Overview

This trial is active, not recruiting.

Conditions critical illness, intensive care, intensive care unit
Sponsor National Institute of General Medical Sciences (NIGMS)
Start date July 2010
End date February 2011
Trial size 6000 participants
Trial identifier NCT01109719, CIITG-2, K23GM071399

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model ecologic or community
Time perspective prospective

Primary Outcomes

Measure
In Patient Mortality
time frame: 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
time frame: ICU discharge or 60 days
ICU length of stay
time frame: ICU discharge or 60 days
Length of hospital stay
time frame: Hospital discharge or 60 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The Association of ICU Organization and Structure on in Patient Mortality
Principal investigator Jonathan Sevransky, MD, MHS
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2010.
Information provided to ClinicalTrials.gov by National Institute of General Medical Sciences (NIGMS).