Cancer
Conditions
Keywords
Cancer (Solid Tumor)
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.
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
BEHAVIORALLLM-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.
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days in the Hospital | 90 days after randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hospital Readmissions | 90 days after randomization | The number of hospital readmissions is defined as the total number of inpatient hospital readmissions, excluding the index hospitalization. |
Countries
United States
Contacts
CONTACTAlexi A Wright, MD, MPH
CONTACTCharlotta J Lindvall, MD, PhD
PRINCIPAL_INVESTIGATORAlexi Wright, MD,MPH
Dana-Farber Cancer Institute
Outcome results
None listed