Validation of a Shared Decision-Making Tool for Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: MS-SUPPORT

• Registration Number: NCT04122989
• Lead Sponsor: Shared Decision Making Resources

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).

Study Timeline

• Study First Submitted: 2019-10-08
• Study First Submitted QC: 2019-10-09
• Study First Posted: 2019-10-10
• Study Start: 2019-11-12
• Primary Completion: 2020-10-26
• Study Completion: 2021-12-23
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 501

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MS-SUPPORT	MS-SUPPORT	Group receives access to an online shared decision making tool (an interactive decision aid) for multiple sclerosis.

Primary Outcome Measures

Name	Time	Method
Start/Switch DMT	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).

Secondary Outcome Measures

Name	Time	Method
Patient-provider communication	Measured once, up to 2 months after the index HCP visit.	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.
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.	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.
Decision Quality	Quarterly, up to 12 month follow-up after the index HCP visit.	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."
Quality of Life--Healthy Days Core Module	Quarterly, up to 12 month follow-up after the index HCP visit.	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.
Adherence to DMT	Quarterly, up to 12 month follow-up after the index HCP visit.	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.
CAHPS Quality of Care	Measured once, up to 2 months after the index HCP visit.	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.

Trial Locations

Locations (1)

Shared Decision Making Resources; 🇺🇸 Georgetown, Maine, United States