title: Home-based palliative approach for people with severe multiple sclerosis and their carers: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Preliminary evidence suggests that palliative care may be useful for people with severe multiple sclerosis (MS). The aim of this study is to determine the effectiveness of a home-based palliative approach (HPA) for people with severe MS and their carers.
  
  
  METHODS
  This is a single-blind randomized controlled trial with a nested qualitative study. Seventy-five severe MS-carer dyads are being randomized (at three centers, one in each area of Italy) to HPA or usual care (UC) in a 2:1 ratio. Each center has a specially trained team consisting of four professionals (physician, nurse, psychologist, social worker). The team makes a comprehensive assessment of the needs of the dyads. HPA content is then agreed on, discussed with the patient's caring physician, and delivered over six months. The intervention is not intended to replace existing services. At later visits, the team checks the HPA delivery and reviews/modifies it as necessary. HPA and UC dyads are assessed at home by a blind examiner at baseline, and three and six months later; they also receive monthly telephone interviews. Dyads assigned to UC receive the examiner's visits and telephone interviews, but not the team visits. Primary outcome measures are changes in symptoms (Palliative care Outcome Scale-Symptoms-MS, POS-S-MS), and quality of life (the Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW), not assessed in patients with severe cognitive compromise) at three and six months. Other outcomes are changes in patient functional status and mood; changes in carer quality of life, mood and caregiving burden; costs; incorporation with standard care; unplanned hospital admissions; referrals to hospice; and deaths. The experience of participants will be evaluated qualitatively by individual semi-structured interviews (HPA patients and carers) and focus group meetings (HPA patients' caring physicians).
  
  
  CONCLUSIONS
  The results of our study will show whether the HPA is feasible and beneficial to people with severe MS and their carers living in the three Italian geographic areas. The nested qualitative study will add to the understanding of the strengths and limitations of the intervention.
  
  
  BACKGROUND
  The trial was registered with Current Controlled Trials (identifier: ISRCTN73082124) on 19 June 2014.
authors.affiliation: Unit of Neuroepidemiology, Foundation IRCCS Neurological Institute C. Besta, Via Celoria 11, 20133, Milan, Italy. solari@istituto-besta.it.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Solari
authors.affiliation: Unit of Neuroepidemiology, Foundation IRCCS Neurological Institute C. Besta, Via Celoria 11, 20133, Milan, Italy. andrea.giordano@istituto-besta.it.
authors.forename: Andrea
authors.initials: A
authors.lastname: Giordano
authors.affiliation: Multiple Sclerosis Unit, Foundation IRCCS S. Lucia Rehabilitation Hospital, Via Ardeatina 306, 00179, Rome, Italy. mg.grasso@hsantalucia.it.
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Grasso
authors.affiliation: Unit of Neuroimmunology, Foundation IRCCS Neurological Institute C. Besta, Via Celoria 11, 20133, Milan, Italy. paolo.confalonieri@istituto-besta.it.
authors.forename: Paolo
authors.initials: P
authors.lastname: Confalonieri
authors.affiliation: Department of Medical and Surgical Sciences and Advanced Technologies, University of Catania; MS Center, Neurology Clinic, University Hospital Policlinico Vittorio Emanuele, Via Santa Sofia 78, 95123, Catania, Italy. patti@unict.it.
authors.forename: Francesco
authors.initials: F
authors.lastname: Patti
authors.affiliation: Department of Neuroscience, Imaging and Clinical Sciences, G. d'Annunzio University of Chieti-Pescara, Via dei Vestini 31, 66100, Chieti, Italy. lugaresi@unich.it.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Lugaresi
authors.affiliation: Department of Therapeutic Research and Medicine Evaluation, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161, Rome, Italy. lucia.palmisano@iss.it.
authors.forename: Lucia
authors.initials: L
authors.lastname: Palmisano
authors.affiliation: Associazione Italiana Sclerosi Multipla, Via Operai 40, 16149, Genoa, Italy. roberta.amadeo@aism.it.
authors.forename: Roberta
authors.initials: R
authors.lastname: Amadeo
authors.affiliation: Associazione Italiana Sclerosi Multipla, Via Operai 40, 16149, Genoa, Italy. giovanni.martino@aism.it.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Martino
authors.affiliation: Fondazione Italiana Sclerosi Multipla, Via Operai 40, 16149, Genoa, Italy. michela.ponzio@aism.it.
authors.forename: Michela
authors.initials: M
authors.lastname: Ponzio
authors.affiliation: Antea Charitable Association, Piazza Santa Maria della Pietà 5, 00135, Rome, Italy. g.casale@antea.net.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Casale
authors.affiliation: Unit of Clinical Psychology, Foundation IRCCS Istituto Nazionale per la Cura dei Tumori, Via Venezian 1, 20133, Milan, Italy. claudia.borreani@istitutotumori.mi.it.
authors.forename: Claudia
authors.initials: C
authors.lastname: Borreani
authors.affiliation: Unit of Palliative Care-Hospice, Niguarda Ca' Granda Hospital, Piazza Ospedale Maggiore 3, 20162, Milan, Italy. ignaziorenzo.causarano@ospedaleniguarda.it.
authors.forename: Renzo
authors.initials: R
authors.lastname: Causarano
authors.affiliation: FARO Charitable Foundation, Via Morgari 12, 10125, Turin, Italy. simone.veronese@fondazionefaro.it.
authors.forename: Simone
authors.initials: S
authors.lastname: Veronese
authors.affiliation: Fondazione Italiana Sclerosi Multipla, Via Operai 40, 16149, Genoa, Italy. paola.zaratin@aism.it.
authors.forename: Paola
authors.initials: P
authors.lastname: Zaratin
authors.affiliation: Fondazione Italiana Sclerosi Multipla, Via Operai 40, 16149, Genoa, Italy. m.a.battaglia@aism.it.
authors.forename: Mario Alberto
authors.initials: MA
authors.lastname: Battaglia
mesh_terms: D017028:Caregivers; D002985:Clinical Protocols; D006699:Home Care Services; D006801:Humans; D009103:Multiple Sclerosis / Q000628:therapy*; D010166:Palliative Care; D016037:Single-Blind Method