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Safe Critical Care: Testing Improvement Strategies

Primary Purpose

Central Line-associated Bloodstream Infection (CLABSI), Ventilator Associated Pneumonia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collaborative Group
Tool Kit
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Central Line-associated Bloodstream Infection (CLABSI) focused on measuring Quality Improvement, Critical Care, Collaboratives, Patient Safety, Tool Kit

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • HCA Hospital Corporation of America

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Collaborative Group

Tool Kit Group

Arm Description

Quality Improvement Virtual Learning Collaborative with Interactive Teleconferences and Tool Kit

Tool Kit of Evidence-Based Guidelines, Education Seminars, and Aide for Quality Improvement Methods

Outcomes

Primary Outcome Measures

CLABSI and VAP Rates
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

Access of Tools and Use of Quality Improvement Strategies
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.

Full Information

First Posted
September 10, 2009
Last Updated
December 8, 2015
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT00975923
Brief Title
Safe Critical Care: Testing Improvement Strategies
Official Title
Safe Critical Care: Testing Improvement Strategies
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Line-associated Bloodstream Infection (CLABSI), Ventilator Associated Pneumonia
Keywords
Quality Improvement, Critical Care, Collaboratives, Patient Safety, Tool Kit

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Collaborative Group
Arm Type
Experimental
Arm Description
Quality Improvement Virtual Learning Collaborative with Interactive Teleconferences and Tool Kit
Arm Title
Tool Kit Group
Arm Type
Active Comparator
Arm Description
Tool Kit of Evidence-Based Guidelines, Education Seminars, and Aide for Quality Improvement Methods
Intervention Type
Behavioral
Intervention Name(s)
Collaborative Group
Other Intervention Name(s)
Collaborative Breakthrough Groups, Collaborative Quality Improvement Groups
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tool Kit
Other Intervention Name(s)
Quality Improvement
Intervention Description
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.
Primary Outcome Measure Information:
Title
CLABSI and VAP Rates
Description
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.
Time Frame
18 Months: 3-month baseline and quarterly post-intervention periods
Secondary Outcome Measure Information:
Title
Access of Tools and Use of Quality Improvement Strategies
Description
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.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodore Speroff, PhD
Organizational Affiliation
Vanderbilt University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
HCA Hospital Corporation of America
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17994522
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.
Results Reference
result
PubMed Identifier
18951395
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.
Results Reference
result
PubMed Identifier
19237884
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.
Results Reference
result
PubMed Identifier
20125046
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.
Results Reference
result
PubMed Identifier
21312329
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.
Results Reference
result

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Safe Critical Care: Testing Improvement Strategies

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