Validation of a Shared Decision-Making Tool for Multiple Sclerosis

Shared Decision Making Resources501 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

501

Conditions

Multiple Sclerosis

Interventions

MS-SUPPORTOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Shared Decision Making Resources

Georgetown, Maine, United States

Outcomes

Primary Outcomes

Start/Switch DMT

Proportion of MS patients that switch or start a disease modifying therapy (DMT).

Time frame: Quarterly during the 12 month follow-up after the index HCP visit.

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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."

Time frame: 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.

Data from ClinicalTrials.gov

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