INTRODUCTION: Many individual Intensive Care Unit (ICU) characteristics have been associated with patient outcomes, including staffing, expertise, continuity and team structure. Separately, many aspects of clinical care in ICUs have been operationalized through the development of complex treatment protocols. The United State Critical Illness and Injury Trials Group-Critical Illness Outcomes Study (USCIITG-CIOS) was designed to determine whether the extent of protocol availability and use in ICUs is associated with hospital survival in a large cohort of United States ICUs. Here, we describe the study protocol and analysis plan approved by the USCIITG-CIOS Steering Committee. METHODS: USCIITG-CIOS is a prospective, observational, ecological multi-centered "cohort" study of mixed ICUs in the U.S. The data collected include organizational information for the ICU (e.g., protocol availability and utilization, multi-disciplinary staffing assessment) and patient level information (e.g. demographics, acute and chronic medical conditions). The primary outcome is all-cause hospital mortality, with the objective being to determine whether there is an association between protocol number and hospital mortality for ICU patients. USCIITG-CIOS is powered to detect a 3% difference in crude hospital mortality between high and low protocol use ICUs, dichotomized according to protocol number at the median. The analysis will utilize regression modeling to adjust for outcome clustering by ICU, with secondary linear analysis of protocol number and mortality and a variety of a priori planned ancillary studies. There are presently 60 ICUs participating in USCIITG-CIOS to enroll approximately 6,000 study subjects. CONCLUSIONS: USCIITG-CIOS is a large multicentric study examining the effect of ICU protocol use on patient outcomes. The primary results of this study will inform our understanding of the relationship between protocol availability, use, and patient outcomes in the ICU. Moreover, given the shortage of intensivists worldwide, the results of USCIITG-CIOS can be used to promote more effective ICU and care team design and will impact the delivery of intensive care services beyond individual practitioners. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01109719.
INTRODUCTION: Many individual Intensive Care Unit (ICU) characteristics have been associated with patient outcomes, including staffing, expertise, continuity and team structure. Separately, many aspects of clinical care in ICUs have been operationalized through the development of complex treatment protocols. The United State Critical Illness and Injury Trials Group-Critical Illness Outcomes Study (USCIITG-CIOS) was designed to determine whether the extent of protocol availability and use in ICUs is associated with hospital survival in a large cohort of United States ICUs. Here, we describe the study protocol and analysis plan approved by the USCIITG-CIOS Steering Committee. METHODS: USCIITG-CIOS is a prospective, observational, ecological multi-centered "cohort" study of mixed ICUs in the U.S. The data collected include organizational information for the ICU (e.g., protocol availability and utilization, multi-disciplinary staffing assessment) and patient level information (e.g. demographics, acute and chronic medical conditions). The primary outcome is all-cause hospital mortality, with the objective being to determine whether there is an association between protocol number and hospital mortality for ICU patients. USCIITG-CIOS is powered to detect a 3% difference in crude hospital mortality between high and low protocol use ICUs, dichotomized according to protocol number at the median. The analysis will utilize regression modeling to adjust for outcome clustering by ICU, with secondary linear analysis of protocol number and mortality and a variety of a priori planned ancillary studies. There are presently 60 ICUs participating in USCIITG-CIOS to enroll approximately 6,000 study subjects. CONCLUSIONS: USCIITG-CIOS is a large multicentric study examining the effect of ICU protocol use on patient outcomes. The primary results of this study will inform our understanding of the relationship between protocol availability, use, and patient outcomes in the ICU. Moreover, given the shortage of intensivists worldwide, the results of USCIITG-CIOS can be used to promote more effective ICU and care team design and will impact the delivery of intensive care services beyond individual practitioners. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01109719.
Authors: Mitchell M Levy; R Phillip Dellinger; Sean R Townsend; Walter T Linde-Zwirble; John C Marshall; Julian Bion; Christa Schorr; Antonio Artigas; Graham Ramsay; Richard Beale; Margaret M Parker; Herwig Gerlach; Konrad Reinhart; Eliezer Silva; Maurene Harvey; Susan Regan; Derek C Angus Journal: Crit Care Med Date: 2010-02 Impact factor: 7.598
Authors: H L Corwin; A Gettinger; R M Rodriguez; R G Pearl; K D Gubler; C Enny; T Colton; M J Corwin Journal: Crit Care Med Date: 1999-11 Impact factor: 7.598
Authors: R Phillip Dellinger; Mitchell M Levy; Jean M Carlet; Julian Bion; Margaret M Parker; Roman Jaeschke; Konrad Reinhart; Derek C Angus; Christian Brun-Buisson; Richard Beale; Thierry Calandra; Jean-Francois Dhainaut; Herwig Gerlach; Maurene Harvey; John J Marini; John Marshall; Marco Ranieri; Graham Ramsay; Jonathan Sevransky; B Taylor Thompson; Sean Townsend; Jeffrey S Vender; Janice L Zimmerman; Jean-Louis Vincent Journal: Crit Care Med Date: 2008-01 Impact factor: 7.598
Authors: Alan H Morris; James Orme; Jonathon D Truwit; Jay Steingrub; Colin Grissom; Kang H Lee; Guoliang L Li; B Taylor Thompson; Roy Brower; Mark Tidswell; Gordon R Bernard; Dean Sorenson; Katherine Sward; Hui Zheng; David Schoenfeld; Homer Warner Journal: Crit Care Med Date: 2008-06 Impact factor: 7.598
Authors: Timothy D Girard; John P Kress; Barry D Fuchs; Jason W W Thomason; William D Schweickert; Brenda T Pun; Darren B Taichman; Jan G Dunn; Anne S Pohlman; Paul A Kinniry; James C Jackson; Angelo E Canonico; Richard W Light; Ayumi K Shintani; Jennifer L Thompson; Sharon M Gordon; Jesse B Hall; Robert S Dittus; Gordon R Bernard; E Wesley Ely Journal: Lancet Date: 2008-01-12 Impact factor: 79.321
Authors: Jonathan E Sevransky; William Checkley; Phabiola Herrera; Brian W Pickering; Juliana Barr; Samuel M Brown; Steven Y Chang; David Chong; David Kaufman; Richard D Fremont; Timothy D Girard; Jeffrey Hoag; Steven B Johnson; Mehta P Kerlin; Janice Liebler; James O'Brien; Terence O'Keefe; Pauline K Park; Stephen M Pastores; Namrata Patil; Anthony P Pietropaoli; Maryann Putman; Todd W Rice; Leo Rotello; Jonathan Siner; Sahul Sajid; David J Murphy; Greg S Martin Journal: Crit Care Med Date: 2015-10 Impact factor: 7.598
Authors: Carmen C Polito; Sushma K Cribbs; Greg S Martin; Terence O'Keeffe; Dan Herr; Todd W Rice; Jonathan E Sevransky Journal: Crit Care Med Date: 2014-05 Impact factor: 7.598
Authors: William Checkley; Greg S Martin; Samuel M Brown; Steven Y Chang; Ousama Dabbagh; Richard D Fremont; Timothy D Girard; Todd W Rice; Michael D Howell; Steven B Johnson; James O'Brien; Pauline K Park; Stephen M Pastores; Namrata T Patil; Anthony P Pietropaoli; Maryann Putman; Leo Rotello; Jonathan Siner; Sahul Sajid; David J Murphy; Jonathan E Sevransky Journal: Crit Care Med Date: 2014-02 Impact factor: 7.598
Authors: James M Blum; Peter E Morris; Greg S Martin; Michelle N Gong; Satish Bhagwanjee; Charles B Cairns; J Perren Cobb Journal: Chest Date: 2013-03 Impact factor: 9.410
Authors: Joshua A Denney; Francesca Capanni; Phabiola Herrera; Augusto Dulanto; Rollin Roldan; Enrique Paz; Amador A Jaymez; Eduardo E Chirinos; Jose Portugal; Rocio Quispe; Roy G Brower; William Checkley Journal: BMJ Open Date: 2015-01-16 Impact factor: 2.692
Authors: Sarina K Sahetya; Christopher Mallow; Jonathan E Sevransky; Greg S Martin; Timothy D Girard; Roy G Brower; William Checkley Journal: Crit Care Date: 2019-11-21 Impact factor: 9.097