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CompletedNCT02694159Updated Jul 22, 2022

Physician Judgment and Machine Predictions

An observational study in Sepsis, sponsored by University of Pennsylvania. Completed. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-07-22.

Sponsored by University of Pennsylvania · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
50,000
Ages
18 Years to 90 Years
Sex
All
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Study summary

The study goal is to improve the value of care and reduce health disparities by developing a targeted set of sophisticated and powerful algorithms to improve upon human clinical judgments. The plan is to use the test case of detecting sepsis in patients in the emergency department (ED) as the first step in improving the value of care and reducing health disparities by developing a targeted set of sophisticated and powerful algorithms to improve upon human clinical judgments. This work will be performed using data from the University of Pennsylvania Health System where a preliminary Early Warning and Response System for Sepsis monitors clinical parameters. The premise underlying all this work is that by improving decision-making, it will both reduce low-value care and health disparities.

Read the detailed description

This study will first ingest large volumes of clinical data on tens of thousands of patients presenting to EDs and transferred to ICUs or general hospital units, and feed these data into a statistical model for prediction of sepsis. This will allow the team to identify a pool of patients who, based on data available to doctors at the time of the ED visit, were highly likely to develop sepsis. Researchers will then analyze physician decision making compared to algorithmic decision making, to understand both the extent of under- and over- diagnosis of sepsis, and which attributes of patients and doctors lead to disparities in care. Then researchers will develop an understanding of how electronic records data could be used in real time to improve physician decision making. An early warning system could help better target interventions for sepsis, drive uptake in under-treated groups, and reduce treatment where it unnecessarily increases costs and risks to patients. In the future, the hope is that this work could lay the foundation for an intelligent decision aid leveraging ML, rather than the current checklist approach to decision support. To describe the process of algorithm development in more detail, the deliverable will be a machine prediction algorithm based on claims and clinical data to support ED physicians making decisions about sepsis. The design of the algorithm and decision aid will address where the greatest area of need is and solve a prediction problem. Researchers will identify where ED physicians are making systematic errors in their judgment thanks to biases and heuristics and tailor our decision support to adapt to the ED workflow. This algorithm and framework will explicitly serve as the project's prototype. The approach will be to first derive a baseline risk model for the development of sepsis in patients meeting specific criteria. The scope of data will include data from the claims history, outpatient electronic health record (EHR) data, and risk factor and survey data. We will then develop a ML model that incorporates additional data streams and modalities including vital signs, lab values, as well as image-based data streams such as telemetry. The fundamental analytical approach taken is to use advanced machine learning techniques. The core of these techniques is to use highly flexible functional forms applied on randomly partitioned data, so that the models are trained on one set of data and then validated - tested - on another set of data. Researchers will use a large set of variables for prediction: patient demographics, comorbidities, a set of relevant clinical variables including lab results, medications, orders, vitals, socioeconomic descriptors, and prior use of medical services derived from longitudinal sources such as through a "180-day lookback" (e.g. data from encounters in the 180 days prior to the indexed encounter). Researchers will also use an extremely large set of individual diagnosis and procedure codes and other raw parameters, rather than aggregating to comorbidities. Researchers will utilize these methods to (1) maximize the ability to predict sepsis, improve care and outcomes and (2) identify a clustering of patients by outcome likelihoods that improves upon existing risk stratification models. The modeling output will include ranking and weights of various factors that together with the grouping will identify sub-groups of patients with specific clinical characteristics in each risk stratum.

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Conditions studied

  • Sepsis
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In context

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Clinical data on tens of thousands of patients presented to ED and transferred to ICUs or general hospital units within the University of Pennsylvania Health System from 2008 to 2014.

Inclusion criteria

  • Patients presented to EDs and transferred to ICUs or general hospital units within the University of Pennsylvania Health System

Exclusion criteria

Exclusion Criteria:

  • Children and adolescents
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
50,000 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Patients developing sepsis

    The primary outcome variable is whether patients developed sepsis.

    Time frame: Two years

Secondary outcomes

  1. Under- and over-diagnosis of sepsis

    The secondary outcome will be a comparison between physician decision making and algorithm decision making on the diagnosis of sepsis. It will be measured by the diagnosis of sepsis as pulled from the medical record.

    Time frame: Two years

  2. Treatment decisions among patients in the emergency department

    Patients who are not diagnosed with sepsis will be compared to those who were diagnosed as well as patients who were not diagnosed with those who should have been diagnosed. Treatment and outcome will be measured and compared between the two samples. This information will be pulled from their medical records.

    Time frame: Two years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02694159
Lead sponsor
University of Pennsylvania
Collaborators
Harvard University
Responsible party
Amol Navathe (Principal Investigator, University of Pennsylvania) — Principal investigator
First posted
Feb 29, 2016
Start date
Feb 2016
Primary completion
Dec 30, 2021
Completion
Dec 30, 2021
Last update
Jul 22, 2022

Study contacts

Amol Navathe, MD, PhD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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