Abstract
Abstract
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.govPro00069595. Retrospectively registered on June 26, 2020. Protocol version: January 2017, version 1.
Funder
University Hospital Foundation
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Medicine (miscellaneous)
Reference88 articles.
1. Atlas of MS 2013: mapping MS around the world [Internet]. Multiple Sclerosis International Federation; 2013. [cited 2020 May 6]. Available from: https://www.msif.org/wp-content/uploads/2014/09/Atlas-of-MS.pdf.
2. GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019;18(5):459–80.
3. Oreja-Guevara C, Potra S, Bauer B, Centonze D, Giambastiani M-P, Giovannoni G, et al. Joint healthcare professional and patient development of communication tools to improve the standard of MS care. Adv Ther. 2019;36(11):3238–52. https://doi.org/10.1007/s12325-019-01071-9.
4. Giovannoni G, Butzkueven H, Dhib-Jalbut S, Hobart J, Kobelt G, Pepper G, et al. Brain health: time matters in multiple sclerosis. Mult Scler Relat Disord. 2016;9(Suppl 1):S5–S48. https://doi.org/10.1016/j.msard.2016.07.003.
5. Alberta Government. The way forward: Alberta’s multiple sclerosis partnership [Internet]. Alberta Government Website. 2013. [cited 2020 May 6]. Available from: https://open.alberta.ca/publications/9781460108574.