Drug Risk Aversion Calculator Use to Facilitate MS Patient Self-efficacy (DRAC)
Primary Purpose
Multiple Sclerosis
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Risk Aversion Calculator
Sponsored by

About this trial
This is an interventional supportive care trial for Multiple Sclerosis
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Calculator
Arm Description
Natural discussion of disease modifier selection conducted without augmentation by risk aversion calculator
Natural discussion of disease modifier selection conducted with augmentation by risk aversion calculator
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Time to new medication start
The amount of time (in days) from initial treatment discussion to treatment start
Medication adherence
The percentage of all prescribed doses of a medication that a patient takes
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03375541
Brief Title
Drug Risk Aversion Calculator Use to Facilitate MS Patient Self-efficacy
Acronym
DRAC
Official Title
Benefits of Drug Risk Aversion Calculation to Multiple Sclerosis Drug Choice and Patient Self-efficacy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Clinical workflow was too high
Study Start Date
March 2018 (Anticipated)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
March 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Natural discussion of disease modifier selection conducted without augmentation by risk aversion calculator
Arm Title
Calculator
Arm Type
Experimental
Arm Description
Natural discussion of disease modifier selection conducted with augmentation by risk aversion calculator
Intervention Type
Other
Intervention Name(s)
Risk Aversion Calculator
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change from Baseline Disease Self-efficacy
Description
Degree of change over time in a person's judgement of how well one can execute courses of action required to manage multiple sclerosis
Time Frame
Baseline and then at the conclusion of the initial 1 day visit
Secondary Outcome Measure Information:
Title
Time to new medication start
Description
The amount of time (in days) from initial treatment discussion to treatment start
Time Frame
6 months
Title
Medication adherence
Description
The percentage of all prescribed doses of a medication that a patient takes
Time Frame
At enrollment and at each subsequent visit for one year
Title
Change from Baseline Disease Self-efficacy at 6 months
Description
Degree of change over time in a person's judgement of how well one can execute courses of action required to manage multiple sclerosis
Time Frame
At enrollment and at 6 months post-visit
Title
Change from Baseline Disease Self-efficacy at 12 months
Description
Degree of change over time in a person's judgement of how well one can execute courses of action required to manage multiple sclerosis
Time Frame
At enrollment and at 12 months post-visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fletcher Hartsell, MD MPH
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Drug Risk Aversion Calculator Use to Facilitate MS Patient Self-efficacy
We'll reach out to this number within 24 hrs