Safe Critical Care: Testing Improvement Strategies

Not Applicable

Completed

• Conditions: Ventilator Associated Pneumonia; Central Line-associated Bloodstream Infection (CLABSI)
• Interventions: Behavioral: Collaborative Group; Behavioral: Tool Kit

• Registration Number: NCT00975923
• Lead Sponsor: 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.

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).

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Study First Submitted: 2009-09-10
• Study First Submitted QC: 2009-09-11
• Study First Posted: 2009-09-14
• Results First Submitted: 2013-06-16
• Status Verified: 2015-12
• Results First Submitted QC: 2015-12-08
• Last Update Submitted: 2015-12-08
• Results First Posted: 2016-01-12
• Last Update Posted: 2016-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collaborative Group	Collaborative Group	Quality Improvement Virtual Learning Collaborative with Interactive Teleconferences and Tool Kit
Tool Kit Group	Tool Kit	Tool Kit of Evidence-Based Guidelines, Education Seminars, and Aide for Quality Improvement Methods

Primary Outcome Measures

Name	Time	Method
CLABSI and VAP Rates	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

Name	Time	Method
Access of Tools and Use of Quality Improvement Strategies	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.

Trial Locations

Locations (1)

HCA Hospital Corporation of America; 🇺🇸 Nashville, Tennessee, United States