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Pilot Study for Postoperative Machine Learning

A Pilot Study for the Effect of Risk Prediction on Anticipatory Guidance and Team Coordination for Postoperative Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04877535
Enrollment
222
Registered
2021-05-07
Start date
2021-06-03
Completion date
2023-05-11
Last updated
2025-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery--Complications

Keywords

Telemedicine, Anesthesia Control Tower, Machine Learning, Forecasting Algorithms, Handoff effectiveness

Brief 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.

Detailed description

Although surgery and anesthesia have become much safer on average, many patients still experience complications after surgery. Some of these complications are likely to be avoided or less severe with early detection and treatment. Barnes-Jewish Hospital has recently started using an Anesthesia Control Tower (ACT), which is a remote group lead by an anesthesiologist who reviews live data from BJH operating rooms and calls the anesthesia provider with concerns to improve reaction times and improve use of best-practices treatments. The ACT also uses machine learning (ML) to calculate patient risks during surgery as a way of measuring when the patient is doing better or worse. The study team suspects that two mechanisms may allow risk prediction to improve postoperative care. First, is that it may make some data more actionable to clinicians. Although intraoperative data is extremely rich with many monitors, drug-response events, and surgical stress reactions to reveal the physiological state of the patient, that data is also extremely specialized and difficult to access. The study team thinks that many times the right interpretation of intraoperative data or the right treatment to give isn't clear until the surgery is nearly finished. The medical team in the recovery room (post-anesthesia care unit, PACU) and surgical wards is responsible for deciding the treatment strategy, but they don't have access to the information from the intraoperative monitors and events. Those providers also lack the familiarity to directly interpret that information and time to review it in detail. Even preoperative information may be less than fully available because the patient may still be too sedated or confused from the anesthesia to explain much about their history. By summarizing these diverse sources of information into a risk profile, machine learning outputs may directly improve the understanding of postoperative providers or improve the identification of patients at elevated risk for postoperative adverse outcomes. A second mechanism derives from behavior changes which may occur in providers in reaction to machine-generated risk profiles. The study team has observed many handoffs from the operating room and PACU include lists of important data, but it is common for the handoff-giver to provide no interpretation (what problem is this information related to) or anticipatory guidance (having identified a potential or actual problem, what should the handoff receiver do). The study team has also observed than once a major risk has been clearly identified along the chain of handoff it tends to be propagated forward with connection to the underlying data, any changes noticed by the current provider, and the current plan. The study team suspects that in the subset of patients with substantially elevated predictions on their risk profile, handoff communication and team coordination for the identified problems may improve. The larger goal is to deploy a report card for each patient that summarizes the preoperative assessment and intraoperative data in a way that is useful for postoperative providers. In this study these ML reports will be integrated into the clinical workflow and determine if it does affect handoff behavior. The study team will also evaluate the information-effect and test the report card for safety by determining if clinicians identify any major inaccuracies related to the implementation. This study is a substudy of a randomized trial of ACT-intraoperative contact (TECTONICS IRB# 201903026), and only patients in the contact (treatment) group will be eligible. The screened patients will be all adults having surgery at BJH with the division of Acute and Critical Care Surgery. Exclusion criteria are a planned ICU admission. For each included patient, the ACT clinician will review the report card information, and the postoperative providers will either be directly contacted or receive an Epic Best Practices Advisory. Our study will be a before-after quasi-experiment, meaning that after a fixed date, all eligible patients will receive the intervention, and the outcome measures will be compared to patients before that date. The outcome measure we will study is handoff effectiveness from the recovery room to wards. Providers will be surveyed on information value, any inaccurate items, or major omissions. The ML report card will not recommend specific treatments, and decisions will remain the hands of the physician in the PACU or wards. The postoperative provider will also be given information about the report card and its limitations. Modifications during piloting We originally intended the report data to be included in the electronic medical record hand off workflow for the pacu receiving nurse, however, due to changes in institutional priorities this was not activated. The study was originally designed as a pre- versus post-intervention comparison. However, it was apparent during pre-intervention data collection (June 3 2021 - July 22 2021) that differences in individual research-assistant's evaluation of hand-off content and changes in other behavior would make this a low validity method. After 2 months, the design was changed to a non-randomized parallel group study with alternating days with the report card turned on or off in a 2:1 ratio. We also took this opportunity to expand the inclusion criteria to include patients with vascular surgery, as they were frequently identified as high-risk. Due to a lack of staff availability, no further enrollment was attempted until October 2022. Enrollment continued from Oct 11 2022 to May 11 2023, with no enrollment in Jan or Feb 2023 due to staff availability.

Interventions

DEVICEML-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

Sponsors

National Center for Advancing Translational Sciences (NCATS)
CollaboratorNIH
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Blended pre-post and parallel design. Participants will be allocated to up to two groups in two time periods.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

ODIN-Pilot will intervene on a subset of TECTONICS participants meeting all the following criteria: 1. Within the TECTONICS contact arm (adults undergoing OR procedures) 2. 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) 3. Surgeon is a member of the Acute and Critical Care Surgery division or the postoperative bed is 16300 observation unit. 4. Planned non-ICU disposition (floor and observation unit collectively ward patients).

Exclusion criteria

1. Not enrolled in TECTONICS Study 2. Randomized to the observation arm in TECTONICS study 3. Planned ICU admission 4. Patients are only included once; if previously included a subsequent surgery is not eligible

Design outcomes

Primary

MeasureTime frameDescription
Overall Handoff Effectiveness8 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

Secondary

MeasureTime frameDescription
Number of Participants With ML Topics Discussed During Handoff8 hours postopBinary. 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
Number of Participants With Anticipatory Guidance During Handoff8 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.
Number of Handoff Receivers Agreeing That They Received All Needed Information8 hours postopReceiving nurses were asked: Did you receive at handoff all the information you needed to safely take care of this patient? \[Yes, No\]

Other

MeasureTime frameDescription
Number of Handoff Recipients Self-reporting Referring to Report Card OR Report Card Observed Directly Referred to During Handoff8 hours postopHandoff 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

Countries

United States

Participant flow

Participants by arm

ArmCount
Stage 1: Usual Care
Pre-intervention period
89
Stage 2: Usual Care
Days with ML report card disabled
39
Stage 2: Intervention
Days with ML report card enabled
94
Total222

Baseline characteristics

CharacteristicStage 2: Usual CareStage 2: InterventionStage 1: Usual CareTotal
Age, Continuous62.5 years
STANDARD_DEVIATION 16.7
57.3 years
STANDARD_DEVIATION 16.5
56.4 years
STANDARD_DEVIATION 15.5
57.9 years
STANDARD_DEVIATION 16.2
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants1 Participants2 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
37 Participants92 Participants85 Participants214 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants2 Participants4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants4 Participants3 Participants9 Participants
Race (NIH/OMB)
Black or African American
12 Participants31 Participants17 Participants60 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
25 Participants59 Participants69 Participants153 Participants
Sex: Female, Male
Female
16 Participants36 Participants46 Participants98 Participants
Sex: Female, Male
Male
23 Participants58 Participants43 Participants124 Participants
Surgery type
Acute Critical Care Surgery
4 Participants13 Participants28 Participants45 Participants
Surgery type
Hepatobiliary
0 Participants2 Participants11 Participants13 Participants
Surgery type
Orthopaedics
13 Participants40 Participants2 Participants55 Participants
Surgery type
Otolaryngology
6 Participants11 Participants12 Participants29 Participants
Surgery type
Plastics
8 Participants4 Participants4 Participants16 Participants
Surgery type
Transplant
1 Participants2 Participants30 Participants33 Participants
Surgery type
Unknown or Other
0 Participants0 Participants2 Participants2 Participants
Surgery type
Vascular
7 Participants22 Participants0 Participants29 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 890 / 390 / 94
other
Total, other adverse events
0 / 890 / 390 / 94
serious
Total, serious adverse events
0 / 890 / 390 / 94

Outcome results

Primary

Overall Handoff Effectiveness

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

Time frame: 8 hours postop

ArmMeasureValue (MEAN)Dispersion
Stage 1: Usual CareOverall Handoff Effectiveness3.9 score on a 0-5 scaleStandard Deviation 0.4
Stage 2: Usual CareOverall Handoff Effectiveness3.9 score on a 0-5 scaleStandard Deviation 0.7
Stage 2: InterventionOverall Handoff Effectiveness4.0 score on a 0-5 scaleStandard Deviation 0.7
p-value: 0.52495% CI: [-0.24, 0.12]t-test, 2 sided
p-value: 0.40395% CI: [-0.4, 0.16]t-test, 2 sided
Secondary

Number of Handoff Receivers Agreeing That They Received All Needed Information

Receiving nurses were asked: Did you receive at handoff all the information you needed to safely take care of this patient? \[Yes, No\]

Time frame: 8 hours postop

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Stage 1: Usual CareNumber of Handoff Receivers Agreeing That They Received All Needed Information72 Participants
Stage 2: Usual CareNumber of Handoff Receivers Agreeing That They Received All Needed Information37 Participants
Stage 2: InterventionNumber of Handoff Receivers Agreeing That They Received All Needed Information91 Participants
p-value: <0.00195% CI: [1.94, 39.25]Fisher Exact
p-value: 0.6395% CI: [0.13, 14.86]Fisher Exact
Secondary

Number of Participants With Anticipatory Guidance During Handoff

Binary. 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.

Time frame: 8 hours postop

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Stage 1: Usual CareNumber of Participants With Anticipatory Guidance During Handoff61 Participants
Stage 2: Usual CareNumber of Participants With Anticipatory Guidance During Handoff35 Participants
Stage 2: InterventionNumber of Participants With Anticipatory Guidance During Handoff85 Participants
p-value: <0.00195% CI: [1.81, 11.13]Fisher Exact
p-value: 195% CI: [0.23, 4.19]Fisher Exact
Secondary

Number of Participants With ML Topics Discussed During Handoff

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

Time frame: 8 hours postop

Population: pre-intervention group did not have ML topics generated for research assistant

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Stage 1: Usual CareNumber of Participants With ML Topics Discussed During Handoff0 Participants
Stage 2: Usual CareNumber of Participants With ML Topics Discussed During Handoff19 Participants
Stage 2: InterventionNumber of Participants With ML Topics Discussed During Handoff47 Participants
p-value: 195% CI: [0.47, 2.38]Fisher Exact
Other Pre-specified

Number of Handoff Recipients Self-reporting Referring to Report Card OR Report Card Observed Directly Referred to During Handoff

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

Time frame: 8 hours postop

Population: Usual care group not eligible

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Stage 1: Usual CareNumber of Handoff Recipients Self-reporting Referring to Report Card OR Report Card Observed Directly Referred to During Handoff5 Participants
Stage 2: Usual CareNumber of Handoff Recipients Self-reporting Referring to Report Card OR Report Card Observed Directly Referred to During Handoff0 Participants
Stage 2: InterventionNumber of Handoff Recipients Self-reporting Referring to Report Card OR Report Card Observed Directly Referred to During Handoff0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026