- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02694159
Physician Judgment and Machine Predictions
20 de julho de 2022 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
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 de estudo
Observacional
Inscrição (Real)
50000
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 90 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patients developing sepsis
Prazo: Two years
|
The primary outcome variable is whether patients developed sepsis.
|
Two years
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Under- and over-diagnosis of sepsis
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Amol Navathe, MD, PhD, University of Pennsylvania
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de fevereiro de 2016
Conclusão Primária (Real)
30 de dezembro de 2021
Conclusão do estudo (Real)
30 de dezembro de 2021
Datas de inscrição no estudo
Enviado pela primeira vez
18 de fevereiro de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de fevereiro de 2016
Primeira postagem (Estimativa)
29 de fevereiro de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
22 de julho de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
20 de julho de 2022
Última verificação
1 de julho de 2022
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 823464
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .