Safe Critical Care: Testing Improvement Strategies

• ClinicalTrials.gov Identifier: NCT00975923
• Recruitment Status: Completed
• First Posted: September 14, 2009
• Results First Posted: January 12, 2016
• Last Update Posted: January 12, 2016
• Sponsor: Vanderbilt University
• Information provided by (Responsible Party): Theodore Speroff, Vanderbilt University

Study Description

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).

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, Tennessee

HCA Hospital Corporation of America

Nashville, Tennessee, United States, 37203

Sponsors and Collaborators

Vanderbilt University

Investigators

• Principal Investigator: Theodore Speroff, PhD; Vanderbilt University School of Medicine

More Information

Publications of Results:

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. Epub 2007 Nov 1.

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. Review.

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.

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.

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.

• Responsible Party: Theodore Speroff, Professor, Vanderbilt University
• ClinicalTrials.gov Identifier: NCT00975923
• Other Study ID Numbers: VU050413; AHRQ U18 HS015934 ( Other Grant/Funding Number: AHRQ U18 015934 )
• First Posted: September 14, 2009
• 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; Collaboratives; Patient Safety; Tool Kit

Additional relevant MeSH terms:

Pneumonia, Ventilator-Associated; Sepsis; Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Healthcare-Associated Pneumonia; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation