Structured Handoff Using Intelligent Framework for Transitions Trial
NCT ID: NCT07251907
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2025-12-15
2026-05-31
Brief Summary
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Detailed Description
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The study will be conducted on general medicine services at the Hospital of the University of Pennsylvania (HUP) and Penn Presbyterian Medical Center (PPMC). Eligible participants include attending hospitalists scheduled for at least five consecutive days on service. Providers will be randomized 1:1 to the intervention or control arm, stratified by site and team. The study will enroll approximately 90 hospitalists contributing about 120 eligible rotations over a 12-week period. The primary outcome is total time (in minutes) spent drafting the end-of-rotation handoff, measured using automated Carelign audit logs. Secondary outcomes include documentation burden (modified NASA Task Load Index), work exhaustion (Stanford Professional Fulfillment Index), and self-reported drafting time. Exploratory measures include tool usability (Net Promoter Score), receiving provider ratings of handoff quality, and electronic health record (EHR) usage metrics (total and after-hours "pajama time").
The trial is unblinded and will be conducted under real-world conditions to maximize generalizability. Analyses will follow an intention-to-treat approach, using linear mixed-effects models with random intercepts for provider to account for repeated rotations. All data will be stored and analyzed in secure, HIPAA-compliant institutional environments. The study has received approval from the University of Pennsylvania Institutional Review Board and Penn Medicine's AI Governance Council.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Standard of care
The control arm will continue usual care without access to the AI drafting feature. Attendings will prepare handoffs themselves using current workflows within Carelign.
No interventions assigned to this group
LLM Tool
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.
LLM tool to draft handoff
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.
Interventions
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LLM tool to draft handoff
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.
Eligibility Criteria
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Inclusion Criteria
* Scheduled for ≥5 consecutive days on service.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Pennsylvania
OTHER
Responsible Party
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Locations
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Hospital of the University of Pennsylvania and Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Haideliza Soto Calderon
Role: primary
Other Identifiers
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SHIFT Trial
Identifier Type: -
Identifier Source: org_study_id