Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000325505
Ethics application status
Approved
Date submitted
18/03/2015
Date registered
9/04/2015
Date last updated
29/04/2019
Date data sharing statement initially provided
15/03/2019
Date results provided
15/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Researching Effective Approaches to Cleaning in Hospitals
Scientific title
In 11 major public and private Australian hospitals, what is the effect of an environmental cleaning bundle intervention on healthcare associated infections (HAIs) and on health care costs?
Secondary ID [1] 286373 0
Nil known
Universal Trial Number (UTN)
U-1111-1167-7862
Trial acronym
REACH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthcare associated infections 294515 0
Condition category
Condition code
Infection 294818 294818 0 0
Other infectious diseases
Public Health 294819 294819 0 0
Health service research
Public Health 294820 294820 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Implementation of a cleaning bundle intervention, consisting of 5 interdependent components (training, audit, communication, product and technique), in 11 hospitals for randomly allocated time periods between 20 weeks and 50 weeks.
Interdependent bundle components are each tailored to meet the site context.

TRAINING
The study team will deliver tailored training activities (reflecting the educational needs identified at each site during the control period through the environmental services pre- intervention surveys):
- at the commencement of the intervention phase for all environmental services staff with a role in environmental cleaning
- as part of induction for new environmental services staff with a role in environmental cleaning
- and as required throughout the intervention phase.

Content of the introductory training activity (1-2 hour face-face session for environmental services staff) in week 1 of the intervention period will minimally include: the bundle components, clearly defined roles and responsibilities for environmental cleaning at the site and the impact of environmental cleaning on HAI.

Additional training sessions will continue throughout the intervention period as required by the site and provide responsive feedback from the bundle audit activities. Training will articulate with existing education events and timings in trial sites as much as possible, including induction for environmental services staff, team meetings and annual training updates.

TECHNIQUE
All environmental services staff at each site will follow an established cleaning technique throughout the intervention period when completing a daily clean or discharge clean.
It will be communicated to environmental services staff through the training and through availability of posters, fact sheets and tip sheets/ cards (e.g on the cleaning trolley).

PRODUCT
Each trial site will have existing supply arrangements for environmental cleaning product, including cleaning equipment. To promote cost-effectiveness and ensure feasibility the product component will be clarified with each site to ensure the product component:
- minimally includes the use of disinfectant for all discharge cleans and for daily cleans of high risk/contact precaution rooms. To ensure organic matter is removed effectively either a 2 in 1 detergent and disinfectant product or a 2-step process will be used
- minimally includes the use of point of care wipes for medical equipment
- is Therapeutic Good Administration approved for that use and setting
- adheres to manufacturers’ instructions for use
- is compatible with other product or application materials (e.g. microfiber cloths) in use
- ensures effective cleaning technique is used.
All environmental services staff with a role in environmental cleaning at the trial site will use this product component throughout the intervention period.

AUDIT
In this cleaning bundle the DAZO fluorescent marker system will be used monthly in the control and intervention periods as an audit tool by the study team or trained members of the site team at each trial site. DAZO® Fluorescent Marking Gel and UV Light system dries on surfaces following application and resists dry abrasion, but is removed with standard cleaning. The locations of the gel dots will be consistent with the Centers for Disease Prevention and Control Environmental Cleaning Checklist in two different bed and bathroom areas in the Intensive Care Unit and in at least 50% of the hospital trial site wards.

In 3 hospital sites the study team will use ATP luminometry bi-monthly in the same ward sites as the fluorescent markers to audit bio burden of the frequent touch surfaces post daily or discharge clean. The 3 hospitals will be located in either South East Queensland or at an investigator affiliated site due to equipment limitations.

COMMUNICATION
The communication component of the bundle will be implemented by the study and site teams, throughout the intervention period. Communication activities will focus on:
- maintaining a positive feedback loop to all staff about the audit results
- the role of the multidisciplinary team in preventing HAI
- creation of a ‘culture of hygiene’ through hospital wide promotional activities to raise the profile and importance of cleaning in reducing infections and support a culture shift in the perception of environmental services staff
- daily contact between cleaning staff and ward leaders or managers
- supporting the participation of cleaning staff on relevant clinical governance committees.

Site adherence with the bundle components will be monitored by the study team through fortnightly site contact and the review of audit results.
Intervention code [1] 291437 0
Prevention
Comparator / control treatment
The study design is a stepped wedge: each hospital acts as its own control for 8 weeks prior to commencing the intervention.
Control group
Active

Outcomes
Primary outcome [1] 294581 0
The (whole of hospital) combined number of healthcare associated Staphylococcus Aureus Bacteremia (SAB) infections, healthcare associated Clostridium Difficule infections (CDI) and positive clinical isolates of Vancomycin Resistant Enterococci (VRE) at each trial site. This is assessed through whole of hospital infection data and reports about these 3 HAIs, along with antimicrobial prescribing data (including antimicrobial agent, daily drug does and occupied bed days) and hand hygiene compliance data, supplied to the project team by the trial site team. Antimicrobial prescribing and hand hygiene rates may impact HAI rates, This data on healthcare associated infections is routinely collected by the trial site for ongoing surveillance.
Timepoint [1] 294581 0
HAI rates, antimicrobial prescribing data, and hand hygiene compliance data will be collected from 1 May 2015 to end of intervention
Primary outcome [2] 294582 0
Changes in costs associated with implementing the bundle relative to changes in health benefits (incremental cost effectiveness ratio). This is assessed by identifying the number and unit cost of resources used in implementing the bundle (including staff, training, cleaning product) and the opportunity cost of infection (treatment costs, bed days lost) quality adjusted life years (QALY) calculations.
Timepoint [2] 294582 0
Baseline (control period) and monthly during intervention period
Secondary outcome [1] 313659 0
The number (and %) of ultraviolet gel dots removed correctly following routine hospital cleaning.
The gel dots will be applied in frequent touch points (as per the Centers for Disease Prevention and Control Environmental Cleaning Checklist) post daily clean in two different bed and bathroom areas in the Intensive Care Unit and in at least 50% of the hospital trial site wards. Wards will be chosen that reflect the National Health Performance Authority (NHPA) risk factors for patient vulnerability: immunosuppressed patients and patients admitted with a risk of infection.

Following cleaning the next day, the sites will be checked using the UV light pen, which will (literally) show if the gel dot remains after the cleaning. The outcome measure will be cleaning success, as number of dots removed divided by the total number of dots placed. All results will be recorded using the iCombat application at the time of data collection.
Timepoint [1] 313659 0
At baseline (control period) and monthly during intervention period.
Secondary outcome [2] 313661 0
Adenosine Tri Phosphate (ATP) bio luminescence (levels of organic matter) in relative light units post cleaning in 3 trial site hospitals.
This will be assessed using an ATP luminometer swabbing sytem in seven frequent touch sites from the checklist used for the UV dots audits in the same bed/bathroom locations in the same wards, bi-monthly to coincide with the UV gel dots audits.
Timepoint [2] 313661 0
At baseline (control period) and two monthly during intervention period
Secondary outcome [3] 313662 0
Changes in staff knowledge and attitudes around environmental cleaning. This will be assessed by pre- and post intervention surveys of the environmental services staff and through discussion groups and interviews of environmental services staff with a role in environmental cleaning, pre- and post intervention.
Timepoint [3] 313662 0
Baseline (control period) and post intervention
Secondary outcome [4] 313663 0
Changes in number (and %) of screening isolates for Methicillin Resistant Staphylococcus Aureus (MRSA).
This is assessed through whole of hospital infection data and reports, supplied to the project team by the trial site team, where this data on MRSA screening isolates is already collected by the trial site for ongoing surveillance.
Timepoint [4] 313663 0
Baseline (control period) and monthly during intervention
Secondary outcome [5] 313664 0
Changes in number (and %) of clinical isolates of multi-resistant organisms
This is assessed through whole of hospital infection data and reports, supplied to the project team by the trial site team, where this data on multi resistant organisms is already collected by the trial site for ongoing surveillance.
Timepoint [5] 313664 0
At baseline (control period) and monthly during intervention period
Secondary outcome [6] 313665 0
Changes in patient perceptions of hospital cleanliness.

This data set is collated from existing hospital-based and approved survey processes and data, supplied to the study team by the trial site team. It could be ward/unit specific or a whole of hospital data set as per what is collected by the hospital as their usual procedure.

Timepoint [6] 313665 0
Baseline and if available during intervention period (existing data set)
Secondary outcome [7] 313666 0
Changes in costs associate with implementing the cleaning bundle
Timepoint [7] 313666 0
Baseline (control period) and monthly during intervention period
Secondary outcome [8] 313667 0
Changes in quality adjusted life years associated with implementing the bundle
Timepoint [8] 313667 0
Baseline (control period) and monthly during the intervention period

Eligibility
Key inclusion criteria
Acute hospitals that:
- have an intensive care unit accredited for advanced clinician training by the College of Intensive Care Medicine
- public hospitals - classified by the National Health Performance Authority (NHPA) as a ‘major hospital'
- private hospitals – over 200 in-patient beds
- have an established healthcare associated infection (HAI) surveillance program in place that collects data on SAB infections, CDI and VRE infections.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hospitals that do not meet all of the inclusion criteria.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation for the study will be performed through the simple computerised allocation of hospital identifiers (letters A to K). Trial sites will be randomly allocated to these identifiers and the intervention timing once 11 sites have been enrolled.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Stepped wedge trial: each hospital receives the intervention with length of the intervention randomly allocated to one of 11 time points between 20 and 50 weeks.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size:
Eleven hospitals with a pre-intervention infection rate (a combination of SAB, CDI and VRE) of 5 per 10,000 patient days will give us 86% power to detect a 20% post-intervention reduction in infection risk. This is based on a two-sided 5% significance level, a within-hospital correlation in infection rates of 0.3 and the stepped intervention timings between 20 and 50 weeks.
Analysis:
The Objective 1 primary outcome of infection rates will be analysed using Poisson regression with the infection counts as the dependent variable and the weekly number of patient days as the denominator. The key independent variable will be the intervention. The model will include a linear term for time to control for any long term patterns in infection rate, and analysed using a generalised linear mixed model (GLMM).

The Objective 1 secondary outcome of success or failure of environmental cleaning as measured by removal of UV gel dots will be examined using a similar GLMM but assuming a binomial response.

The Objective 1 secondary outcome of ATP assays will be quantified and expressed as relative light units, then analysed and correlated with the secondary outcome data (ultraviolet dots).

The Objective 1 outcome of changes in staff knowledge and attitudes around environmental cleaning will be analysed by reviewing the outcomes of pre and post intervention surveys and interviews.

For the Objective 2 primary outcome of cost effectiveness, the incremental cost effectiveness ratio at the hospital level, will be estimated by summing intervention costs and deducting cost savings from reduced lengths of stay and use of health care resources that arise from reduced incidences of infection.

The secondary outcome of changes to costs will be estimates by the extra staff time spent, costs of cleaning products, invisible gels, UV lamps and pathology costs. The changes to health benefits will be estimated in quality adjusted life years using the number of life years saved from reduced infection outcomes, the expected duration of life (had infection not occurred) based on age and co-morbidities.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2015
Actual
27/11/2015
Date of last participant enrolment
Anticipated
26/02/2016
Actual
29/04/2016
Date of last data collection
Anticipated
30/09/2017
Actual
28/02/2018
Sample size
Target
11
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 290943 0
Government body
Name [1] 290943 0
National Health and Medical Research Council (NHMRC)
Country [1] 290943 0
Australia
Funding source category [2] 290944 0
University
Name [2] 290944 0
Queensland University of Technology
Country [2] 290944 0
Australia
Funding source category [3] 290945 0
Other Collaborative groups
Name [3] 290945 0
Wesley Medical Research
Country [3] 290945 0
Australia
Funding source category [4] 290946 0
Commercial sector/Industry
Name [4] 290946 0
Kimberley-Clark Australia Pty Ltd
Country [4] 290946 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
GPO Box 2434
Brisbane, QLD 4001
Country
Australia
Secondary sponsor category [1] 289628 0
Other Collaborative groups
Name [1] 289628 0
Wesley St. Andrew's Research Institute
Address [1] 289628 0
PO Box 499
Toowong QLD 4066
Country [1] 289628 0
Australia
Other collaborator category [1] 278401 0
University
Name [1] 278401 0
Avondale College of Higher Education
Address [1] 278401 0
Avondale College of Higher Education, 185 Fox Valley Road,
Wahroonga
NSW, 2076.
Country [1] 278401 0
Australia
Other collaborator category [2] 278402 0
University
Name [2] 278402 0
Australian Catholic University Limited
Address [2] 278402 0
PO Box 968, North Sydney NSW 2059
Country [2] 278402 0
Australia
Other collaborator category [3] 278403 0
University
Name [3] 278403 0
University of Western Australia
Address [3] 278403 0
35 Stirling Highway, Crawley WA 6009
Country [3] 278403 0
Australia
Other collaborator category [4] 278404 0
Commercial sector/Industry
Name [4] 278404 0
Whiteley Corporation Pty Ltd
Address [4] 278404 0
PO Box 1076
North Sydney NSW 2059
Country [4] 278404 0
Australia
Other collaborator category [5] 278405 0
Commercial sector/Industry
Name [5] 278405 0
Ecolab Pty Ltd
Address [5] 278405 0
PO Box 383
Nrth Ryde BC 1670 NSW
Country [5] 278405 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292545 0
UnitingCare Health Human Research Ethics Committee
Ethics committee address [1] 292545 0
Ethics committee country [1] 292545 0
Australia
Date submitted for ethics approval [1] 292545 0
Approval date [1] 292545 0
02/09/2014
Ethics approval number [1] 292545 0
1413
Ethics committee name [2] 292546 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [2] 292546 0
Ethics committee country [2] 292546 0
Australia
Date submitted for ethics approval [2] 292546 0
Approval date [2] 292546 0
12/11/2014
Ethics approval number [2] 292546 0
1400000828
Ethics committee name [3] 295358 0
St Vincent's Health and Aged Care Human Research Ethics Committee
Ethics committee address [3] 295358 0
Ethics committee country [3] 295358 0
Australia
Date submitted for ethics approval [3] 295358 0
16/09/2015
Approval date [3] 295358 0
15/10/2015
Ethics approval number [3] 295358 0
HREC15/13
Ethics committee name [4] 295359 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [4] 295359 0
Ethics committee country [4] 295359 0
Australia
Date submitted for ethics approval [4] 295359 0
09/09/2015
Approval date [4] 295359 0
06/11/2015
Ethics approval number [4] 295359 0
HREC/15/QRBW/463
Ethics committee name [5] 295360 0
Barwon Health Human Research Ethics Committee
Ethics committee address [5] 295360 0
Ethics committee country [5] 295360 0
Australia
Date submitted for ethics approval [5] 295360 0
10/11/2015
Approval date [5] 295360 0
01/12/2015
Ethics approval number [5] 295360 0
15/159
Ethics committee name [6] 295361 0
Hunter New England Human Research Ethics Committee
Ethics committee address [6] 295361 0
Ethics committee country [6] 295361 0
Australia
Date submitted for ethics approval [6] 295361 0
02/12/2015
Approval date [6] 295361 0
17/12/2015
Ethics approval number [6] 295361 0
LNR/15/HNE/527
Ethics committee name [7] 295362 0
Tasmanian Health and Medical Human Research Ethics Committee
Ethics committee address [7] 295362 0
Ethics committee country [7] 295362 0
Australia
Date submitted for ethics approval [7] 295362 0
25/01/2016
Approval date [7] 295362 0
15/02/2016
Ethics approval number [7] 295362 0
H0015519
Ethics committee name [8] 295363 0
Northern Health Human Research Ethics Committee
Ethics committee address [8] 295363 0
Ethics committee country [8] 295363 0
Australia
Date submitted for ethics approval [8] 295363 0
02/03/2016
Approval date [8] 295363 0
14/04/2016
Ethics approval number [8] 295363 0
LR 03.2016
Ethics committee name [9] 295364 0
Eastern Health Human Research Ethics Committee
Ethics committee address [9] 295364 0
Ethics committee country [9] 295364 0
Australia
Date submitted for ethics approval [9] 295364 0
19/01/2016
Approval date [9] 295364 0
09/02/2016
Ethics approval number [9] 295364 0
LR05/2016
Ethics committee name [10] 295365 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [10] 295365 0
Ethics committee country [10] 295365 0
Australia
Date submitted for ethics approval [10] 295365 0
11/11/2015
Approval date [10] 295365 0
07/01/2016
Ethics approval number [10] 295365 0
470.15 - HREC/15/SAC/457
Ethics committee name [11] 295366 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [11] 295366 0
Ethics committee country [11] 295366 0
Australia
Date submitted for ethics approval [11] 295366 0
16/03/2016
Approval date [11] 295366 0
29/04/2016
Ethics approval number [11] 295366 0
2016-057

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

Contacts
Principal investigator
Name 55858 0
Prof Nicholas Graves
Address 55858 0
Queensland University of Technology
GPO Box 2434
Brisbane QLD 4001
Country 55858 0
Australia
Phone 55858 0
+61 7 3138 3814
Fax 55858 0
Email 55858 0
[email protected]
Contact person for public queries
Name 55859 0
Alison Farrington
Address 55859 0
Queensland University of Technology
GPO Box 2434
Brisbane QLD 4001
Country 55859 0
Australia
Phone 55859 0
+61 7 3138 6132
Fax 55859 0
Email 55859 0
[email protected]
Contact person for scientific queries
Name 55860 0
Alison Farrington
Address 55860 0
Queensland University of Technology
GPO Box 2434
Brisbane QLD 4001
Country 55860 0
Australia
Phone 55860 0
+61 7 3138 6132
Fax 55860 0
Email 55860 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data sets will be available from the statistician (Adrian Barnett) once results are published.
Currently available:
Pre- and post-questionnaire results: attitudes and knowledge of environmental services cleaning staff in 11 Australian hospitals; https://doi.org/10.25912/5c19d34b15ce4
To be available from 09/09/19:
REACH Project: Healthcare associated infections dataset 2019
https://doi.org/10.25912/5c883949ee806
When will data be available (start and end dates)?
Questionnaire data sets currently available; no end date determined
Additional data sets to be available once embargoes lifted and results published.
Available to whom?
The data custodian (study statistician Adrian Barnett) will provide the data sets upon request, pending ethical and other approvals.
Available for what types of analyses?
To be assessed by the data custodian (study statistician Adrian Barnett), pending ethical and other approvals.
How or where can data be obtained?
Data will be made available via a file transfer from the data custodian.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseResearching effective approaches to cleaning in hospitals: protocol of the REACH study, a multi-site stepped-wedge randomised trial.2016https://dx.doi.org/10.1186/s13012-016-0406-6
EmbaseChanges in knowledge and attitudes of hospital environmental services staff: The Researching Effective Approaches to Cleaning in Hospitals (REACH) study.2018https://dx.doi.org/10.1016/j.ajic.2018.02.003
EmbaseAn environmental cleaning bundle and health-care-associated infections in hospitals (REACH): a multicentre, randomised trial.2019https://dx.doi.org/10.1016/S1473-3099%2818%2930714-X
N.B. These documents automatically identified may not have been verified by the study sponsor.