Customized Handoff Protocols for ICU Patient Safety

(HATRICC-US Trial)

Enrolling by invitation at 4 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Pennsylvania
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on improving patient safety in hospitals by creating customized handoff protocols for patient transfers from the operating room to the ICU. The researchers aim to identify the best methods to ensure doctors and nurses follow these protocols, leading to smoother transitions and better patient care. Patients who have recently undergone surgery and are being moved to the ICU at participating hospitals can join this trial. As an unphased trial, it offers patients the chance to contribute to enhancing hospital safety and care practices.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What prior data suggests that this protocol is safe for ICU patient handoffs?

Research has shown that customized handoff protocols in hospitals can enhance patient safety. One study found that these protocols, which standardize the sharing of patient information during transitions, improve communication between doctors and nurses. Better communication leads to fewer mistakes and improved care for patients moving from the operating room to the ICU (intensive care unit).

Another study found that these protocols ensure all critical information about a patient's care is shared between medical teams. This is crucial in critical care areas like the ICU, where patients require close monitoring and rapid responses to changes in their condition.

No reports indicate negative effects from using these handoff protocols, suggesting they are safe and well-tolerated. The focus remains on improving information sharing, not on medication or medical procedures, which generally means fewer risks for patients involved.12345

Why are researchers excited about this trial?

Researchers are excited about the customized handoff protocol because it aims to improve patient safety during the critical transition from the operating room to the ICU. Unlike standard handoff procedures that might be generic and inconsistent, this protocol is tailored to fit the specific needs of each ICU, potentially leading to more effective communication and better patient outcomes. By focusing on a customized approach, the protocol seeks to enhance the uptake and sustained use of best practices among clinicians, ultimately reducing errors and improving overall patient care during these high-risk transitions.

What evidence suggests that this customized handoff protocol is effective for ICU patient safety?

Studies have shown that customized handoff protocols can greatly improve patient safety in intensive care settings. This trial will implement a customized handoff protocol in 12 ICUs to facilitate the transition of care from the operating room to the ICU. Research indicates that a personalized handoff method ensures accurate sharing of important information during this transition. This reduces the likelihood of losing or misunderstanding crucial details about a patient's condition and treatment. By enhancing communication among healthcare providers, these protocols can reduce mistakes and improve patient outcomes. Initial findings suggest that closely following these protocols can lead to better care and potentially save lives.34567

Who Is on the Research Team?

MB

Meghan B Lane-Fall, MD, MSHP

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for English-speaking adults who are admitted to the study hospitals for inpatient care and will experience a handoff from surgery to intensive care. It's also for healthcare workers involved in surgical patient care or with administrative duties related to patient care at these hospitals.

Inclusion Criteria

I am involved in patient care before, during, or after surgery, or I have administrative duties related to patient care.
You must be able to speak English fluently.
I was admitted for care and had surgery, followed by a transfer to the ICU.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Adaptation and implementation of tailored postoperative handoff protocols in 12 ICUs

1 year
Monthly evaluations

Sustainment

Evaluation of the sustainment of the handoff protocols and fidelity over time

3 years
Monthly evaluations

Follow-up

Participants are monitored for safety and effectiveness after implementation

1 year
Quarterly evaluations

What Are the Treatments Tested in This Trial?

Interventions

  • Customized handoff
Trial Overview The study is testing customized post-operative handoff protocols between healthcare teams, aiming to improve communication and patient safety in critical care settings by using implementation science and engineering principles.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Customized Or to ICU handoff protocolExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Published Research Related to This Trial

A quality improvement initiative successfully implemented a standardized handoff tool for transitioning patients from the operating room to the neonatal intensive care unit (NICU), achieving 80% compliance with its use within 12 months.
The initiative improved staff experience and satisfaction during handoffs, although it struggled to maintain consistent attendance of all appropriate providers and did not fully meet goals for immediate family updates.
Handoff Tool Improves Transitions from the Operating Room to the Neonatal Intensive Care Unit.Gallois, JB., Zagory, JA., Barkemeyer, B., et al.[2023]

Citations

Handoffs and transitions in critical care—understanding ...The primary implementation outcome will be fidelity to the customized handoff protocol (unit of analysis: handoff). The primary effectiveness ...
Handoffs and transitions of care in the intensive care unitThis clinical consensus document aims to provide practical guidance to the surgical intensivist on the best practices for patient handoffs and transitions of ...
Handoffs and transitions in critical care—understanding ...The primary implementation outcome will be fidelity to the customized handoff protocol (unit of analysis: handoff). The primary effectiveness ...
Improving Patient Safety in General Hospitals Using ...This study aims to present implementation process and participants' satisfaction of a national project that used a standardized tool for team communication.
Improving Communication in Intensive Care Unit to Ward ...The aim of this study is to evaluate the implementation process of the ICU-PAUSE handoff tool across 10 academic medical centers.
Impact of customised ICU handover protocol on the quality ...Implementation of a customised handover protocol when discharging patients from the ICU was associated with improvement in the quality of the information ...
Use of structured handoff protocols for within-hospital unit ...The handoff (sometimes called handover) of patient care from one clinician to another has been defined as 'a standardised method for transferring information, ...
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