Title: Personalised care for people with Parkinson’s Disease: PD-Care
Funder: Department of Health and Social Care

Abstract: Background and rationale: Parkinson s disease is a progressive neurological condition associated with multiple motor and non-motor symptoms, increasing disability and high resource use. Many symptoms can be effectively managed, but are often not recognised or treated outside specialist settings. Increasing patient participation in management and improving awareness of best practice guidelines in patients, carer and health and care professionals (HCP) in non-specialised settings has potential to reduce symptom burden, disability and health care utilisation. Aim: To develop, optimise and evaluate the clinical and cost-effectiveness of a facilitated self-management intervention for people with Parkinson s disease. Research plan Design: Evidence synthesis, co-design of intervention, feasibility study, randomised-controlled trial of effectiveness and cost-effectiveness, process evaluation. This programme of research is based on the MRC framework for complex interventions. Setting: Secondary care, primary care, community Target population: Community-dwelling people with Parkinson s disease. Exclusion criteria: atypical Parkinsonism, currently an inpatient or living in a care home, lack capacity to take part , life expectancy Work packages WP1: Specifying the core components for PD-Care (Months 0-12) This WP aims to understand the problem and clarify mechanisms of action of the intervention. WP1_1: Systematic Literature Reviews: We will undertake formal systematic reviews summarising the existing evidence on: Evidence on self-management of PD Evidence on best practice management guidelines for PD We will conduct a meta-analysis where appropriate and thematic synthesis of qualitative data. WP1_2: Qualitative studies Two linked qualitative studies with a) semi-structured interviews with people with PD (PwP) and their carers (n=up to 40) and b) focus groups (n=4) and semi-structured interviews (n=up to 20) with HCPs. These will explore experiences and goals for self-management of PD, feasibility, barriers and facilitators for interventions to support this, and models of integration into routine care. Data will be analysed using thematic analysis. The findings from WP 1_1 and 1_2 will, combined with our proposed theoretical framework, inform the overall content and presentation of our intervention. WP2: Development of My PD-Care toolkit and supporting training for HCPs (Months 9-16) The intervention will be developed following the principles of co-design, with partnership with people with PD, carers and practitioners. With parallel iterative user-testing, this will provide a prototype then beta version for further testing. Proposed intervention content: 1) The self-management toolkit (My PD-Care) Information on PD, self-management and accessing support Patient-held adaptable care plan Active self-management of PD, pro-active strategies to prevent deterioration. Identification and management of complications algorithms 2) HCP training package in supporting self-management of PD 3) HCP facilitation of use PD-Care WP3: Feasibility and acceptability of PD-Care in practice (Months 16-23) Feasibility study with people with PD/carers (n=35) and optimisation of both components of the final intervention and study procedures. Data will be collected on uptake, attrition, outcome data collection, feasibility and acceptability. WP4: Randomised controlled trial (RCT) with internal pilot testing clinical and cost effectiveness of PD-Care (Months 17-56) Single-blind RCT of clinical effectiveness in reducing PD-related disability in people with PD/their carers. Participants (n=338) will be recruited from primary and secondary care and individually randomised to receive the intervention or treatment-as-usual (TAU), with follow-up for one-year. The first six months of recruitment (n=80) will form an internal pilot with stop/go criteria. Outcomes: Primary: Movement Disorders Society-Unified Parkinson s Disease Rating Scale (MDS-UPDRS) Part I+II score change. Secondary: MDS-UPDRS motor and total score, Non-Motor Symptoms Scale, health/social care use, quality of life, psychological well-being, self-efficacy, capability, carer burden, carer quality of life, medication, deaths. Health economic evaluation will include incremental cost per quality-adjusted and capability-adjusted life year gained from i) health/social care perspective and ii) societal perspective and a decision-analytic model extrapolating costs/consequences beyond the trial. WP5: Process Evaluation (Months 36-56) Mixed methods process evaluation following MRC guidelines, exploring context, potential mechanisms and steps needed for implementation. This will include questionnaires (n=338), semi-structured interviews with participants (n=20) and providers, audio-recording appointments and analysis of on-line activity. WP6: Implementation and Dissemination (Months 12-60) This WP aims to maximise implementation, and includes development of training materials/user guides, policy briefing documents, commissioning costing models and engagement with stakeholders. Outputs/Impact: This research will provide a novel tool to enable people with PD to take active control of the management of their PD symptoms, and enable patient-led, personalised and evidence-based interaction with health professionals. At the end of this project a theoretically-informed, evidence-based supported self-management intervention with data on effectiveness and cost-effectiveness, will be ready for roll out across the NHS. Benefits to patients/NHS: With growing demand on specialist resources, increasing ability for self-management and enhancing existing care has potential to reduce disability, improve quality of life and decrease unnecessary hospital admissions for people with PD. The results of this study may have implications for the management of other complex long-term conditions in later life in the NHS, and the same model could potentially be modified for other conditions.

Lay abstract: Parkinson's disease (PD) is a progressive brain disorder that affects approximately 127,000 people in the UK. People have increasing difficulty with movement and many other problems including falls, bladder and bowel disturbance, low mood and anxiety, fatigue and sleep disturbance, pain and impaired memory. This can lead to increasing disability, reduced quality of life and unplanned hospital admissions. Management is often complex and management guidelines exist, but access to specialised care is often limited. A personal care plan is one developed by professionals with the patient and their carer, to address specific problems. It can also help healthcare professionals in specialised and non-specialised settings to deliver high quality, evidence-based care. A key component of good care-plans is personalised self-management guidance for patients and carers to use in daily life. These can be most useful when backed up by health and care professionals trained to provide this kind of support. Currently, no standardised care plan for people with Parkinson s exists. This research aims to develop and evaluate a practical approach to personalise and improve care of people with Parkinson s living at home, using an effective self-management tool and care plan supported by trained healthcare professionals. It aims to increase the active involvement of people with Parkinson s and their carers in managing the condition. The research team will provide: A resource to aid providing adaptable personalised care plans, tailored to the person with Parkinson s and carers, to help them plan and manage their care across different settings; A resource to help support personalised and self-care, including how to keep healthy and independent, and guidance on what to do when problems arise; Training for professionals to support people with Parkinson s and carers use the care plan and self-management tools. To achieve this, the research team will work closely with a group of people affected by Parkinson s to: Review the evidence and tools including self-management in Parkinson s and similar conditions and other management guidelines for Parkinson s Talk to people with Parkinson s, carers, health and care professionals about their experiences and goals for Parkinson s care and self-care Bring together the expertise of health and care practitioners, people with Parkinson s and carers to jointly design a self-management toolkit and a training programme for professionals Test whether this toolkit is practical and acceptable, making any necessary adjustments Conduct a large study (clinical trial) to test whether it makes a positive difference to the health and lives of people with Parkinson s and how cost-effective the approach would be if adopted by the NHS and its partners. Identify the resources needed to enable this approach to be rolled out across the NHS, if effective.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES;7.1 INDIVIDUAL CARE NEEDS
Health categories: NEUROLOGICAL