Structured Handoff Using Intelligent Framework for Transitions Trial

NCT07251907 | Recruiting

• 1 other identifier: SHIFT Trial
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Inpatient general medicine attendings will be randomized to have an LLM feature turned on to provide a draft of an off-service handoff within Carelign (an EHR-adjacent provider communication tool). Providers who have access to this feature will be clearly instructed that if they use the LLM-generated draft, they must review and edit it as necessary before finalizing. The study will assess measures of documentation burden (as it relates to writing handoff) - including time spent writing handoff - and work exhaustion in both intervention and control groups.

Conditions

Artificial Intelligence (AI); Large Language Model; Electronic Medical Record; Transitions of Care; Physician Workflow

Outcome Measures

Primary Outcomes (1)

• Time spent drafting end-of-rotation handoff

  Time (minutes) spent drafting the entire end-of-rotation handoff, calculated from Carelign audit logs as the duration between first and last edit per patient (capped at 30 minutes per patient), summed per rotation.

  Over the last 3 days of a given rotation

Secondary Outcomes (3)

• Documentation burden

  Beginning (baseline) and end of study (3 months)

• Work exhaustion

  Beginning (baseline) and end of the study (3 months)

• Total time spent drafting handoff

  Last day of rotation (varies by schedule, typically day 5, 7, or 14 on service)

Other Outcomes (2)

• Incoming provider ratings of handoff quality

  Within 3 days of rotation start

• Overall time spent on EHR

  Last day of rotation (varies by schedule, typically day 5, 7, or 14 on service)

Study Arms (2)

Standard of care

NO INTERVENTION

The control arm will continue usual care without access to the AI drafting feature. Attendings will prepare handoffs themselves using current workflows within Carelign.

LLM Tool

EXPERIMENTAL

The intervention arm will have access to an LLM-assisted draft generation feature within Carelign. This will generate a draft of the handoff, which the provider will then edit as necessary before finalizing.

Other: LLM tool to draft handoff

Interventions

LLM tool to draft handoff OTHER

The intervention arm will have access to an LLM-assisted draft generation feature within Carelign. The feature will be accessed via a 'Draft Handoff' button in the attending handoff tab. The LLM is hosted in Penn's HIPAA-compliant environment and prompt engineering was performed through a series of handoff-specific iterative prompts with continuous quality assessments by the study team. In addition to the structured prompt, it will receive the most recent progress note from the primary team (or admission note, when no progress note is available), and the most recent specialty consult notes (within 72 hours of date of service). Generated drafts are editable; clinicians must review and finalize all content prior to sharing with their colleagues.

LLM Tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General medicine attending physicians at HUP (Medicine, Solid Oncology) or PPMC (Medicine) services.
• Scheduled for ≥5 consecutive days on service.

You may not qualify if:

• \- Jeopardy attendings and moonlighters

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania and Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Central Study Contacts

Eric Bressman, MD

CONTACT

(215) 662-4000; eric.bressman@pennmedicine.upenn.edu

Haideliza Soto Calderon

CONTACT

2152209425; haideliza.soto-calderon@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 26, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)