The cost-effectiveness of specialized nursing interventions for people with Parkinson's disease: the NICE-PD study protocol for a randomized controlled clinical trial.

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 of 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 with usual care (without PDNS) for people with PD in all disease stages. To gain more insight into the deployed interventions and their effects, a preplanned subgroup analysis will be performed on the basis of 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 who have not been treated by a PDNS over the past 2 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 receive 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 Movement Disorders Society-sponsored revision of the Unified Parkinson's Disease Rating Scale part III). Secondary outcomes include nonmotor 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 because 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 will be warranted.

Trial Registration: ClinicalTrials.gov, NCT03830190. Registered February 5, 2019 (retrospectively registered).