Abstract
Background
Current guidelines recommend that every person with Parkinson’s disease (PD) should have access to Parkinson’s Disease Nurse Specialist (PDNS) care. However, there is little scientific evidence on the cost-effectiveness of PDNS care. This hampers wider implementation, creates unequal access to care and possibly leads to avoidable disability and costs. Therefore, we aim to study the (cost-)effectiveness of specialized nursing care provided by a PDNS compared to usual care (without PDNS) for people with PD in all disease stages. To gain more insight into the deployed interventions and their effects, a pre-planned subgroup analysis will be performed based on disease duration (diagnosis <5, 5-10, or >10 years ago).
Methods
We will perform an 18-month, single-blind, randomized controlled clinical trial in eight community hospitals in the Netherlands. A total of 240 people with PD that have not been treated by a PDNS over the past two years will be included, independent of disease severity or duration. In each hospital, 30 patients will randomly be allocated in a 1:1 ratio to either care by a PDNS (who works according to a recent guideline on PDNS care) or usual care. We will use two co-primary outcomes: quality of life (measured with the Parkinson’s Disease Questionnaire-39) and motor symptoms (measured with the MDS-UPDRS part III). Secondary outcomes include non-motor symptoms, health-related quality of life, experienced quality of care, self-management, medication adherence, caregiver burden and coping skills. Data will be collected after 12 months and 18 months by a blinded researcher. A healthcare utilization and productivity loss questionnaire will be completed every 3 months.
Discussion
The results of this trial will have an immediate impact on the current care of people with PD. We hypothesize that, by offering more patients access to PDNS care, quality of life will increase. We also expect healthcare costs to remain equal, as increases in direct medical costs (funding additional nurses) will be offset by a reduced number of consultations with the general practitioner and neurologist. If these outcomes are reached, wide implementation of PDNS care is warranted.
Trial registration
ClinicalTrials.gov: NCT03830190. Registered February 5, 2019 – Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03830190.
Optimal and maximin sample sizes for multicentre cost-effectiveness trials
