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| ID | Type | Description | Link |
|---|---|---|---|
| AHRQ U18 HS015934 | Other Grant/Funding Number | AHRQ U18 015934 |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collaborative Group | Experimental | Quality Improvement Virtual Learning Collaborative with Interactive Teleconferences and Tool Kit |
|
| Tool Kit Group | Active Comparator | Tool Kit of Evidence-Based Guidelines, Education Seminars, and Aide for Quality Improvement Methods |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collaborative Group | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Theodore Speroff, PhD | Vanderbilt University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HCA Hospital Corporation of America | Nashville | Tennessee | 37203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17994522 | Result | 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. | |
| 18951395 | Result |
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Leaders of all medical centers with at least 1 adult or pediatric ICU received an invitation to participate in a Quality Improvement initiative. Hospitals willing to participate were matched on geographic location and ICU volume and then randomized into either the Collaborative or Tool Kit Group in December 2005.
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| ID | Title | Description |
|---|---|---|
| FG000 | Collaborative Group | One group of hospitals is randomly allocated to the Collaborative Group |
| FG001 | Tool Kit Group | One group of hospitals is allocated randomly to the Tool Kit Group |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Unit of analysis is Hospital and ICU
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| ID | Title | Description |
|---|---|---|
| BG000 | Collaborative Group | One group of hospitals is randomly allocated to the Collaborative Group |
| BG001 | Tool Kit Group | One group of hospitals is allocated randomly to the Tool Kit Group |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Participants reporting whether ICU is pediatric (Age < 18 years) or adult (Age > 18 years) on baseline survey |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | A cluster randomized trial randomly assigned hospitals to either the Collaborative or Tool Kit groups, stratified by region within the United States and ICU volume. Implementation and analysis was at the level of the ICU. One of the 30 hospital in the Tool Kit Group was sold, leaving 29 hospitals. Analysis was conducted per protocol. | Posted | Median | Inter-Quartile Range | events/1000 device days | 18 Months: 3-month baseline and quarterly post-intervention periods |
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No other adverse event data were collected other than the primary study outcomes
0 hospital (ICU) participants were at risk as no other adverse events were collected or assessed other than the primary study outcomes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Collaborative Group | Hospitals allocated randomly to the Collaborative Quality Improvement intervention with teleconferences and Tool Kit |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Theodore Speroff | Vanderbilt University School of Medicine | 615-636-9476 | ted.speroff@vanderbilt.edu |
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| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
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| ID | Term |
|---|---|
| D058996 | Quality Improvement |
| ID | Term |
|---|---|
| D004738 | Engineering |
| D013676 | Technology, Industry, and Agriculture |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| Tool Kit | Behavioral | 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. |
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| 18 months |
| 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. |
| 19237884 | Result | 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. |
| 20125046 | Result | 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. |
| 21312329 | Result | 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. |
| BG002 | Total | Total of all reporting groups |
| Number |
| Hospitals |
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| Sex/Gender, Customized | baseline survey, percent of ICU patient volume that is female | Mean | Standard Deviation | Percentage of ICU female patient volume |
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| ICU annual patient volume | Patient volume was collected by a baseline survey of each participating hospital | Median | Inter-Quartile Range | ICU patients/year |
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| ICU mortality rate | Annual ICU mortality rate provided by baseline survey among participating hospitals | Mean | Standard Deviation | ICU mortality rate/year |
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| Medicare case-mix weight | Average Medicare Case-Mix Index for annual ICU patient volume collected by baseline survey of participating hospitals. Patients are assigned to Medicare Severity-Diagnosis Related Groups (MS-DRG) based on principal and secondary diagnoses, age, procedures performed, co-morbidity, complications, discharge status, and gender. Each MS-DRG has a numeric weight that indicates the amount of resources required to treat patients in the group. The index, the average of the MS-DRG weights, measures the relative cost needed to treat the case-mix of patients in a hospital during the calendar year. | Mean | Standard Deviation | Medicare Case-Mix Index/year |
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| OG001 | Tool Kit Group | Hospitals allocated randomly to the Tool Kit containing evidence-based guidelines and aides for conducting quality improvement |
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| Secondary | 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. | per protocol | Posted | Number | Percentage of ICUs | 18 months |
|
|
|
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| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Tool Kit Group | Hospitals allocated randomly to the Tool Kit containing evidence-based guidelines and aides for quality improvement | 0 | 29 | 0 | 29 |
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| D012141 |
| Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Strategies |
|