Integrating Data, Algorithms and Clinical Reasoning for Surgical Risk Assessment

NCT02741986 | Active Not Recruiting

• 2 other identifiers: IRB201600262-NR01GM110240
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Postoperative Complications

Keywords

risk assessment; sepsis; acute kidney injury (AKI)

Outcome Measures

Primary Outcomes (1)

• 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.

  At the end of six months study period.

Secondary Outcomes (2)

• Sensitivity and specificity of risk estimates

  At the end of six months study period.

• Positive and negative predictive values

  At the end of six months study period.

Study Arms (2)

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.

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.

Other: Risk estimation

Interventions

Risk estimation 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); Physicians

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Surgeons and anesthesiologists working in adult inpatient operative practices.

You may not qualify if:

• Surgeons and anesthesiologists working in obstetric and pediatric practices.

Sponsors & Collaborators

• University of Florida: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (2)

UF Health

Gainesville, Florida, 32610-3003, United States

Location

UF Health Jacksonville

Jacksonville, Florida, 32209, United States

Location

MeSH Terms

Conditions

Postoperative Complications; Sepsis; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Azra Bihorac, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: April 18, 2016
• Study Start: October 1, 2016
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: December 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

US (2)