Clinical trial NCT03375541: Drug Risk Aversion Calculator Use to Facilitate MS Patient Self-efficacy
Official title: Benefits of Drug Risk Aversion Calculation to Multiple Sclerosis Drug Choice and Patient Self-efficacy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Disease Self-efficacy
timeFrame: Baseline and then at the conclusion of the initial 1 day visit
Secondary outcomes:
measure: Time to new medication start
timeFrame: 6 months
measure: Medication adherence
timeFrame: At enrollment and at each subsequent visit for one year
measure: Change from Baseline Disease Self-efficacy at 6 months
timeFrame: At enrollment and at 6 months post-visit
measure: Change from Baseline Disease Self-efficacy at 12 months
timeFrame: At enrollment and at 12 months post-visit
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Fletcher Hartsell, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: