Validation of a Shared Decision-Making Tool for Multiple Sclerosis (MS-SUPPORT)

Shared Decision Making Resources

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Other: MS-SUPPORT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04122989

MS700568_0052

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 501 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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501 participants in 2 patient groups

MS-SUPPORT

Experimental group

Description:

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

Treatment:

Other: MS-SUPPORT

Control

No Intervention group

Description:

Usual care