An Artificial Intelligence Algorithm for Identifying Gynecologic Cancer Patients in Need of Outpatient Palliative Care

April 1, 2025 updated by: Mayo Clinic

Piloting an Artificial Intelligence Algorithm Used to Identify Patients in Need of Outpatient (or Ambulatory) Palliative Care in an Oncology Population

This clinical trial tests an artificial intelligence (AI) algorithm for its ability to identify patients who may benefit from a palliative care consult for gynecologic cancer that has spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). A significant delay in referral to palliative care often occurs among patients with cancer. This delay can lead to poorer symptom management, decreased quality of life, and care that does not align with patient goals or values. AI algorithms are computer programs that use step-by-step procedures to solve a problem. In this trial, an AI algorithm is applied to patients' medical records in order to identify patients with a high burden of disease. Information gathered from this study may help researchers learn whether this AI algorithm is useful for identifying patients who could benefit from outpatient palliative care consultation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To pilot an oncology risk prediction model to identify patients who may benefit from outpatient palliative care consultation to improve symptom management and goal-concordant care in this population.

OUTLINE:

Patients' medical records are reviewed for consideration of palliative care consult using AI algorithm once a week (QW) for 6 months.

Study Type

Interventional

Enrollment (Actual)

221

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patient in Enhanced, Electronic health record (EHR)-facilitated Cancer Symptom Control (E2C2) with a diagnosis of advanced gynecologic malignancy (International Classification of Diseases [ICD] codes C51 through C58)
  • Weekly the reviewers will select patients by looking at patients in sorted order starting with the highest score and proceeding down the list and evaluating each patient for exclusion criteria

Exclusion Criteria:

  • Patients that have been seen by palliative care will be excluded for 75 days
  • Patients under the age of 18 years
  • Patients currently enrolled with hospice

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Screening (AI algorithm)
Patients' medical records are reviewed for consideration of palliative care consult using AI algorithm QW for 6 months.
Other: Electronic Health Record Review
Undergo medical record review
Other: Internet-Based Intervention
Use AI algorithm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timely identification for need of palliative care
Time Frame: Up to 6 months
Will be measured as time to the electronic record of consult by the palliative care team in the outpatient setting.
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of palliative care consultations
Time Frame: Up to 6 months
Number of palliative care consultations will be assessed as the number of participants who receive palliative care consultations.
Up to 6 months
Number of advanced care planning notes documented in the electronic health record
Time Frame: Up to 6 months
Participant electronic health records will be reviewed for the number of advanced care planning notes listed.
Up to 6 months
Number of billing codes International Classification of Diseases, 10th Revision for palliative care
Time Frame: Up to 6 months
Participant electronic health records will be reviewed for the number of International Classification of Diseases, 10th Revision (ICD-10) billing codes for palliative care.
Up to 6 months
Positive predictive value of screened patients
Time Frame: Up to 6 months
Will be assessed as the number of patients identified by Artificial Intelligence algorithm who actually received palliative care consultation.
Up to 6 months
Performance metrics on reviewer/oncologist handoff
Time Frame: Up to 6 months
Will be assessed by agreement statistics and descriptive statistics on time between oncology contact and oncology response.
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Rachel D. Havyer, MD, Mayo Clinic in Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2023

Primary Completion (Actual)

June 26, 2024

Study Completion (Actual)

July 26, 2024

Study Registration Dates

First Submitted

December 8, 2023

First Submitted That Met QC Criteria

December 13, 2023

First Posted (Actual)

December 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-008371 (Other Identifier: Mayo Clinic in Rochester)
  • NCI-2023-09943 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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