BRIDGE-SIC Efficacy Trial

Dana-Farber Cancer Institute600 enrolled

Overview

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.

The study will automatically enroll up to 600 DFCI patients with solid tumor cancers admitted to BWH inpatient medical oncology services with a predicted 90-day mortality risk of ≥ 25%. Patients will be randomized 1:1 to intervention vs control arms. The intervention arm will receive LLM-generated SIC summaries sent to their clinical teams, prompting incorporation of patient preferences into care plans. The control arm will receive standard of care. Outcomes will be followed for 90 days post-admission. The study uses a waiver of informed consent and HIPAA authorization due to minimal risk and the need for real-time identification and intervention delivery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

600

Conditions

Cancer

Interventions

LLM-generated SIC summary email to clinical teamsBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: • Patients with elective inpatient admissions (typically for planned administration of chemotherapy or other treatments)

Locations (2)

Brigham and Women's Hospital

Boston, Massachusetts, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 90 days after randomization

Secondary Outcomes

Number of Hospital Readmissions

The number of hospital readmissions is defined as the total number of inpatient hospital readmissions, excluding the index hospitalization.

Time frame: 90 days after randomization

Central 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

Data from ClinicalTrials.gov

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