- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02694159
Physician Judgment and Machine Predictions
20. Juli 2022 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
50000
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 90 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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.
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Patients developing sepsis
Zeitfenster: Two years
|
The primary outcome variable is whether patients developed sepsis.
|
Two years
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Under- and over-diagnosis of sepsis
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Amol Navathe, MD, PhD, University of Pennsylvania
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Februar 2016
Primärer Abschluss (Tatsächlich)
30. Dezember 2021
Studienabschluss (Tatsächlich)
30. Dezember 2021
Studienanmeldedaten
Zuerst eingereicht
18. Februar 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
23. Februar 2016
Zuerst gepostet (Schätzen)
29. Februar 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
22. Juli 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
20. Juli 2022
Zuletzt verifiziert
1. Juli 2022
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 823464
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Sepsis
-
University of California, San FranciscoNational Cancer Institute (NCI)RekrutierungSepsis | Sepsis, schwer | Sepsis und septischer Schock | Sepsis auf der Intensivstation | Sepsis, septischer Schock | Sepsis, schwere Sepsis und septischer Schock | Sepsis mit multipler Organdysfunktion (MOD) | Sepsis mit akuter OrgandysfunktionVereinigte Staaten
-
Assiut UniversityNoch keine RekrutierungSepsis-induzierte Myokarddysfunktion | Sepsis induzierte KardiomyopathieÄgypten
-
University of Kansas Medical CenterUniversity of KansasRekrutierungSepsis | Septischer Schock | Sepsis-Syndrom | Sepsis, schwer | Bakterielle Sepsis | Sepsis-BakterämieVereinigte Staaten
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Jip GroenInBiomeRekrutierungMikrobielle Besiedlung | Neonatale Infektion | Neonatale Sepsis, früher Beginn | Mikrobielle Krankheit | Klinische Sepsis | Kultur-negative neonatale Sepsis | Neonatale Sepsis, später Beginn | Kulturpositive neonatale SepsisNiederlande
-
The University of QueenslandRoyal Brisbane and Women's HospitalUnbekannt
-
Karolinska InstitutetÖrebro University, SwedenAbgeschlossenSepsis | Sepsis-Syndrom | Sepsis, schwerSchweden
-
Ohio State UniversityAbgeschlossenSepsis, schwere Sepsis und septischer SchockVereinigte Staaten
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University of LeicesterUniversity Hospitals, Leicester; The Royal College of AnaesthetistsAbgeschlossenSepsis | Septischer Schock | Schwere Sepsis | Sepsis-SyndromVereinigtes Königreich
-
Beckman Coulter, Inc.Biomedical Advanced Research and Development AuthorityAnmeldung auf EinladungSchwere Sepsis | Schwere Sepsis ohne septischen SchockVereinigte Staaten
-
Indonesia UniversityAbgeschlossenSchwere Sepsis mit septischem Schock | Schwere Sepsis ohne septischen SchockIndonesien