测量护士从业者（NP）主导的护理对多发性硬化症患者抑郁和焦虑水平的影响：一项随机对照试验的研究方案。
Measuring the effects of nurse practitioner (NP)-led care on depression and anxiety levels in people with multiple sclerosis: a study protocol for a randomized controlled trial.
机构信息
Department of Medicine (Neurology), University of Alberta, Edmonton, AB, Canada.
EPICORE Centre, Department of Medicine, University of Alberta, Edmonton, AB, Canada.
出版信息
Trials. 2021 Nov 8;22(1):785. doi: 10.1186/s13063-021-05726-3.
BACKGROUND
Canada has one of the highest rates of multiple sclerosis (MS) in the world. Treatments and supports for people with MS (PwMS) have become increasingly complex, requiring individualized and adaptive care. Specialized NPs provide advanced skills to those with complex medical conditions, with potential to enhance the health, functioning, and quality of life for PwMS. This study aims to determine the effect of a Nurse Practitioner (NP) on depression and anxiety levels in PwMS.
METHODS
We will perform a parallel randomized controlled trial. PwMS who are followed by general private-practice neurologists will be randomly assigned to the intervention group (NP-led care) or the 'usual care' control group (general neurologist or family physician and registered nurse support). In the intervention group, the NP will assess and provide care to the MS patient and their caregiver at a baseline visit, with 3-month and 6-month follow-up visits. PwMS in the control group will receive usual care provided by their community neurologists or family physicians with the standard assistance provided by registered nurses experienced in MS care. The primary outcome will be the difference in change in the patient's anxiety and depression scores as measured by the validated Hospital Anxiety and Depression Scale (HADS) questionnaire at 3 months. Secondary outcomes will include difference in change in HADS at 6 months; Modified Fatigue Impact Scale scores (MSIF) at 3 and 6 months; EQ-5D scores at 3 and 6 months; caregiver health-related quality of life in MS measures (CAREQOL-MS) at 3 and 6 months; number of visits and phone calls to healthcare professionals recorded by patient, and satisfaction with NP-led care vs usual care measured by the validated Consultant Satisfaction Questionnaire.
DISCUSSION
Findings from this study will contribute to exploring benefits of advanced nursing practitioner interventions for PwMS followed by general neurologists and family physicians in a community setting. It will provide evidence of the benefits of NP-led care for PwMS and offer an alternative healthcare resource for management of MS.
TRIAL REGISTRATION
ClinicalTrials.gov Pro00069595 . Retrospectively registered on June 26, 2020. Protocol version: January 2017, version 1.
背景
加拿大是多发性硬化症（MS）发病率最高的国家之一。针对多发性硬化症患者（PwMS）的治疗和支持已变得越来越复杂，需要个性化和适应性护理。专门的执业护士（NP）为患有复杂疾病的患者提供高级技能，有可能提高 PwMS 的健康、功能和生活质量。本研究旨在确定执业护士（NP）对 PwMS 的抑郁和焦虑水平的影响。
方法
我们将进行一项平行随机对照试验。由私人执业普通神经科医生随访的 PwMS 将被随机分配到干预组（NP 主导的护理）或“常规护理”对照组（普通神经科医生或家庭医生和注册护士支持）。在干预组中，NP 将在基线访视时对 MS 患者及其照顾者进行评估和护理，并在 3 个月和 6 个月进行随访。对照组中的 PwMS 将接受他们的社区神经科医生或家庭医生提供的常规护理，并由有经验的注册护士提供 MS 护理的标准协助。主要结局将是 3 个月时经过验证的医院焦虑和抑郁量表（HADS）问卷测量的患者焦虑和抑郁评分变化的差异。次要结局将包括 6 个月时 HADS 变化的差异；改良疲劳影响量表评分（MSIF）在 3 个月和 6 个月；EQ-5D 评分在 3 个月和 6 个月；3 个月和 6 个月时照顾者的多发性硬化症相关生活质量测量（CAREQOL-MS）；患者记录的就诊次数和与医疗保健专业人员的电话次数，以及对 NP 主导护理与常规护理的满意度，通过经过验证的顾问满意度问卷进行测量。
讨论
本研究的结果将有助于探讨在社区环境中由普通神经科医生和家庭医生随访的 PwMS 接受高级执业护士干预的益处。它将为 NP 主导的护理对 PwMS 的益处提供证据，并为 MS 管理提供另一种替代医疗资源。
试验注册
ClinicalTrials.gov Pro00069595。2020 年 6 月 26 日回顾性注册。方案版本：2017 年 1 月，第 1 版。
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