title: Effect of a multifaceted educational program for care staff concerning fecal incontinence in nursing home patients: study protocol of a cluster randomized controlled trial.
abstract: BACKGROUND
  Fecal incontinence has a high prevalence in the older population, which cannot be explained by comorbidity or the anatomical or psychological changes of aging alone. Fecal incontinence leads to a high economic burden to the healthcare system and is an important cause of institutionalization. In addition, fecal incontinence is associated with shame, social isolation and reduced quality of life. The importance of identifying treatable causes in the frail elderly is strongly emphasized. It is recommended that an assessment of fecal incontinence should be implemented as part of an evaluation of older patients. Although there is a substantial evidence base to guide choice of implementation activities targeting healthcare professionals, little implementation research has focused on the care of older people nor involved care processes or care personnel. This study is based on the assumption that fecal incontinence among nursing home patients can be prevented, cured or ameliorated by offering care staff knowledge of best practice through a multifaceted educational program. The primary objective is to test the hypothesis that a multifaceted educational program for nursing home care staff on assessment and treatment of fecal incontinence reduces patients' frequency of fecal incontinence.
  
  
  METHODS
  The study is a two-armed, parallel cluster-randomized controlled trial. Primary outcome is the frequency of fecal incontinence among patients. Sample size calculations resulted in a need for a total sample of 240 patients. Twenty nursing home units in one city in Norway will be recruited and allocated to intervention or control by an independent statistician using computer-generated tables. The intervention is a multifaceted educational program. Units in the control arm will provide care as usual. The intervention period is 3 months. Data will be collected at baseline, 3, and 6 months. Data will be analyzed using mixed effect models with the cluster treated as a random effect.
  
  
  CONCLUSIONS
  This study is the first randomized controlled trial specifically focusing on this neglected area. The result of the study will give evidence for best practice for continence care in nursing homes, and organizational advice concerning implementation strategies.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT02183740 , registered June 2014.
authors.affiliation: Faculty of Nursing, Sør-Trøndelag University College (HiST), Postbox 2320, 7004, Trondheim, Norway. lene.blekken@hist.no.
authors.forename: Lene Elisabeth
authors.initials: LE
authors.lastname: Blekken
authors.affiliation: Faculty of Nursing, Sør-Trøndelag University College (HiST), Postbox 2320, 7004, Trondheim, Norway. anne.g.vinsnes@hist.no.
authors.forename: Anne Guttormsen
authors.initials: AG
authors.lastname: Vinsnes
authors.affiliation: Department of Cardiothoracic Surgery, Department of Cardiology and National Competence Centre for Complex Symptom Disorders, St. Olavs Hospital, Trondheim University Hospital, Postbox 3250, 7006, Trondheim, Norway. kari.hanne.gjeilo@stolav.no.|Department of Circulation and Medical Imaging, Norwegian University of Science and Technology (NTNU), 7491, Trondheim, Norway. kari.hanne.gjeilo@stolav.no.
authors.forename: Kari Hanne
authors.initials: KH
authors.lastname: Gjeilo
authors.affiliation: Department of Public Health and General Practice, Norwegian University of Science and Technology (NTNU), 7491, Trondheim, Norway. siv.morkved@stolav.no.|Clinical Service, St Olavs Hospital, Trondheim University Hospital, Postbox 3250, 7006, Trondheim, Norway. siv.morkved@stolav.no.
authors.forename: Siv
authors.initials: S
authors.lastname: Mørkved
authors.affiliation: Department of Cancer Research and molecular Medicine, Norwegian University of Science and Technology (NTNU), 7491, Trondheim, Norway. oyvind.salvesen@ntnu.no.
authors.forename: Øyvind
authors.initials: Ø
authors.lastname: Salvesen
authors.affiliation: Faculty of Nursing and Midwifery, King' College London, 57 Waterloo Road, London, SE1 8WA, UK. christine.norton@kcl.ac.uk.
authors.forename: Christine
authors.initials: C
authors.lastname: Norton
authors.affiliation: Faculty of Nursing, Sør-Trøndelag University College (HiST), Postbox 2320, 7004, Trondheim, Norway. Sigrid.nakrem@hist.no.
authors.forename: Sigrid
authors.initials: S
authors.lastname: Nakrem
mesh_terms: D002985:Clinical Protocols; D005242:Fecal Incontinence / Q000628:therapy*; D006707:Homes for the Aged; D006801:Humans; D007318:Inservice Training; D009735:Nursing Homes; D009740:Nursing Staff / Q000193:education*; D017063:Outcome Assessment, Health Care; D018401:Sample Size