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

Not Applicable

Completed

• Conditions: Advanced Malignant Female Reproductive System Neoplasm
• Interventions: Other: Electronic Health Record Review; Other: Internet-Based Intervention

• Registration Number: NCT06182332
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-12-08
• Study Start: 2023-12-11
• Study First Submitted QC: 2023-12-13
• Study First Posted: 2023-12-26
• Primary Completion: 2024-06-26
• Study Completion: 2024-07-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening (AI algorithm)	Internet-Based Intervention	Patients' medical records are reviewed for consideration of palliative care consult using AI algorithm QW for 6 months.
Screening (AI algorithm)	Electronic Health Record Review	Patients' medical records are reviewed for consideration of palliative care consult using AI algorithm QW for 6 months.

Primary Outcome Measures

Name	Time	Method
Timely identification for need of palliative care	Up to 6 months	Will be measured as time to the electronic record of consult by the palliative care team in the outpatient setting.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States