Assessing Patient Confidence in Biologic Medications

Wake Forest University (WFU)

Status: Active, not recruiting

Conditions: Psoriasis

Treatments: Behavioral: Anecdotal Evidence; Behavioral: Anecdotal + Research Study Evidence; Behavioral: No Evidence; Behavioral: Research Study Evidence

Study type: Interventional

Funder types: Other

Identifiers

NCT03168347

IRB00043948

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with psoriasis (ICD-9: 696.1)
• Age 18-80

Exclusion criteria

• Individuals younger than 18 (line of questioning necessary for the study may be beyond understanding in this age group)
• Currently or previously managed with a biologic medication

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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400 participants in 4 patient groups, including a placebo group

Anecdotal Evidence

Active Comparator group

Description:

Scenario describes a medication's (biologic's) therapeutic effect results based on anecdotal evidence.

Treatment:

Behavioral: Anecdotal Evidence

Research Study Evidence

Active Comparator group

Description:

Scenario describes a medication's (biologic's) therapeutic effect results based on research study evidence.

Treatment:

Behavioral: Research Study Evidence

Anecdotal + Research Study Evidence

Active Comparator group

Description:

Scenario describes a medication's (biologic's) therapeutic effect results based on research study evidence and anecdotal evidence.

Treatment:

Behavioral: Anecdotal + Research Study Evidence

No Evidence

Placebo Comparator group

Description:

Scenario describes a medication's (biologic's) therapeutic effect with no mention on anecdotal nor research study evidence.

Treatment:

Behavioral: No Evidence