Chemo-SHIELD: Machine Learning to Predict Acute Care During Cancer Therapy

Sponsor
Duke University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05122247
Collaborator
University of California, San Francisco (Other)
12,000
1
11.9
1006.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Machine learning algorithm

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
12000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Generalizable Machine Learning to Predict Acute Care During Outpatient Systemic Cancer
Actual Study Start Date :
Jan 3, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Outcome Measures

Primary Outcome Measures

  1. number of unplanned of hospital admission or emergency department visits during systemic therapy [12 months]

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Health System Durham North Carolina United States 27710

Sponsors and Collaborators

  • Duke University
  • University of California, San Francisco

Investigators

  • Principal Investigator: Manisha Palta, MD, Duke Health

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT05122247
Other Study ID Numbers:
  • Pro00109633
First Posted:
Nov 16, 2021
Last Update Posted:
Apr 11, 2022
Last Verified:
Apr 1, 2022
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
Keywords provided by Duke University

Study Results

No Results Posted as of Apr 11, 2022