N/A
N=222
Pilot Study for Postoperative Machine Learning
Surgery--Complications
Bottom Line
View on ClinicalTrials.gov: NCT04877535 ↗Enrolled (actual)
222
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Overall Handoff Effectiveness — 3.9; 3.9; 4.0 score on a 0-5 scale — p=0.524
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ML-based report card (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Handoff Effectiveness |
3.9; 3.9; 4.0 | 0.524 |
| SECONDARY Number of Participants With ML Topics Discussed During Handoff |
0; 19; 47 | 1.00 |
| SECONDARY Number of Participants With Anticipatory Guidance During Handoff |
61; 35; 85 | <0.001 sig |
| SECONDARY Number of Handoff Receivers Agreeing That They Received All Needed Information |
72; 37; 91 | <0.001 sig |
Summary
The objectives of the study are to determine the interpretability, workflow role, and effect on communications of showing report cards containing Machine Learning (ML)-based risk profiles based on pre- and intra-operative data to postoperative providers.
Eligibility Criteria
Inclusion Criteria
ODIN-Pilot will intervene on a subset of TECTONICS participants meeting all the following criteria:
- Within the TECTONICS contact arm (adults undergoing OR procedures)
- Operating room at BJH South campus (including all of "Pod 2", "Pod 3", "Pod 5") (excluding all procedure suites such as Interventional Radiology, Parkview Tower "Pod 1", Center for Advanced Medicine "Pod 4", Labor and Delivery suites)
- Surgeon is a member of the Acute and Critical Care Surgery division or the postoperative bed is 16300 observation unit.
- Planned non-ICU disposition ("floor" and "observation unit" collectively "ward" patients).
Exclusion Criteria
- Not enrolled in TECTONICS Study
- Randomized to the observation arm in TECTONICS study
- Planned ICU admission
- Patients are only included once; if previously included a subsequent surgery is not eligible
Data sourced from ClinicalTrials.gov (NCT04877535). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.