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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
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45000 participants
Intervention Model: Sequential Assignment
Intervention Model Description: quasi experimental intervention study
Masking: None (Open Label)
Primary Purpose: Prevention
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


Arm Intervention/treatment
Experimental: Intervention
nvHAP-Prevention Bundle
Procedure: nvHAP Prevention Bundle
oral care, (early) mobilization, diagnosis and treatment of dysphagia, respiratory physiotherapy, stop Proton pump Inhibitors (PPI) if reasonable




Primary Outcome Measures :
  1. nvHAP Incidence rate [ Time Frame: up to 3 months post-discharge ]
    non Ventilator-associated Hospital acquired Pneumonia according to ECDC definitions


Secondary Outcome Measures :
  1. Percentage of patients who passed away during hospitalization (in-hospital mortality) [ Time Frame: up to 3 months post-discharge ]
    death during hospitalisation

  2. length of stay [ Time Frame: up to 3 months post-discharge ]
    Duration of hospitalisation


Other Outcome Measures:
  1. 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

  2. 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.

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

The study population consists of all patients hospitalized in nine predefined medical and surgical departments and their corresponding wards chosen based on the following criteria

  • nvHAP rate above the 50th percentile according to UHZ nvHAP data from the year 2017
  • high absolute number of patients with nvHAP according to UHZ nvHAP data from the year 2017
  • organizational structure, e.g. departments sharing same nursing or medical personnel
  • representing both medical and surgical specialties.

Information from the National Library of Medicine

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


Locations
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Switzerland
University Hospital Zurich, Dept. of Infectious Diseases and Hospital Epidemiology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Aline Wolfensberger, MD University of Zurich
Principal Investigator: Lauren Clack, PhD University of Zurich
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03361085    
Other Study ID Numbers: UHZ nvHAP Bundle
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
non-ventilator-associated hospital acquired pneumonia
Hospital-acquired Pneumonia
Healthcare Associated Infection
Adherence
infection prevention
implementation
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Healthcare-Associated Pneumonia
Cross Infection
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Iatrogenic Disease
Disease Attributes
Pathologic Processes