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Multiple SclerosisMS-SUPPORTNCT04122989

Validation of a Shared Decision-Making Tool for Multiple Sclerosis

A study testing MS-SUPPORT in people with Multiple Sclerosis, run by Shared Decision Making Resources at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
MS-SUPPORT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
501 participants
Where
1 siteUnited States
Study dates
12 Nov 2019to 23 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • Unable or unwilling to give informed consent
  • For HCPs:
  • Unable or unwilling to give informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Shared Decision Making Resources

    Georgetown, Maine, 04548

Other trials in United States

About this study

Official title: Validation of a Shared Decision-Making Tool, MS-SUPPORT, to Improve Decisions About Disease Modifying Therapies (DMT) 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.

Read the detailed 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).

Being tested
MS-SUPPORT
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MS-SUPPORTOther

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

Study groups in NCT04122989
Study groupRoleWhat they receive
MS-SUPPORTExperimentalGroup receives access to an online shared decision making tool (an interactive decision aid) for multiple sclerosis.
Receives: Other: MS-SUPPORT
ControlNo interventionUsual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Start/Switch DMT

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

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

Secondary outcomes (6)

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

  2. 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.

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

  3. 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."

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

  4. 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.

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2019
  2. Study start12 Nov 2019
  3. Primary completion26 Oct 2020
  4. Study completion23 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective randomized controlled trial, with 1:1 randomization
Masking
Single blind
Who is masked
Care provider
Enrolment
501 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04122989
Sponsor's protocol ID
MS700568_0052
Acronym
MS-SUPPORT
Status last verified
May 2022
First submitted
8 Oct 2019
Last updated
9 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We will share all Individual Participant Data (IPD) that underlie results in a publication, ensuring that such data are deidentified.

Publications

  • Edwards A, Elwyn G, Hood K, Robling M, Atwell C, Holmes-Rovner M, Kinnersley P, Houston H, Russell I. The development of COMRADE--a patient-based outcome measure to evaluate the effectiveness of risk communication and treatment decision making in consultations. Patient Educ Couns. 2003 Jul;50(3):311-22. doi: 10.1016/s0738-3991(03)00055-7.

    PubMed 12900105

  • Moriarty DG, Zack MM, Kobau R. The Centers for Disease Control and Prevention's Healthy Days Measures - population tracking of perceived physical and mental health over time. Health Qual Life Outcomes. 2003 Sep 2;1:37. doi: 10.1186/1477-7525-1-37.

    PubMed 14498988

  • Sepucha KR, Borkhoff CM, Lally J, Levin CA, Matlock DD, Ng CJ, Ropka ME, Stacey D, Joseph-Williams N, Wills CE, Thomson R. Establishing the effectiveness of patient decision aids: key constructs and measurement instruments. BMC Med Inform Decis Mak. 2013;13 Suppl 2(Suppl 2):S12. doi: 10.1186/1472-6947-13-S2-S12. Epub 2013 Nov 29.

    PubMed 24625035

  • Elwyn G, O'Connor A, Stacey D, Volk R, Edwards A, Coulter A, Thomson R, Barratt A, Barry M, Bernstein S, Butow P, Clarke A, Entwistle V, Feldman-Stewart D, Holmes-Rovner M, Llewellyn-Thomas H, Moumjid N, Mulley A, Ruland C, Sepucha K, Sykes A, Whelan T; International Patient Decision Aids Standards (IPDAS) Collaboration. Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ. 2006 Aug 26;333(7565):417. doi: 10.1136/bmj.38926.629329.AE. Epub 2006 Aug 14.

    PubMed 16908462

  • Pieterse AH, de Vries M, Kunneman M, Stiggelbout AM, Feldman-Stewart D. Theory-informed design of values clarification methods: a cognitive psychological perspective on patient health-related decision making. Soc Sci Med. 2013 Jan;77:156-63. doi: 10.1016/j.socscimed.2012.11.020. Epub 2012 Nov 27.

    PubMed 23219164

  • Reynolds MW, Stephen R, Seaman C, Rajagopalan K. Persistence and adherence to disease modifying drugs among patients with multiple sclerosis. Curr Med Res Opin. 2010 Mar;26(3):663-74. doi: 10.1185/03007990903554257.

    PubMed 20070144

  • Col NF, Solomon AJ, Springmann V, Garbin CP, Ionete C, Pbert L, Alvarez E, Tierman B, Hopson A, Kutz C, Berrios Morales I, Griffin C, Phillips G, Ngo LH. Whose Preferences Matter? A Patient-Centered Approach for Eliciting Treatment Goals. Med Decis Making. 2018 Jan;38(1):44-55. doi: 10.1177/0272989X17724434. Epub 2017 Aug 14.

    PubMed 28806143

  • Col NF, Solomon AJ, Springmann V, Ionete C, Alvarez E, Tierman B, Kutz C, Morales IB, Griffin C, Ngo LH, Jones DE, Phillips G, Hopson A, Pbert L. Evaluation of a Novel Preference Assessment Tool for Patients with Multiple Sclerosis. Int J MS Care. 2018 Nov-Dec;20(6):260-267. doi: 10.7224/1537-2073.2017-021.

    PubMed 30568563

Questions about this trial

What is this clinical trial studying?

A study testing MS-SUPPORT in people with Multiple Sclerosis, run by Shared Decision Making Resources at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Start/Switch DMT (time frame: Quarterly during the 12 month follow-up after the index HCP visit.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04122989, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022; AzTrials last refreshed its copy on 5 Nov 2026.

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