Background
Using bundles to improve implementation of complex interventions
Trial objectives
Objective 1
Objective 2
Methods/design
Study design
Stepped-wedge design
Implementation framework
Study population
Recruitment
The intervention
Developing and piloting
Bundle components
Bundle component | Key activities |
---|---|
Training | - Tailored training activities with environmental services staff at the commencement of the intervention phase, as part of induction for new cleaning staff, and as required throughout the intervention phase - Content to reflect the trial site context and cleaning roles and responsibilities |
Technique | Attention to cleaning technique, including: - A defined and consistent cleaning sequence - A focus on cleaning high risk frequent touch points - The use of sufficient pressure and movement - Adherence to manufacturers’ instructions for product use |
Product | - Disinfectant minimally used for all discharge cleans and for daily cleans of high risk/precautions rooms - Point of care wipes used for medical equipment |
Audit | - Audit activities across the trial site using ultraviolet (UV) marker technology (all trial sites) and adenosine tri-phosphate (ATP) luminosity (3 trial sites) - Regular audit feedback to cleaning staff - Summarised audit results provided to clinical governance committees |
Communication | - Promotion of a team approach - Daily contact between cleaners and ward leaders or managers - Cleaners represented on relevant clinical governance committees |
Implementation
Randomisation
Outcomes and data collection: objective 1: effectiveness of the environmental cleaning bundle
Outcome | Measure | Method |
---|---|---|
Primary outcome | ||
Healthcare-associated infection (HAI) rates in each trial site | Numbers of Staphylococcus aureus bacteraemia (SAB), Clostridium difficile infection (CDI) and clinical isolates of vancomycin resistant enterococci (VRE) and monthly rates per 10,000 occupied bed days | Datasets include all patients across the hospital with a HAI, and data on occupied bed days Collated from: - Hospital infection data and reports for ongoing surveillance - Hospital occupied bed days reports |
Secondary outcome | ||
Hospital cleaning performance—thoroughness of hospital cleaning in each trial site | Number and percentage of ultraviolet (UV) gel dots removed completely following cleaning | DAZO® Fluorescent Marking Gel dots applied to frequent touch sites around two patient cubicle and bathroom areas in the intensive care unit (ICU) and the highest risk wards |
Other outcomes—study specific data set | ||
Bio-burden of frequent touch surfaces post cleaning | Levels of organic matter in relative light units (RLUs) post cleaning in three hospitals | Adenosine tri-phosphate (ATP) bioluminescence measurements |
Other outcomes—study specific data set | ||
Changes in staff knowledge and attitudes around environmental cleaning | Pre-intervention educational needs. Pre- and post-intervention knowledge and attitudes about environmental cleaning and job roles | Environmental services staff questionnaires and discussion groups |
Other outcomes—existing data set | ||
Changes in rates of screening and clinical isolates | Numbers of positive clinical isolates of other multi-resistant organisms per 1000 patient days at risk | Collated from hospital infection data and reports, where available for ongoing surveillance and supplied to project team by trial site team |
Other outcomes—existing data set | ||
Changes in patients’ perception of hospital cleanliness | Patients’ perceptions of cleanliness | Collated from existing hospital-based survey data, where available and supplied to project team by trial site team |
Primary outcome—HAI rates
Secondary outcome—thoroughness of routine hospital cleaning
Other outcomes
Power calculation
Analysis
Outcomes and data collection: objective 2: cost-effectiveness of the environmental cleaning bundle
Outcomes | Measures | Methods | |
---|---|---|---|
Primary outcome: Incremental cost-effectiveness ratio from adoption of the cleaning bundle presented as cost per quality-adjusted life year (QALY) gained (calculated from secondary outcomes) | |||
Secondary outcomes: | |||
1. Changes in costs associated with implementing the bundle | Frequency and value of resources used in implementing the bundle (costs incurred) | Hospital specific items collated from existing hospital-based data sets and supplied to project team by trial site team for analysis. Centralised resources recorded by project team. Valued in 2016 Australian dollars (AUD) | |
Cost of infection in terms of treatment costs, diagnosis costs and bed days saved (potential cost savings) | Calculated using estimates from the literature about the attributable cost of infection. Valued in 2016 AUD | ||
2. Changes in QALYs associated with implementing the bundle | Opportunity cost of infection in terms of: 1. Deaths 2. QALYs | Calculated using estimates from the published literature on attributable mortality and morbidity for infection |