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Understanding Scalability of Critical Care Handoffs

This study is looking at how to improve the process of "handoffs" (when patient information and care responsibilities are transferred) for surgical patients moving from the operating room to the intensive care unit. Researchers are testing a "customized handoff" which uses a structured tool to help healthcare teams share information more effectively. The goal is to see if this standardized approach can reduce new organ failure in patients. The study aims to enroll 4000 participants, including both patients and clinicians. Clinicians must be at least 18 years old, care for surgical patients, and be fluent in English. Patients admitted for inpatient care at the study hospitals are eligible. The study is currently unclear about its recruitment status.

Study design
This interventional study plans to enroll 4000 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Patient outcomes, such as new-onset organ failure, will be measured monthly from Year 1, Quarter 2 until the end of Year 5.

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NCT04571749

Handoffs and Transitions in Critical Care - Understanding Scalability

Enrolling by Invitation
NAAges 18+InterventionalHealth services
University of Pennsylvania
~4,000 participants
Updated 2025-08-08 on ClinicalTrials.gov
What's tested:Customized handoff

At a glance

Recruiting sites
0 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adherence to standardized handoff intervention (Fidelity) measured by number of handoff steps followed.
Measured over This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5.
+1 more outcome measured

Conditions

Patient Handoff
Healthcare Team
Communication
Patient Safety
Intensive Care Units

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Patient Handoff

Where it's being run

5 sites across 4 states
Pennsylvania2
Maryland1
New Jersey1
Texas1

Study leadership

  • Meghan B Lane-Fall, MD, MSHP · PRINCIPAL_INVESTIGATOR · University of Pennsylvania

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥ 18 years
Cares for patients at any point in the surgical continuum of care, including pre-operative, intra-operative, or post-operative care, OR has administrative responsibilities relevant to patient care at the study hospitals
Fluency in English

What this trial measures

  • Adherence to standardized handoff intervention (Fidelity) measured by number of handoff steps followed.This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5.

    Fidelity is defined as adherence to the standardized handoff intervention. Fidelity is a count of handoff steps followed, with scores ranging from 0 to 10. Fidelity will be measured by trained site-based observers. Field notes by trained observers will inform the interpretation of fidelity. Units of analysis: patient level (handoff level), ICU level.

  • New-onset organ failureThis outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year5

    Per-protocol handoffs enable clinicians to follow expected care practices and to anticipate and avoid postoperative deterioration.