VIRtual Versus UsuAL In-office Care for Multiple Sclerosis (VIRTUAL-MS)

Study Overview
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Brief Summary
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The current standard of outpatient MS care depends on in-clinic visits, but MS patients face many barriers to accessing this care. These barriers include those resulting from the disease itself, such as physical limitations, driving restrictions and financial limitations, and they are further compounded by an overall shortage of neurologists. Furthermore, MS care has a significant economic impact, with the estimated indirect and direct costs for treating MS in the US estimated to be > $85.4 billion. Therefore, there is a need to improve access to and reduce cost of MS care, and telehealth is a potential solution. The VIRTUAL-MS study has been designed to evaluate the impact of telehealth care on MS clinical outcomes, costs, and satisfaction compared to in-person care. Additionally, the study aims to evaluate facilitators and barriers to telehealth use to inform widespread implementation.

Detailed Description
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The VIRTUAL-MS study aims to evaluate the impact of telehealth on MS care. The study will conduct a 24 month randomized controlled clinical trial at two Centers (Cleveland Clinic and University of California San Francisco) and will enroll 60 adult people with MS per Center with a recent diagnosis of MS. Participants will be randomized 1:1 to receive follow-up MS care via scheduled telehealth, or standard in-clinic, visits. All participants will have in-person visits at baseline and 24 months with in-person study visit including clinical assessments, patient reported outcomes, and medical history review. All participants will have clinical visits with their neurology clinician every 6 months (months 6, 12, and 18) via in-person or telehealth per randomized arm. The primary objective of this study is to determine if MS care delivered via telehealth is non-inferior compared to in-clinic MS care as measured by worsening in one of the Multiple Sclerosis Functional Composite (MSFC) components at Month 24. The secondary objectives of this study include the following: To determine if MS care delivered via telehealth has superior patient satisfaction compared to in-person MS care as measured by baseline to 24 month change in PSQ-18. To determine if MS care delivered via telehealth is more cost-effective than MS care delivered via in-person visits as measured by total non-medication costs over 24 months. The researchers will also explore other clinical outcomes, treatment adherence, digital outcomes, patient experience, and clinician experience.

Official Title
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Virtual Versus Usual In-office Care for Multiple Sclerosis: A Randomized Trial (VIRTUAL-MS)

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: Multiple Sclerosis Clinical Care Delivery via telehealth
* Other: Multiple Sclerosis Clinical Care Delivery via standard in clinic visits


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages ≥18 MS diagnosis within 12 months of randomization by 2017 McDonald Criteria. Confirmatory MRI within 6 months prior to randomization. Exclusion Criteria: Clinically relevant condition that, in the opinion of the PI, could preclude participation in the study (e.g. neutropenia or wound care requiring frequent monitoring) Inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telehealth care<br>Telehealth visits will be performed using institutionally-approved, secure, web-based teleconferencing. The standard neurology visits will occur every 6 months with their established neurology clinician via telehealth. The comprehensive care will be offered via telehealth or within the patient's local community. The comprehensive care visits will be adapted for the individual participants' needs and symptoms, consistent with standard clinical care. | Other: Multiple Sclerosis Clinical Care Delivery via telehealth<br>* Intervention includes clinical care delivered via telehealth<br>|
| Active Comparator: In-Clinic care<br>Standard neurology visits will be conducted in-clinic visits every 6 months with their established neurology clinician. The comprehensive MS care visits will be conducted in-clinic. The comprehensive care visits will be adapted for the individual participants' needs and symptoms, consistent with standard clinical care. | Other: Multiple Sclerosis Clinical Care Delivery via standard in clinic visits<br>* Intervention includes clinical care delivered via standard in clinic visits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with disability progression | The primary outcome will be disability worsening in one of the Multiple Sclerosis Functional Composite components at 24 months. Worsening is defined as 20% worsening in Timed 25 foot walking speed (T25FW), 20% worsening in the 9 hole peg test (9HPT), 20% worsening in Low Contrast Letter Acuity (LCLA) or a 4 point decrease in the Symbol Digit Modalities Test (SDMT). | Baseline to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Satisfaction Questionnaire Short Form (PSQ-18) | The secondary outcome will assess patient and clinical care team satisfaction via the Patient Satisfaction Questionnaire Short Form (PSQ-18) short form. Minimum value is 1 and maximum value is 5 for each question, where 5 means a better outcome. | Baseline to 24 months | 
| Compare major healthcare costs | The secondary outcome will compare major healthcare costs as measured by total non-medication costs. | Baseline to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple sclerosis, MS, telehealth, healthcare delivery