BRIDGE-SIC Efficacy Trial

NCT07735442 | Not Yet Recruiting

• 1 other identifier: 26-253
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

Brief Summary

This is a pragmatic, prospective, randomized clinical trial to test the effectiveness of large language model (LLM)-generated serious illness conversation (SIC) summaries delivered to patients' inpatient and outpatient clinicians at the time of hospital admission on the primary outcome of days in the hospital in the next 90 days.

Conditions

Cancer

Keywords

Cancer (Solid Tumor)

Outcome Measures

Primary Outcomes (1)

• Number of Days in the Hospital

  The number of days in the hospital is defined as the total number of inpatient days, including days from the index hospitalization and any subsequent hospital admissions during the follow-up period.

  90 days after randomization

Secondary Outcomes (1)

• Number of Hospital Readmissions

  90 days after randomization

Study Arms (2)

Arm 1: Intervention Arm

OTHER

Patients receive an email sent to their inpatient and outpatient clinical teams containing an LLM-generated summary of prior SIC documentation, prompting clinicians to review and discuss care preferences with the patient and align care with patient goals.

Behavioral: LLM-generated SIC summary email to clinical teams

Arm 2: Control Arm

NO INTERVENTION

Patients receive standard of care; SICs may be initiated by patients or clinicians as usual.

Interventions

LLM-generated SIC summary email to clinical teams BEHAVIORAL

An email containing a summary of prior serious illness conversations, generated by a large language model, is sent to the patient's clinical teams at admission, prompting review and discussion of care preferences.

Arm 1: Intervention Arm

Eligibility Criteria

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

You may qualify if:

• DFCI Patients, defined as patients who have a DFCI medical record number.
• Admitted 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 ≥ 25%
• Admitted on a Sunday after 4pm through Friday at 4pm. These time restrictions are necessary for the workflow of this pragmatic pilot trial, as the intervention requires a staff member to send intervention emails during the work week but within \<= approximately 18 hours of admission. Accordingly, we will not enroll patients during holiday time periods (e.g., for a Monday holiday, enrollment would start on Monday at 4pm instead of Sunday at 4pm) or on days where staff absences (e.g., illness) preclude enrollment.

You may not qualify if:

• Patients with elective inpatient admissions (typically for planned administration of chemotherapy or other treatments)

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02214, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Alexi Wright, MD,MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexi A Wright, MD, MPH

CONTACT

6176322334; alexi_wright@dfci.harvard.edu

Charlotta J Lindvall, MD, PhD

CONTACT

6175823491; charlotta_lindvall@dfci.harvard.edu

Study Design

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

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 30, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 30, 2026

Record last verified: 2026-07

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

Locations

US (2)