Clinical trial NCT04136314: Impact of Decision-Framing in Psoriasis
Official title: The Effects of Gain- Versus Loss-Framed Messages on Patient Preferences for Therapies in Individuals With Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis Vulgaris
Psoriatic Arthritis
Psoriasis
Keywords: Decision-Framing
Prospect Theory
Medication Preferences
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Rationale:

Shared decision-making models between clinicians and patients are critical to improving healthcare delivery and adherence to medication. One type of model, decision framing, is rarely studied in medicine. Decision framing is the way that a choice is worded. In a clinical context, patient choices can be worded positively, or "gain-framed", to explain the benefits of a therapy or negatively, or "loss-framed", to explain the risks of not taking a therapy. Previous literature suggests that decision-framing can significantly influence patients' decision-making regarding their healthcare. However, a critical gap exists in understanding how decision framing affects psoriasis patients' preferences for therapies.

Objective:

Determine whether loss-framed messages lead to greater therapy acceptance as compared to gain-framed messages among adults with psoriasis.

Study population:

90 adults with psoriasis will be enrolled from USC ambulatory clinics and the general public.

Intervention:

Subjects will be exposed to gain-framed or loss-framed messages regarding psoriasis therapies. Specifically, gain-framed messages will explain the expected benefits of taking the psoriasis therapy and loss-framed messages will explain the potential risks of not taking the psoriasis therapy.

Study Methodology:

Cross-sectional single-intervention survey.

Detailed description: Study Design:

The investigators will conduct a single intervention cross-sectional study to evaluate the impact of gain-framing versus loss-framing on patients' therapy preferences. This pragmatic study will compare whether patients are more likely to adhere to a hypothetical injectable psoriasis medication after exposure to a short paragraph explaining either the potential benefits after receiving the medication or the potential losses of not receiving the medication. The goal of this pragmatic study is to test whether differences arise in patient preferences depending on how the information they receive is framed.

Recruitment:

The investigators will recruit ninety adults with psoriasis from the Keck Medicine of University of Southern California (USC) Outpatient Care Network and the Los Angeles County+University of Southern California (LAC+USC) Medical Center outpatient clinic network.

Survey Administration:

Ninety subjects will be randomized using the HIPAA-compliant database Research Electronic Data Capture (REDCap) 1:1 to receive a survey regarding a hypothetical therapeutic intervention specific to their disease. All subjects (N=90) will be asked to indicate basic demographic information, such as age, sex, race, and education level. Also, the investigators will ask whether they have been diagnosed with psoriatic arthritis. Importantly, subjects will complete the survey questions anonymously, and no direct patient identifiers or HIPPA-protected information will be collected.

Half of the subjects (n=45) will be presented with a gain-framed message that explains the benefits of receiving a hypothetical injectable psoriasis medication. The other half (n=45) will be presented with a loss-framed message that explains the harms associated with not taking the medication. Both arms will include the same information regarding the possible side effects upon receiving the injection. The following are examples of gain-framed versus loss-framed messages for this study.

Example of a gain-framed question: A new injectable medication is being developed for psoriasis and psoriatic arthritis. If you take this medication, you will have the chance to reduce psoriasis severity, reduce joint pain, and improve how you feel overall. The side effects of this medication include a small chance of pain around the injection site and a small chance of skin infections. How likely are you to take this medication?

Example of a loss-framed question: A new injectable medication for psoriasis is being developed. If you do not take this medication, you will miss out on the chance to improve your skin, your joints, and your overall health. If you do not take this medication, your psoriasis may get worse; you may have worsening pain in your joints from psoriatic arthritis; and you may feel worse overall. The side effects of this medication include a small chance of pain around the injection site and a small chance of skin infections. How likely are you to take this medication?

After each arm is exposed to their respective gain-framed or loss-framed question, each participant will be asked to indicate their preference on a scale from zero to ten. Zero indicates they definitely will not use the medication while ten indicates they definitely will use the medication.

The investigators will not collect any patient protected information, such as name, date of birth, phone numbers, or address. Subjects will fill out the survey anonymously.

Selection of Participants:

With a total sample size of 90 (45 per each group), this study has 80% power to detect a difference of 1.5 in the means between the subjects randomized to positively framed messages versus those randomized to negative framed messages with alpha of 0.05 and standard deviation of 2.5.

Statistical Analysis: The investigators will perform a multivariate regression analysis and a paired t-test to determine statistical and clinical significance. To minimize confounding, the multivariate regression analysis will adjust for demographic and clinical characteristics such as gender and the presence or absence of psoriatic arthritis.

Eligibility criteria: Inclusion Criteria:

* Greater than 18 years of age
* Has physician diagnosed psoriasis with or without psoriatic arthritis
* Able to read and write in either English or Spanish

Exclusion Criteria:

* Less than 18 years of age
* Does not have physician diagnosed psoriasis
* Unable to read and respond to questionnaires in English or Spanish

Primary outcomes:
measure: Gain-framed vs. Loss-framed Survey Responses
timeFrame: Up to 14 weeks
Secondary outcomes:
measure: Effect of Psoriatic Arthritis on Survey Responses
timeFrame: Up to 14 weeks
measure: Effect of Sex on Survey Responses
timeFrame: Up to 14 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
References: