Validation of a Shared Decision-Making Tool for Multiple Sclerosis
Validation of a Shared Decision-Making Tool, MS-SUPPORT, to Improve Decisions About Disease Modifying Therapies (DMT) for Multiple Sclerosis
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- MS-SUPPORT
What it measured
Main measures
Start/Switch DMT
Quarterly during the 12 month follow-up after the index HCP visit.
Other measures (6)
Patient-provider communication
Measured once, up to 2 months after the index HCP visit.
Quality of life (reported by participants)Adherence to DMT
Quarterly, up to 12 month follow-up after the index HCP visit.
Quality of life (reported by participants)Decision Quality
Quarterly, up to 12 month follow-up after the index HCP visit.
Quality of Life--Healthy Days Core Module
Quarterly, up to 12 month follow-up after the index HCP visit.
Quality of life (reported by participants)CAHPS Quality of Care
Measured once, up to 2 months after the index HCP visit.
Decision Conflict
Measured twice. First measurement, up to 1 month after starting the study. Second measurement, up to 2 months after the index HCP visit.
Who could take part
Relapsing and progressive · 18 and over
Show the full criteria
Inclusion 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
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.Results
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.Background
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.Background
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.Background
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.Background
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 intBackground
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.Background
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.
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History
Started
Nov 2019
Main results due
Oct 2020
Finished
Dec 2021