Validation of a Shared Decision-Making Tool for Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

501 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-12

Study Completion Date

2021-12-23

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.

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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).

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized controlled trial, with 1:1 randomization

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Caregivers

Study Groups

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MS-SUPPORT

Group receives access to an online shared decision making tool (an interactive decision aid) for multiple sclerosis.

Group Type EXPERIMENTAL

MS-SUPPORT

Intervention Type OTHER

MS-SUPPORT is a shared decision making tool designed to be used by patients and providers.

Control

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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MS-SUPPORT

MS-SUPPORT is a shared decision making tool designed to be used by patients and providers.

Intervention Type OTHER

Eligibility Criteria

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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

* English-speaking
* Any HCP who manages a participating patient's MS