Drug Risk Aversion Calculator Use to Facilitate MS Patient Self-efficacy

Study Overview
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Brief Summary
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The investigators seek to determine if the use of a Side Effect Aversion Calculator helps patients with multiple sclerosis (MS) more comfortably and rapidly identify the disease modifying drug (DMD) that is best suited for the patient.

Detailed Description
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Settling into the use of a multiple sclerosis disease modifying drug (DMD) can seem like taking an important final examination, consisting of a single multiple choice question with 16 equally appropriate responses, having months or even years to second-guess your choice, and then getting a grade but never being told the correct answer. Making the choice between these options can be overwhelming, leaving patients feeling both disempowered and depersonalized in the decision-making process. In order to allow a better, more personalized, decision-making process the investigators introduce a side effect aversion calculator, which takes a patient's individual side effect aversion profile into consideration when discussing the start of a new disease modifier (initial drug, or drug switch). Subjects will be multiple sclerosis patients who have a provider-identified need for DMD initiation or DMD switch and receive their care at Duke. Recruitment goal is 100 subjects. Those randomized to calculator arms will be reminded that the purpose of the calculator is to facilitate the DMD choice discussion, NOT make the decision. Subjects asked to rate level of concern over adverse events (AEs) across all DMDs. Calculator multiplies subject response by the prevalence reported within DMD prescribing information. Sum of these weighted scores reveals a DMD's Total Aversion score and medication ranking by patient's specific side effect aversion profile, therefore framing discussion. Enrollment visit concludes with survey designed to collect MS clinical history, MS symptoms, medication history, medication adherence and self-efficacy. This same survey is conducted prior to subsequent three clinic visits.

Official Title
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Benefits of Drug Risk Aversion Calculation to Multiple Sclerosis Drug Choice and Patient Self-efficacy

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: Risk Aversion Calculator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years old Be able to read and speak English Be currently treated or starting treatment with an MS disease modifying medication Exclusion Criteria: All of the inclusion criteria must be met. If they cannot be met, then they are excluded from the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Natural discussion of disease modifier selection conducted without augmentation by risk aversion calculator | |
| Experimental: Calculator<br>Natural discussion of disease modifier selection conducted with augmentation by risk aversion calculator | Other: Risk Aversion Calculator<br>* The calculator asks the participant to rate their level of aversion to having a set list of potential medication side effects (0 = no concern; 1 = mild concern; 2 = moderate concern; 3 = moderate to severe concern; 4 = severe concern)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Disease Self-efficacy | Degree of change over time in a person's judgement of how well one can execute courses of action required to manage multiple sclerosis | Baseline and then at the conclusion of the initial 1 day visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to new medication start | The amount of time (in days) from initial treatment discussion to treatment start | 6 months | 
| Medication adherence | The percentage of all prescribed doses of a medication that a patient takes | At enrollment and at each subsequent visit for one year | 
| Change from Baseline Disease Self-efficacy at 6 months | Degree of change over time in a person's judgement of how well one can execute courses of action required to manage multiple sclerosis | At enrollment and at 6 months post-visit | 
| Change from Baseline Disease Self-efficacy at 12 months | Degree of change over time in a person's judgement of how well one can execute courses of action required to manage multiple sclerosis | At enrollment and at 12 months post-visit |