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NCT Number: NCT07735442

BRIDGE-SIC Efficacy Trial

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Number of Days in the Hospital

    Time frame: 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 outcomes

  1. Number of Hospital Readmissions

    Time frame: 90 days after randomization

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

Study contacts

Contact information is provided by the study sponsor or research team.

Alexi A Wright, MD, MPH

CONTACT

[email protected]

6176322334

Charlotta J Lindvall, MD, PhD

CONTACT

[email protected]

6175823491

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

Better Real-time Information on Documentation of Goals of Care for Engagement in Serious Illness Communication (BRIDGE-SIC)

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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