NCT04136314

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

October 21, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

December 15, 2022

Status Verified

December 1, 2022

Enrollment Period

1 month

First QC Date

October 16, 2019

Last Update Submit

December 13, 2022

Conditions

Keywords

Decision-FramingProspect TheoryMedication Preferences

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 14 weeks

Secondary Outcomes (2)

  • Effect of Psoriatic Arthritis on Survey Responses

    Up to 14 weeks

  • Effect of Sex on Survey Responses

    Up to 14 weeks

Study Arms (2)

Gain-Frame Survey [A]

EXPERIMENTAL
Behavioral: Decision-Framed Survey

Loss-Frame Survey [B]

EXPERIMENTAL
Behavioral: Decision-Framed Survey

Interventions

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.

Gain-Frame Survey [A]Loss-Frame Survey [B]

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

Location

MeSH Terms

Conditions

Arthritis, PsoriaticPsoriasis

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Primary/blinded investigator will be blinded to randomization of subject to either group A (gain-framed) or group B (loss-framed) arms. Blinded party will create the randomization master list and provide a given subject's arm allocation to the primary/unblinded investigator once that subject has been enrolled.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 23, 2019

Study Start

October 21, 2019

Primary Completion

November 30, 2019

Study Completion

January 31, 2020

Last Updated

December 15, 2022

Record last verified: 2022-12

Locations