Assessing Patient Confidence in Biologic Medications

Summary

In dermatology, biologic medications are used to treat conditions such as moderate-to-severe psoriasis. These medications generally function to decrease inflammation or disrupt the inflammatory cycle. Examples of biologic medications commonly used in dermatology include tumor necrosis factor-alpha (TNF-alpha), blockers/inhibitors (etanercept, infliximab, certolizumab pegol, golimumab), interleukin 12/23 blockers (ustekinumab) and interleukin 17A blockers (secukinumab, ixekizumab).

Due to biologic medication's efficacy and safety profiles, they have revolutionized dermatology and the general medical field. However, patients may be apprehensive about choosing a biologic medication for a variety of reasons. These include hearing negative information about the drug from friends or family, being nervous about injection, or seeing the drug or its side effects negatively portrayed in the media. Many patients are not aware that clinical trial evidence for biologics exist, and instead may rely on anecdotal evidence in choosing to take these medications.

Because fear of the drug is inherently subjective, it can be modified with appropriate reassurance and presentation of evidence. Physicians must be able to ascertain from where the fear originates and how it can be countered. By understanding what kind of information will allow patients to be confident in their decision to take a biologic, dermatologists can improve outcomes and initiate use of this drug. Furthermore, reducing fear of side effects or adverse events may improve adherence to treatment and may improve treatment outcomes. The investigators propose this study with the goal of learning whether patients are more confident in the potential success of biologic medications in treating their psoriasis after being presented with clinical trial evidence, anecdotal evidence, or both.

Conditions

• Psoriasis

Interventions

BEHAVIORAL

Anecdotal Evidence

Communicate basic information on the therapeutic effect of a drug using only anecdotal evidence.

BEHAVIORAL

Research Study Evidence

Communicate basic information on the therapeutic effect of a drug using only research study evidence.

BEHAVIORAL

Anecdotal + Research Study Evidence

Communicate basic information on the therapeutic effect of a drug using only anecdotal and research study evidence.

BEHAVIORAL

No Evidence

Communicate basic information on the therapeutic effect of a drug using neither anecdotal evidence nor research study evidence.

Sponsors & Collaborators

• Wake Forest University Health Sciences

  lead OTHER

Principal Investigators

• Steve R Feldman, MD, PhD · Wake Forest University Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-01

Primary Completion

2021-06-03

Completion

2021-06-03

Countries

• United States

Study Locations