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Trial registered on ANZCTR


Registration number
ACTRN12624000062527
Ethics application status
Approved
Date submitted
13/12/2023
Date registered
25/01/2024
Date last updated
29/08/2024
Date data sharing statement initially provided
25/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluate the effectiveness of the SAFET nursing care bundle in protecting skin from DEvice harm across the liFEspan iN Critical illnEss: The DEFENCE project
Scientific title
A hybrid type 2 effectiveness-implementation study with a sequential, multi-centre, incomplete stepped wedge cluster trial to evaluate the effectiveness of the SAFET nursing care bundle to prevent device related pressure injuries in ICU patients across the lifespan
Secondary ID [1] 310836 0
Grant ID: APP2022546: Issuing authority: Australian Government (NH&MRC Partnership Scheme)
Universal Trial Number (UTN)
Trial acronym
DEFENCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Device-related pressure injuries 332293 0
Condition category
Condition code
Skin 329007 329007 0 0
Other skin conditions
Injuries and Accidents 329008 329008 0 0
Other injuries and accidents
Public Health 329205 329205 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The DEFENCE study aims to co-develop implementation strategies, and then test, evaluate and disseminate a bundle of evidence-based, cost-effective scalable practices to prevent medical device-related pressure injury in critically ill patients of all ages: the SAFET bundle.

The SAFET Bundle spans 5 elements to prevent device related pressure injuries. 1) Select and size the device for the patient 2) Assess and protect the skin surrounding the device and associated tubing and cords 3) Fix and secure the device to maintain patency and performance 4) Evaluate and exchange the position of the device if possible and 5) Timely removal of devices as needed.

This project uses a hybrid type 2 effectiveness-implementation method, comprising of two phases. The first phase consists of a mixed method approach informed by the Consolidated Framework for Implementation Research (CFIR) which will be used to identify site specific barriers and enablers to the uptake of evidence and co-design of tailor-made strategies for bundle implementation – the SAFET bundle - to eliminate device-related pressure injuries.

Adjacent to the trial is a number of research activities to evaluate the SAFET bundle implementation and its cost effectiveness and its sustainability.

Phase 1 survey and workshops will be conducted before any site starts Phase 2. Additional Phase 1 survey (costing) and site implementation meetings (no participants) will be conducted in the set up and control periods. Phase 1 starts with an survey to identify possible implementation barriers to the SAFET bundle. This survey will be conducted by clinical staff participants who will be notified about the surveys through their normal workplace communication channels such as in-service or their work email. Quantitative data from the initial implementation survey will be analysed descriptively and mapped to CIFR constructs

Following the survey and before the start of Phase 2, three 2-3 hour workshops (10 participants each) will be conducted to analyse the results. These will be run by Study Investigators. Identified CFIR barriers from survey will be used to generate matched implementation strategies using the Expert Recommendations for Implementing Change (ERIC) matching tool for all sites. This will prioritize the recommended strategies through consensus building and nominal group techniques. Workshop attendees will be identified through purposive sampling of clinical staff, implementation practitioners and health consumers from all 8 ICU sites. Participants will be invited to participate via their normal workplace communication channels such as in-service or their work email or assessing local consumer networks for consumer participants.

Cost effectiveness of both the implementation of the SAFET bundle and the invention will be analysed.
1) An implementation costing analysis will estimate the cost of co-developing the implementation strategies in Phase 1. Information from the Implementation surveys, combined with project documentation (activity logs) including meeting minutes and workshop attendance records, will be used to determine costs (primarily salaries) associated with co-developing the tailored implementation strategies [Phase 1, before the start of any Phase 2 activities].
2) Willingness to pay survey. Participants will be asked to consider what they would be willing to pay, in monetary terms, for a given outcome. Participants are typically asked to consider this in the context of paying from their own pocket, given their current financial circumstances and budgetary considerations. This short survey will involve purposively sampling from three key participant groups: health service managers and decision makers; ICU clinicians; and health consumers. [Phase 1, before the start of any Phase 2 activities].
3) Cost effectiveness analysis from three costing activities A) Activity logs of any training, stakeholder engagement and facilitation activities [Phase 2, control, transition and intervention periods] b) SAFET bundle costings including recourses, consumables and staff time to deliver the bundle [Phase 2 Intervention period, final month] and c) Device related pressure injury treatment costs [Phase 2, control, transition and intervention periods]

Phase 2 will test the impact of the SAFET bundle and implementation strategies in practice using a sequential, multi-centre, incomplete, stepped-wedge, cluster randomised trial design compared to standard care.

The Phase 2 trial will be conducted in five public hospitals in Queensland over 8 ICUs or cluster including neonatal, paediatric and adult ICUs. The trial period (17 month period) for each ICU will involve a month of project set up, 4-month control period, 2 month transition period where the intervention is introduced, 6-month intervention period, 3-month wash out period and a 1-month sustainability period. Patient data collection will occur during the control, transition, intervention and sustainability periods. The steps are one month periods with a new ICU starting every month. Order of ICU enrolments will be determined by a pragmatic randomisation. Thus each ICU, selected randomly, will start sequentially in one month steps over an eight month period and will finish in one month steps again over eight months, The total trial period for all 8 ICUs will cover 24 months.

The Clusters (ICUs) are:-
1) Mater Mothers Hospital Neonatal ICU
2) Queensland Children's Hospital Paediatric ICU
3) Royal Brisbane and Women's Hospital Neonatal ICU
4) Royal Brisbane and Women's Hospital Adult ICU
5) The Prince Charles Hospital Adult ICU
6) Townsville University Hospital Neonatal ICU
7) Townsville University Hospital Paediatric ICU
8) Townsville University Hospital Adult ICU

The SAFET care bundle will be introduced in the transition period (two months). Site investigators and study champions will liaison with ICU clinicians to provide training and assistance with implementation of the bundle elements. Strategies to introduce the SAFET bundle will be identified through the Phase 1 processes (Implementation survey and workshop followed by Implementation meeting at each site) and will be adapted for each site. The elements of the SAFET bundle will remain the same through all ICU sites but will be tailored for each site depending on devices used, patient population and clinical practices.

The elements of the SAFET bundle include:-
1) Select and size the device. Device application should be based on direct clinical need, and they should be sized and fitted to the patient.
2) Assess and protect the skin. The condition of the skin and mucous membranes under and around the device can serve as an early indicator of tissue damage from pressure. Regular assessment of these areas should be conducted (8-hourly minimum) as part of routine skin assessment.
3) Fix and secure. Most devices are fixed to the skin surface with tape or strapping creating high pressure and shear forces at the device-skin interface. The primary recommendation for securement is a simple method that minimises the mechanical pressure of the device against the tissues or, if appropriate, keeps the device free in the orifice.
4) Evaluate and exchange position. Simple steps to reposition or rotate devices to redistribute or offload pressure over different parts of the tissues should be performed regularly (optimally at least 4-hourly), noting this is device-type dependent. Care should be taken to ensure the device is not dependent by minimising the gravitational pull of the device on the skin and other tissues.
5) Timely removal. Timely removal of, or changing the device location, should be considered regularly (at least daily), and devices should be removed as soon as clinically possible.

The devices will include those to assist with breathing (endotracheal tubes, bite block, high flow nasal prongs, face masks, nasal cannula, CPAP and tracheostomy); feeding (nasogastric and orogastric tubes, percutaneous endoscopic gastrostomy and jejunostomy); catheters (central lines, arterial lines, peripherally inserted central catheter, ecmo, dialysis catheter, peripheral intravenous catheters); probes (oxygen saturation probe, blood pressure cuffs, ECG dots and leads, iWatch, temperature and glucose monitors, intracranial pressure monitoring probes and tubes); Indwelling and suprapubic catheters; restraints and braces (cervical collar, x-fixes, traction, pin sites, splints and braces, wrist/ankle restraints); bowel management systems (bowel management system, faecal containment device, rectal tubes); and others (DVT prophylaxis (stockings and compression devices), epidurals, cooling and warming blankets, heel wedges).

The patient population for Phase 2 will be all patients admitted to the 8 cluster ICUs who have at least one device and have not been previously enrolled in the trial. Patients will exit the trial after 21 days or discharge from the ICU or death. Patients will be selected from the population for data collection by randomisation. Patient data collection will include patient demographic and clinical characteristics, devices and securements information, compliance with the SAFET bundle (only in the intervention and sustainability periods) and presence of device related pressure injuries

Obtaining individual consent from patients is impractical and as the intervention is a care bundle of known clinical practices and quality improvement in nature, we have a waiver of consent to collect de-identified patient data.

Protocol compliance on each of the 5 SAFET bundle elements will be assessed daily during research nurse observation (yes/no). The sustainability of the bundle will be assessed during the sustainability period of one month, following a three month wash out period [4th month post intervention]. Nursing ICU staff will be surveyed for the study acceptability, appropriateness, feasibility and sustainability. Proportion of device related pressure injuries will be measured during this sustainability month.
Intervention code [1] 327580 0
Prevention
Comparator / control treatment
A sequential, multi-centre, incomplete stepped-wedge cluster randomised control trial design will be used to evaluate the SAFET care bundle of evidence-based clinical practices compared with standard nursing care. Every cluster ICU will provide a 4-month control period data on device-related pressure injuries. Standard nursing care will be the practices and procedures used by nurses in each separate ICU to prevent and treat device related pressure injuries.
Control group
Active

Outcomes
Primary outcome [1] 336805 0
The proportion of patients with at least one new ICU device-related pressure injury in the intervention group compared to control /usual care.
Timepoint [1] 336805 0
During the control and intervention periods. Observations taken daily for the length of the patient admission until trial exit at day 21 or discharge or death.
Secondary outcome [1] 429723 0
New ICU Device-related pressure injury proportions per 1000 bed days in the intervention group compared to control /usual care.
Timepoint [1] 429723 0
During the control and intervention periods. Observations taken daily for the length of the patient admission until trial exit at day 21 or discharge or death.
Secondary outcome [2] 429725 0
Time to new ICU device-related pressure injury development in the intervention group compared to control /usual care.
Timepoint [2] 429725 0
During the control and intervention periods. Observations taken daily for the length of the patient admission until trial exit at day 21 or discharge or death.
Secondary outcome [3] 429726 0
Number of new ICU device related pressure injuries per patient in the intervention group compared to control /usual care.
Timepoint [3] 429726 0
During the control and intervention periods. Observations taken daily for the length of the patient admission until trial exit at day 21 or discharge or death.
Secondary outcome [4] 429727 0
Translational process evaluation (80% bundle adherence)
Timepoint [4] 429727 0
Patient daily data collection during Intervention period only.
Secondary outcome [5] 429728 0
Cost effectiveness of the SAFET bundle care (intervention period) based on health economics analysis.
Timepoint [5] 429728 0
All three measures will be collected daily in the final month of the intervention period.
Secondary outcome [6] 429732 0
Proportion of patients with new ICU device-related pressure injuries during the sustainability period compared to the intervention period.
Timepoint [6] 429732 0
During the control and intervention periods. Observations taken daily for the length of the patient admission until trial exit at day 21 or discharge or death
Secondary outcome [7] 430466 0
The type/stage of new ICU device-related pressure injuries
Timepoint [7] 430466 0
At all patient data collection periods - Control, Transition, Intervention and Sustainability periods in the step-wedge trial. Observations taken daily for the length of the patient admission until trial exit at day 21 or discharge or death.
Secondary outcome [8] 430482 0
Implementation outcomes of acceptability [the perception that the SAFET bundle is agreeable or satisfactory]
Timepoint [8] 430482 0
The survey will be conducted in the sustainability period - 4th month post intervention period.
Secondary outcome [9] 430483 0
Implementation outcomes of appropriateness [the perceived fit or compatibility of the SAFET bundle to address device related pressure injuries]
Timepoint [9] 430483 0
The survey will be conducted in the sustainability period - 4th month post intervention period.
Secondary outcome [10] 430484 0
Implementation outcomes of feasibility [the extent to which the SAFET bundle can be successfully used by each partner site]
Timepoint [10] 430484 0
The survey will be conducted in the sustainability period - 4th month post intervention period.
Secondary outcome [11] 430485 0
Implementation outcomes of sustainability [normalization of complexed interventions]
Timepoint [11] 430485 0
The survey will be conducted in the sustainability period - 4th month post intervention period.
Secondary outcome [12] 430488 0
Willingness to pay to avoid device related pressure injury questionnaire
Timepoint [12] 430488 0
Phase 1 before the start of any patient data collection (control period) of any of the ICU sites.
Secondary outcome [13] 430489 0
Implementation Survey [Barrier survey]
Timepoint [13] 430489 0
Phase 1 before the start of any patient data collection (control period) of any of the ICU sites.
Secondary outcome [14] 430490 0
Implementation Workshops to prioritize the recommended implementation strategies
Timepoint [14] 430490 0
Phase 1 before the start of any patient data collection (control period) of any of the ICU sites.
Secondary outcome [15] 430494 0
Cost effectiveness Evaluation (Composite measure)
Timepoint [15] 430494 0
For each element of this composite measure
1) Phase 1 before the start of any ICU control period
2) Final month (6th month) of the Intervention period
3) Both control and intervention periods

Eligibility
Key inclusion criteria
Admitted patients have at least one therapeutic device
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient has not been previously enrolled in the study

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The unit of randomisation is the 'cluster' not the recruited patient. The clusters (8 ICUs) will be randomised using computer software to a unique start sequence in the stepped wedge design. Each cluster will start in the control phase and cross over to intervention conditions. Sequence generation will be conducted by the Chief Investigator statistician.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Other
Other design features
Hybrid type 2 effectiveness-implementation trial using a sequential, multi-centre, incomplete, stepped-wedge, cluster randomised trial design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Generalised linear mixed models will be used to analyse primary and secondary outcomes. The primary outcome of device related pressure injury prevalence between control and intervention periods will be modelled to include fixed effects for time, random cluster, and random cluster by time effects. The correlation structure for the random cluster by time interaction will allow two-period decay, enabling correlation within the same measurement period to differ to that from a different measurement period. Results for generalised linear mixed models will be presented as proportions, rates, means, relative risks and risk differences with 95% confidence intervals using appropriate link functions. Time to device related pressure injury will also be examined using mixed effects Cox regression models with hazard ratios and 95% intervals reported. Assumptions of all models will be examined using residuals. Models will be adjusted for important clinical and demographic factors. The primary analysis of all endpoints will be ‘intention-to-treat’, with ‘per protocol’ analyses assessing the effect of protocol compliance. Protocol compliance and performance (dose response) will be assessed by considering percentage compliance (yes/no) for the five components of the bundle, with compliance categorised into groups of increasing gradients from no compliance (0%) to full compliance (100%) and included as a factor in the model. Missing values will not be imputed but will be considered through the mixed modelling approach, which assumes a missing at random mechanism. Sensitivity analyses will consider models assuming missing not at random mechanism, such as shared parameter models. Two-tailed p-values of <0.05 will be considered significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2024
Actual
Date of last participant enrolment
Anticipated
31/08/2026
Actual
Date of last data collection
Anticipated
31/08/2026
Actual
Sample size
Target
5017
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 25928 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 25929 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [3] 25930 0
Mater Mother's Hospital - South Brisbane
Recruitment hospital [4] 25931 0
The Prince Charles Hospital - Chermside
Recruitment hospital [5] 25932 0
Townsville University Hospital - Douglas
Recruitment postcode(s) [1] 41763 0
4029 - Herston
Recruitment postcode(s) [2] 41764 0
4101 - South Brisbane
Recruitment postcode(s) [3] 41765 0
4032 - Chermside
Recruitment postcode(s) [4] 41766 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 315081 0
Government body
Name [1] 315081 0
National Health and Medical Research Council (NHMRC)
Country [1] 315081 0
Australia
Funding source category [2] 315412 0
Hospital
Name [2] 315412 0
Townsville University Hospital
Country [2] 315412 0
Australia
Funding source category [3] 315413 0
Hospital
Name [3] 315413 0
Royal Brisbane and Women's Hospital
Country [3] 315413 0
Australia
Funding source category [4] 315423 0
Hospital
Name [4] 315423 0
The Prince Charles Hospital
Country [4] 315423 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
University of Queensland ST LUCIA QLD 4072
Country
Australia
Secondary sponsor category [1] 317476 0
None
Name [1] 317476 0
Address [1] 317476 0
Country [1] 317476 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314029 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee [EC00175]
Ethics committee address [1] 314029 0
Ethics committee country [1] 314029 0
Australia
Date submitted for ethics approval [1] 314029 0
09/10/2023
Approval date [1] 314029 0
08/11/2023
Ethics approval number [1] 314029 0
62 Graham Street, South Brisbane QLD 4101

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

Contacts
Principal investigator
Name 130174 0
Prof Fiona Coyer
Address 130174 0
Level 3, Chamberlain Building (35), University of Queensland, St Lucia, 4072
Country 130174 0
Australia
Phone 130174 0
+61 7 3365 2068
Fax 130174 0
Email 130174 0
f.coyer@uq.edu.au
Contact person for public queries
Name 130175 0
Fiona Coyer
Address 130175 0
Level 3, Chamberlain Building (35), University of Queensland, St Lucia, 4072
Country 130175 0
Australia
Phone 130175 0
+61 7 3365 2068
Fax 130175 0
Email 130175 0
f.coyer@uq.edu.au
Contact person for scientific queries
Name 130176 0
Fiona Coyer
Address 130176 0
Level 3, Chamberlain Building (35), University of Queensland, St Lucia, 4072
Country 130176 0
Australia
Phone 130176 0
+61 7 3365 2068
Fax 130176 0
Email 130176 0
f.coyer@uq.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
Individual participant data will not be shared. The outcomes of the trial will share with the public via peer-reviewed journal publications, presentations and various guidelines.


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
No additional documents have been identified.