Clinical trial NCT00975923: Safe Critical Care: Testing Improvement Strategies
Official title: Safe Critical Care: Testing Improvement Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Line-associated Bloodstream Infection (CLABSI)
Ventilator Associated Pneumonia
Keywords: Quality Improvement
Critical Care
Collaboratives
Patient Safety
Tool Kit
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2009-09-14
Enrollment: 59
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: CLABSI and VAP Rates
timeFrame: 18 Months: 3-month baseline and quarterly post-intervention periods
Secondary outcomes:
measure: Access of Tools and Use of Quality Improvement Strategies
timeFrame: 18 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: HCA Hospital Corporation of America
state: Tennessee
Study officials:
affiliation: Vanderbilt University School of Medicine
name: Theodore Speroff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Talbot TR, Tejedor SC, Greevy RA, Burgess H, Williams MV, Deshpande JK, McFadden P, Weinger MB, Englebright J, Dittus RS, Speroff T. Survey of infection control programs in a large national healthcare system. Infect Control Hosp Epidemiol. 2007 Dec;28(12):1401-3. doi: 10.1086/523867. Epub 2007 Nov 1.
citation: Wall RJ, Ely EW, Talbot TR, Weinger MB, Williams MV, Reischel J, Burgess LH, Englebright J, Dittus RS, Speroff T, Deshpande JK. Evidence-based algorithms for diagnosing and treating ventilator-associated pneumonia. J Hosp Med. 2008 Sep;3(5):409-22. doi: 10.1002/jhm.317.
citation: Patel RP, Gambrell M, Speroff T, Scott TA, Pun BT, Okahashi J, Strength C, Pandharipande P, Girard TD, Burgess H, Dittus RS, Bernard GR, Ely EW. Delirium and sedation in the intensive care unit: survey of behaviors and attitudes of 1384 healthcare professionals. Crit Care Med. 2009 Mar;37(3):825-32. doi: 10.1097/CCM.0b013e31819b8608.
citation: France DJ, Greevy RA Jr, Liu X, Burgess H, Dittus RS, Weinger MB, Speroff T. Measuring and comparing safety climate in intensive care units. Med Care. 2010 Mar;48(3):279-84. doi: 10.1097/MLR.0b013e3181c162d6.
citation: Speroff T, Ely EW, Greevy R, Weinger MB, Talbot TR, Wall RJ, Deshpande JK, France DJ, Nwosu S, Burgess H, Englebright J, Williams MV, Dittus RS. Quality improvement projects targeting health care-associated infections: comparing Virtual Collaborative and Toolkit approaches. J Hosp Med. 2011 May;6(5):271-8. doi: 10.1002/jhm.873. Epub 2011 Feb 10.