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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group A: LLM-Generated SIC Summary Email 		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.
  • Other: LLM SIC Summary Email
    A Large Language Model-based platform is integrated with the Health Vision Platform, a HIPAA-compliant, electronic health record data management system. Real-time summaries of prior SIC with be sent to clinicians caring for participants in the intervention arm. An email will be sent to the inpatient attending and responding clinician encouraging the team to review the SIC summary, discuss care preferences with the patient and ensure care is aligned with preferences and goals. If no SIC documentation is found, the email will instead encourage the outpatient oncologist to share information regarding undocumented SICs that may have occurred, as well as prompt inpatient and outpatient teams to engage the patient in SIC. For patients with no SIC documentation who are still admitted 72 hours later, the RA will send an additional email prompting SIC or asking the clinician to indicate that an SIC is not appropriate. Patients will also receive standard of care.
No Intervention
Group B: Usual Care 		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.

Recruiting Locations

Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02115
Contact:
Christopher Manz, MD, MSHP
617-632-3315
Christopher_manz@dfci.harvard.edu

More Details

Status
Recruiting
Sponsor
Dana-Farber Cancer Institute

Study Contact

Christopher Manz, MD
617-632-3315
Christopher_Manz@dfci.harvard.edu

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.