- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02694159
Physician Judgment and Machine Predictions
20 juillet 2022 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Réel)
50000
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 90 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patients developing sepsis
Délai: Two years
|
The primary outcome variable is whether patients developed sepsis.
|
Two years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Under- and over-diagnosis of sepsis
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Amol Navathe, MD, PhD, University of Pennsylvania
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 février 2016
Achèvement primaire (Réel)
30 décembre 2021
Achèvement de l'étude (Réel)
30 décembre 2021
Dates d'inscription aux études
Première soumission
18 février 2016
Première soumission répondant aux critères de contrôle qualité
23 février 2016
Première publication (Estimation)
29 février 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 juillet 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 juillet 2022
Dernière vérification
1 juillet 2022
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 823464
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .