Customized Handoff Protocols for ICU Patient Safety

(HATRICC-US Trial)

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Research staff

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

4000 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators will leverage implementation science and engineering to adapt, implement, and rigorously evaluate tailored postoperative handoff protocols and implementation strategies. In doing so, the investigators will develop a vital understanding of the factors needed for successful and sustained use of evidence-based interventions in acute care. This knowledge will inform approaches to bridge the evidence-to-practice gap that prevents effective interventions from realizing the promise of improved patient outcomes in acute care settings.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Customized handoff?

Research shows that using standardized handoff protocols, which are similar to customized handoffs, can reduce medical errors and improve patient safety during transitions between different hospital units, such as from the operating room to the ICU. ^{1 2 3 4 5}

Is the customized handoff protocol generally safe for use in humans?

Research shows that improving handoff processes in hospitals can enhance patient safety by reducing communication errors, which are a common cause of adverse events (unintended harm to patients). Studies have demonstrated that standardized handoff protocols can improve safety during patient transfers, such as from surgery to the ICU. ^{3 6 7 8 9}

How is the customized handoff treatment different from other treatments for ICU patient safety?

The customized handoff treatment is unique because it focuses on creating a standardized process for transferring patient information between medical teams in the ICU, which helps reduce errors and improve communication. Unlike other treatments that might focus on medication or procedures, this approach enhances patient safety by ensuring critical information is consistently and accurately shared during transitions. ^{2 3 10 11 12}

Research Team

Meghan B Lane-Fall, MD, MSHP

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Customized Or to ICU handoff protocol Experimental Treatment 1 Intervention

Tailored implementation strategies will be used in 12 ICUs to facilitate the uptake and sustained use of a customized handoff protocol to be used by clinicians at the time of patient care transition from the operating room to the intensive care unit.

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Handoff Tool Improves Transitions from the Operating Room to the Neonatal Intensive Care Unit. Gallois, JB., Zagory, JA., Barkemeyer, B., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Improving clinical handover between intensive care unit and general ward professionals at intensive care unit discharge. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Handoff Tool Improves Transitions from the Operating Room to the Neonatal Intensive Care Unit. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A standard handoff improves cardiac surgical patient transfer: operating room to intensive care unit. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Ticket to ride: reducing handoff risk during hospital patient transport. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Handoff from Operating Room to Intensive Care Unit: Specific Pathways to Decrease Patient Adverse Events. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Handoff improvement and adverse event reduction programme implementation in paediatric intensive care units in Argentina: a stepped-wedge trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Communication at Transitions of Care. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Decreasing handoff-related care failures in children's hospitals. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Physician Transition of Care: Benefits of I-PASS and an Electronic Handoff System in a Community Pediatric Residency Program. [2018]

10. Switzerland pubmed.ncbi.nlm.nih.gov

A Model for a Standardized and Sustainable Pediatric Anesthesia-Intensive Care Unit Hand-Off Process. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Standardization of Pediatric Noncardiac Operating Room to Intensive Care Unit Handoffs Improves Communication and Patient Care. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

In search of common ground in handoff documentation in an Intensive Care Unit. [2021]