Proactive and Integrated Management and Empowerment in Parkinson's Disease (PRIME-UK): A New Model of Care (PRIME-RCT)

University of Bristol

Status: Completed

Conditions: Parkinsonism

Treatments: Other: PRIME Parkinson Care; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05127057

2020-7271

Details and patient eligibility

About

People living with Parkinson's disease experience progressive motor and non-motor symptoms, which negatively impact on health-related quality of life. Symptoms emerge and evolve as the disease progresses.

Current care models are often inadequate to meet their needs.

This study 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.

Full description

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 study 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.

Enrollment: 214 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Have a diagnosis of parkinsonism made by a movement disorder specialist
2. Be willing to participate
3. Have the ability to provide informed consent to participant, or where unable to do so due to cognitive impairment, availability of a close friend or relative to act as a personal consultee
4. Age 18 years and above.
5. Resident within the geographical catchment area of Royal United Hospital Bath NHS Foundation Trust, UK

Exclusion criteria

1. Patients with drug, infection or toxin induced parkinsonism
2. Patients who lack capacity to participate but do not have anyone who can be a consultee to provide advice regarding the patient's wishes and views
3. Patients with a current medical, cognitive or psychosocial issue or co-enrolment in other study that, in the opinion of the site investigator, would interfere with adherence to study requirements.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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214 participants in 2 patient groups, including a placebo group

PRIME Parkinson Care

Experimental group

Description:

PRIME Parkinson Care is a multi-component model of care comprising individual components: a) Case management b) Empowerment of patients and care givers c) Empowerment of healthcare professionals d) IT infrastructure.

Treatment:

Other: Usual Care

Other: PRIME Parkinson Care

Usual care

Placebo Comparator group

Description:

Usual care provided by NHS

Treatment:

Other: Usual Care