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Trial registered on ANZCTR


Registration number
ACTRN12622001143718
Ethics application status
Approved
Date submitted
16/08/2022
Date registered
22/08/2022
Date last updated
27/09/2023
Date data sharing statement initially provided
22/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised control trial investigating the effect of a thorough cleaning technique for shared medical equipment on the rate of healthcare associated infections
Scientific title
A randomised control trial investigating the effect of a thorough cleaning technique for shared medical equipment on the rate of healthcare associated infections
Secondary ID [1] 307788 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthcare associated infection 327366 0
Condition category
Condition code
Infection 324490 324490 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this stepped wedge design, there are 5 clusters, with two wards making up cluster. Each step (time period) in the trial is 6 weeks. At each step, the next cluster will transition from control to intervention. Therefore, the length of the intervention will vary from 6 weeks (last cluster to transition) to 30 weeks (first cluster to transition).

The intervention will consist of 1) additional cleaning and 2) education, audit and feedback on cleanliness to cleaning and nursing staff. Further detail on these two components of the intervention are provided below. This multi-modal approach is grounded in the literature and recent research. The primary target for the intervention are cleaning staff.


Additional cleaning
During the intervention phase, each ward will receive an additional 3 hours cleaning per weekday by dedicated (nominated) cleaners. This is in addition to routine cleaning that already occurs. The use of dedicated cleaners will reduce the risk of contamination The additional cleaning will focus on specific shared medical equipment at a minimum frequency. The use of a Therapeutic Goods Administration (TGA) registered disinfectant wipe effective against a range bacteria and viruses will be used for additional cleaning. The fidelity of the additional cleaning will be measured using the fluorescent markers, described in the next section. In addition, items that have been cleaned but remain in storage until use will be labelled as cleaned, using bright labelling. This will enable clinical staff can easily identify which equipment is clean and ready for use.

Education, audit and feedback
The dedicated cleaners undertaking the additional cleaning will undergo education and training prior to commencement of the intervention. Education prior to the invention will include at least a 1 hour in-service, where cleaning technique will be taught and practiced. This will occur no longer than 2 months prior to the commencement of the intervention. The training will be delivered by staff experienced in education and cleaning practice. Standard operation procedures for cleaning specific items of shared medical equipment will be developed, and subsequently explained at the in-service. These will also be readily available for staff for future reference as needed.


The benefits and role of audit, including the use of fluorescent markers (FM), in assessing environmental cleaning, is well documented. Audit and feedback to the cleaning staff involved in the additional cleaning, will include the use of FM technology, in which invisible gel dots that are removed by cleaning are applied to surfaces. The dots are invisible to the naked eye, resist dry abrasion, and are removed completely by routine cleaning. A structured auditing approach, with staff feedback underpinned by education, will aid improvements in cleaning, as shown in multiple studies.

During the intervention phase:
• audit results will be reported to cleaning staff at the time of audit; cleaning supervisors and the nurse unit manager.
• audit results will be used to inform further education and training.
• additional reports will be provided for internal committees, such as the Infection Prevention and Control committee, as required.

Collection process for FM audits
The research team will sample up to ten pieces of shared equipment, minimum of 4 different types of equipment per ward each fortnight through the control and intervention periods. The choice of equipment will be undertaken using a random process, generated using Microsoft Excel, of nominated pieces of equipment on each ward. The person undertaking the FM audit will be a member of the research team not involved in the randomisation process and they are not part of the cleaning staff. Cleaning staff will not be aware of the exact placement of the dots. The timing of the sampling and reaudit will require some flexibility, to ensure there has been an opportunity to clean the equipment between application of the FM and subsequent review. The equipment will be checked by the research team using an ultraviolet light torch to determine whether the dot had been completely removed. The timeframe between the FM placement and checking removal will be approximately 24 hours, to allow the opportunity for the equipment to have been cleaned once.
Intervention code [1] 324250 0
Behaviour
Comparator / control treatment
The current standard level and frequency of cleaning int hospital, based on Gosford Hospital procedures and policy.
Control group
Active

Outcomes
Primary outcome [1] 332316 0
The proportion of in-patients aged equal to or greater than 18 years old with a healthcare associated infection (HAI) as measured by a HAI point prevalence study (PPS). The source data for the point prevalence surveys will be patient medical records. This includes medical notes, pathology and radiological records.
Timepoint [1] 332316 0
Fortnightly point prevalence surveys during the course of the stepped wedge design. Survey will occur until the end of the trial i.e. 9 months.
Secondary outcome [1] 412999 0
The thoroughness of cleaning as being the probability that a dot (single item) was completely removed, as measured by the florescent gel and ultraviolet light system
Timepoint [1] 412999 0
Fortnightly, throughout the course of the stepped wedge design. They will occur until the end of the trial i.e. 9 months.
Secondary outcome [2] 413000 0
The cost-effectiveness of using the intervention.

For the secondary outcome, the costs of adopting the intervention will prospectively collected from hospital financial records. Excess length-of-stay estimates will be sourced from studies identified by systematic reviews.

Timepoint [2] 413000 0
This outcome will be evaluated at the end of the trial i.e. 9 months.

Eligibility
Key inclusion criteria
This project collects data associated with human beings only. Data from all patients (>18 years old) who are admitted to one of the 10 wards on the day of the point prevalence survey is undertaken will be used.

The cleaning staff involved in the intervention will be cleaners who using clean the wards as part of their usual duties. This will be via an expression of interest process.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
<18 years
Not a patient on an enrolled ward at the time the point prevalence survey is undertaken.

Cleaning staff who do not usually perform ward and hospital cleaning as part of their normal duties will not be eligible to take part in the expression of interest.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation for the study will be performed through the allocation of ward identifiers prior to commencement of the intervention roll-out. The allocation is undertaken by a person off site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
Stepped-wedge design. There will be sequential roll-out of the environmental cleaning bundle over 36 weeks. All wards receive the intervention, with the timing randomised. Wards will be randomly allocated to intervention timing.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size
The study design ensures a sample size sufficient to detect a reduction of at least 35% in total HAI infection, with a baseline point prevalence of 11%. It is powered at 80%, based on a two-sided 5% significance level with an inter-cluster correlation of 0.3 and coefficient of variation of 0.65 – allowing for variation in cluster size. A stepped-wedge sample size formula was used, considering the number and size of clusters and the time period. The required cluster size is 132 (66 per ward), achieved with two wards forming clusters and three PPS each time-period (N=3,960 - 5 clusters, 6 time periods). The baseline infection rate was determined using recently published work by the applicant and reductions identified in a recent RCT. Varying the intra-cluster correlation between 0.2 and 0.5 produced minimum sample sizes per cluster-period of 94 (47 per ward) to 150 (75 per ward).

Primary outcome analysis
For the primary outcome, a generalised mixed model will be used, to estimate changes in fortnightly cases of HAI. To standardise rates, fortnightly numbers of HAIs (combined, all types of HAIs) will be divided by the number of at risk patients. Models will have a random intercept for each ward to control for baseline differences and fixed effects for the intervention and study time. Models had a random intercept for each ward to control for baseline differences between wards, a linear fixed effect to control for unrelated changes over time, and a binary independent variable for the intervention that switched from “no” to “yes” one week after the intervention started to allow for a delay in the intervention effect.

We will undertake sensitivity analyses to determine the possibility of a delayed intervention effect of longer than one week, the influence of each ward, and the effect of the intervention on the most common and serious HAIs – pneumonia, urinary tract infections, blood stream infections and surgical site infection. The delayed intervention effect will be modelled at 2 and 4 weeks after each ward’s intervention start date. The influence of each ward will be examined using a leave-one-hospital-out analysis examining changes to the intervention effect and Cook’s distances.

Secondary outcome analysis

FM audits
We will analyse data from fortnightly cleaning audits using a binomial generalised linear mixed model with a logit link function on the proportion of frequent touch points that were deemed cleaned. A random intercept will be included for each ward. The effect of the intervention will be tested in three ways: a binary intervention effect, to model an immediate improvement in cleaning; a linear intervention effect, defined as weeks after each ward’s intervention start date, to model a more gradual improvement over time; and a combined binary–linear intervention effect.

Cost effectiveness
The cost- effectiveness of the intervention will be evaluated from the perspective of the hospital decision maker. Cost-effectiveness will be summarised by the incremental cost-effectiveness ratio and net monetary benefit, which offer different summaries of the change in costs versus health benefits. Probabilistic sensitivity analysis will be undertaken to account for uncertainty in model parameters and its impact on cost-effectiveness outcomes.

Uncertainties in parameter estimates will be captured using appropriate statistical distributions to describe the variability. The fitted distributions will be subject to random re-samples simulated 10,000 times. The distributions of all prior parameters are used to estimate the posterior distributions of ‘change to costs’ and ‘change to QALY’ outcomes. The decision will be informed by plotting cost-effectiveness acceptability curves with threshold value between zero and 100,000 per QALY gained, and using the net monetary benefits framework. These approaches are semi Bayesian and appropriately account for all parameter uncertainty for the adoption decisions.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/03/2023
Actual
20/03/2023
Date of last participant enrolment
Anticipated
10/11/2023
Actual
Date of last data collection
Anticipated
17/11/2023
Actual
Sample size
Target
3960
Accrual to date
2600
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22979 0
Gosford Hospital - Gosford
Recruitment postcode(s) [1] 38287 0
2250 - Gosford
Recruitment postcode(s) [2] 38288 0
2250 - West Gosford

Funding & Sponsors
Funding source category [1] 312059 0
Government body
Name [1] 312059 0
National Health and Medical Research Council
Country [1] 312059 0
Australia
Primary sponsor type
University
Name
Avondale University
Address
582 Freemans Drive (PO Box 19), Cooranbong NSW 2265, Australia
Country
Australia
Secondary sponsor category [1] 313563 0
None
Name [1] 313563 0
Address [1] 313563 0
Country [1] 313563 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311468 0
Hunter New England HREC
Ethics committee address [1] 311468 0
Ethics committee country [1] 311468 0
Australia
Date submitted for ethics approval [1] 311468 0
01/09/2022
Approval date [1] 311468 0
23/09/2022
Ethics approval number [1] 311468 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121202 0
Prof Brett Mitchell
Address 121202 0
Avondale University, 582 Freemans Drive (PO Box 19), Cooranbong NSW 2265, Australia
Country 121202 0
Australia
Phone 121202 0
+61 2 4980 2397
Fax 121202 0
Email 121202 0
brett.mitchell@avondale.edu.au
Contact person for public queries
Name 121203 0
Brett Mitchell
Address 121203 0
Avondale University, 582 Freemans Drive (PO Box 19), Cooranbong NSW 2265, Australia
Country 121203 0
Australia
Phone 121203 0
+61 2 4980 2397
Fax 121203 0
Email 121203 0
brett.mitchell@avondale.edu.au
Contact person for scientific queries
Name 121204 0
Brett Mitchell
Address 121204 0
Avondale University, 582 Freemans Drive (PO Box 19), Cooranbong NSW 2265, Australia
Country 121204 0
Australia
Phone 121204 0
+61 2 4980 2397
Fax 121204 0
Email 121204 0
brett.mitchell@avondale.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Aggregrated data only will be stored, consistent with ethics application (waiver of consent).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16926Study protocol  brett.mitchell@avondale.edu.au Please contact the lead investigator as required.
16927Ethical approval  brett.mitchell@avondale.edu.au Contact the lead investigator



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomised controlled trial investigating the effect of improving the cleaning and disinfection of shared medical equipment on healthcare-associated infections: the CLEaning and Enhanced disiNfection (CLEEN) study.2023https://dx.doi.org/10.1186/s13063-023-07144-z
N.B. These documents automatically identified may not have been verified by the study sponsor.