Integrating Data, Algorithms and Clinical Reasoning for Surgical Risk Assessment

NCT ID: NCT02741986

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2028-11-30

Brief Summary

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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

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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

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Postoperative Complications

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Risk estimation

Intervention Type OTHER

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.

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.

Risk estimation

Intervention Type OTHER

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.

Interventions

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Risk estimation

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Surgeons and anesthesiologists working in adult inpatient operative practices.

Exclusion Criteria

Surgeons and anesthesiologists working in obstetric and pediatric practices.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Azra Bihorac, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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UF Health

Gainesville, Florida, United States

Site Status

UF Health Jacksonville

Jacksonville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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R01GM110240

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB201600262-N

Identifier Type: -

Identifier Source: org_study_id

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