title: The impact of nUrsiNg DEliRium Preventive INnterventions in the Intensive Care Unit (UNDERPIN-ICU): A study protocol for a multi-centre, stepped wedge randomized controlled trial.
abstract: BACKGROUND
  Delirium is a common disorder in Intensive Care Unit (ICU) patients and is associated with serious short- and long-term consequences, including re-intubations, ICU readmissions, prolonged ICU and hospital stay, persistent cognitive problems, and higher mortality rates. Considering the high incidence of delirium and its consequences, prevention of delirium is imperative. This study focuses on a program of standardized nursing and physical therapy interventions to prevent delirium in the ICU, called UNDERPIN-ICU (nUrsiNg DEliRium Preventive INterventions in the ICU).
  
  
  OBJECTIVE
  To determine the effect of the UNDERPIN-ICU program on the number of delirium-coma-free days in 28days and several secondary outcomes, such as delirium incidence, the number of days of survival in 28 and 90days and delirium-related outcomes.
  
  
  METHODS
  A multicenter stepped wedge cluster randomized controlled trial.
  
  
  METHODS
  Eight to ten Dutch ICUs will implement the UNDERPIN-ICU program in a randomized order. Every two months the UNDERPIN-ICU program will be implemented in an additional ICU following a two months period of staff training. UNDERPIN-ICU consists of standardized protocols focusing on several modifiable risk factors for delirium, including cognitive impairment, sleep deprivation, immobility and visual and hearing impairment.
  
  
  METHODS
  ICU patients aged ≥18years (surgical, medical, or trauma) and at high risk for delirium, E-PRE-DELIRIC ≥35%, will be included, unless delirium was detected prior ICU admission, expected length of ICU stay is less then one day or when delirium assessment is not possible.
  
  
  CONCLUSIONS
  For every intervention the balance between putative benefit and potential unwanted side effects needs to be considered. In non-ICU patients, it has been shown that a similar program resulted in a significant reduction of delirium incidence and duration. Recent small studies using multi component interventions to prevent delirium in ICU patients have also shown beneficial effect, without unwanted side effects. We therefore feel that the proportionality of potential positive effects of the UNDERPIN-ICU program, weighed against potential unwanted side effects is favourable. Since this has not been rigorously proven in ICU patients, we will study the effects of this program in ICU patients using a stepped wedge design.
  
  
  BACKGROUND
  The study is registered in the clinical trials registry: https://clinicaltrials.gov/.
  Standard Protocol Items: Recommendations for Interventional Trails (SPIRIT).
authors.affiliation: Department of Intensive Care Medicine, Radboud Institute for Health Sciences, Radboud University Medical Center, P.O. Box 9101, 6500HB Nijmegen, The Netherlands. Electronic address: Annelies.Wassenaar@radboudumc.nl.
authors.forename: Annelies
authors.initials: A
authors.lastname: Wassenaar
authors.affiliation: Department of Intensive Care Medicine, Radboud Institute for Health Sciences, Radboud University Medical Center, P.O. Box 9101, 6500HB Nijmegen, The Netherlands. Electronic address: Paul.Rood@radboudumc.nl.
authors.forename: Paul
authors.initials: P
authors.lastname: Rood
authors.affiliation: Faculty of Health Sciences, University of Southampton, Tremona Road, Southampton, SO16 6YD, UK; Scientific Institute for Quality of Healthcare, Radboud Institute for Health Sciences, Radboud University Medical Center, P.O. Box 9101, 6500HB Nijmegen, The Netherlands. Electronic address: l.schoonhoven@soton.ac.uk.
authors.forename: Lisette
authors.initials: L
authors.lastname: Schoonhoven
authors.affiliation: Department of Epidemiology, Biostatistics and Health Technology Assessment, Radboud University Medical Center, P.O. Box 9101, 6500HB Nijmegen, The Netherlands. Electronic address: Steven.Teerenstra@radboudumc.nl.
authors.forename: Steven
authors.initials: S
authors.lastname: Teerenstra
authors.affiliation: Department of Intensive Care Medicine, Radboud Institute for Health Sciences, Radboud University Medical Center, P.O. Box 9101, 6500HB Nijmegen, The Netherlands; Scientific Institute for Quality of Healthcare, Radboud Institute for Health Sciences, Radboud University Medical Center, P.O. Box 9101, 6500HB Nijmegen, The Netherlands. Electronic address: Marieke.Zegers@radboudumc.nl.
authors.forename: Marieke
authors.initials: M
authors.lastname: Zegers
authors.affiliation: Department of Intensive Care Medicine, Radboud Institute for Health Sciences, Radboud University Medical Center, P.O. Box 9101, 6500HB Nijmegen, The Netherlands; Radboud Center for Infectious Diseases, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, P.O. Box 9101, 6500HB Nijmegen, The Netherlands. Electronic address: Peter.Pickkers@radboudumc.nl.
authors.forename: Peter
authors.initials: P
authors.lastname: Pickkers
authors.affiliation: Department of Intensive Care Medicine, Radboud Institute for Health Sciences, Radboud University Medical Center, P.O. Box 9101, 6500HB Nijmegen, The Netherlands. Electronic address: Mark.vandenBoogaard@radboudumc.nl.
authors.forename: Mark
authors.initials: M
authors.lastname: van den Boogaard
mesh_terms: D000293:Adolescent; D000328:Adult; D003693:Delirium / Q000451:nursing / Q000517:prevention & control*; D006801:Humans; D007362:Intensive Care Units; D009426:Netherlands; D055815:Young Adult
keywords: Adult; Critical care; Delirium; Intensive care; Intervention study; Nurses; Randomized controlled trial