NCT03361085

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

Terminated NA Last updated 14 July 2020

What this trial tests

NA trial testing nvHAP Prevention Bundle in Hospital-acquired Pneumonia in 45,000 participants. Terminated before completion.

Timeline

1 January 2018

Primary endpoint
28 February 2020

28 February 2020

Quick facts

Lead sponsor	University of Zurich
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Design	sequential
Masking	none
Primary purpose	prevention
Enrollment	45,000
Start date	1 January 2018
Primary completion	28 February 2020
Estimated completion	28 February 2020
Sites	1 location across Switzerland

Drugs / interventions tested

• nvHAP Prevention Bundle

Conditions studied

• Hospital-acquired Pneumonia — all drugs for Hospital-acquired Pneumonia →
• Healthcare Associated Infection — all drugs for Healthcare Associated Infection →
• Infection Prevention — all drugs for Infection Prevention →

Sponsor

University of Zurich

Who can join

18 and older, any sex, with Hospital-acquired Pneumonia or Healthcare Associated Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Prevention of non-ventilator-associated hospital-acquired pneumonia in Switzerland: a type 2 hybrid effectiveness-implementation trial.
   Wolfensberger A, Clack L, von Felten S, Faes Hesse M, et al · · 2023 · cited 17× · PMID 36893785 · DOI 10.1016/s1473-3099(22)00812-x
2. Care bundles for improving outcomes in patients with COVID-19 or related conditions in intensive care - a rapid scoping review.
   Smith V, Devane D, Nichol A, Roche D. · · 2020 · cited 11× · PMID 33348427 · DOI 10.1002/14651858.cd013819
3. 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.
   Wolfensberger A, Clack L, von Felten S, Kusejko K, et al · · 2020 · cited 10× · PMID 32807090 · DOI 10.1186/s12879-020-05271-5