Clinical trial NCT04122989: Validation of a Shared Decision-Making Tool for Multiple Sclerosis
Official title: Validation of a Shared Decision-Making Tool, MS-SUPPORT, to Improve Decisions About Disease Modifying Therapies (DMT) for Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Shared Decision Making Resources
Sponsor class: OTHER
Collaborators: name: EMD Serono
name: Multiple Sclerosis Association of America
First posted: 2019-10-10
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized controlled trial, with 1:1 randomization
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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).

Eligibility 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

Primary outcomes:
measure: Start/Switch DMT
timeFrame: Quarterly during the 12 month follow-up after the index HCP visit.
Secondary outcomes:
measure: Patient-provider communication
timeFrame: Measured once, up to 2 months after the index HCP visit.
measure: Adherence to DMT
timeFrame: Quarterly, up to 12 month follow-up after the index HCP visit.
measure: Decision Quality
timeFrame: Quarterly, up to 12 month follow-up after the index HCP visit.
measure: Quality of Life--Healthy Days Core Module
timeFrame: Quarterly, up to 12 month follow-up after the index HCP visit.
measure: CAHPS Quality of Care
timeFrame: Measured once, up to 2 months after the index HCP visit.
measure: Decision Conflict
timeFrame: Measured twice. First measurement, up to 1 month after starting the study. Second measurement, up to 2 months after the index HCP visit.
Other outcomes:
Locations:
city: Georgetown
country: United States
facility: Shared Decision Making Resources
state: Maine
Study officials:
affiliation: Shared Decision Making Resources
name: Nananda Col, MD, MPH, MPP
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.