BRIDGE-SIC Efficacy Trial
Purpose
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.
Condition
- Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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)
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm 1: Intervention Arm |
An email is sent to patients' 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. |
|
|
No Intervention Arm 2: Control Arm |
Patients receive standard of care; SICs may be initiated by patients or clinicians as usual. |
|
Recruiting Locations
Boston, Massachusetts 02214
More Details
- Status
- Recruiting
- Sponsor
- Dana-Farber Cancer Institute
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.