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Completed

NCT Number: NCT06182332

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Electronic Health Record Review

Other

Undergo medical record review

Internet-Based Intervention

Other

Use AI algorithm

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 26, 2023
Registry last updated
Apr 4, 2025

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.

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