Safe Critical Care: Testing Improvement Strategies

This study has been completed.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00975923
First received: September 10, 2009
Last updated: November 5, 2010
Last verified: November 2010
  Purpose

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 Intervention
Hospital Associated Infection
Central Line-associated Bloodstream Infection
Ventilator Associated Pneumonia
Behavioral: Collaborative Group
Behavioral: Tool Kit

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Safe Critical Care: Testing Improvement Strategies

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • CLABSI and VAP rates [ Time Frame: 18 Months: 3-month baseline and quarterly post-intervention periods ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ICUs' implementation of the CLABSI and VAP process interventions [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
  • access of tools, participation in web seminars, and use of quality improvement strategies [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: February 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Collaborative Group
One group of hospitals is randomly allocated to the Collaborative Group
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 listserv designed to stimulate interaction among teams.
Other Names:
  • Collaborative Breakthrough Groups
  • Collaborative Quality Improvement Groups
Active Comparator: Tool Kit Group
One group of hospitals is allocated randomly to the Tool Kit Group
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

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

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00975923

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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Theodore Speroff, PhD Professor, Vanderbilt University School of Medicine
ClinicalTrials.gov Identifier: NCT00975923     History of Changes
Other Study ID Numbers: VU050413, 1U18H5015934-01
Study First Received: September 10, 2009
Last Updated: November 5, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Quality Improvement
Critical Care
Collaboratives
Patient Safety
Tool Kit

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury

ClinicalTrials.gov processed this record on July 26, 2014