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Completed

NCT Number: NCT04122989

Validation of a Shared Decision-Making Tool for Multiple Sclerosis

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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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shared Decision Making Resources

Georgetown, Maine, 04548, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MS-SUPPORT

Other

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

Primary outcomes

  1. Start/Switch DMT

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

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

Secondary outcomes

  1. Patient-provider communication

    Time frame: Measured once, up to 2 months after the index HCP visit.

    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.

  2. Adherence to DMT

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

    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.

  3. Decision Quality

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

    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."

  4. Quality of Life--Healthy Days Core Module

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

    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.

  5. CAHPS Quality of Care

    Time frame: Measured once, up to 2 months after the index HCP visit.

    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.

  6. Decision Conflict

    Time frame: Measured twice. First measurement, up to 1 month after starting the study. Second measurement, up to 2 months after the index HCP visit.

    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.

Sponsors and collaborators

Lead sponsor

Shared Decision Making Resources

Other

Collaborators

  • EMD Serono
  • Multiple Sclerosis Association of America

Registry information

Official study title

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

Acronym: MS-SUPPORT

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Oct 10, 2019
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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