Home-based palliative approach for people with severe multiple sclerosis and their carers: study protocol for a randomized controlled trial

Abstract

BackgroundPreliminary 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/designThis 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).DiscussionThe 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.Trial registrationThe trial was registered with Current Controlled Trials (identifier: ISRCTN73082124) on 19 June 2014.

Need for palliative care for neurological diseases

“…The effects of these diseases on patients' relatives or caregivers, like stress, depression, social withdrawal, and reduced quality of life, should not be underestimated [21][22][23]. The palliative care approach provides for looking after these aspects as well by involving the relatives and having an accurate and continuous communication and information exchange [24].…”

“…There are many goals of palliative treatment in the advanced stages of multiple sclerosis. These may include issues such Neurol Sci as cognitive impairment, psychiatric and sleep disorders, bladder and sphincter disorders, dysphagia, complications caused by immobility (pressure ulcers, infections), and pain often caused by spasticity, thus requiring a different approach compared to oncological pain [23,26]. In many cases, the general picture becomes complicated by the presence of frequent infections and moving difficulty related to environmental features.…”

Erratum to: Home-based palliative approach for people with severe multiple sclerosis and their carers: study protocol for a randomized controlled trial

“…Unfortunately, the original version of this article [1] contained an error. The correct paragraph can be found below:…”

Opening locked doors: Integrating a palliative care approach into the management of patients with severe multiple sclerosis

“…Early findings indicate that the integration of PC is beneficial for these patients and their relatives. 31 To bring together established MS care with PC for severely affected patients, we implemented a regional pilot hotline in 2012 connecting severely affected MS patients, caregivers, and health professionals to more information about PC. 16 The preliminary evaluation of the hotline came to the conclusion that the hotline was well accepted by patients and their formal and informal caregivers, and seems to be a valuable service in order to gain information about and access to PC.…”