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Safe Critical Care: Testing Improvement Strategies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Theodore Speroff, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00975923
First received: September 10, 2009
Last updated: December 8, 2015
Last verified: December 2015
Results First Received: June 16, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: 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
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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
  Description
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]
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 1  
[1] 1 hospital was sold, yielding 29 hospitals in the Tool Kit Group



  Baseline Characteristics
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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
  Description
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  
Number of Participants  
[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  
Gender, Customized [2]
[units: Percentage of ICU female patient volume]
Mean (Standard Deviation)
     
Average % Female     49.7  (5.7)     50.3  (7.7)     50  (6)  
ICU annual patient volume [3]
[units: ICU patients/year]
Median (Inter-Quartile Range)
  568  
  (294 to 904)  
  578  
  (244 to 1077)  
  570  
  (250 to 950)  
ICU mortality rate [4]
[units: ICU mortality rate/year]
Mean (Standard Deviation)
  5.7  (3.1)     7.1  (3.6)     6  (3.5)  
Medicare case-mix weight [5]
[units: Medicare Case-Mix Index/year]
Mean (Standard Deviation)
  1221  (1007)     1295  (1110)     1250  (1000)  
[1] Participants reporting whether ICU is pediatric (Age < 18 years) or adult (Age > 18 years) on baseline survey
[2] baseline survey, percent of ICU patient volume that is female
[3] Patient volume was collected by a baseline survey of each participating hospital
[4] Annual ICU mortality rate provided by baseline survey among participating hospitals
[5] 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
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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
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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
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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
e-mail: ted.speroff@vanderbilt.edu


Publications of Results:

Responsible Party: Theodore Speroff, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00975923     History of Changes
Other Study ID Numbers: VU050413
AHRQ U18 HS015934 ( Other Grant/Funding Number: AHRQ U18 015934 )
Study First Received: September 10, 2009
Results First Received: June 16, 2013
Last Updated: December 8, 2015
Health Authority: United States: Institutional Review Board