Study protocol on advance care planning in multiple sclerosis (ConCure-SM): intervention construction and multicentre feasibility trial

Abstract

IntroductionMultiple sclerosis (MS) is the most common cause of progressive neurological disability in young adults. The use of advance care planning (ACP) for people with progressive MS (pwPMS) remains limited. The ConCure-SM project aims to assess the effectiveness of a structured ACP intervention for pwPMS. The intervention consists of a training programme on ACP for healthcare professionals caring for pwPMS, and a booklet to be used during the ACP conversation. Herein, we describe the first two project phases.MethodsIn phase 1 we translated and adapted, to the Italian legislation and MS context, the ACP booklet of the National ACP Programme for New Zealand. Acceptability, comprehensibility and usefulness of the booklet were assessed via 13 personal cognitive interviews with pwPMS and significant others (SOs), and one health professional focus group. Based on these findings, we will revise the booklet. In phase 2 we will conduct a single-arm pilot/feasibility trial with nested qualitative study. Participants will be 40 pwPMS, their SOs, health professionals from six MS and rehabilitation centres in Italy. In the 6 months following the ACP conversation, we will assess completion of an advance care plan document (primary outcome), as well as safety of the intervention. Secondary outcomes will be a range of measures to capture the full process of ACP; patient-carer congruence in treatment preferences; quality of patient-clinician communication and caregiver burden. A qualitative process evaluation will help understand the factors likely to influence future implementation and scalability of the intervention.Ethics and disseminationThe project is coleaded by a neurologist and a bioethicist. Phase 1 has received ethical approvals from each participating centre, while phase 2 will be submitted to the centres in May 2021. Findings from both phases will be disseminated widely through peer-reviewed publications, conferences and workshops.Trial registration numberISRCTN48527663; Pre-results.

Italian cross-cultural adaptation of the Quality of Communication questionnaire and the 4-item advance care planning engagement questionnaire

“…The cognitive debriefing of the QOC highlighted ways in which the QOC’s EOL communication items were found to be challenging, to both patients and SOs. To protect participants in the ConCure-SM pilot trial from the challenges of these items, we decided to make a major amendment to the trial protocol [ 7 ]. The amendment consisted in the use of the interviewer-administered version of the QOC/QOC-SO in an adaptive form: the section on communication about EOL care (8 items), and one item on the overall (EOL) communication skills of the physician are administered only to participants in whom this topic was addressed during the ACP conversation.…”

“…Questionnaire refinement and devise of the QOC-SO : Each translated questionnaire was refined after the expert feedback, and proof read. A patient self-assessed and a SO version (QOC-SO) were produced from the interviewer-administered Italian version, as well as a physician version (QOC-Doc), the latter including only the last two items (items 18 and 19), assessing the overall communication skills of the physician [ 7 ].…”

“…The intervention consists of a healthcare professional training program in shared decision-making and ACP, and use of a booklet during the ACP conversation. A range of measures are collected in the pilot/feasibility trial inscribed in the project (trial registration number: ISRCTN48527663) in order to capture the full process of ACP and to assess whether the intervention has any effect on completion of an advance care plan document (primary outcome measure), congruence in treatment preferences between patients and their caregivers, quality of patient–clinician communication and caregiver burden [ 7 ]. Of these, two self-reported measures, the 19-item Quality of Communication (QOC) questionnaire [ 8 ] and the 4-item ACP-Engagement (4-item ACP-E) questionnaire [ 6 ] were not available in Italian.…”

“…We translated-adapted these two questionnaires. Moreover, to assess the communication skills of the physician involved in the ACP conversation considering the perspective of all the participants–the patient, the physician and, when applicable, the patient’s significant other (SO), we devised a SO version (QOC-SO) and a physician version (QOC-Doc, not presented here) from the Italian version of the patient self-assessed QOC [ 7 ].…”

Editorial: Shared decision-making in neurology

“…Besides MS, recently published SDM papers focus on stroke ( 11 ), early dementia ( 12 ), and rare neurological disorders ( 13 ). Finally, improvement in goals-of-care conversations and advance care planning implementation is part of SDM and of utmost importance in neurology ( 14 , 15 ).…”