People with severe progressive multiple sclerosis (pwPMS) across various health care settings in Italy Nervous System Diseases Multiple sclerosis
Conditions
Interventions
The ConCure-SM intervention consists of an advance care plan (ACP) conversation involving the people with progressive multiple sclerosis (pwPMS), and their specially trained caring physicians, using t
two 4 h empirical sessions (one each day) on conducting ACP conversations in various clinical scenarios using the ConCure-SM booklet through guided role-play exercises
and two 45 min self-evaluation sessions (at the beginning and at the end of the training program).
The ACP conversation involves the pwPMS, the ACP-trained physician involved in their care, and, whe
Sponsors
Istituto Neurologico Carlo Besta
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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 criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completion of (dated and signed) advance care plan (ACP) document during the six months of the study measured using between baseline and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 by a specially trained third observer using the Observing Patient Involvement in Shared Decision Making (OPTION) scale, an observer-based scale that evaluates the behavior of the physician in terms of patient involvement in decision-making 2.2. The Quality of Communication Questionnaire (QOC) completed by participants after the ACP conversation 2.3. The QOC significant other (SO) version completed by SOs after the ACP conversation 2.4. The QOC physician version (last two items) completed by physicians after the ACP conversation 3. Quality of life measured using the Multiple Sclerosis Quality of Life 29-item questionnaire (MSQOL-29) electronic version at baseline and 6 months 4. Mood symptoms measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, 1 week, and 6 months 5. Caregiver burden measured using the Zarit Burden Interview (ZBI) at baseline, 1 week, and 6 months 6. Safety measured from the incidence of Serious Adverse Events (SAE) (defined as an emotional breakdown resulting in hospitalization, suicidal attempt, or death) which will be monitored using the implementation of a thorough safety data monitoring plan and assessed at 6 months 7. Feasibility of the study, and sample size estimation for a subsequent phase III trial, should this be feasible, measured using the following between baseline and 6 months: 7.1. The number of pwPMS who accept the invitation to participate in the study 7.2. The number of pwPMS who receive the intervention 7.3. The rate of recruitment and refusal to participate 7.4. The rate of attendance of 6-month follow-up 7.5. | — |
Countries
Italy
Outcome results
None listed