PROTECT - trial: a multicentre prospective pragmatic RCT and health economic analysis of the effect of tailored repositioning to prevent pressure ulcers - study protocol.

Aim: The aims of this trial were as follows: (1) to compare the (cost-) effectiveness of a turning and repositioning system and an algorithm for a tailored repositioning vs. usual care to improve reposition frequency in patients at risk; and (2) to compare the (cost-) effectiveness of standardized incontinence care vs. usual care.

Background: Pressure ulcers are a serious and common problem for hospitalized patients. In many countries, pressure ulcers are recognized as a national health issue and governments designate pressure ulcers as one of the most important sentinel events for health care. International guidelines recommend the use of pressure redistributing support surfaces, systematic patient repositioning and preventive skin care to prevent pressure ulcers. Interventions should be patient-tailored and based on a thorough assessment of both the patient and contextual risk factors. There is a lack of rigorous research addressing the effectiveness of a turning and repositioning system and it is unclear how to tailor the frequency and posture to specific patient needs.

Design: Multicentre, cluster, three-arm, randomized, controlled pragmatic trial and a cost-effectiveness analysis. The ward is the unit of randomization.

Methods: Tailored repositioning, the use of a device to facilitate patient repositioning and an optimal procedure for incontinence care will be combined. Participating wards will be intensive care units, geriatric and rehabilitation wards. A sample size calculation was performed (80% power, α = 0·05). This study is approved by the Ethics Committee (February 2016).

Discussion: Data collection is currently ongoing. The results are expected to be obtained in March 2017.