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

NCT07147023 | Active Not Recruiting

• 1 other identifier: 25-314
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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

Advanced Cancer; Cancer; End of Life

Keywords

Advanced Cancer; Cancer; Serious Illness; End of Life Care

Outcome Measures

Primary Outcomes (1)

• Serious Illness Conversation (SIC) summary accuracy

  Primary outcome: We will assess SIC summary accuracy by reviewing the source documentation for each bullet point of the 5 domains of the SIC summary. The RA will read each bullet point, read the source note for the date cited in the summary and indicate with a 1 (supported) or 0 (not supported) whether the documentation supports the summarized point. If a summarized point is scored as 0, the MPIs will independently review the item and assign a 1 or 0 to indicate whether the unsupported summary could negatively impact patient care. SIC summary accuracy will be determined at the patient level as the proportion of bullet points supported by underlying documentation divided by the total number of bullet points (i.e., a score from 0 to 1). We will determine the average SIC accuracy score across all patients for the study. We will also report the percent of LLM-SIC summary statements that are unsupported and clinically significant and provide qualitative descriptions of these instances.

  1 week

Secondary Outcomes (4)

• Feasibility (successful delivery of the intervention)

  1 week

• Clinician Perspectives of Clinical Utility

  1 week

• Participant Perspectives on Inpatient and Outpatient Clinician Understanding of their Care Preferences and Acceptability of SIC Summaries

  1 week

• New Documentation of SIC

  1 week

Other Outcomes (6)

• Length of hospitalization

  1 week

• Days in the hospital

  90 days

• Number of hospitalizations

  90 days

Study Arms (2)

Group A: LLM-Generated SIC Summary Email

EXPERIMENTAL

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

Group B: Usual Care

NO INTERVENTION

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.

Interventions

LLM SIC Summary Email OTHER

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.

Group A: LLM-Generated SIC Summary Email

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Patients with elective inpatient admissions (typically for chemotherapy or other treatments)
• The clinician fills one of the following roles for the enrolled patient:
• inpatient attending on the medical oncology team
• outpatient Dana-Farber medical oncologist

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Neoplasms; Death

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher Manz, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 28, 2025
• Study Start: September 15, 2025
• Primary Completion: April 15, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (2)