Modular Prevention Bundle for Non-ventilator-associated Hospital-acquired Pneumonia (nvHAP)

NCT03361085 | Terminated

• 1 other identifier: UHZ nvHAP Bundle
• Study Type: interventional
• Target: 45,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hospital-acquired Pneumonia; Healthcare Associated Infection; Infection Prevention

Keywords

non-ventilator-associated hospital acquired pneumonia; Hospital-acquired Pneumonia; Healthcare Associated Infection; Adherence; infection prevention; implementation

Outcome Measures

Primary Outcomes (1)

• nvHAP Incidence rate

  non Ventilator-associated Hospital acquired Pneumonia according to ECDC definitions

  up to 3 months post-discharge

Secondary Outcomes (2)

• Percentage of patients who passed away during hospitalization (in-hospital mortality)

  up to 3 months post-discharge

• length of stay

  up to 3 months post-discharge

Other Outcomes (3)

• 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)

  at four timepoints (baseline, 2-3 months 4-6 months and 10-12 months after start implentation, 10

• Adherence score per department and timepoint

  at four timepoints (baseline, 2-3 months 4-6 months and 10-12 months after start implentation, 10

• Implementation success evaluated by semi-structured interview and focus group interview

  at three timepoints ( 2-3 months 4-6 months and 10-12 months after start implentation, 10

Study Arms (1)

Intervention

EXPERIMENTAL

nvHAP-Prevention Bundle

Procedure: nvHAP Prevention Bundle

Interventions

nvHAP Prevention Bundle PROCEDURE

oral care, (early) mobilization, diagnosis and treatment of dysphagia, respiratory physiotherapy, stop Proton pump Inhibitors (PPI) if reasonable

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Dept. of Infectious Diseases and Hospital Epidemiology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (2)

• Wolfensberger A, Clack L, von Felten S, Faes Hesse M, Saleschus D, Meier MT, Kusejko K, Kouyos R, Held L, Sax H. Prevention of non-ventilator-associated hospital-acquired pneumonia in Switzerland: a type 2 hybrid effectiveness-implementation trial. Lancet Infect Dis. 2023 Jul;23(7):836-846. doi: 10.1016/S1473-3099(22)00812-X. Epub 2023 Mar 6.

  PMID: 36893785 DERIVED

• Wolfensberger A, Clack L, von Felten S, Kusejko K, Faes Hesse M, Jakob W, Saleschus D, Meier MT, Kouyos R, Held L, Sax H. Implementation and evaluation of a care bundle for prevention of non-ventilator-associated hospital-acquired pneumonia (nvHAP) - a mixed-methods study protocol for a hybrid type 2 effectiveness-implementation trial. BMC Infect Dis. 2020 Aug 17;20(1):603. doi: 10.1186/s12879-020-05271-5.

  PMID: 32807090 DERIVED

MeSH Terms

Conditions

Healthcare-Associated Pneumonia; Cross Infection

Condition Hierarchy (Ancestors)

Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aline Wolfensberger, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

• Lauren Clack, PhD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: quasi experimental intervention study

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: December 4, 2017
• Study Start: January 1, 2018
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)