BRIDGE-SIC Efficacy Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LLM-generated SIC summary email to clinical teams.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Better Real-time Information on Documentation of Goals of Care for Engagement in Serious Illness Communication (BRIDGE-SIC)
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.
Detailed description
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.
Interventions
- Behavioral LLM-generated SIC summary email to clinical teams
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.
Primary outcome measures
- Number of Days in the Hospital [Time frame: 90 days after randomization]
Secondary outcome measures (1)
- Number of Hospital Readmissions [Time frame: 90 days after randomization]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 2 centers
- Brigham and Women's Hospital — Boston
- Dana Farber Cancer Institute — Boston
Identifiers
NCT: NCT07735442 · 26-253