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

Patrocinadores

Patrocinador principal: Shared Decision Making Resources

Colaborador: EMD Serono
Multiple Sclerosis Association of America
Multiple Sclerosis Alliance of Southern Colorado

Fuente Shared Decision Making Resources
Resumen breve

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.

Descripción detallada

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).

Estado general Recruiting
Fecha de inicio November 12, 2019
Fecha de Terminación June 30, 2021
Fecha de finalización primaria May 1, 2020
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Start/Switch DMT Quarterly during the 12 month follow-up after the index HCP visit.
Resultado secundario
Medida Periodo de tiempo
Patient-provider communication Measured once, up to 2 months after the index HCP visit.
Adherence to DMT Quarterly, up to 12 month follow-up 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.
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.
Inscripción 575
Condición
Intervención

Tipo de intervención: Other

Nombre de intervención: MS-SUPPORT

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

Etiqueta de grupo de brazo: MS-SUPPORT

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Nananda Col, MD, MPH, MPP Principal Investigator Shared Decision Making Resources
Contacto general

Apellido: Nananda F Col, MD, MPH, MPP

Teléfono: 2073712599

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Copia de seguridad de contactos: Investigador: Shared Decision Making Resources Nananda F Col, MD 207-272-9829 [email protected] Nananda F Col, MD Principal Investigator
Ubicacion Paises

United States

Fecha de verificación

March 2020

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: MS-SUPPORT

Tipo: Experimental

Descripción: Group receives access to an online shared decision making tool (an interactive decision aid) for multiple sclerosis.

Etiqueta: Control

Tipo: No Intervention

Descripción: Usual care

Acrónimo MS-SUPPORT
Datos del paciente Yes
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Descripción del modelo de intervención: Prospective randomized controlled trial, with 1:1 randomization

Propósito primario: Health Services Research

Enmascaramiento: Single (Care Provider)

Fuente: ClinicalTrials.gov