Randomized controlled trial of a home-based palliative approach for people with severe multiple sclerosis

Abstract

Background:Evidence on the efficacy of palliative care in persons with severe multiple sclerosis (MS) is scarce.Objective:To assess the efficacy of a home-based palliative approach (HPA) for adults with severe MS and their carers.Methods:Adults with severe MS-carer dyads were assigned (2:1 ratio) to either HPA or usual care (UC). At each center, a multi-professional team delivered the 6-month intervention. A blind examiner assessed dyads at baseline, 3 months, and 6 months. Primary outcome measures were Palliative care Outcome Scale-Symptoms-MS (POS-S-MS) and Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW, not assessed in severely cognitively compromised patients).Results:Of 78 dyads randomized, 76 (50 HPA, 26 UC) were analyzed. Symptom burden (POS-S-MS) significantly reduced in HPA group compared to UC (p = 0.047). Effect size was 0.20 at 3 months and 0.32 at 6 months, and statistical significance was borderline in per-protocol analysis (p = 0.062). Changes in SEIQoL-DW index did not differ in the two groups, as changes in secondary patient and carer outcomes.Conclusion:HPA slightly reduced symptoms burden. We found no evidence of HPA efficacy on patient quality of life and on secondary outcomes.

Participant perspectives of a home-based palliative approach for people with severe multiple sclerosis: A qualitative study

“…In the PeNSAMI RCT, the HPA teams identified the pre-specified care needs (11 pre-set categories forming three domains, namely “managing everyday life”, “organization”, “psychosocial”) and those which were/were not fulfilled at the end of the intervention [ 11 ]. While these three macro areas were also detected in the present qualitative study, the overlap between the sub-categories of needs and their fulfilment is not complete in the two sets of data.…”

“…The PeNSAMI (Palliative Network for Severely Affected Adults with Multiple Sclerosis in Italy) trial, the most recently published study, was a two-arm parallel, examiner-blind RCT that assessed a home palliative approach (HPA) in 50 patient-caregiver dyads versus usual care in 26 dyads. Participant characteristics and the intervention are summarized in S1 Appendix ; the full trial protocol and results are reported elsewhere [ 10 , 11 ]. Although the PeNSAMI intervention was carefully planned with the direct participation of key stakeholders [ 6 ], it was less effective than anticipated: while symptom burden was reduced, the reduction was later than expected, and changes in QOL and other patient and caregiver outcomes did not differ compared to usual care [ 11 ].…”

Improving patient outcomes through palliative care integration in other specialised health services: what we have learned so far and how can we improve?

“…A study in Turin in Italy considered a broader group of neurological diseases-MND/ALS, MS, PD and Parkinson's plus disorders-and showed that the involvement of the wider multidisciplinary palliative care team led to improvement in symptoms-pain, breathlessness, sleep disturbance and bowel symptomsand quality of life, but no significant changes in caregiver burden (29). However an Italian study on short term input in MS showed the involvement of specialist nurses, who had received extra training in palliative care and support, did lead to a reduced symptom burden but had no effect on quality of life or other outcomes (30).…”

Living with Multiple Sclerosis in Europe: Pharmacological Treatments, Cost of Illness, and Health-Related Quality of Life Across Countries

“…COI studies are often carried out together with costutility analyses and Quality of Life Surveys (60,61). The focus of the literature is on new therapeutic options as well as the progressive forms of the disease; some research projects concerning palliative approaches to severe MS or communication in SP MS are being carried out (62).…”