title: Multifaceted intervention to enhance the screening and care of hospitalised malnourished children: study protocol for the PREDIRE cluster randomized controlled trial.
abstract: BACKGROUND
  Hospital malnutrition is an underestimated problem and as many as half of malnourished patients do not receive appropriate treatment. In order to extend the management of malnutrition in health care facilities, multidisciplinary teams focusing on clinical nutrition were established in France. The establishment of such teams within hospital facilities remains nonetheless difficult. We have consequently developed a multifaceted intervention coordinated by a Nutritional Support Team (NST). Our study aims to evaluate the impact of this multifaceted intervention coordinated by a NST, in adherence to recommended practices for the care of malnourished children, among health care workers of a paediatric university hospital.
  
  
  METHODS
  We carried out 1) a six-month observational phase focusing on the medical care procedures relative to malnourished children followed by 2) a cluster randomised controlled trial phase to evaluate the impact of a multidisciplinary nutrition team over an 18 month time frame.Based on power analyses and assuming a conservative intracluster correlation coefficient, 1289 children were needed to detect a 25% difference in rates between the two groups of the cluster trial.The implementation of our intervention was coordinated by the NST and had three major components: a) access to a computerised malnutrition screening system associated with an automatic alert system, b) an awareness campaign directed toward the health care workers and c) a leadership based strategy.Main outcomes included the number of daily weighings during hospitalisation, the investigation of malnutrition etiology and the management of malnutrition by a dietician and/or the NST.Due to the clustered nature of the data with children nested in departments, a generalized estimated equations approach will be used to analyse the impact of the multifaceted intervention on primary and secondary outcomes.
  
  
  CONCLUSIONS
  Our results will provide an overall response regarding the effectiveness of our multifaceted intervention and we should be able to suggest an organization and mode of operation of NST.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01081587.
authors.affiliation: Hospices Civils de Lyon, Pôle Information Médicale Évaluation Recherche, Lyon F-69003, France. sandrine.touzet@chu-lyon.fr
authors.forename: Sandrine
authors.initials: S
authors.lastname: Touzet
authors.forename: Antoine
authors.initials: A
authors.lastname: Duclos
authors.forename: Angélique
authors.initials: A
authors.lastname: Denis
authors.forename: Lioara
authors.initials: L
authors.lastname: Restier-Miron
authors.forename: Pauline
authors.initials: P
authors.lastname: Occelli
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Polazzi
authors.forename: Daniel
authors.initials: D
authors.lastname: Betito
authors.forename: Guillaume
authors.initials: G
authors.lastname: Gamba
authors.forename: Fleur
authors.initials: F
authors.lastname: Cour-Andlauer
authors.forename: Cyrille
authors.initials: C
authors.lastname: Colin
authors.forename: Alain
authors.initials: A
authors.lastname: Lachaux
authors.forename: Noël
authors.initials: N
authors.lastname: Peretti
mesh_terms: D000293:Adolescent; D002648:Child; D015362:Child Nutrition Disorders / Q000175:diagnosis* / Q000178:diet therapy*; D002675:Child, Preschool; D016000:Cluster Analysis; D020000:Decision Support Systems, Clinical; D005260:Female; D005602:France; D006760:Hospitalization; D006801:Humans; D007223:Infant; D008297:Male; D008403:Mass Screening / Q000592:standards*; D008505:Medical Staff, Hospital; D010348:Patient Care Team