Safe Critical Care: Testing Improvement Strategies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00975923
Recruitment Status : Completed
First Posted : September 14, 2009
Results First Posted : January 12, 2016
Last Update Posted : January 12, 2016
Information provided by (Responsible Party):
Theodore Speroff, Vanderbilt University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Conditions: Central Line-associated Bloodstream Infection (CLABSI)
Ventilator Associated Pneumonia
Interventions: Behavioral: Collaborative Group
Behavioral: Tool Kit

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Leaders of all medical centers with at least 1 adult or pediatric ICU received an invitation to participate in a Quality Improvement initiative. Hospitals willing to participate were matched on geographic location and ICU volume and then randomized into either the Collaborative or Tool Kit Group in December 2005.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Collaborative Group One group of hospitals is randomly allocated to the Collaborative Group
Tool Kit Group One group of hospitals is allocated randomly to the Tool Kit Group

Participant Flow:   Overall Study
    Collaborative Group   Tool Kit Group
STARTED   30   30 
COMPLETED   30   29 [1] 
Withdrawal by Subject                0                1 
[1] 1 hospital was sold, yielding 29 hospitals in the Tool Kit Group

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Unit of analysis is Hospital and ICU

Reporting Groups
Collaborative Group One group of hospitals is randomly allocated to the Collaborative Group
Tool Kit Group One group of hospitals is allocated randomly to the Tool Kit Group
Total Total of all reporting groups

Baseline Measures
   Collaborative Group   Tool Kit Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   30   60 
Age, Customized [1] 
[Units: Hospitals]
Pediatric ICU (Age < 18 years)   0   0   0 
Adult ICU (Age >= 18 years)   30   30   60 
[1] Participants reporting whether ICU is pediatric (Age < 18 years) or adult (Age > 18 years) on baseline survey
Gender, Customized [1] 
[Units: Percentage of ICU female patient volume]
Mean (Standard Deviation)
Average % Female   49.7  (5.7)   50.3  (7.7)   50  (6) 
[1] baseline survey, percent of ICU patient volume that is female
ICU annual patient volume [1] 
[Units: ICU patients/year]
Median (Inter-Quartile Range)
 (294 to 904) 
 (244 to 1077) 
 (250 to 950) 
[1] Patient volume was collected by a baseline survey of each participating hospital
ICU mortality rate [1] 
[Units: ICU mortality rate/year]
Mean (Standard Deviation)
 5.7  (3.1)   7.1  (3.6)   6  (3.5) 
[1] Annual ICU mortality rate provided by baseline survey among participating hospitals
Medicare case-mix weight [1] 
[Units: Medicare Case-Mix Index/year]
Mean (Standard Deviation)
 1221  (1007)   1295  (1110)   1250  (1000) 
[1] Average Medicare Case-Mix Index for annual ICU patient volume collected by baseline survey of participating hospitals. Patients are assigned to Medicare Severity-Diagnosis Related Groups (MS-DRG) based on principal and secondary diagnoses, age, procedures performed, co-morbidity, complications, discharge status, and gender. Each MS-DRG has a numeric weight that indicates the amount of resources required to treat patients in the group. The index, the average of the MS-DRG weights, measures the relative cost needed to treat the case-mix of patients in a hospital during the calendar year.

  Outcome Measures

1.  Primary:   CLABSI and VAP Rates   [ Time Frame: 18 Months: 3-month baseline and quarterly post-intervention periods ]

2.  Secondary:   Access of Tools and Use of Quality Improvement Strategies   [ Time Frame: 18 months ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Each participant tailored their interventions; we were not able to test the components of CQI. Data were dependent on self-reports. Our collaborative was virtual and does not address benefits from face-to-face networking of large scale projects.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr. Theodore Speroff
Organization: Vanderbilt University School of Medicine
phone: 615-636-9476

Publications of Results:

Responsible Party: Theodore Speroff, Vanderbilt University Identifier: NCT00975923     History of Changes
Other Study ID Numbers: VU050413
AHRQ U18 HS015934 ( Other Grant/Funding Number: AHRQ U18 015934 )
First Submitted: September 10, 2009
First Posted: September 14, 2009
Results First Submitted: June 16, 2013
Results First Posted: January 12, 2016
Last Update Posted: January 12, 2016