Evaluate the effectiveness of the SAFE-T nursing care bundle in protecting skin from DEvice harm across the liFEspan iN Critical illnEss: The DEFENCE project

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.

The SAFE-T Bundle is an evidence-based nursing care bundle comprising five elements to prevent medical device-related pressure injuries in critically ill patients. The SAFE-T Bundle provides guidance to ICU clinicians regarding selection and sizing of devices, assessment and protection of skin, device fixation and securement, repositioning of devices, and timely device removal. Site-specific implementation strategies, including education and training, will be developed through the Phase 1 implementation survey, workshops and site implementation meetings. The bundle elements remain consistent across sites but are tailored to the devices used, patient population and clinical practices at each ICU. The SAFE-T Bundle consists of five elements: 1. Select and size the device: Device application should be based on direct clinical need, and devices should be appropriately 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, including associated tubing and cords, should be assessed regularly as part of routine skin assessment (minimum 8-hourly). Appropriate measures should be used to protect areas at risk of pressure-related tissue damage. 3. Fix and secure the device: Devices should be fixed and secured to maintain patency and performance while minimising mechanical pressure and shear forces at the device-skin or device-tissue interface. Where appropriate, devices should be kept free within an orifice rather than creating pressure against surrounding tissues. 4. Evaluate and exchange the position of the device: Devices should be repositioned or rotated where possible to redistribute or offload pressure over different parts of the tissues, optimally at least 4-hourly where appropriate and depending on device type. Care should be taken to minimise gravitational pull of the device on the skin and other tissues. 5. Timely removal of devices: Removal of, or changing the location of, devices should be considered regularly (at least daily), with devices removed as soon as clinically possible. The bundle applies to a broad range of medical devices, including devices used for breathing (endotracheal tubes, bite blocks, high-flow nasal prongs, face masks, nasal cannulae, CPAP and tracheostomy); feeding (nasogastric and orogastric tubes, PEG and jejunostomy); vascular access and other catheters (central lines, arterial lines, PICCs, ECMO, dialysis and peripheral intravenous catheters); monitoring probes (oxygen saturation probes, blood pressure cuffs, ECG dots and leads, temperature and glucose monitors, intracranial pressure monitoring probes and tubes); indwelling and suprapubic catheters; restraints and braces; bowel management systems; and other devices including DVT prophylaxis devices, epidurals, and cooling and warming blankets. The SAFE-T Bundle will be delivered by ICU nursing staff as part of routine patient care. Site investigators and study champions will provide training, education and assistance to ICU clinicians during implementation. The implementation strategies will be informed by the Phase 1 implementation survey and workshops and further adapted through implementation meetings at each participating ICU. The SAFE-T Bundle will be incorporated into routine nursing care at the bedside. Site investigators and study champions will support implementation through education, training, liaison with ICU clinicians and assistance with implementation of the five bundle elements. The implementation approach will be adapted to each ICU according to local barriers and enablers, devices used, patient population and existing clinical practices, while the five SAFE-T Bundle elements remain unchanged. The SAFE-T Bundle will be introduced during a two-month transition period. The bundle will then be delivered as part of routine nursing care throughout the six-month intervention period. The bundle will subsequently be assessed during a one-month sustainability period following a three-month wash-out period. The individual bundle activities are incorporated into routine care at clinically appropriate intervals: skin assessment at a minimum of 8-hourly, repositioning or exchange of device position optimally at least 4-hourly where appropriate and device removal or relocation considered at least daily. The intervention will be delivered in eight ICUs across five public hospitals in Queensland, comprising neonatal, paediatric and adult ICU settings. The participating ICUs are the Mater Mothers Hospital Neonatal ICU; Queensland Children's Hospital Paediatric ICU; Royal Brisbane and Women's Hospital Neonatal ICU and Adult ICU; The Prince Charles Hospital Adult ICU; and the Neonatal, Paediatric and Adult ICUs at Townsville University Hospital. Adherence to the SAFE-T Bundle will be monitored by research nurses through direct observation of nursing care. Compliance with each of the five SAFE-T Bundle elements will be recorded using yes/no measures. Compliance will be assessed during the intervention and sustainability periods. Sustainability of bundle implementation will be assessed during the one-month sustainability period following the three-month wash-out period. Nursing ICU staff will also be surveyed regarding the acceptability, appropriateness, feasibility and sustainability of the intervention.