Electronic Medical RecordSHIFTNCT07251907
Structured Handoff Using Intelligent Framework for Transitions Trial
A study testing LLM tool to draft handoff in people with Electronic Medical Record and Transitions of Care, run by University of Pennsylvania at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Electronic Medical Record, Transitions of Care, Physician Workflow
- What is being tested?
- LLM tool to draft handoff
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to 11 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General medicine attending physicians at HUP (Medicine, Solid Oncology) or PPMC (Medicine) services.
- Scheduled for ≥5 consecutive days on service.
Who cannot join
- Jeopardy attendings and moonlighters
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania and Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Structured Handoff Using Intelligent Framework for Transitions (SHIFT) Trial: A Randomized Controlled Trial of AI-Assisted End-of-Rotation Handoff Between Hospitalists
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.
Read the detailed description
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.
- Conditions
- Electronic Medical Record, Transitions of Care, Physician Workflow, Artificial Intelligence (AI), Large Language Model
- Being tested
- LLM tool to draft handoff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLM tool to draft handoffOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: LLM tool to draft handoff |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Over the last 3 days of a given rotation
Secondary outcomes (3)
Documentation burden
Measured via the modified NASA-Task Load Index
Measured: Beginning (baseline) and end of study (3 months)
Work exhaustion
Measured via the Stanford professional fulfillment index
Measured: Beginning (baseline) and end of the study (3 months)
Total time spent drafting handoff
Measured via first and last edits (overall) in Carelign on last day of rotation
Measured: Last day of rotation (varies by schedule, typically day 5, 7, or 14 on service)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start15 Dec 2025
- Primary completion26 Apr 2026
- Study completion11 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electronic Medical RecordStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251907
- Sponsor's protocol ID
- SHIFT Trial
- Acronym
- SHIFT
- Status last verified
- Jun 2026
- First submitted
- 17 Nov 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured Handoff Using Intelligent Framework for Transitions (SHIFT) Trial: A Randomized Controlled Trial of AI-Assisted End-of-Rotation Handoff Between Hospitalists
- ClinicalTrials.gov ID
- NCT07251907
- Acronym / sponsor ID
- SHIFT / SHIFT Trial
- Conditions
- Electronic Medical Record, Transitions of Care, Physician Workflow, Artificial Intelligence (AI), Large Language Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 26 Apr 2026 (actual)
- Study completion
- 11 May 2026 (actual)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: LLM tool to draft handoffThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- General medicine attending physicians at HUP (Medicine, Solid Oncology) or PPMC (Medicine) services.
- Scheduled for ≥5 consecutive days on service.
Key exclusion criteria (1 listed)
- Jeopardy attendings and moonlighters
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LLM tool to draft handoffThe 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. | Other | LLM Tool |
Primary outcome
Time spent drafting end-of-rotation handoff
Time frame: 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.
3 secondary outcomes
Documentation burden
Time frame: Beginning (baseline) and end of study (3 months)
Work exhaustion
Time frame: Beginning (baseline) and end of the study (3 months)
Total time spent drafting handoff
Time frame: Last day of rotation (varies by schedule, typically day 5, 7, or 14 on service)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LLM tool to draft handoff in people with Electronic Medical Record and Transitions of Care, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time spent drafting end-of-rotation handoff (time frame: Over the last 3 days of a given rotation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.