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

NCT06182332 | Completed

• 2 other identifiers: 23-008371NCI-2023-09943
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Malignant Female Reproductive System Neoplasm

Outcome Measures

Primary Outcomes (1)

• Timely identification for need of palliative care

  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 Outcomes (5)

• Number of palliative care consultations

  Up to 6 months

• Number of advanced care planning notes documented in the electronic health record

  Up to 6 months

• Number of billing codes International Classification of Diseases, 10th Revision for palliative care

  Up to 6 months

• Positive predictive value of screened patients

  Up to 6 months

• Performance metrics on reviewer/oncologist handoff

  Up to 6 months

Study Arms (1)

Screening (AI algorithm)

EXPERIMENTAL

Patients' medical records are reviewed for consideration of palliative care consult using AI algorithm QW for 6 months.

Other: Electronic Health Record Review; Other: Internet-Based Intervention

Interventions

Electronic Health Record Review OTHER

Undergo medical record review

Screening (AI algorithm)

Internet-Based Intervention OTHER

Use AI algorithm

Screening (AI algorithm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Rachel D. Havyer, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 26, 2023
• Study Start: December 11, 2023
• Primary Completion: June 26, 2024
• Study Completion: July 26, 2024
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

US (1)