Redesigning Parkinson’s disease care: rationale, methods and baseline data from the PRIME-UK Parkinson’s randomised controlled trial

Background: Current models of Parkinson’s disease (PD) care may not account for the complexity and significant heterogeneity in symptoms of PD, which emerge and fluctuate over time, coupled with multi-morbidity and frailty. Individuals’ unique phenotype, needs and experience may be overlooked in a system that often lacks continuity, patient-involvement and proactivity. PRIME Parkinson has been designed to deliver innovative, cohesive, proactive and personalised care, which is responsive to arising problems. The ongoing PRIME randomised controlled trial (RCT) will determine whether PRIME care is able to improve outcomes in people with PD, including those often excluded from RCTs, to enhance their experience of living with parkinsonism.

Methods: This single-centre randomized controlled trial (RCT) recruits adults with parkinsonism from the PRIME cross-sectional study and routine clinical settings. Those lacking capacity are eligible if they have a personal consultee. Participants are randomised to receive either ‘usual care’ or ‘PRIME care’, a complex multi-disciplinary individualised care programme. The primary outcome is “goal attainment” measured using the Bangor Goal Setting Interview. Secondary outcomes include other measures of health and wellbeing.

Results: We have consented 125 people (22nd March 2023), with six requiring a personal consultee. The mean age is 75±8 years and 31.5% are female. Participants most commonly have Idiopathic PD (n=96, 88%) spread across all Hoehn and Yahr Stages, with a predominance for stages 2 (n=49, 41.1%) and 3 (n=35, 29.4%). Median disease duration is 5 years (IQR 4-10). Most live in their own homes (n=102, 92.7%) and 20 were consented and assessed at home. We identified 38 participants (30.1%) who were frail (score >4 on the Clinical Frailty Scale). The median MDS Non-Motor Score is 85 (IQR 43-142) and mean UPDRS part III score is 44 (SD 20, range 2-100). The median MoCA score is 24 (IQR 21-27 range 0-30). Participants are taking a mean of 7 medications (SD 4, range 1- 15) and 7 (6.4%) use device-aided therapies.

Conclusion: We will describe our experience and challenges to date in delivering this complex intervention to establish if PRIME-Parkinson care supports personal goal attainment and positively impacts health and wellbeing in people with parkinsonism.