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Physician Judgment and Machine Predictions

2022년 7월 20일 업데이트: 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.

연구 개요

상태

완전한

정황

상세 설명

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.

연구 유형

관찰

등록 (실제)

50000

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Patients developing sepsis
기간: Two years
The primary outcome variable is whether patients developed sepsis.
Two years

2차 결과 측정

결과 측정
측정값 설명
기간
Under- and over-diagnosis of sepsis
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

협력자

수사관

  • 수석 연구원: Amol Navathe, MD, PhD, University of Pennsylvania

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2016년 2월 1일

기본 완료 (실제)

2021년 12월 30일

연구 완료 (실제)

2021년 12월 30일

연구 등록 날짜

최초 제출

2016년 2월 18일

QC 기준을 충족하는 최초 제출

2016년 2월 23일

처음 게시됨 (추정)

2016년 2월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 7월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 7월 20일

마지막으로 확인됨

2022년 7월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 823464

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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