Modular Prevention Bundle for Non-ventilator-associated Hospital-acquired Pneumonia (nvHAP)
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|ClinicalTrials.gov Identifier: NCT03361085|
Recruitment Status : Terminated (COVID-Epidemic with changes in patient mix, restructuring of wards/departments, new standard-precautions)
First Posted : December 4, 2017
Last Update Posted : July 14, 2020
Background: Hospital acquired pneumonia (HAP) is divided in two distinct groups, ventilator-associated pneumonia (VAP) and non-ventilator-associated HAP (nvHAP). Although nvHAP occurs more frequently than VAP and results in similar mortality and costs, prevention guidelines and prevention focus almost exclusively on VAP. Scientific evidence about nvHAP prevention is scarce. Therefore, we designed a mixed-methods study to investigate the effectiveness of a newly developed nvHAP prevention bundle and factors that influence its implementation.
Methods: This single-centre project at the 950-bed University Hospital Zurich (UHZ) will engage the wards of nine departments with substantial nvHAP rates. The nvHAP bundle consists of five primary prevention measures: 1) oral care, 2) identification and treatment of patients with dysphagia, 3) mobilization, 4) stopping unnecessary proton pump inhibitors, and, 5) respiratory therapy. Implementation includes the engagement of department-level implementation teams, who sustain the 'core' intervention components of education, training, and environmental restructuring and adapt the implementation strategy to local needs. The effects of the implementation will be analysed by a mixed-method approach. As primary outcome, nvHAP incidence rates will be analysed by Poisson regression models to compare incidence rates before, during, and after the implementation phases (on the hospital and department level). In addition, the association between process indicators and nvHAP incidence rates will be analysed using longitudinal Poisson regression models. A longitudinal, qualitative study and formative evaluation based on interviews and focus groups identifies supporting or hindering factors for implementation success in participating departments dynamically over time. This accumulating implementation experience will be constantly fed back to the implementation teams and thus, represents an active implementation element.
Discussion: This comprehensive mixed-methods study is designed to accomplish both, measure the effectiveness of a new prevention bundle against nvHAP and provide insights into how and why it worked or failed. The results of this study may contribute substantially to patient safety in the area of a rediscovered healthcare-associated infection - nvHAP.
|Condition or disease||Intervention/treatment||Phase|
|Hospital-acquired Pneumonia Healthcare Associated Infection Infection Prevention||Procedure: nvHAP Prevention Bundle||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45000 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||quasi experimental intervention study|
|Masking:||None (Open Label)|
|Official Title:||Modular Prevention Bundle for Non-ventilator-associated Hospital-acquired Pneumonia (nvHAP)|
|Actual Study Start Date :||January 1, 2018|
|Actual Primary Completion Date :||February 28, 2020|
|Actual Study Completion Date :||February 28, 2020|
Procedure: nvHAP Prevention Bundle
oral care, (early) mobilization, diagnosis and treatment of dysphagia, respiratory physiotherapy, stop Proton pump Inhibitors (PPI) if reasonable
- nvHAP Incidence rate [ Time Frame: up to 3 months post-discharge ]non Ventilator-associated Hospital acquired Pneumonia according to ECDC definitions
- Percentage of patients who passed away during hospitalization (in-hospital mortality) [ Time Frame: up to 3 months post-discharge ]death during hospitalisation
- length of stay [ Time Frame: up to 3 months post-discharge ]Duration of hospitalisation
- Percentage of patients in whom the respective prevention measure was correctly applied (prevention measures are: oral care, mobilisation, dysphagia screening, stopping proton pump inhibitors, respiratory therapy) [ Time Frame: at four timepoints (baseline, 2-3 months 4-6 months and 10-12 months after start implentation, 10 ]Aderence to the five prevention measures: oral care, Identification and treatment of patients with dysphagia, mobilization, Stop proton pump inhibitors if not indicated, respiratory physiotherapy
- Adherence score per department and timepoint [ Time Frame: at four timepoints (baseline, 2-3 months 4-6 months and 10-12 months after start implentation, 10 ]The 'nvHAP adherence score' is calculated by summing up the five proportions of executed prevention measures (i.e. nvHAP adherence indicator = 1) and dividing it by factor five. In the above example it would be (32/45 + 20/50 + 48/50 + 42/50 + 24/32)/5 = 0.732.
- Implementation success evaluated by semi-structured interview and focus group interview [ Time Frame: at three timepoints ( 2-3 months 4-6 months and 10-12 months after start implentation, 10 ]We will use a qualitative definition of implementation success composed of the following four implementation outcomes: acceptability, appropriateness, protocol fidelity, and sustainability
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361085
|University Hospital Zurich, Dept. of Infectious Diseases and Hospital Epidemiology|
|Zurich, ZH, Switzerland, 8091|
|Principal Investigator:||Aline Wolfensberger, MD||University of Zurich|
|Principal Investigator:||Lauren Clack, PhD||University of Zurich|