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Clinical Trial
. 2025 Oct 7;20(10):e0331220.
doi: 10.1371/journal.pone.0331220. eCollection 2025.

Advance care planning in multiple sclerosis (ConCure-SM): A multicenter single-arm pilot and feasibility study

Alessandra Solari  1 , Ludovica De Panfilis  2   3 , Roberta Martina Zagarella  4 , Luca Ghirotto  5 , Mariangela Farinotti  1 , Alberto Gajofatto  6   7 , Maria Grazia Grasso  8 , Paola Kruger  9 , Alessandra Lugaresi  10   11 , Katia Mattarozzi  12 , Sara Montepietra  13 , Francesco Patti  14 , Eugenio Pucci  15 , Michela Rimondini  16 , Claudio Solaro  17 , Marta Perin  18 , Andrea Giordano  1   19 , Simone Veronese  20 ; ConCure-SM project
Affiliations
Clinical Trial

Advance care planning in multiple sclerosis (ConCure-SM): A multicenter single-arm pilot and feasibility study

Alessandra Solari et al. PLoS One. .

Abstract

Background: Advance care planning (ACP) practice in people with progressive multiple sclerosis (PwPMS) remains limited. ConCure-SM project aims to assess the effectiveness of a structured ACP intervention (clinician's training programme and use of a booklet during ACP conversations) using a multi-phased design.

Methods: Single-arm pilot/feasibility trial involving PwPMS, their significant others (SOs), and clinicians from six Italian centers. Primary study outcome was completion of an advance care plan document (ACP-Doc). Other outcomes included safety, feasibility of enrollment and assessment, and (analyzed using mixed-methods approach) Hospital Anxiety and Depression Scale (HADS), quality of communication, quality of life (MSQOL-29), and caregiver burden. Participants were interviewed to identify factors influencing the ACP implementation process.

Results: Seventy-five PwPMS were eligible out of 164 screened; 56/75 (75%) refused participation and 19 were included. Of these, 11 (58% vs 30% hypothesized) completed the ACP-Doc. A total of 25 adverse events (increase in anxiety) occurred, three possibly related to the intervention, and we found a worsening of HADS-Anxiety score (p = 0.02) and MSQOL-29 mental health composite score (p = 0.04) during follow-up. PwPMS/SO interviews revealed four themes: significance of the ACP process (on the individual, on relation with clinicians), its impact (on emotions, on family relations), preparedness as key, and challenges (practicability, SO commitment). Barriers and facilitators for ACP were identified in two clinician focus groups.

Conclusions: The intervention supported neurologists in guiding PwPMS in their ACP. However, trial findings and the high proportion of refusals point to the need to enrich the intervention with a new component targeting PwPMS and SOs.

Trial registration: ISRCTN48527663.

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Conflict of interest statement

AL reports grants from Novartis, during the conduct of the study; personal fees from Biogen, Merck Serono, Mylan, Novartis, Roche, Sanofi/Genzyme, Teva and FISM. FP received personal compensation for serving on advisory board and/or speaking activities by Almirall, Bayer, Biogen, Bristol Meyers & Squibb, Merck, Novartis Roche, Sanofi and TEVA; he further received research grants by Biogen Italy, Biogen Global, Merck, University of Catania, FISM and Reload Onlus Patients Association. AS received personal compensation for serving on advisory board and speaking activities by Almirall and Merck. All the other authors have no competing interests. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. CONSORT 2010-SPI flow diagram of the trial.
ACP, advance care planning; PROM, patient-reported outcome; RRMS, relapsing remitting multiple sclerosis; SO, significant other; ZBI, Zarit Burden Interview. Boxes with dotted line identify missing PROMs.
Fig 2
Fig 2. Facilitators and barriers identified in our analysis of focus groups with clinicians using the Normalization Process Theory constructs.
See this image and copyright information in PMC

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