Cost-Effectiveness of Specialized Nursing Interventions for Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 2
- 主要终点
- Disease-specific health-related quality of life: Parkinson's disease Questionnaire (PDQ-39)
研究概览
简要总结
Background: Current guidelines recommend that every person with Parkinson's disease (PD) should have access to Parkinson's Disease Nurse Specialist (PDNS) care. Thus, hospitals increasingly offer PDNS care to their patients with PD. However, there is currently little scientific evidence on the cost-effectiveness of PDNS care. Consequently, many hospitals lack the nursing capacity to offer PDNS care to all patients, which creates unequal access to care and possibly avoidable disability and costs.
Objective: The investigators aim to study the (cost-)effectiveness of specialized nursing care provided by a PDNS as compared to no PDNS care for people with PD in all disease stages. To gain more insight into the used interventions and their effects, a subgroup analysis will be performed based on disease duration (diagnosis made <5, 5-10, or >10 years ago).
Methods: The investigators will perform an 18-month, single-blind, randomized controlled clinical trial in eight community hospitals in the Netherlands. A total of 240 people with idiopathic 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 PDNS care according to the Dutch Guideline on PDNS care or no nursing intervention (continuing usual care). For the allocation of participants, a computer-generated list of random numbers will be used. The co-primary outcome measures are Quality of Life (QoL) and motor symptoms. Secondary outcomes include PD symptoms, mobility, non-motor symptoms, health-related quality of life, experienced quality of care, self-management, medication adherence, caregiver quality of life, coping skills and caregiver burden. Data will be collected after 12 months and 18 months. A healthcare utilization and productivity loss questionnaire will be completed every 3 months by both the patient and the caregiver.
Hypothesis: The investigators hypothesize that, by offering more patients access to PDNS care, QoL will increase with equal healthcare costs. Increasing direct medical costs (for nurse staffing) 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 needed.
详细描述
- Background The Parkinson's Disease Nurse Specialist (PDNS) can fulfill a pivotal role in the multidisciplinary team of people with PD. The PDNS was introduced in 1989 in the United Kingdom to bridge the gap between medical management and the unique personal needs of patients. To obtain greater uniformity in care delivery by a PDNS and to facilitate the efficacy of nursing care in PD, the Dutch Guideline 'Nursing care in Parkinson's disease' was published in 2016. The main roles of the PDNS are clearly described in the Guideline, and include 1) providing information, education and instruction; 2) supporting the patient and caregiver in the promotion of self-management; 3) supporting psychosocial care questions; 4) prevention; 5) specialized diagnostic strategies and therapeutic nursing interventions; and 6) multidisciplinary collaboration.
Based on expert opinion from healthcare professionals, the Dutch guideline advises that every person with PD could benefit from PDNS care, including those in early-stage disease where delivery of information, education about medication compliance and support in self-management are critical. So far, only three studies have evaluated PDNS care and they have found inconsistent results. Overall, they indicate that PDNS care may improve patient wellbeing, physical functioning and general health status and reduce anxiety and depression, but definite conclusions could not be drawn. Moreover, there is little evidence that shows that quality of life actually improves with PDNS care and to date, no studies have been performed that evaluated the cost-effectiveness of PDNS care.
Currently, most hospitals in The Netherlands offer PDNS care, since it is advised in the Dutch Multidisciplinary Guideline. However many centers still lack the nursing capacity to offer PDNS care to all patients because the scientific evidence is inconclusive. This situation creates an undesirable inequality in access to care and presumably leads to avoidable disability and costs (e.g. from early admissions to nursing homes or crisis admissions to the hospital). Therefore, the investigators aim to study the cost-effectiveness of specialized nursing care provided by a PDNS as compared to no PDNS care for people with PD. 2. Study design The NICE-PD study is an 18-month, single-blind randomized controlled clinical trial that will be performed in eight community hospitals in the Netherlands. A total of 240 people with PD will be included (120 in each group) and equally distributed over the participating hospitals. The investigators have selected hospitals where, due to lack of sufficient PDNS staff, only a proportion of PD patients currently has access to PDNS care. This provides the investigators with a unique opportunity to identify patients who at present have no access to PDNS care, and to randomize them within hospitals (at the patient level) between PDNS care and no nursing intervention.
Eligible patients will be allocated randomly to either PDNS care or usual care in a 1:1 ratio, using a computer-generated list of random numbers. To ascertain an equal representation of patients, the investigators will stratify for disease duration (according to pre-defined subgroups, i.e. disease duration <5 years, 5-10 years and >10 years). The PDNS intervention will be carried out according to the Dutch 'Guideline Nursing care in PD'. A blinded researcher will perform the clinical assessments at baseline (t0), after 12 months (t1) and after 18 months (t2). Patients and caregivers will also be asked to complete a set of questionnaires at t0, t1 and t2. Finally, every three months patients and their caregivers will complete an online questionnaire about healthcare utilization, costs and productivity loss. 3. Intervention
The PDNS intervention will be performed according to the Dutch 'Guideline Nursing care in PD' published in 2015. The intervention is not standardized, but tailored to the patients' and caregivers' needs. This includes the following:
- Assessment of individual care needs of people with PD and their caregivers. The PDNS performs a specific nursing assessment related to the medical, physical, psychological and social domains.
- Development of a patient-centered treatment plan that supports the patient and caregiver in self-management. The PDNS composes a multidisciplinary plan, based on the results of the individual assessment, and as prioritized by the patient and caregiver (shared decision making). The treatment plan is developed according to the national self-management framework.
- Specific nursing interventions. The intervention varies across disease stages and is tailored to the specific problems and needs of individual patients and their caregivers. The Guideline on PDNS care describes general- and specific nursing interventions. General interventions consist of providing information and education, disease management (e.g. considering advanced treatment options such as DBS) and monitoring (e.g. of caregiver burden). Specific nursing interventions are described for the following areas: mental functions, fatigue, sleep, urogenital functions, sexuality, medication adherence, orthostatic hypotension, caregiver burden, coping, mobility, self-management and dietary issues (table 2 provides examples of such interventions).
- Collaboration with other healthcare professionals. The PDNS stimulates and supports multidisciplinary collaboration between healthcare professionals based on the individual patient-centered treatment plan. The PDNS also plays a pivotal role in the timely referral to other healthcare professionals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Due to the type of intervention (Parkinson's disease nurse specialist care), the participant and care provider cannot be masked. The investigator and outcome assessor (conducting the questionnaires) will be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of idiopathic PD;
- •Sufficient knowledge of the Dutch language to fill out questionnaires;
- •Age 18 years or older at the time of diagnosis;
- •All disease stages, regardless of disease severity or disease duration;
- •Not having received care from a PDNS in the past two years;
- •A score of ≥ 18 on the Mini-Mental State Examination (MMSE13) and ≥ 12 on the Frontal Assessment Battery (FAB14).
排除标准
- •A type of atypical parkinsonism caused by medication (e.g. neuroleptics), a metabolic disorder (e.g. Wilson's disease), encephalitis or a neurodegenerative disorder (e.g. multiple system atrophy, progressive supranuclear palsy, corticobasal syndrome).
- •Residing in a nursing home or another type of residential care facility (because the PDNS is not operational there).
- •Any other medical or psychiatric disorder that, in the opinion of the researcher, may compromise participation in the study.
结局指标
主要结局
Disease-specific health-related quality of life: Parkinson's disease Questionnaire (PDQ-39)
时间窗: Baseline, change from baseline quality of life at 12 months, change from baseline quality of life at 18 months
Parkinson's disease Questionnaire (PDQ-39). Total score range: 0-100, including 8 subcategories. Subcategories are summed to compute the total score. A lower score means a better outcome.
Motor symptoms
时间窗: Baseline, change from baseline motor symptoms at 12 months, change from baseline motor symptoms at 18 months
Movement Disorders Society-sponsored revision of the Unified Parkinson's Disease Rating Scale part III (MDS-UPDRS part III). Total score range: 0-132. A lower score means a better outcome.
次要结局
- Mobility(Baseline, change from baseline TUG at 12 months, change from baseline TUG at 18 months)
- Non-motor symptoms(Baseline, change from baseline at 12 months, change from baseline at 18 months)
- Health-related quality of life: EuroQoL5D (EQ5D)(Baseline, change from baseline at 12 months, change from baseline at 18 months)
- Health-related quality of life of the caregiver: EuroQoL5D (EQ5D)(Baseline, change from baseline at 12 months, change from baseline at 18 months)
- Skills of proactive coping of the caregiver(Baseline, change from baseline at 12 months, change from baseline at 18 months)
- Medical consumption of the patient(Baseline, change from baseline at 3 months, 6 months, 9 months, 12 months, 15 months and 18 months)
- Medical consumption of the caregiver related to providing care to the patient(Baseline, change from baseline at 3 months, 6 months, 9 months, 12 months, 15 months and 18 months)
- Non-motor symptoms (anxiety and depression)(Baseline, 12 months, 18 months)
- Medication adherence(Baseline, change from baseline at 12 months, change from baseline at 18 months)
- Productivity loss of the caregiver related to providing care to the patient(Baseline, change from baseline at 3 months, 6 months, 9 months, 12 months, 15 months and 18 months)
- Caregiver burden(Baseline, change from baseline at 12 months, change from baseline at 18 months)
- Longitudinal Parkinson's disease symptoms(Baseline, change from baseline Parkinson's disease symptoms at 12 months, change from baseline Parkinson's disease symptoms at 18 months)
- Self-management(Baseline, change from baseline at 12 months, change from baseline at 18 months)
- Caregiver quality of life: CarerQol-7D(Baseline, change from baseline at 12 months, change from baseline at 18 months)
- Experienced quality of and experience with provided healthcare: Consumer Quality Index (CQI)(Baseline, change from baseline at 12 months, change from baseline at 18 months)
- Productivity loss of the patient(Baseline, change from baseline at 3 months, 6 months, 9 months, 12 months, 15 months and 18 months)
- Nighttime sleep problems and daytime sleepiness(Baseline, change from baseline at 12 months, change from baseline at 18 months)