A resource for advance care planning in multiple sclerosis
Advance care planning intervention for people with multiple sclerosis: pilot and feasibility trial
What it found
A paper reports the results; we have not read it yet. See Papers below.
What it measured
Main measures
Completion of (dated and signed) advance care plan (ACP) document during the six months of the study measured using between baseline and 6 months
Other measures (1)
1. Advance care plan (ACP) engagement measured using the 4-item ACP engagement questionnaire on the trial web platform at baseline, 1 week, and 6 months 2. Quality of communication about future medical treatment and end of life (EOL) care (physician's skills) measured using the following after the ACP conversation: 2.1. The unobtrusively audio-taped and verbatim-transcribed ACP conversation rated
Mood and sleepQuality of life (reported by participants)SafetyFeasibility
Who could take part
Progressive MS · 18 to 100
Show the full criteria
Inclusion criteria
Inclusion: 1. Aged ≥18 years 2. Diagnosed with primary or secondary progressive multiple sclerosis from ≥1 year before inclusion 3. Able to communicate in Italian 4. Gave written consent 5. Advance care plan (ACP) relevant as has ≥1 of the following conditions: 5.1. Expressed desire for ACP 5.2. Questions about own future 5.3. Thoughts about hastening death or medically assisted suicide 5.4. High risk for death within two years measured using the ‘Surprise Question’ 5.5. High risk for development of severe cognitive compromise/dementia within two years 5.6. High risk for development of impairments preventing communication within two years 5.7. Significant suffering (such as uncontrolled physical symptoms, psychosocial issues, or existential issues) Exclusion: 1. Severe cognitive compromise, a score of <19 on the Mini-Mental State Examination (MMSE) 2. Impairments preventing communication 3. Psychosis or other serious psychiatric conditions 4. Advance care plan (ACP) document completed
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Background and study aims Advance care planning (ACP) is advocated to provide better care at the end-of-life (EOL) for people suffering from chronic progressive diseases, included severe, progressive multiple sclerosis (pwPMS). However, ACP uptake is low, and healthcare professionals (HPs) appear hesitant to engage with these discussions. A recent guideline on palliative care in pwPMS found no evidence of the effects of ACP in this population. Multiple sclerosis (MS) is the most common cause of non-traumatic disability in young adults. The progressive form of the disease is caused by loss of the protective insulation around nerves and nerve damage and can lead to complex needs and severe disability for a variable period. Previously an ACP booklet has produced involving: pwPMS, pwPMS’ significant others (SOs), such as family members, and HPs. This booklet explains the concepts of advance directives and ACP according to the Italian Law 219/2017, describes why ACP is important in Multiple Sclerosis, and provides guidance for pwPMS considering an ACP. This study aims to set up and evaluate the effectiveness of an ACP intervention in pwPMS in different MS care settings in Italy. This intervention will involve a conversation between pwPMS and their physician about the ACP using the ConCure-SM booklet. The physician and other HPs will also be provided with training in order to conduct these conversations. Who can participate? Adult pwPMS where an advance care plan (ACP) is relevant and has not already been completed What does the study involve? This study will involve the training of HPs at the participating centers on ACP for pwPMS and have focus group meetings with HPs to investigate their experiences. Then the safety and effectiveness of conducting a conversation between the pwPMS and their physician about the ACP using the ConCure-SM booklet will be tested over 6 months at six centers (MS centers and rehabilitation centers) across the three geographic areas of Italy. Participants and their carers will be invited to personal semi-structured interviews and asked to complete questionnaires and the study will assess for how many participants an advance care plan document is completed. The study will investigate the differences in treatment preferences between pwPMS and their carers, pwPMS mood symptoms, and caregiver burden. Participants will also be asked about the quality of communication about future medical treatment and EOL care by physicians. What are the possible benefits and risks of participating? Expected benefits include increased pwPMS autonomy and shared decision-making through early conversations and planning ahead, increased congruence in treatment preferences between pwPMS and their carers, increased satisfaction of SOs, and increased competencies and satisfaction of HPs. As far as risks are concerned, since a study-related increase in emotional burden cannot be excluded, pwPMS mood symptoms will be carefully monitored. Where is the study run from? Istituto Neurologico Carlo Besta (Italy) When is the study starting and how long is it expected to run for? From August 2020 to February 2024 Who is funding the study? Fondazione Italiana Sclerosi Multipla (Italy) Who is the main contact? Dr Alessandra Solari, alessandra.solari@istituto-besta.it
Papers
Loading reviews and guidelines…
History
Started
Nov 2021
Finished
Feb 2024