PeNSAMI Phase 2: a multicenter Italian trial of home-based palliative

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Background and study aims There is very limited proof that palliative care in people with severe multiple sclerosis (MS) is beneficial. In the initial phase of the study, we identified care needs by asking people with severe MS, their carers, and health professionals from a range of MS-related disciplines. We identified the following needs: Managing everyday life (symptoms, personal care/hygiene, activities of daily living, outdoor mobility/transport); psychosocial aspects (relationships/communication, leisure/holidays, psychological wellbeing/social role); and organizational aspects (information, access to services, co-ordination of services, competent professionals). Based on a literature review and our qualitative findings, we devised the study intervention. In the present phase, our home-based palliative care program (study intervention) will be compared with standard care in people with severe MS and their carers. Who can participate? Adults with primary or secondary progressive MS with two or more unmet care needs from those identified in the initial phase of the study. What does the study involve? Participants are randomly allocated to one of two groups: either home palliative care integrated with standard care, or standard care alone. At each of the three participating centers, there will be a specially trained palliative care team (PCT) consisting of four professionals (physician, nurse, psychologist, and social worker). At first visit the PCT makes a comprehensive assessment of the patient-carer dyad. The treatment plan is agreed on, discussed with the doctor, and delivered (the intervention is not intended to replace existing services). At subsequent visits (≥ 2 home visits per month in the first trimester, as needed thereafter) the PCT checks the way the programme is delivered and reviews/modifies it as necessary. Participants assigned to the control group will receive the three examiner visits and the monthly telephone interviews, but not the PCT visits (see the Interventions field). At the end of follow-up, control group dyads are offered the home palliative care program. We will ask the participants how they felt about the intervention. What are the possible benefits and risks of participating? We do not expect negative effects due to participation in this study. However, we will carefully monitor any unplanned hospitalizations, emergency ward visits, and deaths over the 6-month period. Where is the study run from? Three Italian MS centres: 1. Foundation IRCCS Neurological Institute 'Carlo Besta', Milan (lead centre) 2. Foundation IRCCS, S. Lucia Rehabilitation Hospital, Rome 3. University Hospital Policlinico Vittorio Emanuele, Catania When is the study starting and how long is it expected to run for? Recruitment started in January 2015 and is expected to end by June 2015. Who is funding the study? The Italian MS Foundation (Fondazione Italiana Sclerosi Multipla) (FISM), Italy. Who is the main contact? Dr Alessandra Solari Alessandra.Solari@istituto-besta.it