TY - JOUR
T1 - Handoffs and transitions in critical care—understanding scalability
T2 - study protocol for a multicenter stepped wedge type 2 hybrid effectiveness-implementation trial
AU - Lane-Fall, Meghan B.
AU - Christakos, Athena
AU - Russell, Gina C.
AU - Hose, Bat Zion
AU - Dauer, Elizabeth D.
AU - Greilich, Philip E.
AU - Hong Mershon, Bommy
AU - Potestio, Christopher P.
AU - Pukenas, Erin W.
AU - Kimberly, John R.
AU - Stephens-Shields, Alisa J.
AU - Trotta, Rebecca L.
AU - Beidas, Rinad S.
AU - Bass, Ellen J.
N1 - Funding Information:
○ Advisory Board: James Abernathy III, MD; Mark Nunnally, MD; Matthew Weinger, MD, MS; Anne Sales, PhD ○ CRCs, RAs: Oluwatobi Bakare, Emily Kim, Melanie Kleid, Eric Savoy ○ CPORT: Janice Ashton, Lakisha Gaskins
Funding Information:
The National Heart, Lung, and Blood Institute of the United States National Institutes of Health funded this study through an investigator-initiated research grant (1R01HL153735-01; PI: Lane-Fall). The funder had no role in the design of the study and will have no role in data collection, analysis, interpretation, or manuscript writing.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - Background: The implementation of evidence-based practices in critical care faces specific challenges, including intense time pressure and patient acuity. These challenges result in evidence-to-practice gaps that diminish the impact of proven-effective interventions for patients requiring intensive care unit support. Research is needed to understand and address implementation determinants in critical care settings. Methods: The Handoffs and Transitions in Critical Care—Understanding Scalability (HATRICC-US) study is a Type 2 hybrid effectiveness-implementation trial of standardized operating room (OR) to intensive care unit (ICU) handoffs. This mixed methods study will use a stepped wedge design with randomized roll out to test the effectiveness of a customized protocol for structuring communication between clinicians in the OR and the ICU. The study will be conducted in twelve ICUs (10 adult, 2 pediatric) based in five United States academic health systems. Contextual inquiry incorporating implementation science, systems engineering, and human factors engineering approaches will guide both protocol customization and identification of protocol implementation determinants. Implementation mapping will be used to select appropriate implementation strategies for each setting. Human-centered design will be used to create a digital toolkit for dissemination of study findings. The primary implementation outcome will be fidelity to the customized handoff protocol (unit of analysis: handoff). The primary effectiveness outcome will be a composite measure of new-onset organ failure cases (unit of analysis: ICU). Discussion: The HATRICC-US study will customize, implement, and evaluate standardized procedures for OR to ICU handoffs in a heterogenous group of United States academic medical center intensive care units. Findings from this study have the potential to improve postsurgical communication, decrease adverse clinical outcomes, and inform the implementation of other evidence-based practices in critical care settings. Trial registration: ClinicalTrials.gov identifier: NCT04571749. Date of registration: October 1, 2020.
AB - Background: The implementation of evidence-based practices in critical care faces specific challenges, including intense time pressure and patient acuity. These challenges result in evidence-to-practice gaps that diminish the impact of proven-effective interventions for patients requiring intensive care unit support. Research is needed to understand and address implementation determinants in critical care settings. Methods: The Handoffs and Transitions in Critical Care—Understanding Scalability (HATRICC-US) study is a Type 2 hybrid effectiveness-implementation trial of standardized operating room (OR) to intensive care unit (ICU) handoffs. This mixed methods study will use a stepped wedge design with randomized roll out to test the effectiveness of a customized protocol for structuring communication between clinicians in the OR and the ICU. The study will be conducted in twelve ICUs (10 adult, 2 pediatric) based in five United States academic health systems. Contextual inquiry incorporating implementation science, systems engineering, and human factors engineering approaches will guide both protocol customization and identification of protocol implementation determinants. Implementation mapping will be used to select appropriate implementation strategies for each setting. Human-centered design will be used to create a digital toolkit for dissemination of study findings. The primary implementation outcome will be fidelity to the customized handoff protocol (unit of analysis: handoff). The primary effectiveness outcome will be a composite measure of new-onset organ failure cases (unit of analysis: ICU). Discussion: The HATRICC-US study will customize, implement, and evaluate standardized procedures for OR to ICU handoffs in a heterogenous group of United States academic medical center intensive care units. Findings from this study have the potential to improve postsurgical communication, decrease adverse clinical outcomes, and inform the implementation of other evidence-based practices in critical care settings. Trial registration: ClinicalTrials.gov identifier: NCT04571749. Date of registration: October 1, 2020.
KW - Critical care
KW - Ergonomics
KW - Evidence-based practice
KW - Human factors engineering
KW - Hybrid effectiveness-implementation trials
KW - Implementation science
KW - Medical communication
KW - Patient handoff
KW - Patient safety
KW - Postoperative period
KW - Transition of care
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UR - http://www.scopus.com/inward/citedby.url?scp=85108103236&partnerID=8YFLogxK
U2 - 10.1186/s13012-021-01131-1
DO - 10.1186/s13012-021-01131-1
M3 - Article
C2 - 34130725
AN - SCOPUS:85108103236
SN - 1748-5908
VL - 16
JO - Implementation Science
JF - Implementation Science
IS - 1
M1 - 63
ER -