Better Real-time Information on Documentation of Goals of Care for Engagement in Serious Illness Communication (BRIDGE-SIC)

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: Advanced Cancer; Cancer; End of Life

Treatments: Other: LLM SIC Summary Email

Study type: Interventional

Funder types: Other

Identifiers

NCT07147023

25-314

Details and patient eligibility

About

The goal of this study is to test the accuracy of Large Language Model-generated serious illness communication (SIC) summaries, the feasibility of delivering the SIC summaries, and to collect perspectives on the SIC summaries from clinicians and participants with cancer. Large Language Models (LLMs) are artificial intelligence programs that can perform various natural language processing tasks.

Full description

The study will enroll up to 70 Dana-Farber patients admitted to Brigham and Women's hospital who have an elevated mortality prediction at admission. The research study procedures include randomization to intervention or control arms on admission (3:1 intervention to control). For patients in the intervention arm, a large language model query will summarize serious illness communication documentation in their medical record screening from the prior 6 months. A summary of the documentation will be sent to the inpatient and outpatient oncology clinicians within 24 hours of admission; these clinicians will be asked to review the summaries, discuss with the patient and incorporate into care plans as appropriate. For patients with no SIC documented on day 4 of the admission, a second email will be sent. Control patients will receive usual care, which is no email sent to their oncology teams. All patients will be offered to participate in an interview on day 4 of their admission about their communication with their care teams. For patients in both arms, inpatient and outpatient oncology attendings will be sent an email survey regarding SIC for the patient and, if applicable, the utility of the SIC summaries.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Participant Inclusion Criteria:

• Dana-Farber Cancer Institute participants
• Admission to an inpatient solid tumor medical oncology service at BWH (including beds that are considered to be DFCI beds within BWH)
• Age ≥ 18 years
• Mortality prediction ≥ 40%
• Admitted on a Sunday after 4pm, Monday or Tuesday before 4pm. These time restrictions are necessary for the workflow of this pragmatic pilot trial, as an individual will need to send out the intervention emails and interview patients approximately 48-72 hours after admission, both of which need to occur during the work week.

Participant Exclusion Criteria:

-Patients with elective inpatient admissions (typically for chemotherapy or other treatments)

Clinician Inclusion Criteria:

-The clinician fills one of the following roles for the enrolled patient:

• inpatient attending on the medical oncology team
• outpatient Dana-Farber medical oncologist

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group A: LLM-Generated SIC Summary Email

Experimental group

Description:

45 participants will be randomized. Participants will have the option of completing a one-time in-person interview with study staff on their perceptions of SIC and the acceptability of LLM-generated summaries of SIC.

Treatment:

Other: LLM SIC Summary Email

Group B: Usual Care

No Intervention group

Description:

15 participants will be randomized and will receive standard oncology care. Participants will have the option of completing a one-time in-person interview with study staff on their perceptions of SIC and the acceptability of LLM-generated summaries of SIC.