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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

HATRICC-US Trial 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.Check my eligibility

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.See study design

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.

HATRICC-US Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

HATRICC-US Trial 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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence to standardized handoff intervention (Fidelity) measured by number of handoff steps followed.

New-onset organ failure

Secondary outcome measures

AHRQ PSI 10: Postoperative physiologic or metabolic derangement rate (effectiveness)

Respiratory Failure

AHRQ PSI 12: Perioperative pulmonary embolism or DVT rate (effectiveness)

+13 more

HATRICC-US 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,833 Previous Clinical Trials

47,303,496 Total Patients Enrolled

University of PennsylvaniaLead Sponsor

2,000 Previous Clinical Trials

42,877,088 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,949,588 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining vacancies in this scientific research project?

"Clinicaltrials.gov indicates that the recruitment period for this trial has concluded, as it was originally posted on July 1st 2021 and last updated August 18th 2022. However, there are currently 63 other studies actively recruiting participants at the moment."

Answered by AI

What are the foremost aims of this investigation?

"This trial seeks to assess the efficacy of a new treatment, service, practice or innovation through the evaluation of its New-onset organ failure in participants over 5 years. The Acceptability of Intervention Measure (AIM) will be employed to measure perception among stakeholders and AHRQ PSI 10: Postoperative physiologic or metabolic derangement rate shall serve as an effectiveness outcome. Additionally, a composite measure comprised of different component indicators related to adverse events shall also be utilized for data collection."

Answered by AI

Are there multiple locations offering this research trial within the city limits?

"There are 5 sites actively participating in this clinical trial, including Cooper Health located in Camden, UT Southwestern Medical Center situated in Dallas and Johns Hopkins found in Baltimore. Additionally, there exists two other medical centres associated with the project."

Answered by AI

Recent research and studies

Implementation ScienceJournal

Handoffs and Transitions in Critical Care—understanding Scalability: Study Protocol for a Multicenter Stepped Wedge Type 2 Hybrid Effectiveness-implementation Trial

Lane-Fall, Meghan B., Athena Christakos, Gina C. Russell, Bat-Zion Hose, Elizabeth D. Dauer, Philip E. Greilich, Bommy Hong Mershon, et al.. 2021. “Handoffs and Transitions in Critical Care—understanding Scalability: Study Protocol for a Multicenter Stepped Wedge Type 2 Hybrid Effectiveness-implementation Trial”. Implementation Science. Springer Science and Business Media LLC. doi:10.1186/s13012-021-01131-1.

clinicaltrials.govStudy

Handoffs and Transitions in Critical Care - Understanding Scalability

2021. "Handoffs and Transitions in Critical Care - Understanding Scalability". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04571749.