CIOS: Critical Illness Outcomes Study

• Sponsor: National Institute of General Medical Sciences (NIGMS) (NIH)
• Overall Status: Unknown status
• CT.gov ID: NCT01109719
• Collaborator: (none)
• Enrollment: 6,000
• Location: 1
• Duration (Months): 9
• Patients Per Site Per Month: 666.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Critical Illness; Intensive Care; Intensive Care Unit

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.

1. 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 6000 participants
• Observational Model: Ecologic or Community
• Time Perspective: Prospective
• Official Title: The Association of ICU Organization and Structure on in Patient Mortality
• Study Start Date: Jul 1, 2010
• Anticipated Primary Completion Date: Feb 1, 2011
• Anticipated Study Completion Date: Apr 1, 2011

Outcome Measures

Primary Outcome Measures

1. In Patient Mortality [Hospital discharge or 60 days]

Secondary Outcome Measures

1. 2. Mortality prior to ICU discharge 3. Length of ICU stay 4. Length of hospital stay ICU mortality [ICU discharge or 60 days]

2. ICU length of stay [ICU discharge or 60 days]

3. Length of hospital stay [Hospital discharge or 60 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Bayview Medical Center	Baltimore	Maryland	United States	21224

Sponsors and Collaborators

• National Institute of General Medical Sciences (NIGMS)

Investigators

• Principal Investigator: Jonathan Sevransky, MD, MHS, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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. Erratum in: N Engl J Med. 2007 Jun 21;356(25):2660.
• 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. Review.
• 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.

• ClinicalTrials.gov Identifier: NCT01109719
• Other Study ID Numbers: CIITG-2; K23GM071399
• First Posted: Apr 23, 2010
• Last Update Posted: Aug 25, 2010
• Last Verified: Aug 1, 2010

• Keywords provided by , ,: Protocol; Critical pathway; Intensive care units
• Additional relevant MeSH terms: Critical Illness

Study Results

No Results Posted as of Aug 25, 2010