Acute Kidney Injury, Hospital Mortality, Perioperative/Postoperative Complications, Surgery--Complications
Conditions
Keywords
Telemedicine, Anesthesia Control Tower, Machine Learning, Forecasting Algorithms, Randomized Controlled Trial, PACU
Brief summary
The ODIN-Report study will be a randomized controlled trial of the effect of providing machine learning risk forecasts to providers caring for patients immediately after surgery on serious complications. The complications studied will be ICU admission or death on wards, acute kidney injury, and hospital length of stay.
Detailed description
This will be a single center, randomized, controlled, pragmatic clinical trial. The investigators will screen surgical patients enrolled in TECTONICS (NCT03923699) and randomized to intraoperative contact. Near the end of the operation, the investigators will calculate the same machine learning risk forecasts of major complications as TECTONICS, and enroll patients if all of the following are true: (1) No ICU admission is intended (2) ML mortality risk forecast is in top 15% of historical PACU patients. Patients will be randomized 1:1:1 to no contact, brief contact, and full contact. The postoperative provider (PACU physician, anesthesiologist, ward clinician) will be notified before arrival of the risk forecast in the contact groups, and in the full contact group an additional set of explanatory ML outputs will be provided. The intention-to-treat principle will be followed for all analyses.
Interventions
DEVICEAnesthesia Control Tower Notification
Real-time data will be monitored through the AlertWatch system as well as the electronic health record. Risk forecasts of adverse events (30 day mortality, acute kidney injury, postoperative delirium, respiratory failure), PACU length of stay, and hospital length of stay will be generated by a machine learning algorithm. Additional outputs identifying the most important predictors and their effects will be combined with risk forecasts to form a report card.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
1:1:1 randomization between standard of care (no contact), postoperative contact (brief), postoperative contact (long).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Enrolled in TECTONICS Study (ID 201903026, NCT03923699), in OR randomized to contact * workweek hours * preoperative assessment completed * estimated risk of mortality in top 15% of historical PACU patients
Exclusion criteria
* Not enrolled in TECTONICS Study * Operating room randomized to non-contact in TECTONICS * Planned ICU admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unplanned ICU admission | 7 days post-op | Admission to a "critical care" bed regardless of rationale or duration at any point in the follow up time frame. Patients who expire without transfer to ICU will be marked as positive. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Kidney Injury | 7 days post-op | Postoperative laboratory values and urine output will be used to calculate Kidney Disease Improving Global Outcomes grades of acute kidney injury. Where unavailable, baseline Glomerular filtration rate will be assumed to be age, sex, and body size normal. |
| Hospital length of stay | 30 days post-op | The duration in days between end of anesthesia care and discharge from the performing hospital. |
Contacts
PRINCIPAL_INVESTIGATORChristopher R King, MD, PhD
Washington University School of Medicine
Outcome results
None listed