Critical Illness Outcomes Study (CIOS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by National Institute of General Medical Sciences (NIGMS).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier:
NCT01109719
First received: April 22, 2010
Last updated: August 23, 2010
Last verified: August 2010
  Purpose

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
Critical Illness
Intensive Care
Intensive Care Unit

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: The Association of ICU Organization and Structure on in Patient Mortality

Further study details as provided by National Institute of General Medical Sciences (NIGMS):

Primary Outcome Measures:
  • In Patient Mortality [ Time Frame: Hospital discharge or 60 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 2. Mortality prior to ICU discharge 3. Length of ICU stay 4. Length of hospital stay ICU mortality [ Time Frame: ICU discharge or 60 days ] [ Designated as safety issue: No ]
  • ICU length of stay [ Time Frame: ICU discharge or 60 days ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: Hospital discharge or 60 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 6000
Study Start Date: July 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109719

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Investigators
Principal Investigator: Jonathan Sevransky, MD, MHS Johns Hopkins University
  More Information

Publications:
Responsible Party: Jonathan Sevransky, MD, MHS, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01109719     History of Changes
Other Study ID Numbers: CIITG-2, K23GM071399
Study First Received: April 22, 2010
Last Updated: August 23, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of General Medical Sciences (NIGMS):
Protocol
Critical pathway
Intensive care units

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014