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Customized Handoff Protocols for ICU Patient Safety (HATRICC-US Trial)

N/A
Waitlist Available
Led By Meghan B Lane-Fall, MD, MSHP
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at quarterly intervals starting year 1, quarter 2 and continuing until the end of year 5.
Awards & highlights
No Placebo-Only Group

Summary

This trial will adapt, implement, and evaluate protocols for postoperative handoffs in order to improve patient outcomes in acute care settings.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial focuses on improving communication procedures rather than medical treatments, there are no direct physical side effects. However, changes in protocol may affect workflow efficiency and stress levels among staff.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at quarterly intervals starting year 1, quarter 2 and continuing until the end of year 5.
This trial's timeline: 3 weeks for screening, Varies for treatment, and at quarterly intervals starting year 1, quarter 2 and continuing until the end of year 5. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adherence to standardized handoff intervention (Fidelity) measured by number of handoff steps followed.
New-onset organ failure
Secondary study objectives
AHRQ PSI 10: Postoperative physiologic or metabolic derangement rate (effectiveness)
Respiratory Failure
AHRQ PSI 12: Perioperative pulmonary embolism or DVT rate (effectiveness)
+13 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Customized Or to ICU handoff protocolExperimental Treatment1 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.

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,938 Previous Clinical Trials
47,788,298 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
2,082 Previous Clinical Trials
42,723,330 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,826 Previous Clinical Trials
8,162,518 Total Patients Enrolled

Media Library

Customized handoff Clinical Trial Eligibility Overview. Trial Name: NCT04571749 — N/A
Handover Research Study Groups: Customized Or to ICU handoff protocol
Handover Clinical Trial 2023: Customized handoff Highlights & Side Effects. Trial Name: NCT04571749 — N/A
Customized handoff 2023 Treatment Timeline for Medical Study. Trial Name: NCT04571749 — N/A
~480 spots leftby Jun 2025