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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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:

  1. 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.
  2. 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.

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 groups in NCT06434220
Study groupRoleWhat they receive
Physician assessment before interventionNo interventionNo intervention. Physician is surveyed to provide their assessment of patient disposition.
Physician assessment after baseline model interventionActive comparatorPhysician 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 interventionActive comparatorPhysician 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.

  1. 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

  2. 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)
  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.

  1. First posted30 May 2024
  2. Study start1 Jan 2027 (estimated)
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 Sep 2027 (estimated)

Resources

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)
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 28188202
  • Barak-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 34010406
  • Barak-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 34912043
  • Barak-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 28557729
  • La Cava WG, Lett E, Wan G. Fair admission risk prediction with proportional multicalibration. Proc Mach Learn Res. 2023;209:350-378.

    PubMed 37576024

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.

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