NCT06434220

Brief 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 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Jan 2027

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed
2.6 years until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

May 20, 2024

Last Update Submit

April 7, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    Within 24 hours of survey

  • Patient final disposition (admitted/discharged)

    The final disposition of the patient, whether admitted to an inpatient service or discharged

    Within 24 hours of survey

Secondary Outcomes (1)

  • Model-assessed ED disposition

    Within 24 hours of survey

Study Arms (3)

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.

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.

Diagnostic Test: Fairness-aware model

Interventions

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.

Physician assessment after fairness-aware model intervention
Baseline modelDIAGNOSTIC_TEST

Model prediction of patient disposition including feature importance scores driving prediction.

Physician assessment after baseline model intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Board certified emergency department attending physicians currently employed by Boston Children's Hospital

You may not qualify if:

  • Physicians are excluded from completely surveys for patients who they are currently caring for

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 28188202BACKGROUND
  • 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.

    PMID: 34010406BACKGROUND
  • 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.

    PMID: 34912043BACKGROUND
  • 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.

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

    PMID: 37576024BACKGROUND

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
We conduct a randomized, double-blind, controlled before-after (CBA) study of board-certified ED attending physicians not currently caring for patients in the BCH ED over a period of six to twelve weeks. In this experiment, the "treatment" consists of an ML recommendation provided to the ED physicians, who predict admission decisions for individual patients before and after receiving it. The "control" surveys receive the original POPP model recommendation, and "treatment" surveys receive a "fairness-aware" model, determined in prior work to mitigate biases in performance with respect to patient demographics
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 20, 2024

First Posted

May 30, 2024

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share