MS Wellness Navigator: The Effect of Nurse Practitioner (NP-led) Care on Mood, Anxiety and Health Related Quality of Life in People With Multiple Sclerosis - A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 248
- 试验地点
- 2
- 主要终点
- Difference in Change in Hospital Anxiety & Depression Scale - Depression (HADS-D) and Hospital Anxiety & Depression Scale-Anxiety (HADS-A) scores
研究概览
简要总结
MS is the leading cause of non-traumatic disability in young adults. Canada and Alberta, have the highest prevalence of people with multiple sclerosis (PwMS) in the world. To keep PwMS as functional as possible, a multi-disciplinary team is considered essential in the approach to treating people with MS. Because of the high numbers of PwMS in Northern Alberta, private-practice general neurologists provide care to a large number of PwMS outside of a multi-disciplinary tertiary care setting. It is challenging for these general neurologists with busy office practices to deliver optimal care to PwMS who have high care needs. The investigators wish to evaluate the effects of nurse practitioner (NP) led care for PwMS on their depression and anxiety levels at 3 and 6 months compared to "usual care' (community neurologists and MS registered nurses) in addition to measuring quality of life for PwMS and their caregivers, fatigue levels, monitor their outpatient healthcare usage and patient's satisfaction of care provided. The investigators wish to conduct a prospective randomized controlled trial examining NP intervention care for PwMS. It is hypothesized that PwMS whose care is managed by an NP will have less depression and anxiety (as measured by the Hospital Anxiety and Depression Scale - HADS) at 3 months.
详细描述
Background:
MS is the leading cause of non-traumatic disability in young adults. It is most commonly diagnosed in people between the ages of 20 to 50, causing visible and invisible disability that limits functioning and progresses over time. Canada has one of the highest prevalence of MS in the world; Alberta has the highest rate of MS in Canada (340/100 000 population). Having MS is associated with significant economic, physical and psychological burdens on the individual with corresponding burden upon society.
Global approach to treating and supporting PwMS has become multidisciplinary, multi-pronged and increasingly complex; MS impacts a person's physical, psychological and social well-being. Despite advances in healthcare for PwMS in the 21st century, multiple studies have reported a number of unmet care needs for PwMS: in areas of healthcare delivery, education, counselling and psychological support, and in supporting their informal caregivers. Recently, a study of over 1000 PwMS, reported that a higher number of reported health and social care-related unmet needs predicted lower health related quality of life, with all domains of the EQ5D-3L as being important.
PwMS prefer multidisciplinary care, recommended as essential by international multiple sclerosis experts. It has been reported that NPs are well-placed providers for PwMS, with their expertise in chronic disease management and quality of life approach. A recent integrative review identified three themes to the role of the MS nurse specialist: (1) longitudinal care co-coordinator; (2) care provider; and (3) expert resource. In one questionnaire study, PwMS indicated that they preferred contacting the specialized MS nurse above other health professionals. In addition, having NPs to enhance the multi-disciplinary team could potentially provide healthcare cost-savings: in the United States, NP-led care was reported to be cost-saving in comparison to physician-led care.
Private-practice general neurologists and family doctors provide care to approximately 2000 PwMS outside of a tertiary multi-disciplinary clinic setting with a wide catchment area extending across Central and Northern Alberta, Northern BC, Saskatchewan and Northwest Territories. It is challenging for general neurologists and family doctors to balance care of PwMS with the pressures of busy office practices in a fee-for-service setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The research team will randomize consented patients who meet inclusion criteria on a 1:1 ratio on a centralized secure website. Block randomization (using variable block sizes) will be used to ensure there are equal participants in the intervention and control arms and to further conceal allocation. Participants will be randomized to either the intervention group of NP-led care or the control group of standard care provided by community neurologist and registered nurse. Due to the nature of the intervention, blinding of the providers or patients will not be possible. However, the statistician will be blinded as to which group represents the intervention and control. All participants will be given appointment with the NP, either within 4 to 6 weeks if randomized to the intervention arm, or at 6 months after study conclusion if in usual care arm.
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
- •>/= 18 years of age
- •a MS diagnosis (by 2010 MacDonald MS criteria (Polman et al 2011)
- •Followed by a private-practice general neurologist and/or family doctor in the Northern Alberta region
- •Willingness to give consent
- •Ability to complete questionnaires
- •Willingness to attend outpatient visits with NP
- •English-speaking
- •Were able to use a computer
- •Initially, we limited inclusion to those who are experiencing disability from their MS (Expanded Disability status Scale (EDSS) 3.0 to 8.5 . In 2018, due to poor recruitment, the inclusion criteria were opened to include any PwMS and was not limited to disability level.
排除标准
- •Under the age of 18 years old
- •Unable to provide consent
- •Unable to attend appointments with the NP
- •Did not speak English
- •Referred to or followed by neurologists within the tertiary University MS clinic setting
- •Those who had central nervous system inflammatory disorders other than MS
结局指标
主要结局
Difference in Change in Hospital Anxiety & Depression Scale - Depression (HADS-D) and Hospital Anxiety & Depression Scale-Anxiety (HADS-A) scores
时间窗: 3 months
Hospital Anxiety \& Depression Scale (D subcategory for depression levels, A subcategory for anxiety levels). This is a common depression and anxiety measurement instrument used in multiple sclerosis. Minimum score is 0, and maximum score is 21. Higher scores indicate worse outcome. Three papers report total HADS scores in PwMS. Using the information from Honarmand and Feinstein \[Baseline scores and standard deviation (SD)\] and the following assumptions 90% power and a two-sided alpha of 0.05, a total sample size of 200 (100 in each group) was required to detect 1.5 difference between the intervention and the control groups. This sample size was inflated to 220 to account for possible dropouts, losses to follow-up and withdrawals of consent.
次要结局
- Difference in Change Modified Fatigue Impact Scale (MFIS) score(3 and 6 months)
- Qualitative Consultant Satisfaction Questionnaire (CSQ)(6 months)
- Difference in Change in Euro Quality of Life Measurement (EQ5D)(3 and 6 months)
- Difference in Change in Hospital Anxiety & Depression Scale - Depression (HADS-D) and Hospital Anxiety & Depression Scale-Anxiety (HADS-A) scores(6 months)
- Difference in Change in Caregiver Health-Related Quality of Life in MS (CAREQOL-MS)(3 and 6 months)
- Number of Participant Outpatient Healthcare Interactions/Visits(3 and 6 months)