NCT00975923

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 14, 2009

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

January 12, 2016

Completed
Last Updated

January 12, 2016

Status Verified

December 1, 2015

Enrollment Period

2.2 years

First QC Date

September 10, 2009

Results QC Date

June 16, 2013

Last Update Submit

December 8, 2015

Conditions

Keywords

Quality ImprovementCritical CareCollaborativesPatient SafetyTool Kit

Outcome Measures

Primary Outcomes (1)

  • 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.

    18 Months: 3-month baseline and quarterly post-intervention periods

Secondary Outcomes (1)

  • Access of Tools and Use of Quality Improvement Strategies

    18 months

Study Arms (2)

Collaborative Group

EXPERIMENTAL

Quality Improvement Virtual Learning Collaborative with Interactive Teleconferences and Tool Kit

Behavioral: Collaborative Group

Tool Kit Group

ACTIVE COMPARATOR

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

Behavioral: Tool Kit

Interventions

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.

Also known as: Collaborative Breakthrough Groups, Collaborative Quality Improvement Groups
Collaborative Group
Tool KitBEHAVIORAL

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.

Also known as: Quality Improvement
Tool Kit Group

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Medical centers with at least one adult or pediatric ICU.
  • Medical centers within the Hospital Corporation of America (HCA) were eligible for enrollment.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HCA Hospital Corporation of America

Nashville, Tennessee, 37203, United States

Location

Related Publications (5)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Quality Improvement

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EngineeringTechnology, Industry, and AgricultureQuality of Health CareHealth Services Administration

Limitations and Caveats

Each participant tailored their interventions; we were not able to test the components of CQI. Data were dependent on self-reports. Our collaborative was virtual and does not address benefits from face-to-face networking of large scale projects.

Results Point of Contact

Title
Dr. Theodore Speroff
Organization
Vanderbilt University School of Medicine

Study Officials

  • Theodore Speroff, PhD

    Vanderbilt University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 10, 2009

First Posted

September 14, 2009

Study Start

February 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

January 12, 2016

Results First Posted

January 12, 2016

Record last verified: 2015-12

Locations