DA: Psoriatic Arthritis and Psoriasis Treatment Decision Aid

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03737045
• Collaborator: Pfizer (Industry)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

The purpose of this study is to create and test a patient decision aid that facilitates the shared decision-making process when patients with psoriasis and/or psoriatic arthritis are starting or switching to a new therapy.

Condition or Disease	Intervention/Treatment	Phase
Psoriatic Arthritis; Psoriasis	Other: Decision Aid	N/A

Detailed Description

Prior to the interventional study, we will develop a decision aid using design thinking. In this interventional study, we will implement and test a patient-centered decision aid for therapy selection among patients with psoriasis and/or psoriatic arthritis who are starting or switching to a new medication.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Patients and providers will use a web-based or paper decision aid. They will not be assigned to specific arms or undergo randomized treatment.Patients and providers will use a web-based or paper decision aid. They will not be assigned to specific arms or undergo randomized treatment.
• Masking: None (Open Label)
• Masking Description: Participants will have a choice of decision aids (web or paper) and will not be blinded. The study team will be aware of each prototype and decision aid that participants use.
• Primary Purpose: Other
• Official Title: Developing a Patient-centered Patient Decision Aid for Psoriasis and/or Psoriatic Arthritis Using Design Thinking.
• Actual Study Start Date: Dec 1, 2018
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Decision Aid Testing Participants will have the opportunity to test the different decision aid prototypes while selecting new treatment/therapy.	Other: Decision Aid; Participants will test decision aid prototypes that are designed to assist them in choosing a medication.

Outcome Measures

Primary Outcome Measures

1. Patient and provider self-reported perceptions of the decision aid as measured by satisfaction survey [Up to 24 months]

   Satisfaction survey to rate the decision aid and shared decision-making process

Secondary Outcome Measures

1. Number of times decision aid was used in consultation for patients switching therapies or starting a new treatment. [Up to 24 months]

   Rates of of the decision aid use

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age 18 years or older

2. Diagnosis of psoriasis (as confirmed by dermatologist) or psoriatic arthritis (as confirmed by rheumatologist)

3. Treated at Penn

In addition to the above, for the observation and implementation phases of the study:

1. Initiation of a new psoriasis or psoriatic arthritis treatment

• Biosimilars that have been approved by the FDA and available on the US market will similarly be eligible for participation

• Patients may be taking other traditional DMARDs.

• A washout period is not required.

Exclusion Criteria:

1. Unable to give informed consent

2. Youth, under the age of 18 years

3. Patients without psoriasis or psoriatic arthritis

4. Not being treated at a Penn clinic

In addition to the above, for the observation and implementation phases of the study:

1. Not starting or switching to a new medication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital at the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania
• Pfizer

Investigators

• Principal Investigator: Alexis Ogdie-Beatty, MD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03737045
• Other Study ID Numbers: 831515
• First Posted: Nov 9, 2018
• Last Update Posted: Jan 11, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Pennsylvania: Decision Aid; Shared Decision-Making
• Additional relevant MeSH terms: Arthritis; Arthritis, Psoriatic; Psoriasis

Study Results

No Results Posted as of Jan 11, 2022