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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.
Trials ( IF 2.0 ) Pub Date : 2020-01-15 , DOI: 10.1186/s13063-019-3926-y
Danique L M Radder 1 , Herma H Lennaerts 2 , Hester Vermeulen 3 , Thies van Asseldonk 4 , Cathérine C S Delnooz 5 , Rob H Hagen 6 , Marten Munneke 1 , Bastiaan R Bloem 1 , Nienke M de Vries 1
Affiliation  

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).

中文翻译:

帕金森氏病患者的专业护理干预的成本效益:用于随机对照临床试验的NICE-PD研究方案。

背景技术当前的指南建议,每个患有帕金森氏病(PD)的人都应获得帕金森氏病护理专家(PDNS)的护理。但是,几乎没有科学证据证明PDNS护理的成本效益。这阻碍了更广泛的实施,造成了不平等的护理机会,并可能导致可避免的残疾和费用。因此,我们的目的是研究与所有疾病阶段的PD患者的常规护理(无PDNS)相比,PDNS提供的专业护理的(成本)效果。为了更深入地了解已部署的干预措施及其效果,将根据疾病持续时间(诊断<5、5-10或> 10年前)进行预先计划的亚组分析。方法我们将执行18个月的单盲,荷兰八家社区医院的随机对照临床试验。与疾病严重程度或持续时间无关的总共240名PD患者在过去2年中未接受PDNS治疗。在每家医院中,将以1:1的比例随机分配30名患者,以接受PDNS(根据最近的PDNS护理指南工作)的护理或常规护理。我们将使用两个共同的主要结局:生活质量(以39号帕金森氏病问卷测量)和运动症状(以运动障碍协会赞助的帕金森氏病统一评分量表第III部分修订)。次要结果包括非运动症状,与健康相关的生活质量,经验丰富的护理质量,自我管理,药物依从性,护理人员负担和应对技巧。盲人研究人员将在12个月和18个月后收集数据。每3个月将填写一份医疗保健利用率和生产率损失调查表。讨论该试验的结果将对PD患者的当前护理产生直接影响。我们假设通过为更多的患者提供PDNS护理服务,生活质量将会提高。我们还预计医疗保健费用将保持不变,因为直接医疗费用的增加(为额外的护士提供资金)将被与全科医生和神经科医生的咨询减少所抵消。如果达到这些结果,将有必要广泛实施PDNS护理。试验注册ClinicalTrials.gov,NCT03830190。注册于2019年2月5日(追溯注册)。
更新日期:2020-01-15
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