Viewing Study NCT04571749



Ignite Creation Date: 2024-05-06 @ 3:15 PM
Last Modification Date: 2024-10-26 @ 1:46 PM
Study NCT ID: NCT04571749
Status: ENROLLING_BY_INVITATION
Last Update Posted: 2023-09-05
First Post: 2020-07-30

Brief Title: Handoffs and Transitions in Critical Care - Understanding Scalability
Sponsor: University of Pennsylvania
Organization: University of Pennsylvania

Study Overview

Official Title: Handoffs and Transitions in Critical Care - Understanding Scalability
Status: ENROLLING_BY_INVITATION
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: HATRICC-US
Brief Summary: 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
Detailed Description: Surgical patients who require post-surgical critical care are usually transferred from the operating room OR to the intensive care unit ICU for ongoing care The process of transferring the patient from the OR to the ICU is called a handoff Handoffs involve the transfer of patient information and transfer of patient care responsibilities from the OR team to the ICU team Multiple studies suggest that these handoffs can expose patients to preventable harm which can be avoided with standardization of the handoff The Handoffs and Transitions in Critical Care HATRICC IRB 819726 study started in 2014 developed and implemented a standardized OR to ICU handoff process in two Penn surgical ICUs SICUs that did not have a standardized handoff process

Four clinicians surgeon anesthetist ICU provider and ICU nurse from two teams surgical and intensive care usually take part in handoff communication During the HATRICC study the investigators evaluated handoff communication between the OR and ICU teams before and after implementation of the new standardized handoff process the HATRICC process in multiple ways using observations interviews focus groups and surveys The investigators demonstrated a 20 improvement in information exchange after implementation of the HATRICC standardized handoff process a process tailored to meet the needs of the different clinicians participating in OR to ICU handoffs

Prior studies have indicated short-term success in standardizing OR to ICU handoffs but sustainability of these improvement interventions has been less well studied Two studies have demonstrated sustained or improved information exchange following the institution of structured OR to ICU handoff processes but the factors influencing sustainability remain to be elucidated

The aims of this study are to

1 Ascertain determinants of OR-to-ICU handoff protocol adoption and use in 12 adult and pediatric ICUs in five health systems
2 Adapt handoff protocols using engineering approaches and select tailored implementation strategies with implementation mapping
3 Test the effectiveness of tailored multifaceted multilevel implementation strategies
4 Design and create a digital toolkit for other ICUs to identify implementation determinants customize OR-to-ICU handoff protocol and select appropriate implementation strategies

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01HL153735 NIH None httpsreporternihgovquickSearchR01HL153735