Prediction of Patient Deterioration Using Machine Learning

NCT ID: NCT05045742

Last Updated: 2021-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-20

Study Completion Date

2021-12-01

Brief Summary

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This is a retrospective observational study drawing on data from the Brigham and Women's Home Hospital database. Sociodemographic and clinic data from a training cohort were used to train a machine learning algorithm to predict patient deterioration throughout a patient's admission. This algorithm was then validated in a validation cohort.

Detailed Description

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Conditions

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Infection Heart Failure Chronic Obstructive Pulmonary Disease Asthma Gout Flare Chronic Kidney Diseases Hypertensive Urgency Atrial Fibrillation Rapid Anticoagulants; Increased

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Training

A subset of patients that are used to train the machine learning algorithm.

Traditional vital sign alarms versus the BioVitals Index vs the National Early Warning Score 2

Intervention Type OTHER

We will retrospectively compare the alarms produced from traditional vital sign alarms (thresholds set by clinicians) versus the BioVitals Index vs the National Early Warning Score 2

Validation

A subset of patients that are "held back" and used to validate the algorithm's accuracy.

Traditional vital sign alarms versus the BioVitals Index vs the National Early Warning Score 2

Intervention Type OTHER

We will retrospectively compare the alarms produced from traditional vital sign alarms (thresholds set by clinicians) versus the BioVitals Index vs the National Early Warning Score 2

Interventions

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Traditional vital sign alarms versus the BioVitals Index vs the National Early Warning Score 2

We will retrospectively compare the alarms produced from traditional vital sign alarms (thresholds set by clinicians) versus the BioVitals Index vs the National Early Warning Score 2

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Cared for in the Brigham and Women's Home Hospital study

Exclusion Criteria

Incomplete continuous monitoring data
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biofourmis Inc.

INDUSTRY

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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David Levine

Attending Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Levine, MD MPH MA

Role: PRINCIPAL_INVESTIGATOR

Associate Physician

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Brigham and Women's Faulkner Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2017P002583d

Identifier Type: -

Identifier Source: org_study_id

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