title: Home visits as part of a new care pathway (iAID) to improve quality of care and quality of life in ostomy patients: a cluster-randomized stepped-wedge trial.
abstract: OBJECTIVE
  Morbidity in patients with an ostomy is high. A new care pathway, including perioperative home visits by enterostomal therapists, was studied to assess whether more elaborate education and closer guidance could reduce stoma-related complications and improve quality of life (QoL), at acceptable cost.
  
  
  METHODS
  Patients requiring an ileostomy or colostomy, for any inflammatory or malignant bowel disease, were included in a 15-centre cluster-randomized 'stepped-wedge' study. Primary outcomes were stoma-related complications and QoL, measured using the Stoma-QOL, 3 months after surgery. Secondary outcomes included costs of care.
  
  
  RESULTS
  The standard pathway (SP) was followed by 113 patients and the new pathway (NP) by 105 patients. Although the overall number of stoma-related complications was similar in both groups (SP 156, NP 150), the proportion of patients experiencing one or more stoma-related complications was significantly higher in the NP (72% vs 84%, risk difference 12%; 95% CI: 0.3-23.3%). Although in the NP more patients had stoma-related complications, QoL scores were significantly better (P < 0.001). In the SP more patients required extra care at home for their ostomy than in the NP (60.6% vs 33.7%, respectively; risk difference 26.9%, 95% CI: 13.5-40.4%). Stoma revision was done more often in the SP (n = 11) than in the NP (n = 2). Total costs in the SP did not differ significantly from the NP.
  
  
  CONCLUSIONS
  The NP did not reduce the number of stoma-related complications but did lead to improved quality of care and life, against similar costs. Based on these results the NP, including perioperative home visits by an enterostomal therapist, can be recommended.
authors.affiliation: Department of Surgery, University Medical Centre Leiden, Leiden, The Netherlands.
authors.forename: M F
authors.initials: MF
authors.lastname: Sier
authors.affiliation: Department of Surgery, Albert Schweitzer Hospital Dordrecht, Dordrecht, The Netherlands.
authors.forename: R J
authors.initials: RJ
authors.lastname: Oostenbroek
authors.affiliation: Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: M G W
authors.initials: MGW
authors.lastname: Dijkgraaf
authors.affiliation: Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: G J
authors.initials: GJ
authors.lastname: Veldink
authors.affiliation: Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: W A
authors.initials: WA
authors.lastname: Bemelman
authors.affiliation: Department of Surgery, Diakonessen Hospital Utrecht, Utrecht, The Netherlands.
authors.forename: A
authors.initials: A
authors.lastname: Pronk
authors.affiliation: Department of Surgery, Rijnstate Hospital Arnhem, Arnhem, The Netherlands.
authors.forename: E J
authors.initials: EJ
authors.lastname: Spillenaar-Bilgen
authors.affiliation: Department of Surgery, Martini Hospital Groningen, Groningen, The Netherlands.
authors.forename: W
authors.initials: W
authors.lastname: Kelder
authors.affiliation: Department of Surgery, Medical Centre Leeuwarden, Leeuwarden, The Netherlands.
authors.forename: C
authors.initials: C
authors.lastname: Hoff
authors.affiliation: Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: D T
authors.initials: DT
authors.lastname: Ubbink
mesh_terms: D000368:Aged; D016000:Cluster Analysis; D003125:Colostomy / Q000534:rehabilitation; D019091:Critical Pathways / Q000592:standards*; D004766:Enterostomy / Q000534:rehabilitation*; D005260:Female; D006792:House Calls; D006801:Humans; D007081:Ileostomy / Q000534:rehabilitation; D008297:Male; D008875:Middle Aged; D011182:Postoperative Care / Q000379:methods* / Q000592:standards; D058996:Quality Improvement; D011788:Quality of Life; D012107:Research Design; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
keywords: Ostomy; care pathway; cluster randomized clinical trial; complications; quality of life; stepped wedge