Assessing Patient Confidence in Biologic Medications

Study Overview
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Brief Summary
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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.

Official Title
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Assessing Patient Confidence in Biologic Medications

Conditions
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Psoriasis

Intervention / Treatment
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* Behavioral: Anecdotal Evidence
* Behavioral: Research Study Evidence
* Behavioral: Anecdotal + Research Study Evidence
* Behavioral: No Evidence


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anecdotal Evidence<br>Scenario describes a medication's (biologic's) therapeutic effect results based on anecdotal evidence. | Behavioral: Anecdotal Evidence<br>* Communicate basic information on the therapeutic effect of a drug using only anecdotal evidence.<br>|
| Active Comparator: Research Study Evidence<br>Scenario describes a medication's (biologic's) therapeutic effect results based on research study evidence. | Behavioral: Research Study Evidence<br>* Communicate basic information on the therapeutic effect of a drug using only research study evidence.<br>|
| Active Comparator: Anecdotal + Research Study Evidence<br>Scenario describes a medication's (biologic's) therapeutic effect results based on research study evidence and anecdotal evidence. | Behavioral: Anecdotal + Research Study Evidence<br>* Communicate basic information on the therapeutic effect of a drug using only anecdotal and research study evidence.<br>|
| Placebo Comparator: No Evidence<br>Scenario describes a medication's (biologic's) therapeutic effect with no mention on anecdotal nor research study evidence. | Behavioral: No Evidence<br>* Communicate basic information on the therapeutic effect of a drug using neither anecdotal evidence nor research study evidence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral survey responses | Oral survey response from 1 (not willing) to 10 (completely willing) scale to take a treatment | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Decision making