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

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 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 ?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).

SUBMITTER: Radder DLM

PROVIDER: S-EPMC6961317 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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

Radder Danique L M DLM Lennaerts Herma H HH Vermeulen Hester H van Asseldonk Thies T Delnooz Cathérine C S CCS Hagen Rob H RH Munneke Marten M Bloem Bastiaan R BR de Vries Nienke M NM

Trials 20200115 1

<h4>Background</h4>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 (w ...[more]

PMID: 31941538

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Project description:BackgroundChronic diseases, including cardiovascular diseases, diabetes, chronic obstructive pulmonary disease, and cerebrovascular diseases, contribute to the most significant disease burden worldwide, negatively impacting patients and their family members. People with chronic diseases have common modifiable behavioral risk factors, including smoking, alcohol overconsumption, and unhealthy diets. Digital-based interventions for promoting and sustaining behavioral changes have flourished in recent years, although evidence of the cost-effectiveness of such interventions remains inconclusive.ObjectiveIn this study, we aimed to investigate the cost-effectiveness of digital health interventions for behavioral changes among people with chronic diseases.MethodsThis systematic review evaluated published studies focused on the economic evaluation of digital tools for behavioral change among adults with chronic diseases. We followed the Population, Intervention, Comparator, and Outcomes framework to retrieve relevant publications from 4 databases: PubMed, CINAHL, Scopus, and Web of Science. We used the Joanna Briggs Institute's criteria for economic evaluation and randomized controlled trials to assess the risk of bias in the studies. Two researchers independently screened, assessed the quality, and extracted data from the studies selected for the review.ResultsIn total, 20 studies published between 2003 and 2021 fulfilled our inclusion criteria. All the studies were conducted in high-income countries. These studies used telephones, SMS text messaging, mobile health apps, and websites as digital tools for behavior change communication. Most digital tools for interventions focused on diet and nutrition (17/20, 85%) and physical activity (16/20, 80%), and a few focused on smoking and tobacco control (8/20, 40%), alcohol reduction (6/20, 30%), and reduction of salt intake (3/20, 15%). Most studies (17/20, 85%) used the health care payer perspective for economic analysis, and only 15% (3/20) used the societal perspective. Only 45% (9/20) of studies conducted a full economic evaluation. Most studies (7/20, 35%) based on full economic evaluation and 30% (6/20) of studies based on partial economic evaluation found digital health interventions to be cost-effective and cost-saving. Most studies had short follow-ups and failed to include proper indicators for economic evaluation, such as quality-adjusted life-years, disability-adjusted life-years, lack of discounting, and sensitivity analysis.ConclusionsDigital health interventions for behavioral change among people with chronic diseases are cost-effective in high-income settings and can therefore be scaled up. Similar evidence from low- and middle-income countries based on properly designed studies for cost-effectiveness evaluation is urgently required. A full economic evaluation is needed to provide robust evidence for the cost-effectiveness of digital health interventions and their potential for scaling up in a wider population. Future studies should follow the National Institute for Health and Clinical Excellence recommendations to take a societal perspective, apply discounting, address parameter uncertainty, and apply a lifelong time horizon.

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Dataset Information

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

Publications

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

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