Prediction of Patient Deterioration Using Machine Learning

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05045742
Collaborator
Biofourmis Inc. (Industry)
500
2
8.4
250
29.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Traditional vital sign alarms versus the BioVitals Index vs the National Early Warning Score 2

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Prediction of Patient Deterioration Using Machine Learning
Actual Study Start Date :
Mar 20, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Training

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

Other: 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

Validation

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

Other: 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

Outcome Measures

Primary Outcome Measures

  1. Alarm burden [From admission to discharge, measured in hours, on average 5 days]

    The number of alarms fired per patient per hour

Secondary Outcome Measures

  1. Sensitivity for recognition of a safety composite [From admission to discharge, on average 5 days]

    The sensitivity (true positives divided by condition positives) for detection of a safety composite (overnight visit, extra unplanned visit, transfer back to the hospital, death during admission, delirium, loss of consciousness, or other major event).

  2. Specificity for recognition of a safety composite [From admission to discharge, on average 5 days]

    The specificity (true negatives divided by condition negatives) for detection of a safety composite (overnight visit, extra unplanned visit, transfer back to the hospital, death during admission, delirium, loss of consciousness, or other major event).

  3. Positive predictive value for recognition of a safety composite [From admission to discharge, on average 5 days]

    The positive predictive value (true positives divided by the sum of true positives plus false positives) for detection of a safety composite (overnight visit, extra unplanned visit, transfer back to the hospital, death during admission, delirium, loss of consciousness, or other major event).

  4. Negative predictive value for recognition of a safety composite [From admission to discharge, on average 5 days]

    The negative predictive value (true negatives divided by the sum of true negatives plus false negatives) for detection of a safety composite (overnight visit, extra unplanned visit, transfer back to the hospital, death during admission, delirium, loss of consciousness, or other major event).

  5. Rate of alarms with clinical utility [From admission to discharge, on average 5 days]

    We will use general estimating equations (GEE) with three outcomes per patient (the number of clinically important alarms for BioVitals, NEWS2, and traditional vital signs); the GEE will account for the clustering between the three outcomes on a patient. The GEE will use a negative binomial marginal model with a log-link for the number of alarms with clinical utility and an offset for log length-of stay (in hours); with this model, we model the rate per hour of number of alarms with clinical utility with BI, NEWS2, and traditional vital signs. The main covariate in the negative binomial model will be a three-level covariate for method: BI vs NEWS2 vs traditional vital signs, and the exponential of the effect of this covariate will be a pair-wise rate ratio for BI vs NEWS2 vs traditional vital signs.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

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

Exclusion Criteria:

Incomplete continuous monitoring data

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brigham and Women's Hospital Boston Massachusetts United States 02115
2 Brigham and Women's Faulkner Hospital Boston Massachusetts United States 02130

Sponsors and Collaborators

  • Brigham and Women's Hospital
  • Biofourmis Inc.

Investigators

  • Principal Investigator: David Levine, MD MPH MA, Associate Physician

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David Levine, Attending Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT05045742
Other Study ID Numbers:
  • 2017P002583d
First Posted:
Sep 16, 2021
Last Update Posted:
Sep 16, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 16, 2021