Clinical trial NCT01109719: Critical Illness Outcomes Study
Official title: The Association of ICU Organization and Structure on in Patient Mortality
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Illness
Intensive Care
Intensive Care Unit
Keywords: Protocol
Critical pathway
Intensive care units
Lead sponsor: National Institute of General Medical Sciences (NIGMS)
Sponsor class: NIH
First posted: 2010-04-23
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients present in study ICU's on the days of enrollement

Brief summary: We will test whether the way that an intensive care unit is organized can influence patient related outcomes such as mortality. We will test whether who works in the ICU, and how the ICU is managed will affect the care received by patients. The primary study hypothesis is whether the number of clinical protocols present in an intensive care unit is linked to patient mortality

Detailed description: Title: Do ICU Structural and Procedural Factors Influence Patient Related Outcomes: The Critical Illness Outcome Study (CIOS)

Objectives: This is an exploratory ecologic study designed to examine the organizational and structural factors present in adult intensive care units in the United States. A second objective is to determine whether these organizational and structural factors are associated with patient related outcomes. In addition, we intend to examine whether these organizational and structural issues are associated with patient treatments.

Hypotheses: (Ho) A. The number of protocols used in an ICU is inversely associated with ICU and hospital survival for critically ill patients.

B. Compliance with disease specific protocols is not independently associated with hospital survival for critically ill patients

Specific Aims

1. To describe the organizational structure of participating intensive care units
2. To determine whether the number of protocols used in an intensive care unit is associated with ICU and hospital survival for critically ill patients
3. To determine the frequency with which ICU's follow disease specific protocols for patients with sepsis and ALI

Study Design

1. Prospective ecologic study of 50-60 adult intensive care units and admitted patients
2. ICU organizational and structural data will be collected for each participating ICU
3. 125-200 adult patients in each intensive care unit will be enrolled. Patients within the ICU on a varying, specific day each week will be included. Demographic and treatment variables will be collected for that day on that patient. Outcome data will be collected on ICU and hospital discharge.

Eligibility criteria: Inclusion Criteria:

- Hospitalized adult patient in a study ICU on the date of data collection. This includes patients who may be in ICU despite not having critical illness for reasons such as lack of floor beds.

Exclusion Criteria:

-

1. Patient enrolled on previous study collection day 2 Previous enrollment into other study ICU 3. Age \< 18 years

Primary outcomes:
measure: In Patient Mortality
timeFrame: Hospital discharge or 60 days
Secondary outcomes:
measure: 2. Mortality prior to ICU discharge 3. Length of ICU stay 4. Length of hospital stay ICU mortality
timeFrame: ICU discharge or 60 days
measure: ICU length of stay
timeFrame: ICU discharge or 60 days
measure: Length of hospital stay
timeFrame: Hospital discharge or 60 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jonathan Sevransky, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Umoh NJ, Fan E, Mendez-Tellez PA, Sevransky JE, Dennison CR, Shanholtz C, Pronovost PJ, Needham DM. Patient and intensive care unit organizational factors associated with low tidal volume ventilation in acute lung injury. Crit Care Med. 2008 May;36(5):1463-8. doi: 10.1097/CCM.0b013e31816fc3d0.
citation: Levy MM, Rapoport J, Lemeshow S, Chalfin DB, Phillips G, Danis M. Association between critical care physician management and patient mortality in the intensive care unit. Ann Intern Med. 2008 Jun 3;148(11):801-9. doi: 10.7326/0003-4819-148-11-200806030-00002.
citation: Pronovost PJ, Angus DC, Dorman T, Robinson KA, Dremsizov TT, Young TL. Physician staffing patterns and clinical outcomes in critically ill patients: a systematic review. JAMA. 2002 Nov 6;288(17):2151-62. doi: 10.1001/jama.288.17.2151.
citation: Pronovost P, Needham D, Berenholtz S, Sinopoli D, Chu H, Cosgrove S, Sexton B, Hyzy R, Welsh R, Roth G, Bander J, Kepros J, Goeschel C. An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med. 2006 Dec 28;355(26):2725-32. doi: 10.1056/NEJMoa061115.
citation: Ali NA, Gutteridge D, Shahul S, Checkley W, Sevransky J, Martin GS. Critical Illness Outcome Study: An Observational Study on Protocols and Mortality in Intensive Care Units. Open Access J Clin Trials. 2011 Sep 23;2011(3):55-65. doi: 10.2147/OAJCT.S24223.