undergoing major surgery. All surgeons and anesthesiologists at large single-center tertiary academic center will be recruited to participate in this study. The IPS system will be implemented in real time and will generate risk scores for postoperative complications for patients planned to undergo surgery performed by the physicians enrolled in the study. Physicians will be asked to provide their risk scores (using visual analog risk scale from 0-100) for the same patients before and after interacting with the IPS. They will also have the opportunity to review computer-generated risk scores and provide their feedback. The information will be collected during two six-month periods. At the end of each 6-months period predicted risk estimates will be compared to the true occurrence of the complications. Predictive performance of physicians' risk scores will be compared to IPS generated risk scores using the comparison between area under the receiver-operating curve (AUC), sensitivity, specificity and positive and negative predicted values.
- Conditions
- Postoperative Complications
- Being tested
- Risk estimation
- Keywords
- risk assessment, sepsis, acute kidney injury (AKI)
- Medical subject headings
- Postoperative Complications, Sepsis, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk estimationOther
Physicians will be asked to provide their risk scores (ranging from 0 to 100) for postoperative complications prior to surgery and immediately after the surgery for the same patients that IPS is producing the scores. Physicians will provide scores both before and after reviewing the risk scores produced by the IPS.
The IPS system will generate risk scores (ranging from 0 to 100) for postoperative complications prior to surgery and immediately after the surgery for patients taken care by the physicians enrolled in the study.
| Study group | Role | What they receive |
|---|---|---|
| Physicians | All surgeons and anesthesiologists at large single-center tertiary academic center will be recruited to participate in this study.
Intervention: Risk estimation prior to surgery and immediately after the surgery.
Physicians will be asked to provide their risk scores (ranging from 0 to 100) for postoperative complications prior to surgery and immediately after the surgery for the same patients that IPS is producing the scores. Physicians will provide scores both before and after reviewing the risk scores produced by the IPS. Receives: Other: Risk estimation | |
| Intelligent Perioperative System (IPS) | Intelligent perioperative system (IPS) is designed as the set of computer softwares and algorithms that in real-time predict risk for postoperative complications using routine clinical data in electronic health records. The system is designed as the self-learning system with the ability to interact with physicians and solicit their feedback.
Intervention: Risk estimation prior to surgery and immediately after the surgery.
The IPS system will generate risk scores (ranging from 0 to 100) for postoperative complications prior to surgery and immediately after the surgery for patients taken care by the physicians enrolled in the study. Receives: Other: Risk estimation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the receiver operating curve (AUC) of risk estimates
At the end of each 6-months period predicted risk estimates will be compared to the true occurrence of the complications. Predictive performance of physicians' will be compared to IPS by comparing the area under the receiver-operating curves (AUC) for risk estimates.
Measured: At the end of six months study period.
Secondary outcomes (2)
Sensitivity and specificity of risk estimates
At the end of each 6-months period predicted risk estimates will be compared to the true occurrence of the complications. Predictive performance of physicians' will be compared to IPS by comparing the sensitivity and specificity for risk estimates.
Measured: At the end of six months study period.
Positive and negative predictive values
At the end of each 6-months period predicted risk estimates will be compared to the true occurrence of the complications. Predictive performance of physicians' will be compared to IPS by comparing the Positive and negative predictive values for risk estimates.
Measured: At the end of six months study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startOct 2016
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Azra Bihorac, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741986
- Sponsor's protocol ID
- IRB201600262-N
- Other IDs
- R01GM110240
- Acronym
- IDEALIST
- Status last verified
- Jun 2025
- First submitted
- 13 Apr 2016
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All deidentified data will be governed by University of Florida Integrated Data Repository. The investigators will comply with local, state, and federal laws, such as the Privacy Rule, a Federal regulation under the Health Insurance Portability and Accountability Act (HIPAA). The investigators will follow the general NIH data sharing guidance and provide a data sharing plan to be reviewed and approved by the relevant NIGMS Program Officer.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Data, Algorithms and Clinical Reasoning for Surgical Risk Assessment (IDEALIST)
- ClinicalTrials.gov ID
- NCT02741986
- Acronym / sponsor ID
- IDEALIST / IRB201600262-N
- Conditions
- Postoperative Complications
- Keywords
- risk assessment, sepsis, acute kidney injury (AKI)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- Oct 2016
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 18 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brief Summary: The goal of this study is to implement and test an intelligent perioperative system (IPS) that in real-time predicts risk for postoperative complications using routine clinical data collected in electronic health records. The accuracy of computer-generated risk scores will be compared to physician's risk scores for the same patients. Physicians will be also asked to provide the opinion regarding the computer-generated risk scores using interactive interface with the program. The information regarding the risk scores performance will be collected during the two 6-month periods. The accuracy of IPS and physicians will be compared at the end at those two time periods.
Detailed description
Postoperative complications significantly increase morbidity, mortality and cost after surgery. In the current clinical practice the prediction of the risk for developing complications after surgery is manly based on physicians' clinical judgment. The predictive accuracy of that judgment is limited and poorly studied. The investigators will design an intelligent perioperative system (IPS) as the set of computer software and algorithms that in real-time predict risk for postoperative complications using routine clinical data in electronic health records. The system is designed as the self-learning system with the ability to interact with physicians and solicit their feedback. This study will compare the clinical judgment of physicians with computer generated risk scores for patients undergoing major surgery. All surgeons and anesthesiologists at large single-center tertiary academic center will be recruited to participate in this study. The IPS system will be implemented in real time and will generate risk scores for postoperative complications for patients planned to undergo surgery performed by the physicians enrolled in the study. Physicians will be asked to provide their risk scores (using visual analog risk scale from 0-100) for the same patients before and after interacting with the IPS. They will also have the opportunity to review computer-generated risk scores and provide their feedback. The information will be collected during two six-month periods. At the end of each 6-months period predicted risk estimates will be compared to the true occurrence of the complications. Predictive performance of physicians' risk scores will be compared to IPS generated risk scores using the comparison between area under the receiver-operating curve (AUC), sensitivity, specificity and positive and negative predicted values.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physicians | – | Other: Risk estimationAll surgeons and anesthesiologists at large single-center tertiary academic center will be recruited to participate in this study. Intervention: Risk estimation prior to surgery and immediately after the surgery. Physicians will be asked to provide their risk scores (ranging from 0 to 100) for postoperative complications prior to surgery and immediately after the surgery for the same patients that IPS is producing the scores. Physicians will provide scores both before and after reviewing the risk scores produced by the IPS. |
| Intelligent Perioperative System (IPS) | – | Other: Risk estimationIntelligent perioperative system (IPS) is designed as the set of computer softwares and algorithms that in real-time predict risk for postoperative complications using routine clinical data in electronic health records. The system is designed as the self-learning system with the ability to interact with physicians and solicit their feedback. Intervention: Risk estimation prior to surgery and immediately after the surgery. The IPS system will generate risk scores (ranging from 0 to 100) for postoperative complications prior to surgery and immediately after the surgery for patients taken care by the physicians enrolled in the study. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All surgeons and anesthesiologists in the adult inpatient operative practices at the single-center academic tertiary center will be enrolled. Physicians in obstetric and pediatric practices will be excluded.
Key inclusion criteria (1 listed)
- Surgeons and anesthesiologists working in adult inpatient operative practices.
Key exclusion criteria (1 listed)
- Surgeons and anesthesiologists working in obstetric and pediatric practices.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk estimationPhysicians will be asked to provide their risk scores (ranging from 0 to 100) for postoperative complications prior to surgery and immediately after the surgery for the same patients that IPS is producing the scores. Physicians will provide scores both before and after reviewing the risk scores produced by the IPS. The IPS system will generate risk scores (ranging from 0 to 100) for postoperative complications prior to surgery and immediately after the surgery for patients taken care by the physicians enrolled in the study. | Other | Intelligent Perioperative System (IPS), Physicians |
Primary outcome
Area under the receiver operating curve (AUC) of risk estimates
Time frame: At the end of six months study period.
At the end of each 6-months period predicted risk estimates will be compared to the true occurrence of the complications. Predictive performance of physicians' will be compared to IPS by comparing the area under the receiver-operating curves (AUC) for risk estimates.
2 secondary outcomes
Sensitivity and specificity of risk estimates
Time frame: At the end of six months study period.
Positive and negative predictive values
Time frame: At the end of six months study period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: Yes. All deidentified data will be governed by University of Florida Integrated Data Repository. The investigators will comply with local, state, and federal laws, such as the Privacy Rule, a Federal regulation under the Health Insurance Portability and Accountability Act (HIPAA). The investigators will follow the general NIH data sharing guidance and provide a data sharing plan to be reviewed and approved by the relevant NIGMS Program Officer.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azra Bihorac, MD principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the receiver operating curve (AUC) of risk estimates (time frame: At the end of six months study period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.