Trial Outcomes & Findings for Pilot Study for Postoperative Machine Learning (NCT NCT04877535)
NCT ID: NCT04877535
Last Updated: 2025-04-04
Results Overview
After handoff was completed, receiving nurses were asked: Globally, how effective was the handover 1. Not at all effective 2. Somewhat effective 3. Moderately effective 4. Very effective 5. Extremely effective The item is taken from PMID:25806398 but has no name
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
222 participants
Primary outcome timeframe
8 hours postop
Results posted on
2025-04-04
Participant Flow
Participant milestones
| Measure |
Stage 1: Usual Care
The standard of care. The report card will be electronically generated (to determine eligibility) but it will not be visible to clinicians.
|
Stage 2: Usual Care
The standard of care. The report card will be electronically generated (to determine eligibility) but it will not be visible to clinicians. Patients who have a previous assignment (from another day) are not eligible.
|
Stage 2: Intervention
ML will be used to create a report card for each patient that summarizes the preoperative assessment and intraoperative data. Report card data will be made available to providers through multiple methods: integration into electronic health records workflows, electronic health records notifications, mobile device notifications, and print outs in the paper chart
ML-based report card: PACU and ward providers caring for participants will be notified by Anesthesia Control Tower clinicians before arrival if the patient's report card. The notification will contain a report card of the patient's forecast risk of major adverse events, explanatory machine-learning outputs, most influential pre- and intraoperative data, and predicted treatments.The ML risk profile generated for each patient will include risk of 30 day mortality, risk of respiratory failure, risk of acute kidney injury, and risk of postoperative delirium
Patients who have a previous assignment (from another day) are not eligible.
|
|---|---|---|---|
|
Overall Study
STARTED
|
89
|
39
|
94
|
|
Overall Study
COMPLETED
|
89
|
39
|
94
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study for Postoperative Machine Learning
Baseline characteristics by cohort
| Measure |
Stage 1: Usual Care
n=89 Participants
Pre-intervention period
|
Stage 2: Usual Care
n=39 Participants
Days with ML report card disabled
|
Stage 2: Intervention
n=94 Participants
Days with ML report card enabled
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.4 years
STANDARD_DEVIATION 15.5 • n=99 Participants
|
62.5 years
STANDARD_DEVIATION 16.7 • n=107 Participants
|
57.3 years
STANDARD_DEVIATION 16.5 • n=206 Participants
|
57.9 years
STANDARD_DEVIATION 16.2 • n=7 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
98 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
124 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
85 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
92 Participants
n=206 Participants
|
214 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
60 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
153 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Surgery type
Acute Critical Care Surgery
|
28 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
45 Participants
n=7 Participants
|
|
Surgery type
Orthopaedics
|
2 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
55 Participants
n=7 Participants
|
|
Surgery type
Otolaryngology
|
12 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
|
Surgery type
Plastics
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
|
Surgery type
Transplant
|
30 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
|
Surgery type
Vascular
|
0 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
|
Surgery type
Hepatobiliary
|
11 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Surgery type
Unknown or Other
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 8 hours postopAfter handoff was completed, receiving nurses were asked: Globally, how effective was the handover 1. Not at all effective 2. Somewhat effective 3. Moderately effective 4. Very effective 5. Extremely effective The item is taken from PMID:25806398 but has no name
Outcome measures
| Measure |
Stage 1: Usual Care
n=89 Participants
Pre-intervention period
|
Stage 2: Usual Care
n=39 Participants
Days with ML report card disabled
|
Stage 2: Intervention
n=94 Participants
Days with ML report card enabled.
|
|---|---|---|---|
|
Overall Handoff Effectiveness
|
3.9 score on a 0-5 scale
Standard Deviation 0.4
|
3.9 score on a 0-5 scale
Standard Deviation 0.7
|
4.0 score on a 0-5 scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 8 hours postopPopulation: pre-intervention group did not have ML topics generated for research assistant
Binary. A research assistant observed the handoff and recorded if any topics identified by the ML algorithm (in the report card) were discussed included in the handoff
Outcome measures
| Measure |
Stage 1: Usual Care
Pre-intervention period
|
Stage 2: Usual Care
n=39 Participants
Days with ML report card disabled
|
Stage 2: Intervention
n=94 Participants
Days with ML report card enabled.
|
|---|---|---|---|
|
Number of Participants With ML Topics Discussed During Handoff
|
0 Participants
|
19 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: 8 hours postopBinary. A research assistant observed the handoff and recorded if expected problems or plans to address expected problems were conveyed, or if no expected problems or plans to address expected problems were conveyed.
Outcome measures
| Measure |
Stage 1: Usual Care
n=89 Participants
Pre-intervention period
|
Stage 2: Usual Care
n=39 Participants
Days with ML report card disabled
|
Stage 2: Intervention
n=94 Participants
Days with ML report card enabled.
|
|---|---|---|---|
|
Number of Participants With Anticipatory Guidance During Handoff
|
61 Participants
|
35 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: 8 hours postopReceiving nurses were asked: Did you receive at handoff all the information you needed to safely take care of this patient? \[Yes, No\]
Outcome measures
| Measure |
Stage 1: Usual Care
n=89 Participants
Pre-intervention period
|
Stage 2: Usual Care
n=39 Participants
Days with ML report card disabled
|
Stage 2: Intervention
n=94 Participants
Days with ML report card enabled.
|
|---|---|---|---|
|
Number of Handoff Receivers Agreeing That They Received All Needed Information
|
72 Participants
|
37 Participants
|
91 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 hours postopPopulation: Usual care group not eligible
Handoff was observed by a research assistant. In the intervention group only, each nurse was asked Did you look at or discuss the postoperative report card for this patient? \[Yes, No\] Additionally, the research assistant noted if they observed the report card being referred to be the handoff-giving team. \[Yes, No\] The measure is positive if either the self report or research-assistant recorded a "Yes"
Outcome measures
| Measure |
Stage 1: Usual Care
n=94 Participants
Pre-intervention period
|
Stage 2: Usual Care
Days with ML report card disabled
|
Stage 2: Intervention
Days with ML report card enabled.
|
|---|---|---|---|
|
Number of Handoff Recipients Self-reporting Referring to Report Card OR Report Card Observed Directly Referred to During Handoff
|
5 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Stage 1: Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 2: Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 2: Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Christopher King
Washington University School of Medicine
Phone: (314) 362-8649
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place