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OpenTrials
Completed

NCT Number: NCT05122247

Machine Learning to Predict Acute Care During Cancer Therapy

The objective of this study is to apply a validated machine-learning based model (SHIELD-RT, NCT04277650) to a cohort of patients undergoing systemic therapy as outpatient cancer treatment to generate an automatic system for the prediction of unplanned hospital admission rates and emergency department encounters.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Health System

Durham, North Carolina, 27710, United States

About this study

A previously described machine learning (ML)-based model accurately predicted ED visits or hospitalizations for cancer patients undergoing radiation therapy or chemoradiation. An IRB approved prospective randomized trial, SHIELD-RT (NCT04277650) found that preemptive intervention for patients undergoing radiation and chemoradiation based on the ML model's risk stratification decreased the relative risk of acute care visits by 50%, showing that ML-guided escalation of care improved personalized supportive care and treatment compliance while decreasing healthcare costs.

The objective of this study is to apply this validated ML based model to a cohort of patients undergoing systemic therapy as outpatient cancer treatment to generate an automatic system for the prediction of unplanned hospital admission rates and emergency department encounters. Once validated, this study will add to the previously published body of evidence supporting a randomized trial evaluating the ML algorithm's ability to assign intervention for patients receiving systemic therapy at highest risk for acute care encounters.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • had treatment encounter in the Duke Medical Oncology department from January 7th, 2019 to June 30th, 2019
  • DUHS medical record available

Exclusion criteria

-

Treatment and study plan

Machine learning algorithm

Other

machine learning directed identification of chemotherapy patients at high-risk for emergency department acute care and/or hospitalization

Primary outcomes

  1. number of unplanned of hospital admission or emergency department visits during systemic therapy

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • University of California, San Francisco

Registry information

Official study title

Generalizable Machine Learning to Predict Acute Care During Outpatient Systemic Cancer

Acronym: Chemo-SHIELD

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 16, 2021
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.