Hospital-acquired Pneumonia Clinical Trial
Official title:
Modular Prevention Bundle for Non-ventilator-associated Hospital-acquired Pneumonia (nvHAP)
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.
Methods
Aim:
With this mixed-methods study, we aim to investigate the impact of the implementation of a
newly designed nvHAP prevention bundle on the nvHAP incidence rate among inpatients in our
tertiary care hospital. We will quantify the adherence to the individual bundle elements and
qualitatively identify the factors that influence successful implementation.
Objectives:
1. To determine the nvHAP bundle effectiveness on the nvHAP incidence rate
2. To determine the adherence the nvHAP bundle and each of the bundle elements
3. To relate adherence to nvHAP bundle elements with nvHAP incidence rate
4. To qualitatively monitor changes and identify trends in implementation outcomes
throughout the study periods
5. To identify which factors in the implementation setting are associated with the actual
degree of local implementation of the nvHAP bundle
Study setting:
The study is conducted at the University Hospital Zurich (UHZ), Switzerland, a 950-bed
tertiary-care teaching hospital covering all medical specialties except paediatrics and
orthopaedics.
Study population:
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; 1)
nvHAP rate above the 50th percentile according to UHZ nvHAP data from the year 2017; 2) high
absolute number of patients with nvHAP according to UHZ nvHAP data from the year 2017; 3)
organizational structure, e.g. departments sharing same nursing or medical personnel; 4)
representing both medical and surgical specialties.
Intervention:
The nvHAP bundle: The University Hospital Zurich nvHAP bundle was designed by an
interprofessional and interdisciplinary group of experts. Elements were chosen based on the
evidence, although scarce, of their effectiveness and based on their anticipated feasibility
and implementability. The bundle consists of five prevention measures (details see Annex
nvHAP Bundle).
1. Oral care, i.e. mechanical and pharmacological oral care
2. Identification and treatment of patients with dysphagia, i.e. by applying a 'modified
swallowing assessment' (MSA) adapted from the 'Standardized Swallowing Assessment' by
Perry et al. (15) (Annex 'MSA Perry')
3. Mobilization, i.e. mobilization at least twice daily
4. Stopping unnecessary PPI and antacids
5. Respiratory therapy As not all bundle elements apply to all patients, the patients will
first be assessed for indication of the respective prevention measure after admission,
clinical deterioration, and major surgery during hospital stay. The execution of the
bundle element has to be documented in the electronic medical record (EMR).
Implementation strategy and formative evaluation: Our implementation strategy is designed to
increase ownership and local adoption in each department by engaging local implementation
teams, who establish department-specific actions based on local needs. This strategy is also
intended to facilitate adaptability, i.e. the degree to which the intervention can be adapted
to meet local needs (16, 17). Based on an initial behavioural analysis informed by
sensitizing frameworks (see below, "Implementation Frameworks") (16, 18, 19), we identified
the following as promising intervention functions to increase adherence to the nvHAP bundle:
increasing knowledge and understanding about the nvHAP bundle elements through education;
imparting skills through technical training; and changing the physical context to increase
awareness and support performance of nvHAP measures through environmental restructuring.
Whereas these intervention functions to increase adherence to the nvHAP bundle elements make
up the foreseeable core intervention components, each department is encouraged to adapt the
delivery of these components and to employ additional promotional components according to
local context, making up the 'soft periphery' of the intervention.
Local implementation teams, composed of one nurse, one physician and one physiotherapist,
will be established in each department. During recurrent "action plan" meetings, the local
implementation team from each department, with support from the nvHAP study team, will be
responsible for assessing the current implementation status with respect to each bundle
element and establishing an "action plan" with a list of planned actions aimed to increase
adherence to bundle elements according to local needs. Local implementation teams will be
responsible for implementing the nvHAP bundle in their respective departments. Established
"action plans" will be revisited to assess progress and refine necessary actions, as
described below.
The nvHAP study team, based in the infection prevention department, will form a central
coordinating team to provide local teams with support, example training materials, and
feedback on process and outcome data. Additionally, we will employ a formative approach,
during which we aim to continuously identify influences on implementation efforts (e.g.
barriers and facilitators) and feed these insights back to local implementation teams to
optimize the potential for implementation success (20). This formative evaluation will occur
in stages throughout the project, as described by Stetler and colleagues (20) and presented
in Table 1. The formative evaluation will rely primarily on "action plan" meetings as an
opportunity to feed information back to local implementation teams regarding identified
barriers and facilitators to implementation and to refine implementation action plans
accordingly.
Study design:
This mixed methods study collects and analyses quantitative and qualitative data collected
during the three study periods (baseline, implementation, and intervention period).
Study periods:
Baseline period will start at the same time for all departments and will be of different
length (minimum 12 months) as implementation of nvHAP prevention measures will occur at the
department level and the start of implementation activities is chosen by every department,
primarily relying on availability of resources.
We define three study periods on the department level, 1) department baseline period, before
implementation of nvHAP bundle in the specific department; 2) department implementation
period, a two month time frame starting with the beginning of implementation activities in
the respective department; 3) department intervention period following the department
implementation period.
On the hospital level the three periods are defined as follows: 1) hospital baseline period,
before starting implementation in the first department; 2) hospital implementation period,
from the beginning of the implementation period of the first department until end of
implementation period of the last included department; 3) hospital intervention period
following the hospital implementation period.
Implementation framework:
Our study is theoretically informed by the Consolidated Framework for Implementation Research
(CFIR) (16) and the Theoretical Domains Framework (TDF). Both the CFIR and the TDF integrate
findings from theoretical literature into synthesized frameworks consisting of constructs
that may mediate behaviour change. Whereas the TDF domains represent a set of constructs
related to individual behaviour change, the CFIR domains include constructs relating to
broader organizational behaviour change. For the current inquiry, we find the use of both
frameworks useful to capture influencers of behaviour at the individual level, as well as the
department, the overall hospital, and the wider environmental context. The CFIR and the TDF
will inform the intervention implementation strategy, as previously described, and guide the
qualitative data collection (semi-structured interview guides) and analyses (use of TDF as
deductive coding framework). In particular, use of these sensitising frameworks throughout
our study will facilitate the timely identification of barriers and facilitators and will
also provide insights as to which additional intervention components are most likely to be
successful in addressing the identified barriers.
Data collection:
Data sources: In the study hospital, all patient data are charted electronically via an EMR
system. Selected data are stored in a clinical data warehouse.
NvHAP surveillance We apply the European Centre for Disease Prevention and Control (ECDC)
definition criteria for pneumonia that are used in the ECDC point prevalence studies (10)
(Annex 'ECDC Definition nvHAP') and a validated semi-automated surveillance system for nvHAP
is used (22). Place of nvHAP acquisition is defined as department, ward and room to which the
patient was affiliated 48h before first symptoms of nvHAP, unless shorter incubation period
was evident from patient history.
Process indicators:
Process indicators portraying adherence to the nvHAP bundle elements will be monitored in two
ways. First, for all five prevention measures, at least one surrogate parameter for adherence
is continuously extracted from the EMR of the total patient population (continuous process
indicators; see Annex 'Process indicators'). This parameter, e.g. toothbrushing provided by
nurses, will be expressed per department, and month, and either hospital days or admissions.
Second, we will monitor process indicators on a sample basis with individual assessment of a
subset of patients at four different time points per department (intermittent process
indicators; see Annex 'Process indicators'). The latter allows a more detailed description of
adherence, including non-documented prevention measures (e.g. oral care executed by patient)
and takes into consideration the individual need of patients for the specific prevention
measure (e.g. respiratory therapy is indicated only in a subset of patients). From the
intermittent process indicators the 'nvHAP adherence score' will assess patient based
adherence per department and time point. The score is based on samples of 50 patients, the
'nvHAP adherence indicator' takes the value 1 in the case the specific prevention measure was
completed in the specific patient, 0 if that was not the case, and "empty" in the case of
missing values. The 'nvHAP adherence score' is calculated by summing up the five proportions
of patients with completed specific prevention measures (i.e. 'nvHAP adherence indicator'=1)
dividing it by factor five (Annex 'nvHAP adherence score').
Qualitative data collection:
Longitudinal qualitative data will be collected throughout the project as portrayed in Figure
2, including action plan interviews with local implementation teams, drop-in interviews with
frontline staff, and focus group interviews, as described in Table 2. These three data
collection activities will allow for rigorous triangulation of findings among data sources
and will all inform the ongoing formative evaluation (see Table 1).
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