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

September 10, 2009
September 14, 2009
June 16, 2013
January 12, 2016
January 12, 2016
February 2006
April 2008   (Final data collection date for primary outcome measure)
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.
CLABSI and VAP Rates [ Time Frame: 18 Months: 3-month baseline and quarterly post-intervention periods ]
Complete list of historical versions of study NCT00975923 on Archive Site
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.
  • ICUs' implementation of the CLABSI and VAP process interventions [ Time Frame: 18 Months ]
  • access of tools, participation in web seminars, and use of quality improvement strategies [ Time Frame: 18 months ]
Not Provided
Not Provided
Safe Critical Care: Testing Improvement Strategies
Safe Critical Care: Testing Improvement Strategies
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.
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).
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
  • Central Line-associated Bloodstream Infection (CLABSI)
  • Ventilator Associated Pneumonia
  • 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
  • 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
  • Experimental: Collaborative Group
    Quality Improvement Virtual Learning Collaborative with Interactive Teleconferences and Tool Kit
    Intervention: Behavioral: Collaborative Group
  • Active Comparator: Tool Kit Group
    Tool Kit of Evidence-Based Guidelines, Education Seminars, and Aide for Quality Improvement Methods
    Intervention: Behavioral: Tool Kit

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2008
April 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
1 Year and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
AHRQ U18 HS015934 ( Other Grant/Funding Number: AHRQ U18 015934 )
Not Provided
Not Provided
Theodore Speroff, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: Theodore Speroff, PhD Vanderbilt University School of Medicine
Vanderbilt University
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP