Protecting skin from DEvice harm across the liFEspan iN Critical illnEss: The DEFENCE project.

Eliminate harm from devices for all critically ill patients by co-developing implementation strategies, and then testing, evaluating and disseminating the SAFET bundle of evidence-based, cost-effective scalable practices to prevent medical device-related pressure injury in critically ill patients of all ages.

Australian New Zealand Clinical Trials Registry: ACTRN12624000062527

Background

Therapeutic and monitoring devices are essential to guide and support the clinical care of critically ill patients, yet such devices are recognised increasingly as a potential source of harm to the skin and mucous membranes in the form of pressure injury. A therapeutic device-related pressure injury is defined as an injury to the skin or mucous membrane in direct contact with a therapeutic device, because of sustained pressure from the device.

Device-related pressure injuries are an iatrogenic hospital-acquired problem that is reported commonly in critically ill babies, children and adults. These populations require a significantly high number of devices (average of 8) at any one-time due to their unstable medical conditions and the necessity for life-saving interventions. Device-related pressure injuries can occur at any anatomical location where a therapeutic device is in contact with the skin or mucous membrane such as the face, neck, ear and extremities.

Informed by our significant body of work we are conducting a two-phase implementation-effectiveness study. Device-related pressure injury incidence is the primary outcome. Secondary outcomes include device-related pressure injury stage/category; time to device-related pressure injury development; number of device-related pressure injury /patient; cost of interventions, staff attitudes; translational process evaluation. 
The project intervention is the introduction of the SAFET bundle of care.

The SAFET bundle is a collection of known clinical practices which improve pressure injury rates and contains five elements:

1. Select and size the device,
2. Assess and protect the skin,
3. Fix and secure devices,
4. Evaluate and exchange device position, and
5. Timely removal.

In Phase 1, we are co-developing tailored site-specific implementation strategies to support local uptake of the SAFET bundle. Using an implementation science framework, a sequential mixed method study will be conducted to understand local factors, such as barriers and facilitators, to implementing the SAFET bundle intervention and tailoring the bundle to individual site clinical practice whether neonatal, paediatric or adult ICU.

For Phase 2, we are testing the effectiveness of the SAFET bundle using a sequential, multi-centre, incomplete, stepped-wedge, cluster randomised trial design (SWCRT). Four phases (periods) will be sequentially rolled-out across the eight neonatal, paediatric and adult ICUs (clusters): usual care exposure (control) 4 months; intervention establishment (implementation/transition of the SAFET bundle) 2 months; intervention exposure (intervention) 6 months; and a sustainability 1 month following a 3 month washout period post intervention period.