- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02694159
Physician Judgment and Machine Predictions
20 luglio 2022 aggiornato da: Amol Navathe, University of Pennsylvania
Physician Judgment and Machine Predictions: Improving Medical Decisions Using Machine Learning
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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
50000
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 90 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
Inclusion Criteria:
- Patients presented to EDs and transferred to ICUs or general hospital units within the University of Pennsylvania Health System
Exclusion Criteria:
- Children and adolescents
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Patients developing sepsis
Lasso di tempo: Two years
|
The primary outcome variable is whether patients developed sepsis.
|
Two years
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Under- and over-diagnosis of sepsis
Lasso di tempo: Two years
|
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.
|
Two years
|
|
Treatment decisions among patients in the emergency department
Lasso di tempo: Two years
|
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.
|
Two years
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Amol Navathe, MD, PhD, University of Pennsylvania
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 febbraio 2016
Completamento primario (Effettivo)
30 dicembre 2021
Completamento dello studio (Effettivo)
30 dicembre 2021
Date di iscrizione allo studio
Primo inviato
18 febbraio 2016
Primo inviato che soddisfa i criteri di controllo qualità
23 febbraio 2016
Primo Inserito (Stima)
29 febbraio 2016
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
22 luglio 2022
Ultimo aggiornamento inviato che soddisfa i criteri QC
20 luglio 2022
Ultimo verificato
1 luglio 2022
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 823464
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .