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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

Brief Summary:
One group of hospitals participated in a collaborative approach for healthcare quality improvement while another group was provided only a tool kit. The investigators' objective was to determine if the Collaborative would perform better at preventing central line-associated bloodstream infections (CLABSI) and ventilator-associated pneumonias (VAP). Hospitals were randomized to the Tool Kit or Collaborative conditions. The investigators' study evaluated the effects on care processes and outcomes of a multi-institutional quality improvement initiative focused on preventing hospital associate infections. The investigators' hypothesis was that the strategies for implementing safe critical care practice will differ in level of achievement whereby the Collaborative group will perform better than the Tool Kit group. The outcome measure comprised clinical event rates and an index of safe practices that represent a bundling of key process measures related to evidence-based practices for preventing catheter-related blood-stream infections and ventilator-associated pneumonia in the intensive care unit.

Condition or disease Intervention/treatment Phase
Central Line-associated Bloodstream Infection (CLABSI) Ventilator Associated Pneumonia Behavioral: Collaborative Group Behavioral: Tool Kit Not Applicable

Detailed Description:
Continuous quality improvement (CQI) methodologies provide a framework for initiating and sustaining improvements in complex systems.1 By definition, CQI engages frontline staff in iterative problem solving using plan-do-study-act cycles of learning, with decision-making based on real-time process measurements. The Institute for Healthcare Improvement (IHI) has sponsored Breakthrough Series (BTS) Collaboratives since 1996 to accelerate the uptake and impact of quality improvement. These collaboratives are typically guided by evidence-based clinical practice guidelines, incorporate change methodologies, and rely on clinical and process improvement subject matter experts. Organizations have been adopting the collaborative model, and there is a growing literature on its positive impact. This collaborative approach to healthcare improvement has appealing face validity but lacks definitive evidence of its effectiveness. A recent derivative of collaboratives has been deployment of tool kits for quality improvement. Intuition suggests that such tools kits may help to enable change, and, thus some agencies advocate the simpler approach of disseminating tool kits as a change strategy. We sought to compare the collaborative model with the tool kit model for improving care. Recommendations and guidelines for central line-associated bloodstream infection (CLABSI) and ventilator-associated pneumonia (VAP) prevention have not been implemented reliably, resulting in unnecessary ICU morbidity and mortality and fostering a national call for improvement. Our study evaluated the effects on care processes and outcomes of a multi-institutional quality improvement initiative focused on preventing CLABSI and VAP in the intensive care unit (ICU).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Safe Critical Care: Testing Improvement Strategies
Study Start Date : February 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Arm Intervention/treatment
Experimental: Collaborative Group
Quality Improvement Virtual Learning Collaborative with Interactive Teleconferences and Tool Kit
Behavioral: Collaborative Group
In addition to the Tool Kit materials and web site support, facility leaders and managers in this group agreed to participate in a Collaborative to improve critical care. The Collaborative differed from the IHI BTS model in that teams did not come together for face-to-face educational and planning sessions but instead attended web seminars and teleconferences. Between these "virtual" learning sessions, teams implemented some of the suggested change ideas, measured the results of those changes, and reported back to the larger group. Teams were supported through monthly educational and troubleshooting conference calls, individual coaching by faculty members, and an e-mail listserver designed to stimulate interaction among teams.
Other Names:
  • Collaborative Breakthrough Groups
  • Collaborative Quality Improvement Groups

Active Comparator: Tool Kit Group
Tool Kit of Evidence-Based Guidelines, Education Seminars, and Aide for Quality Improvement Methods
Behavioral: Tool Kit
Hospitals received a tool kit:evidence-based guidelines, CLABSI/VAP fact sheets, change ideas,quality improvement and teamwork methods, standardized data collection and charting tools. Periodic reminders of their commitment to the Safe Critical Care Initiative and access to web site containing all of the educational seminars, clinical tools, and quality improvement tools. ICUs in this group were on their own to initiate and implement a local hospital quality improvement initiative preventing CLABSI and VAP.
Other Name: Quality Improvement

Primary Outcome Measures :
  1. CLABSI and VAP Rates [ Time Frame: 18 Months: 3-month baseline and quarterly post-intervention periods ]
    Central line associated bloodstream infections(CLABSI) and ventilator associated pneumonias (VAP) using Centers for Disease Control and Prevention definitions as number of events per 1,000 device days, data collection and surveillance methods.

Secondary Outcome Measures :
  1. Access of Tools and Use of Quality Improvement Strategies [ Time Frame: 18 months ]
    Follow-up survey of ICU nurse and quality managers for all participating medical centers from Jan 2008 through April 2008 included questions about the implementation of process interventions: Access and use of clinical guidelines tools, access and use of quality improvement tools, and types of quality improvement implementation strategies.

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Medical centers with at least one adult or pediatric ICU.
  • Medical centers within the Hospital Corporation of America (HCA) were eligible for enrollment.

Exclusion Criteria:

  • Nonresponse to invitation to participate in our Safe Critical Care Initiative.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00975923

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United States, Tennessee
HCA Hospital Corporation of America
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Vanderbilt University
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Principal Investigator: Theodore Speroff, PhD Vanderbilt University School of Medicine
Additional Information:
Publications of Results:
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Responsible Party: Theodore Speroff, Professor, Vanderbilt University Identifier: NCT00975923    
Other Study ID Numbers: VU050413
AHRQ U18 HS015934 ( Other Grant/Funding Number: AHRQ U18 015934 )
First Posted: September 14, 2009    Key Record Dates
Results First Posted: January 12, 2016
Last Update Posted: January 12, 2016
Last Verified: December 2015
Keywords provided by Theodore Speroff, Vanderbilt University:
Quality Improvement
Critical Care
Patient Safety
Tool Kit
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Healthcare-Associated Pneumonia
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Systemic Inflammatory Response Syndrome