Whilst the clinical problems, treatment and care needs of people with Parkinson’s disease in the early stages are increasingly well known, there is little information on those in the late stages who have the greatest needs. This project aimed to assess the clinical problems and impact of late stage Parkinsonism on patients and their carers, examine what their medical and social needs are, as well as their use, costs and impact of, health-care in six European countries. These aims were achieved through the following tasks: a full systematic reviews of the existing literature; qualitative interviews were conducted with people with late stage parkinsonism and with carers, and in-depth assessments were performed in a large, representative number of 692 individuals affected by late stage parkinsonism and their carers. We also conducted a randomised trial examining the impact of a specialist review and recommendations to the primary physician. The study also examined the usefulness of existing assessment tools in the population of patients with late stage parkinsonism. Bringing together the information from these different work streams, we identified the key problems encountered by people with late stage parkinsonism and their carers, including a range of motor and non-motor problems, of which problems Off-periods, autonomic features, cognitive impairment and neuropschiatric features such as delusions, hallucinations, apathy, depression and dementia were most frequent and severe. These were common in patients at home but particularly those in nursing homes, who were often given other treatments for these problems in addition to the antiparkinsonian medications. The qualitative interviews provided information on what support and care needs exist from patients‘ and carers‘ points of view. In addition to the clinical problems, and access to treatments for these, the interviews revealed that the complex needs of this populations require a more flexibility and personalised service than is currently received. It was also found that support for patients in their own homes and positive relationships with healthcare providers help those with Parkinson’s keep independent and maintain a sense of themselves, and that the provision of information help them maintain some control and stay at home. Family caregivers were the main co-ordinators and monitors of care delivery, with significant impact on their own lives, demonstrated in the analysis of qualitative and quantitative data. The treatment trial identified deficiencies in the current model of management in this disease stage in the traditional secondary care model, including the diffiulties in providing information and advice that is translated into management changes, but showed that specialist input, despite the limitations in implementation, improves quality of life in late stage parkinsonism. Taking the information from the literature reviews and the quantitative and qualitative studies, we devised a new tool to assess patients with late stage parkinsonism in any setting to provide the most appropriate care for patients in this complex late disease stage. Further data analysis is ongoing on longitudinal changes. Our data will provide the basis for better provision of treatment and care of this underserved population and support care for this severely affected patient group.The aim of this project is to evaluate the needs and provision of care for patients in the late stages of Parkinsonism and their carers in several European countries, to compare the effectiveness of different health and social care systems, and to lay the foundation for improved outcomes in this population. We will undertake an in-depth assessment of patients and their care arrangements in a population recruited through networks in six European countries. The systems and procedures that are used in the provision of care will be reviewed through a systematic literature review, interviews and assessments of patients, carers and health care providers, and through a trial comparing assessment by a specialist with management suggestions, guidance and access to telephone advice to that of usual care. Through interviews, questionnaire assessment and review of current health-care and social care arrangement, we will assess the needs, provision of care and use of health-care resources, and their impact on patient and carer outcomes in different countries. National and regional databases will also be interrogated to identify current practice and use of health-care resources and drug usage. A systematic literature review of the evidence for effective management strategies, analysis of the study data, and evaluation of change in outcomes following specialist review will provide the basis for recommendations in the management of late stage Parkinsonism. We will also evaluate potentially useful outcome measures for use in this patient group. In addition to charting the needs and current care provision for late stage Parkinsonism in different European countries, its cost and effectiveness, and an analysis of health-care and social care predictors of improved outcome, the project will produce a platform for the assessment of patients with late stage Parkinsonism, their current treatment and care provision, as well as guidelines on the management of this late disease phase.

Quantitative assessments (scale and questionnaires) and qualitative interviews. Quantitative data collection: Once screened and consented participants met with a member of the research team who administered the assessments /outcome measures as listed below, at at up to four time points. Specifically these were, T1: Baseline with randomisation, T2: 6 months after baseline (intervention completed), T3: 12 months after baseline (telephone with patient and/or carer or optional in-person assessment) and T4: 18 months after baseline (telephone with patient and/or carer or optional in-person assessment). Certain measures were self-completion, but in many cases the researcher was required to assist with completion. The majority of assessments took place in participants homes, and breaks were taken as needed by participants, or split across a couple of assessment visits. The timing of the assessments were arranged for a mutually convenient time so that the Parkinson’s medications were at their most effective. Paper questionnaires were used to collect the data. The following measures were used: Participant with Parkinson’s completed: Quality of life and health status: EQ-5D (incl. VAS), PDQ-8. Meaning of life: SMiLE. Satisfaction with Care: Likert scale. Carer completed: Carer health status: EQ-5D (incl VAS). Satisfaction with Support: Likert scale. Carer burden: Zarit burden scale. Patient Quality of Life (if pwp unable to completed PDQ-8): DEMQOL-Proxy. Clinician completed: Activities of daily living: UPDRS-ADL (part II) Schwab & England. Demographic/social data. Checklist of symptoms, treatments, and tests. Clinical rating/judgement: CGI,Hoehn and Yahr UPDRS Parts I, III, IV. Cognitive assessment: MMSE+clock drawing + fluency. Neuropsychiatric and other non-motor symptoms: Pill questionnaire, Neuropsychiatric Inventory (NPI-12, ) Non-motor symptom scale, Geriatric Depression Scale. Basic palliative assessment: ESAS-(PD). Survival assessment. Resource utilisation. Comorbidities: Charlson-Index. Evaluation of implementation. Blood pressure lying/standing. Saliva samples (optional). Randomisation to intervention: Randomisation was performed centrally by the central office of the Coordinating Center for Clinical Trials in Marburg. Investigators completed the study specific randomisation form, and KKS reported the randomisation result back to the centre. The chance for randomisation to the intervention group or the standard care group was 3:1. Permuted block randomisation was used, stratified by country, dementia (yes/ no) and residence (nursing home or similar/ home). Qualitative data collection: Semi-structured interviews were conducted with 7 men and 3 women with Parkinson’s over a period of twelve months during 2016. The timing of the interviews were arranged for a mutually convenient time so that the Parkinson’s medications were at their most effective. Interviews were in the style of a natural conversation and took place at the participant’s place of residence. These conversations were guided by the study specific topic guide that was developed by members of the CLaSP consortium involved in the qualitative arm of the project. The topics were based on the study objectives and refined during workshops, skype conferences and practice sessions for interviewers led by researchers experienced in qualitative methods. The open-ended interview questions explored the experiences and perceived impact of needs and services, formal and informal support, deficits and barriers to care provision, and future care decisions were explored. All interviews were recorded by digital recorder.