CDC Prevention Epicenters Wake Up and Breathe Collaborative
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Harvard Pilgrim Health Care
- Enrollment
- 3,342
- Locations
- 5
- Primary Endpoint
- Change in VAC rate.
Overview
Brief Summary
Ventilator-associated pneumonia (VAP) is a common complication of mechanical ventilation associated with significant morbidity, including prolongation of mechanical ventilation and increased ICU and hospital length-of-stay. Numerous strategies have been proposed to decrease the occurrence of VAP among ventilated patients. Most notably, optimizing the use of daily sedative interruptions and daily spontaneous breathing trials can improve sedative management, decrease ventilator time, improve outcomes for mechanically ventilated patients,and possibly decrease VAP.Combining daily sedative interruption with daily spontaneous breathing trials confers additive improvement in ventilator days, intensive care days, and possibly mortality compared to daily spontaneous breathing trials alone.
The primary aim of this study is to determine the impact of an opt-out protocol for paired daily sedative interruptions and spontaneous breathing trials on VAP rates using a new streamlined VAP definition. The investigators will evaluate the responsiveness of CDC's proposed new surveillance definitions for ventilator-associated events to this quality improvement initiative. The study will be nested within the Epicenters Streamlined versus Conventional VAP Surveillance Study. Nine of the 18 hospitals in the larger study will be participating in this intervention arm.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •all patients in participating units on mechanical ventilation for at least one calendar day beting treated with continuous sedatives or standing orders for sedatives. Patients receiving mechanical ventilation through either an endotracheal or tracheostomy tube will be eligible.
Exclusion Criteria
- •moribund status or plans for withdrawal of life support
Outcomes
Primary Outcomes
Change in VAC rate.
Time Frame: 12 months
A new definition for VAP is the primary focus of this study. This new definition (referred to as "streamlined VAP" or "sVAP") is under consideration by the CDC as a potential replacement for the current NHSN VAP definition and, as such, will be closely evaluated to determine if it can reflect meaningful changes in patient care. Thus, we will assess the change in monthly sVAP rates from study start to study end using an interrupted time series analysis. Note that CDC released new surveillance definitions for ventilator-associated events in late 2012. Given that CDC definitions are the defacto surveillance standard, we switched the primary study outcome from sVAP to ventilator-associated conditions ("VAC"). All data elements required to assess for VAC were included in this study from the outset hence we did not have to collect any additional historical data in order to apply CDC's VAC definition.
Secondary Outcomes
- Hospital-specific outcomes(12-months)
- Patient-specific outcomes(12-months)
- ICU-specific outcomes(12-months)
Investigators
Michael Klompas MD, MPH, FRCPC
Principal Investigator
Harvard Pilgrim Health Care