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.

Mícheál Ó Breasail, Emily J Henderson, Sirwan K L Darweesh, Yoav Ben-Shlomo, Marten Munneke, Bas Bloem, William Hollingworth, Chris Metcalfe, Agnes J Smink, Fiona E Lithander, Danielle E Brazier, Edward W Richfield, Katherine Lloyd, Matthew D Smith, Angelika Halteren, Jan Ypinga, Emma Tenison

Journal: Trials 2023;24(1):147

PMID: 36849987

Free Full Text on BioMed Central View on PubMed

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.

Address: Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 1NU, UK. [email protected].; Liggins Institute, University of Auckland, Auckland, 1142, New Zealand. [email protected].; Department of Nutrition and Dietetics, University of Auckland, Auckland, 1142, New Zealand. [email protected].; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 1NU, UK.; Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.; North Bristol NHS Trust, Southmead Hospital, Westbury-on-Trym, Bristol, BS10 5NB, UK.; Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, BS8 2PS, UK.; Royal United Hospitals Bath NHS Foundation Trust, Combe Park, Bath, BA1 3NG, UK.

DOI: 10.1186/s13063-023-07084-8

Link outs

Free resources

Full Text Sources:

Medical:

https://medlineplus.gov/parkinsonsdisease.html

MeSH Terms: Adult, Humans, Parkinson Disease, Quality of Life, Hospitalization, Informed Consent, United Kingdom, Randomized Controlled Trials as Topic