- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02694159
Physician Judgment and Machine Predictions
20. juli 2022 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
50000
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Patients developing sepsis
Tidsramme: Two years
|
The primary outcome variable is whether patients developed sepsis.
|
Two years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Under- and over-diagnosis of sepsis
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Amol Navathe, MD, PhD, University of Pennsylvania
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2016
Primær færdiggørelse (Faktiske)
30. december 2021
Studieafslutning (Faktiske)
30. december 2021
Datoer for studieregistrering
Først indsendt
18. februar 2016
Først indsendt, der opfyldte QC-kriterier
23. februar 2016
Først opslået (Skøn)
29. februar 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. juli 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. juli 2022
Sidst verificeret
1. juli 2022
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 823464
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Sepsis
-
University of California, San FranciscoNational Cancer Institute (NCI)RekrutteringSepsis | Sepsis, svær | Sepsis og septisk chok | Sepsis på intensiv afdeling | Sepsis, septisk chok | Sepsis, Svær Sepsis og Septisk Shock | Sepsis med multipel organdysfunktion (MOD) | Sepsis med akut organdysfunktionForenede Stater
-
Assiut UniversityIkke rekrutterer endnuSepsis-induceret myokardiedysfunktion | Sepsis induceret kardiomyopatiEgypten
-
University of Kansas Medical CenterUniversity of KansasRekrutteringSepsis | Septisk chok | Sepsis syndrom | Sepsis, svær | Sepsis bakteriel | Sepsis BakteriæmiForenede Stater
-
Jip GroenInBiomeRekrutteringMikrobiel kolonisering | Neonatal infektion | Neonatal sepsis, tidligt opstået | Mikrobiel sygdom | Klinisk sepsis | Kultur Negativ Neonatal Sepsis | Neonatal sepsis, sent opstået | Kultur Positiv Neonatal SepsisHolland
-
The University of QueenslandRoyal Brisbane and Women's HospitalUkendt
-
Karolinska InstitutetÖrebro University, SwedenAfsluttetSepsis | Sepsis syndrom | Sepsis, sværSverige
-
Ohio State UniversityAfsluttetSepsis, Svær Sepsis og Septisk ShockForenede Stater
-
University of LeicesterUniversity Hospitals, Leicester; The Royal College of AnaesthetistsAfsluttetSepsis | Septisk chok | Alvorlig sepsis | Sepsis syndromDet Forenede Kongerige
-
Indonesia UniversityAfsluttetAlvorlig sepsis med septisk stød | Alvorlig sepsis uden septisk stødIndonesien
-
Beckman Coulter, Inc.Biomedical Advanced Research and Development AuthorityTilmelding efter invitationAlvorlig sepsis | Alvorlig sepsis uden septisk stødForenede Stater