Critical Illness Outcomes Study (CIOS)

The Association of ICU Organization and Structure on in Patient Mortality

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

Study Overview

• Status: Unknown
• Conditions: Critical Illness; Intensive Care Unit; Intensive Care

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.

• Study Type: Observational
• Enrollment (Anticipated): 6000

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adult patients present in study ICU's on the days of enrollement

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
In Patient Mortality	Hospital discharge or 60 days

Secondary Outcome Measures

Outcome Measure	Time Frame
2. Mortality prior to ICU discharge 3. Length of ICU stay 4. Length of hospital stay ICU mortality	ICU discharge or 60 days
ICU length of stay	ICU discharge or 60 days
Length of hospital stay	Hospital discharge or 60 days

Collaborators and Investigators

• Sponsor: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Jonathan Sevransky, MD, MHS, Johns Hopkins University

Publications and helpful links

General Publications

• 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. 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. doi: 10.1001/jama.288.17.2151.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Anticipated): February 1, 2011
• Study Completion (Anticipated): April 1, 2011

Study Registration Dates

• First Submitted: April 22, 2010
• First Submitted That Met QC Criteria: April 22, 2010
• First Posted (Estimate): April 23, 2010

Study Record Updates

• Last Update Posted (Estimate): August 25, 2010
• Last Update Submitted That Met QC Criteria: August 23, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Intensive care units; Protocol; Critical pathway
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: CIITG-2; K23GM071399 (U.S. NIH Grant/Contract)