Abstract
BackgroundCanada 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.MethodsWe 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.DiscussionFindings 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 registrationClinicalTrials.govPro00069595. Retrospectively registered on June 26, 2020. Protocol version: January 2017, version 1.
Highlights
Canada has one of the highest rates of multiple sclerosis (MS) in the world
This is because of studies suggesting that people with MS (PwMS) scoring high on depression levels often have not been previously identified as having depression or anxiety within a cohort [28], and that even those with previously identified depression or anxiety are often undertreated [45]
The primary outcome of depression and anxiety score changes at 3 months was chosen as the primary outcome due to published studies examining efficacy of interventions for depression and anxiety for PwMS carrying out active intervention strategies ranging in duration from 6 to 16 weeks, demonstrating overall efficacy in mainly depression and suggested efficacy in anxiety by a systematic review and meta-analysis [47]
Summary
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. Multiple sclerosis (MS) is the leading cause of nontraumatic disability in young adults [1,2,3,4] It is most commonly diagnosed in people between the ages of 15 and 40, with visible symptoms such as walking difficulties, balance, coordination, and double vision, in addition to unseen symptoms such as fatigue, cognitive issues, depression, anxiety, and pain. The resources (e.g. education, counseling, support, care) provided to PwMS should evolve and change as a person’s MS progresses and their needs change [15] Despite this recognition for multidisciplinary and personalized care, healthcare and patient outcomes for PwMS in the twenty-first century has not advanced [3]. The EQ5D-3 L includes the five dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/
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