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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 belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at quarterly intervals starting year 1, quarter 2 and continuing until the end of year 5.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at quarterly intervals starting year 1, quarter 2 and continuing until the end of year 5.
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 moreAwards & 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
Eligibility Criteria:
This trial includes the following eligibility 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.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Customized Or to ICU handoff protocol
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.