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

NCT ID: NCT03375541

Last Updated: 2018-05-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-31
• Study Completion Date: 2019-03-31

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

Natural discussion of disease modifier selection conducted without augmentation by risk aversion calculator

Group Type: NO_INTERVENTION

No interventions assigned to this group

Calculator

Natural discussion of disease modifier selection conducted with augmentation by risk aversion calculator

Group Type: EXPERIMENTAL

Risk Aversion Calculator

Intervention Type: OTHER

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)

Interventions

Risk Aversion Calculator

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)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fletcher Hartsell, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Duke University

Other Identifiers

Pro00081429

Identifier Type: -

Identifier Source: org_study_id