title: INTroducing A Care bundle To prevent pressure injury (INTACT) in at-risk patients: A protocol for a cluster randomised trial.
abstract: BACKGROUND
  Pressure injuries are a significant clinical and economic issue, affecting both patients and the health care system. Many pressure injuries in hospitals are facility acquired, and are largely preventable. Despite growing evidence and directives for pressure injury prevention, implementation of preventative strategies is suboptimal, and pressure injuries remain a serious problem in hospitals.
  
  
  OBJECTIVE
  This study will test the effectiveness and cost-effectiveness of a patient-centred pressure injury prevention care bundle on the development of hospital acquired pressure injury in at-risk patients.
  
  
  METHODS
  This is a multi-site, parallel group cluster randomised trial. The hospital is the unit of randomisation.
  
  
  METHODS
  Adult medical and surgical patients admitted to the study wards of eight hospitals who are (a) deemed to be at risk of pressure injury (i.e. have reduced mobility), (b) expected to stay in hospital for ≥48h, (c) admitted to hospital in the past 36h; and (d) able to provide informed consent will be eligible to participate. Consenting patients will receive either the pressure injury prevention care bundle or standard care. The care bundle contains three main messages: (1) keep moving; (2) look after your skin; and (3) eat a healthy diet. Nurses will receive education about the intervention. Patients will exit the study upon development of a pressure injury, hospital discharge or 28 days, whichever comes first; transfer to another hospital or transfer to critical care and mechanically ventilated. The primary outcome is incidence of hospital acquired pressure injury. Secondary outcomes are pressure injury stage, patient participation in care and health care costs. A health economic sub-study and a process evaluation will be undertaken alongside the trial. Data will be analysed at the cluster (hospital) and patient level. Estimates of hospital acquired pressure injury incidence in each group, group differences and 95% confidence interval and p values will be reported.
  
  
  CONCLUSIONS
  To our knowledge, this is the first trial of an intervention to incorporate a number of pressure injury prevention strategies into a care bundle focusing on patient participation and nurse-patient partnership. The results of this study will provide important information on the effectiveness and cost-effectiveness of this intervention in preventing pressure injuries in at-risk patients. If the results confirm the utility of the developed care bundle, it could have a significant impact on clinical practice worldwide.
  
  
  BACKGROUND
  This trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12613001343796.
authors.affiliation: NHMRC Centre of Research Excellence in Nursing, Griffith University, Australia; Centre for Health Practice Innovation, Griffith University, Australia; Menzies Health Institute Queensland, Griffith University, Australia.
authors.forename: Wendy
authors.initials: W
authors.lastname: Chaboyer
authors.affiliation: Alfred Health, Australia; School of Nursing and Midwifery, Deakin University, Australia.
authors.forename: Tracey
authors.initials: T
authors.lastname: Bucknall
authors.affiliation: NHMRC Centre of Research Excellence in Nursing, Griffith University, Australia; Royal Brisbane and Women's Hospital, Australia.
authors.forename: Joan
authors.initials: J
authors.lastname: Webster
authors.affiliation: School of Nursing, Midwifery and Paramedicine, Australian Catholic University, Australia; Nursing Research Institute, St Vincent's Health Australia (Sydney), Australia.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: McInnes
authors.affiliation: Royal Brisbane and Women's Hospital, Australia.
authors.forename: Merrilyn
authors.initials: M
authors.lastname: Banks
authors.affiliation: Centre for Health Practice Innovation, Griffith University, Australia; University of the Sunshine Coast, Australia.
authors.forename: Marianne
authors.initials: M
authors.lastname: Wallis
authors.affiliation: NHMRC Centre of Research Excellence in Nursing, Griffith University, Australia; Centre for Health Practice Innovation, Griffith University, Australia; Menzies Health Institute Queensland, Griffith University, Australia.
authors.forename: Brigid M
authors.initials: BM
authors.lastname: Gillespie
authors.affiliation: NHMRC Centre of Research Excellence in Nursing, Griffith University, Australia; Menzies Health Institute Queensland, Griffith University, Australia; University of Queensland, Australia.
authors.forename: Jennifer A
authors.initials: JA
authors.lastname: Whitty
authors.affiliation: Faculty of Medicine, University of Kuwait, Kuwait; Griffith University, Australia.
authors.forename: Lukman
authors.initials: L
authors.lastname: Thalib
authors.affiliation: NHMRC Centre of Research Excellence in Nursing, Griffith University, Australia; Centre for Health Practice Innovation, Griffith University, Australia; Menzies Health Institute Queensland, Griffith University, Australia. Electronic address: s.roberts@griffith.edu.au.
authors.forename: Shelley
authors.initials: S
authors.lastname: Roberts
authors.affiliation: University of Manchester, United Kingdom.
authors.forename: Nicky
authors.initials: N
authors.lastname: Cullum
mesh_terms: D003362:Cost-Benefit Analysis; D006801:Humans; D010043:Outcome and Process Assessment, Health Care; D064872:Patient Care Bundles / Q000379:methods*; D010358:Patient Participation; D018802:Patient-Centered Care; D003668:Pressure Ulcer / Q000191:economics / Q000517:prevention & control*
keywords: Care bundle; Patient centred care; Patient participation; Pressure injury prevention; Pressure ulcer prevention