Patient Outcome AssessmentNCT06434220
Effect of Predictive Model on ED Physician Assessments of Patient Disposition
A study testing Baseline model and Fairness-aware model in people with Patient Outcome Assessment, run by Boston Children's Hospital.
Trial summary
The goal of this study is to measure the impact of fairness-aware algorithms on physician predictions of ED patient admission. Using an experimentally validated machine learning model tuned for equitable outcomes, the investigators quantify the impact of model recommendations on ED physician assessments of admission… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Outcome Assessment
- What is being tested?
- Baseline model and Fairness-aware model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Board certified emergency department attending physicians currently employed by Boston Children's Hospital
Who cannot join
- Physicians are excluded from completely surveys for patients who they are currently caring for
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this study is to measure the impact of fairness-aware algorithms on physician predictions of ED patient admission. Using an experimentally validated machine learning model tuned for equitable outcomes, the investigators quantify the impact of model recommendations on ED physician assessments of admission risk in a silent, prospective study. The investigators survey ED physicians who are not currently caring for patients using live site data. To quantify the impact of the model on ED physician assessments of admission risk, the investigators collect physician assessments before and after consulting the (original or updated) model prediction.
The investigators measure ED physician adherence to model suggestions, along with the predictive accuracy and equity of downstream patient outcomes. The outcome of this study is an empirical measure of the extent to which fair ML models may influence admission decisions to mitigate health care disparities.
Read the detailed description
Specific Aims/Objectives:
- Measure the effect of the sharing of a model prediction of admission on an attending physician's assessment of patient disposition within one hour from presentation at a tertiary academic pediatric hospital.
- Measure the effect of the sharing of a model prediction from a model tuned for equal subgroup performance on an attending physician's assessment of patient disposition within one hour from presentation at a tertiary academic pediatric hospital.
Background and Significance:
Machine learning (ML) models increasingly provide clinical decision support (CDS) to care teams to help prioritize individuals for specific care based on their predicted health needs and outcomes. AI/ML methods can have a particularly high impact on resource allocation in emergency departments (EDs) across the U.S., which have been described by the Institute for Medicine as "nearing the breaking point" of over-capacity. Unfortunately, models often perform poorly on disinvested subpopulations relative to the population as a whole. As a result, ML models may exacerbate downstream health disparities by under-performing on marginalized patient subpopulations, especially when models are expanded to multiple care centers and or used without subgroup monitoring for long periods of time.
Many prediction models have been developed in recent years to predict patient disposition from the ED, including a prediction tool developed by our group and currently in piloting stages at Boston Children's Hospital, South Shore Hospital, and Children's Hospital of Los-Angeles. Our prediction tool, the Predictor of Patient Placement (POPP) provides an accurate, real-time likelihood of admission based on data available in the electronic health record at the time of the visit. Advance notice of likely admissions can have an important impact on ED waiting and boarding times with the potential to improve flow and patient satisfaction.
To this end, the investigation team has submitted a grant proposal to the National Library of Medicine (NLM) [1R01LM014300 - 01A1] that researches the development and validation of fairness-aware prediction models of patient admission. Aim 2 of this grant studies the effect of these models on ED physician assessments of patient disposition, and corresponds to this protocol. The NLM has indicated its intention to fund this proposal and the investigators are in the process of submitting documents to finalize the award. This component of the study is slated for year 3 of the study.
Preliminary Studies
The investigators conducted a series of initial retrospective studies that established that patient admission could be predicted with machine learning models ahead of time in the BCH ED, progressively during the visit, as well as across other medical centers with good accuracy (AUROC 0.9-0.93).
Next, the investigators found that the accuracy of POPP in predicting admission likelihood added value to the gestalt assessments of ED attending physicians. The positive predictive value for the prediction of admission was 66% for the clinicians, 73% for POPP, and 86% for a hybrid model combining the two.
Finally, the investigators developed methods for post-processing the ED prediction models to make them well-calibrated across patient demographic groups defined by race, sex, and insurance product.
The model predictions are currently used to help with bed coordination, but given their high value, may also improve decision making at the bed-side. With this study, our goal is to now test, in a simulated, safe, and realistic setting, how model recommendations affect the assessments of admission likelihood by ED attending physicians.
- Conditions
- Patient Outcome Assessment
- Being tested
- Baseline model, Fairness-aware model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline modelDiagnostic test
Model prediction of patient disposition including feature importance scores driving prediction.
Fairness-aware modelDiagnostic test
Model prediction of patient disposition including feature importance scores driving prediction. This model has been tuned to minimize subgroup calibration errors.
| Study group | Role | What they receive |
|---|---|---|
| Physician assessment before intervention | No intervention | No intervention. Physician is surveyed to provide their assessment of patient disposition. |
| Physician assessment after baseline model intervention | Active comparator | Physician is shown a baseline model recommendation for patient disposition including description of factors driving the model prediction. Receives: Diagnostic Test: Baseline model |
| Physician assessment after fairness-aware model intervention | Active comparator | Physician is shown a model recommendation form a model tuned for subgroup performance for patient disposition including description of factors driving the model prediction. Receives: Diagnostic Test: Fairness-aware model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician-assessed ED disposition (likelihood of admission)
The primary outcome is physician-assessed ED disposition (categorized as admission or discharge), before and after viewing a model prediction, compared to final disposition of patient
Measured: Within 24 hours of survey
Patient final disposition (admitted/discharged)
The final disposition of the patient, whether admitted to an inpatient service or discharged
Measured: Within 24 hours of survey
Secondary outcomes (1)
Model-assessed ED disposition
The model prediction's assessment of ED disposition compared to final disposition of patient
Measured: Within 24 hours of survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Jan 2027 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Patient Outcome AssessmentStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William La Cava, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434220
- Sponsor's protocol ID
- IRB-P00048537
- Status last verified
- Apr 2026
- First submitted
- 20 May 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barak-Corren Y, Israelit SH, Reis BY. Progressive prediction of hospitalisation in the emergency department: uncovering hidden patterns to improve patient flow. Emerg Med J. 2017 May;34(5):308-314. doi: 10.1136/emermed-2014-203819. Epub 2017 Feb 10.
PubMed 28188202Barak-Corren Y, Agarwal I, Michelson KA, Lyons TW, Neuman MI, Lipsett SC, Kimia AA, Eisenberg MA, Capraro AJ, Levy JA, Hudgins JD, Reis BY, Fine AM. Prediction of patient disposition: comparison of computer and human approaches and a proposed synthesis. J Am Med Inform Assoc. 2021 Jul 30;28(8):1736-1745. doi: 10.1093/jamia/ocab076.
PubMed 34010406Barak-Corren Y, Chaudhari P, Perniciaro J, Waltzman M, Fine AM, Reis BY. Prediction across healthcare settings: a case study in predicting emergency department disposition. NPJ Digit Med. 2021 Dec 15;4(1):169. doi: 10.1038/s41746-021-00537-x.
PubMed 34912043Barak-Corren Y, Fine AM, Reis BY. Early Prediction Model of Patient Hospitalization From the Pediatric Emergency Department. Pediatrics. 2017 May;139(5):e20162785. doi: 10.1542/peds.2016-2785.
PubMed 28557729La Cava WG, Lett E, Wan G. Fair admission risk prediction with proportional multicalibration. Proc Mach Learn Res. 2023;209:350-378.
PubMed 37576024
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Predictive Model on ED Physician Assessments of Patient Disposition
- ClinicalTrials.gov ID
- NCT06434220
- Acronym / sponsor ID
- IRB-P00048537
- Conditions
- Patient Outcome Assessment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to measure the impact of fairness-aware algorithms on physician predictions of ED patient admission. Using an experimentally validated machine learning model tuned for equitable outcomes, the investigators quantify the impact of model recommendations on ED physician assessments of admission risk in a silent, prospective study. The investigators survey ED physicians who are not currently caring for patients using live site data. To quantify the impact of the model on ED physician assessments of admission risk, the investigators collect physician assessments before and after consulting the (original or updated) model prediction.
The investigators measure ED physician adherence to model suggestions, along with the predictive accuracy and equity of downstream patient outcomes. The outcome of this study is an empirical measure of the extent to which fair ML models may influence admission decisions to mitigate health care disparities.
Detailed description
Specific Aims/Objectives:
- Measure the effect of the sharing of a model prediction of admission on an attending physician's assessment of patient disposition within one hour from presentation at a tertiary academic pediatric hospital.
- Measure the effect of the sharing of a model prediction from a model tuned for equal subgroup performance on an attending physician's assessment of patient disposition within one hour from presentation at a tertiary academic pediatric hospital.
Background and Significance:
Machine learning (ML) models increasingly provide clinical decision support (CDS) to care teams to help prioritize individuals for specific care based on their predicted health needs and outcomes. AI/ML methods can have a particularly high impact on resource allocation in emergency departments (EDs) across the U.S., which have been described by the Institute for Medicine as "nearing the breaking point" of over-capacity. Unfortunately, models often perform poorly on disinvested subpopulations relative to the population as a whole. As a result, ML models may exacerbate downstream health disparities by under-performing on marginalized patient subpopulations, especially when models are expanded to multiple care centers and or used without subgroup monitoring for long periods of time.
Many prediction models have been developed in recent years to predict patient disposition from the ED, including a prediction tool developed by our group and currently in piloting stages at Boston Children's Hospital, South Shore Hospital, and Children's Hospital of Los-Angeles. Our prediction tool, the Predictor of Patient Placement (POPP) provides an accurate, real-time likelihood of admission based on data available in the electronic health record at the time of the visit. Advance notice of likely admissions can have an important impact on ED waiting and boarding times with the potential to improve flow and patient satisfaction.
To this end, the investigation team has submitted a grant proposal to the National Library of Medicine (NLM) [1R01LM014300 - 01A1] that researches the development and validation of fairness-aware prediction models of patient admission. Aim 2 of this grant studies the effect of these models on ED physician assessments of patient disposition, and corresponds to this protocol. The NLM has indicated its intention to fund this proposal and the investigators are in the process of submitting documents to finalize the award. This component of the study is slated for year 3 of the study.
Preliminary Studies
The investigators conducted a series of initial retrospective studies that established that patient admission could be predicted with machine learning models ahead of time in the BCH ED, progressively during the visit, as well as across other medical centers with good accuracy (AUROC 0.9-0.93).
Next, the investigators found that the accuracy of POPP in predicting admission likelihood added value to the gestalt assessments of ED attending physicians. The positive predictive value for the prediction of admission was 66% for the clinicians, 73% for POPP, and 86% for a hybrid model combining the two.
Finally, the investigators developed methods for post-processing the ED prediction models to make them well-calibrated across patient demographic groups defined by race, sex, and insurance product.
The model predictions are currently used to help with bed coordination, but given their high value, may also improve decision making at the bed-side. With this study, our goal is to now test, in a simulated, safe, and realistic setting, how model recommendations affect the assessments of admission likelihood by ED attending physicians.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physician assessment before intervention | No intervention | –No intervention. Physician is surveyed to provide their assessment of patient disposition. |
| Physician assessment after baseline model intervention | Active comparator | Diagnostic Test: Baseline modelPhysician is shown a baseline model recommendation for patient disposition including description of factors driving the model prediction. |
| Physician assessment after fairness-aware model intervention | Active comparator | Diagnostic Test: Fairness-aware modelPhysician is shown a model recommendation form a model tuned for subgroup performance for patient disposition including description of factors driving the model prediction. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Board certified emergency department attending physicians currently employed by Boston Children's Hospital
Key exclusion criteria (1 listed)
- Physicians are excluded from completely surveys for patients who they are currently caring for
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 |
|---|---|---|
| Baseline modelModel prediction of patient disposition including feature importance scores driving prediction. | Diagnostic test | Physician assessment after baseline model intervention |
| Fairness-aware modelModel prediction of patient disposition including feature importance scores driving prediction. This model has been tuned to minimize subgroup calibration errors. | Diagnostic test | Physician assessment after fairness-aware model intervention |
Primary outcome
Physician-assessed ED disposition (likelihood of admission)
Time frame: Within 24 hours of survey
The primary outcome is physician-assessed ED disposition (categorized as admission or discharge), before and after viewing a model prediction, compared to final disposition of patient
Patient final disposition (admitted/discharged)
Time frame: Within 24 hours of survey
The final disposition of the patient, whether admitted to an inpatient service or discharged
1 secondary outcome
Model-assessed ED disposition
Time frame: Within 24 hours of survey
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 28188202Barak-Corren Y, Israelit SH, Reis BY. Progressive prediction of hospitalisation in the emergency department: uncovering hidden patterns to improve patient flow. Emerg Med J. 2017 May;34(5):308-314. doi: 10.1136/emermed-2014-203819. Epub 2017 Feb 10.
- Background: PubMed 34010406Barak-Corren Y, Agarwal I, Michelson KA, Lyons TW, Neuman MI, Lipsett SC, Kimia AA, Eisenberg MA, Capraro AJ, Levy JA, Hudgins JD, Reis BY, Fine AM. Prediction of patient disposition: comparison of computer and human approaches and a proposed synthesis. J Am Med Inform Assoc. 2021 Jul 30;28(8):1736-1745. doi: 10.1093/jamia/ocab076.
- Background: PubMed 34912043Barak-Corren Y, Chaudhari P, Perniciaro J, Waltzman M, Fine AM, Reis BY. Prediction across healthcare settings: a case study in predicting emergency department disposition. NPJ Digit Med. 2021 Dec 15;4(1):169. doi: 10.1038/s41746-021-00537-x.
- Background: PubMed 28557729Barak-Corren Y, Fine AM, Reis BY. Early Prediction Model of Patient Hospitalization From the Pediatric Emergency Department. Pediatrics. 2017 May;139(5):e20162785. doi: 10.1542/peds.2016-2785.
- Background: PubMed 37576024La Cava WG, Lett E, Wan G. Fair admission risk prediction with proportional multicalibration. Proc Mach Learn Res. 2023;209:350-378.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline model and Fairness-aware model in people with Patient Outcome Assessment, run by Boston Children's Hospital.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William La Cava, PhD (4133200544, william.lacava@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician-assessed ED disposition (likelihood of admission) (time frame: Within 24 hours of survey). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06434220, which also lists 5 linked publications.
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 13 Apr 2026.