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PROTECT – trial: a multicentre prospective pragmatic RCT and health economic analysis of the effect of tailored repositioning to prevent pressure ulcers – study protocol
Author(s) -
De Meyer Dorien,
Van Damme Nele,
Van den Bussche Karen,
Van Hecke Ann,
Verhaeghe Sofie,
Beeckman Dimitri
Publication year - 2017
Publication title -
journal of advanced nursing
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.948
H-Index - 155
eISSN - 1365-2648
pISSN - 0309-2402
DOI - 10.1111/jan.13166
Subject(s) - medicine , randomized controlled trial , protocol (science) , psychological intervention , health care , randomization , observational study , cluster randomised controlled trial , rehabilitation , physical therapy , medical emergency , nursing , alternative medicine , surgery , pathology , economics , economic growth
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.