Clinical and Cost-Effectiveness of the "UCL Live Well With Parkinson's" Toolkit: A Randomised Controlled Trial.

BACKGROUND

Self-management approaches in people with Parkinson's disease (PD) have potential to improve patient outcomes and reduce complications leading to hospital admissions. We aimed to evaluate the clinical and cost-effectiveness of the UCL Live Well with Parkinson's toolkit, a facilitated self-management intervention for people with PD.

METHODS

This two-arm randomised controlled trial in England (Trial Registration: ISRCTN92831552) recruited community-dwelling people with PD from NHS sites and self-referral. They were randomly assigned to the intervention or treatment as usual (TAU), and assessed at baseline, 6- and 12-month follow-up. The primary outcome was the PDQ-39 score, a PD-specific health-related quality of life measure, at 12-months with planned subgroup analyses. Secondary outcomes included non-motor and motor activities of daily living (MDS-UPDRS part I&II), utility values and QALYs derived from the EQ-5D-5L, and total health and social care costs over 12-months. The economic evaluation was based on cost-utility analysis using cost per QALY. All assessors were blinded to group allocation. Analysis was by intention to treat.

FINDINGS: 166 participants were randomised to the intervention and 180 to TAU, with 12-month follow-up assessments available in 141 (84.9%) and 164 (91.1%), respectively. The primary endpoint (PDQ-39 score) was similar for patients in the intervention and TAU groups (-1.03; 95% CI (-3.03 to 0.97)). Subgroup analyses of PDQ-39 scores in underserved groups however favoured the intervention (-4.0; 95% CI (-6.8 to -1.1)). The combined MDS-UPDRS part I + II score was improved in the intervention compared to the TAU group (-2.61; 95% CI (-4.58 to -0.64)). QALYs were not different between groups (0.018; 95% CI (-0.006 to 0.042) but total health and social care costs over 12-months were lower in the intervention group compared to TAU (-£1282; 95% CI (-£2700 to -£118)), driven mainly by reduced unplanned hospital admissions. Adverse events were similar in both groups. The Live Well with Parkinson's intervention alongside TAU was 99% cost-effective compared to TAU at a decision threshold of £20,000 per QALY and 98% at £30,000.

INTERPRETATION: The UCL Live Well with Parkinson's toolkit did not significantly improve health-related quality of life scores overall but improved activities of daily living and reduced health-care costs in comparison to TAU, mainly through reduced unplanned hospital admissions.

FUNDING: National Institute for Health and Care Research RP-PG-1016-20001.