Psoriasis VulgarisNCT04136314
Impact of Decision-Framing in Psoriasis
A study testing Decision-Framed Survey in people with Psoriasis Vulgaris and Psoriatic Arthritis, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Vulgaris, Psoriatic Arthritis, Psoriasis
- What is being tested?
- Decision-Framed Survey
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2019to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Less than 18 years of age
- Does not have physician diagnosed psoriasis
- Unable to read and respond to questionnaires in English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90089
About this study
Official title: The Effects of Gain- Versus Loss-Framed Messages on Patient Preferences for Therapies in Individuals With Psoriasis
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.
Read more
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.
Read the 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.
- Conditions
- Psoriasis Vulgaris, Psoriatic Arthritis, Psoriasis
- Being tested
- Decision-Framed Survey
- Keywords
- Decision-Framing, Prospect Theory, Medication Preferences
- Medical subject headings
- Arthritis, Psoriatic, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision-Framed SurveyBehavioural
Survey will ask all subjects for will be asked to indicate basic demographic information, such as age, sex, race, and education level. Also, subjects will indicate whether they have been diagnosed with psoriatic arthritis. Importantly, patients will complete the survey questions anonymously, and no direct patient identifiers or HIPPA-protected information will be collected. Subjects will then be asked to indicate their preference for a hypothetical injectable medication after exposure to [A] a gain-framed message or [B] a loss-framed message.
| Study group | Role | What they receive |
|---|---|---|
| Gain-Frame Survey [A] | Experimental | Not described Receives: Behavioral: Decision-Framed Survey |
| Loss-Frame Survey [B] | Experimental | Not described Receives: Behavioral: Decision-Framed Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gain-framed vs. Loss-framed Survey Responses
Difference in survey responses based on exposure to gain-frame or loss-frame question. After exposure to the positively or negatively framed question, subjects will be asked how likely they would agree to receive a hypothetical injectable medication. The subjects will answer with a Likert scale ranging from 0 to 10, with 0 indicating they will definitely not want the medication and 10 indicating they will definitely want the medication. Each enrolled subject will complete the survey only once.
Measured: Up to 14 weeks
Secondary outcomes (2)
Effect of Psoriatic Arthritis on Survey Responses
Difference in survey responses based on history of psoriatic arthritis. All study participants will be asked to include basic demographic information, such as their age, race, ethnicity, sex, and highest level of education. All subjects will also be asked whether they have ever been diagnosed with psoriatic arthritis. The investigators will then determine if stratifying the presence or absence of psoriatic arthritis impacts the subjects' response on the 11-point Likert scale described above.
Measured: Up to 14 weeks
Effect of Sex on Survey Responses
Difference in survey responses based on subject sex. All study participants will be asked to include basic demographic information, such as their age, race, ethnicity, sex, and highest level of education. The investigators will then determine if stratification based on sex impacts the subjects' responses on the 11-point Likert scale described above.
Measured: Up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start21 Oct 2019
- Primary completion30 Nov 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, April Armstrong, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136314
- Sponsor's protocol ID
- HS-19-00740
- Status last verified
- Dec 2022
- First submitted
- 16 Oct 2019
- Last updated
- 15 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Gain- Versus Loss-Framed Messages on Patient Preferences for Therapies in Individuals With Psoriasis
- ClinicalTrials.gov ID
- NCT04136314
- Acronym / sponsor ID
- HS-19-00740
- Conditions
- Psoriasis Vulgaris, Psoriatic Arthritis, Psoriasis
- Keywords
- Decision-Framing, Prospect Theory, Medication Preferences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 23 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gain-Frame Survey [A] | Experimental | Behavioral: Decision-Framed Survey |
| Loss-Frame Survey [B] | Experimental | Behavioral: Decision-Framed Survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Less than 18 years of age
- Does not have physician diagnosed psoriasis
- Unable to read and respond to questionnaires in English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision-Framed SurveySurvey will ask all subjects for will be asked to indicate basic demographic information, such as age, sex, race, and education level. Also, subjects will indicate whether they have been diagnosed with psoriatic arthritis. Importantly, patients will complete the survey questions anonymously, and no direct patient identifiers or HIPPA-protected information will be collected. Subjects will then be asked to indicate their preference for a hypothetical injectable medication after exposure to [A] a gain-framed message or [B] a loss-framed message. | Behavioural | Gain-Frame Survey [A], Loss-Frame Survey [B] |
Primary outcome
Gain-framed vs. Loss-framed Survey Responses
Time frame: Up to 14 weeks
Difference in survey responses based on exposure to gain-frame or loss-frame question. After exposure to the positively or negatively framed question, subjects will be asked how likely they would agree to receive a hypothetical injectable medication. The subjects will answer with a Likert scale ranging from 0 to 10, with 0 indicating they will definitely not want the medication and 10 indicating they will definitely want the medication. Each enrolled subject will complete the survey only once.
2 secondary outcomes
Effect of Psoriatic Arthritis on Survey Responses
Time frame: Up to 14 weeks
Effect of Sex on Survey Responses
Time frame: Up to 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision-Framed Survey in people with Psoriasis Vulgaris and Psoriatic Arthritis, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gain-framed vs. Loss-framed Survey Responses (time frame: Up to 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.