Structured Handoff Using Intelligent Framework for Transitions (SHIFT) Trial: A Randomized Controlled Trial of AI-Assisted End-of-Rotation Handoff Between Hospitalists
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Time spent drafting end-of-rotation handoff
研究概览
简要总结
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.
详细描述
The Structured Handoff Using Intelligent Framework for Transitions (SHIFT) Trial is a pragmatic, parallel-group randomized controlled trial designed to evaluate whether an artificial intelligence (AI) tool integrated into the Carelign handoff platform can reduce documentation time and burden among inpatient hospitalists. The AI feature uses a large language model (LLM) tuned for clinical summarization to generate an editable draft of the end-of-rotation handoff. Hospitalists randomized to the intervention arm will have access to a "Draft Handoff" button within Carelign, which automatically generates a structured, editable handoff draft using data from recent notes in the electronic health record. Clinicians are required to review and edit all draft content before finalizing and sharing the handoff with colleagues. Providers in the control arm will continue using standard handoff workflows within Carelign without AI assistance.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General medicine attending physicians at HUP (Medicine, Solid Oncology) or PPMC (Medicine) services.
- •Scheduled for ≥5 consecutive days on service.
排除标准
- •- Jeopardy attendings and moonlighters
研究组 & 干预措施
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.
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.
干预措施: LLM tool to draft handoff (Other)
结局指标
主要结局
Time spent drafting end-of-rotation handoff
时间窗: Over the last 3 days of a given rotation
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.
次要结局
- 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))