Validation of a Shared Decision-Making Tool, MS-SUPPORT, to Improve Decisions About Disease Modifying Therapies (DMT) for Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 501
- 试验地点
- 1
- 主要终点
- Start/Switch DMT
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Unable or unwilling to give informed consent
- •Inclusion criteria:
- •English-speaking
- •Any HCP who manages a participating patient's MS
- •Exclusion criteria:
- •Unable or unwilling to give informed consent
研究组 & 干预措施
MS-SUPPORT
Group receives access to an online shared decision making tool (an interactive decision aid) for multiple sclerosis.
干预措施: MS-SUPPORT (Other)
Control
Usual care
结局指标
主要结局
Start/Switch DMT
时间窗: 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).
次要结局
- Adherence to DMT(Quarterly, up to 12 month follow-up after the index HCP visit.)
- Patient-provider communication(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.)
- 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.)
- CAHPS Quality of Care(Measured once, up to 2 months after the index HCP visit.)