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


METHODS
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).


CONCLUSIONS
Data collection is currently ongoing. The results are expected to be obtained in March 2017.
University Centre for Nursing and Midwifery, Ghent University, Belgium.
Dorien
http://orcid.org/0000-0002-9893-6231
D
De Meyer
University Centre for Nursing and Midwifery, Ghent University, Belgium.
Nele
N
Van Damme
University Centre for Nursing and Midwifery, Ghent University, Belgium.
Karen
http://orcid.org/0000-0001-5308-8729
K
Van den Bussche
University Centre for Nursing and Midwifery, Ghent University, Belgium.|Ghent University hospital, Belgium.
Ann
http://orcid.org/0000-0003-3576-7159
A
Van Hecke
University Centre for Nursing and Midwifery, Ghent University, Belgium.|Ghent University hospital, Belgium.
Sofie
S
Verhaeghe
University Centre for Nursing and Midwifery, Ghent University, Belgium.
Dimitri
http://orcid.org/0000-0003-3080-8716
D
Beeckman
D000293:Adolescent; D000328:Adult; D000368:Aged; D016000:Cluster Analysis; D003362:Cost-Benefit Analysis; D003625:Data Collection; D004506:Education, Nursing / Q000379:methods; D006801:Humans; D008875:Middle Aged; D056888:Patient Positioning / Q000191:economics / Q000379:methods*; D003668:Pressure Ulcer / Q000191:economics / Q000451:nursing / Q000517:prevention & control*; D055815:Young Adult
health economic analysis; incontinence care; incontinence-associated dermatitis; nursing; pressure ulcer; prevention; randomized controlled pragmatic trial; repositioning; tailored