Surgery--ComplicationsNCT04877535
Pilot Study for Postoperative Machine Learning
A study testing ML-based report card in people with Surgery--Complications, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery--Complications
- What is being tested?
- ML-based report card
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2021to 11 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study for the Effect of Risk Prediction on Anticipatory Guidance and Team Coordination for Postoperative Care
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.
Read the 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.
- Conditions
- Surgery--Complications
- Being tested
- ML-based report card
- Keywords
- Telemedicine, Anesthesia Control Tower, Machine Learning, Forecasting Algorithms, Handoff effectiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ML-based report cardDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Stage 2: Intervention | Experimental | 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
Patients who have a previous assignment (from another day) are not eligible. Receives: Device: ML-based report card |
| Stage 2: Usual Care | No intervention | 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 1: Usual Care | No intervention | The standard of care. The report card will be electronically generated (to determine eligibility) but it will not be visible to clinicians. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Handoff Effectiveness
After handoff was completed, receiving nurses were asked:
Globally, how effective was the handover
- Not at all effective
- Somewhat effective
- Moderately effective
- Very effective
- Extremely effective
The item is taken from PMID:25806398 but has no name
Measured: 8 hours postop
Secondary outcomes (3)
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
Measured: 8 hours postop
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.
Measured: 8 hours postop
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]
Measured: 8 hours postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start3 Jun 2021
- Primary completion11 May 2023
- Study completion11 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgery--ComplicationsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Blended pre-post and parallel design. Participants will be allocated to up to two groups in two time periods.
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Christopher R King, MD, PhD, Principal investigator, Washington Univeristy School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877535
- Sponsor's protocol ID
- 202103210
- Other IDs
- KL2TR002346
- Status last verified
- Mar 2025
- First submitted
- 3 May 2021
- Last updated
- 4 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data are a subset of TECTONICS and will be have the same sharing plan / restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for the Effect of Risk Prediction on Anticipatory Guidance and Team Coordination for Postoperative Care
- ClinicalTrials.gov ID
- NCT04877535
- Acronym / sponsor ID
- 202103210
- Conditions
- Surgery--Complications
- Keywords
- Telemedicine, Anesthesia Control Tower, Machine Learning, Forecasting Algorithms, Handoff effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 11 May 2023 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 7 May 2021 (actual)
- Results
- Posted 4 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Blended pre-post and parallel design. Participants will be allocated to up to two groups in two time periods.
| Arm | Type | Receives |
|---|---|---|
| Stage 2: Intervention | Experimental | Device: ML-based report cardML 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 Patients who have a previous assignment (from another day) are not eligible. |
| Stage 2: Usual Care | No intervention | –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 1: Usual Care | No intervention | –The standard of care. The report card will be electronically generated (to determine eligibility) but it will not be visible to clinicians. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ML-based report cardPACU 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 | Device | Stage 2: Intervention |
Primary outcome
Overall Handoff Effectiveness
Time frame: 8 hours postop
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
3 secondary outcomes
Number of Participants With ML Topics Discussed During Handoff
Time frame: 8 hours postop
Number of Participants With Anticipatory Guidance During Handoff
Time frame: 8 hours postop
Number of Handoff Receivers Agreeing That They Received All Needed Information
Time frame: 8 hours postop
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data are a subset of TECTONICS and will be have the same sharing plan / restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher R King, MD, PhD principal investigator
Washington Univeristy School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ML-based report card in people with Surgery--Complications, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Handoff Effectiveness (time frame: 8 hours postop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025; AzTrials last refreshed its copy on 29 Oct 2026.