Proactive and Integrated Management and Empowerment in Parkinson’s Disease protocol for a randomised controlled trial (PRIME-UK) to evaluate a new model of care
Fiona E. Lithander,
Emma Tenison,
Jan Ypinga,
Angelika Halteren,
Matthew D. Smith,
Katherine Lloyd,
Edward W. Richfield,
Danielle E. Brazier,
Mícheál Ó Breasail,
Agnes J. Smink,
Chris Metcalfe,
William Hollingworth,
Bas Bloem,
Marten Munneke,
Yoav Ben-Shlomo,
Sirwan K. L. Darweesh,
Emily J. Henderson
Affiliations
Fiona E. Lithander
Population Health Sciences, Bristol Medical School, University of Bristol
Emma Tenison
Population Health Sciences, Bristol Medical School, University of Bristol
Jan Ypinga
Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre
Angelika Halteren
Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre
Matthew D. Smith
Population Health Sciences, Bristol Medical School, University of Bristol
Katherine Lloyd
Population Health Sciences, Bristol Medical School, University of Bristol
Edward W. Richfield
North Bristol NHS Trust, Southmead Hospital
Danielle E. Brazier
Population Health Sciences, Bristol Medical School, University of Bristol
Mícheál Ó Breasail
Population Health Sciences, Bristol Medical School, University of Bristol
Agnes J. Smink
Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre
Chris Metcalfe
Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol
William Hollingworth
Population Health Sciences, Bristol Medical School, University of Bristol
Bas Bloem
Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre
Marten Munneke
Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre
Yoav Ben-Shlomo
Population Health Sciences, Bristol Medical School, University of Bristol
Sirwan K. L. Darweesh
Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre
Emily J. Henderson
Population Health Sciences, Bristol Medical School, University of Bristol
Abstract Background People living with Parkinson’s disease experience progressive motor and non-motor symptoms, which negatively impact on health-related quality of life and can lead to an increased risk of hospitalisation. It is increasingly recognised that the current care models are not suitable for the needs of people with parkinsonism whose care needs evolve and change as the disease progresses. This trial aims to evaluate whether a complex and innovative model of integrated care will increase an individual’s ability to achieve their personal goals, have a positive impact on health and symptom burden and be more cost-effective when compared with usual care. Methods This is a single-centre, randomised controlled trial where people with parkinsonism and their informal caregivers are randomised into one of two groups: either PRIME Parkinson multi-component model of care or usual care. Adults ≥18 years with a diagnosis of parkinsonism, able to provide informed consent or the availability of a close friend or relative to act as a personal consultee if capacity to do so is absent and living in the trial geographical area are eligible. Up to three caregivers per patient can also take part, must be ≥18 years, provide informal, unpaid care and able to give informed consent. The primary outcome measure is goal attainment, as measured using the Bangor Goal Setting Interview. The duration of enrolment is 24 months. The total recruitment target is n=214, and the main analyses will be intention to treat. Discussion This trial tests whether a novel model of care improves health and disease-related metrics including goal attainment and decreases hospitalisations whilst being more cost-effective than the current usual care. Subject to successful implementation of this intervention within one centre, the PRIME Parkinson model of care could then be evaluated within a cluster-randomised trial at multiple centres.
