Validation of a Shared Decision-Making Tool for Multiple Sclerosis

Study Overview
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Brief Summary
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This study evaluates a novel shared decision making tool for multiple sclerosis (MS). Half the patients will be given access to MS-SUPPORT before their scheduled appointment with their healthcare provider, the other half will not be given access.

Detailed Description
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MS-SUPPORT is a novel shared-decision making tool. More specifically, it is a web-based decision aid (DA) that includes 'values clarification exercises' to support people with MS (PwMS) incorporate their preferences and values when faced with a DMT treatment decision. Each 'values clarification exercise' includes a written passage about a specific topic, with a series of questions. It covers topical domains related to living with MS and treatment decision making, including but not limited to lifestyle, tolerability, safety, risk tolerance, health goals, and personal values. This validation study will evaluate the effect of using MS-SUPPORT on starting or switching DMTs, patient-provider communication, DMT adherence, Quality of Life (QoL), decision quality (the concordance of the treatment chosen, which includes no treatment, with the patient's values), quality of care, and decisional conflict. Participants will include adult patients with relapsing forms of MS and their MS healthcare providers (HCP). Patients will be randomized into one of two groups: MS-SUPPORT (intervention) or Usual Care (control).

Official Title
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Validation of a Shared Decision-Making Tool, MS-SUPPORT, to Improve Decisions About Disease Modifying Therapies (DMT) for Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: MS-SUPPORT


Participation Criteria
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Eligibility Criteria
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For MS patients: Inclusion criteria: Able to read and write in English Live within the United States and receive MS care in the USA 18 years or older Having a diagnosis of a relapsing form of MS, including Relapsing Remitting Multiple Sclerosis (RRMS), active secondary progressive MS, and Clinically Isolated Syndrome (CIS) Having access to the internet Having a valid email address Have a healthcare provider who is managing their MS Having an upcoming appointment with an MS healthcare provider to manage their MS within the next 12 weeks Exclusion criteria: • Unable or unwilling to give informed consent For HCPs: Inclusion criteria: English-speaking Any HCP who manages a participating patient's MS Exclusion criteria: • Unable or unwilling to give 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
Interventional Model Description: Prospective randomized controlled trial, with 1:1 randomization
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MS-SUPPORT<br>Group receives access to an online shared decision making tool (an interactive decision aid) for multiple sclerosis. | Other: MS-SUPPORT<br>* MS-SUPPORT is a shared decision making tool designed to be used by patients and providers.<br>|
| No Intervention: Control<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Start/Switch DMT | Proportion of MS patients that switch or start a disease modifying therapy (DMT). | Quarterly during the 12 month follow-up after the index HCP visit. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-provider communication | We will use COMRADE, a validated patient self-report scale that measures communication, decision-making effectiveness, satisfaction with healthcare provider communication, and confidence in the decision made. | Measured once, up to 2 months after the index HCP visit. | 
| Adherence to DMT | We will measure self-reported adherence to DMTs by asking patients to report the number of doses they took in the past month (or relevant dosing interval for that DMT if dosing is less frequent than one month) and divide that by the number of expected doses during that dosing interval. This value ranges from 0.0 to 1.0, with 1.0 indicating perfect adherence. | Quarterly, up to 12 month follow-up after the index HCP visit. | 
| Decision Quality | We will assess the extent to which the treatment chosen is consistent with the patient values by asking a question such as My treatment plan is helping me achieve my treatment goals and My treatment plan reflects what's important to me when I think about the pros and cons of treatment. | Quarterly, up to 12 month follow-up after the index HCP visit. | 
| Quality of Life--Healthy Days Core Module | We will use the 4-item Healthy Days Core Module from the Health-Related Quality of Life (HR-QOL-14). This module assesses self-rated general health, including the number of days that the person is limited in their usual mental and physical activities. This measure was originally drawn from the State-based Behavioral Risk Factor Surveillance System (BRFSS) which has been used since 1993. | Quarterly, up to 12 month follow-up after the index HCP visit. | 
| CAHPS Quality of Care | The 4-item communication items from the Patient Experience Measures from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Health Plan Survey coupled with a global assessment of their HCP and a single item from the CAHPS® Clinician & Group Surveys, Patient-Centered Medical Home (PCMH4: Someone from provider's office talked with patient about specific health goals) will be assessed. | Measured once, up to 2 months after the index HCP visit. | 
| Decision Conflict | A 4-item validated short-form of the original decisional conflict scale (SURE) will be used. These 4 items ask yes/no questions; the scoring algorithm combines the total score (maximum 4, minimum 0). Any score under 4 is considered a positive for decisional conflict. | Measured twice. First measurement, up to 1 month after starting the study. Second measurement, up to 2 months after the index HCP visit. |