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Psoriatic Arthritis and Psoriasis Treatment Decision Aid (DA)

Primary Purpose

Psoriatic Arthritis, Psoriasis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision Aid
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Psoriatic Arthritis focused on measuring Decision Aid, Shared Decision-Making

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  4. 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:

  5. Not starting or switching to a new medication

Sites / Locations

  • Hospital at the University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Decision Aid Testing

Arm Description

Participants will have the opportunity to test the different decision aid prototypes while selecting new treatment/therapy.

Outcomes

Primary Outcome Measures

Patient and provider self-reported perceptions of the decision aid as measured by satisfaction survey
Satisfaction survey to rate the decision aid and shared decision-making process

Secondary Outcome Measures

Number of times decision aid was used in consultation for patients switching therapies or starting a new treatment.
Rates of of the decision aid use

Full Information

First Posted
October 31, 2018
Last Updated
January 6, 2023
Sponsor
University of Pennsylvania
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03737045
Brief Title
Psoriatic Arthritis and Psoriasis Treatment Decision Aid
Acronym
DA
Official Title
Developing a Patient-centered Patient Decision Aid for Psoriasis and/or Psoriatic Arthritis Using Design Thinking.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis, Psoriasis
Keywords
Decision Aid, Shared Decision-Making

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
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.
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Decision Aid Testing
Arm Type
Other
Arm Description
Participants will have the opportunity to test the different decision aid prototypes while selecting new treatment/therapy.
Intervention Type
Other
Intervention Name(s)
Decision Aid
Intervention Description
Participants will test decision aid prototypes that are designed to assist them in choosing a medication.
Primary Outcome Measure Information:
Title
Patient and provider self-reported perceptions of the decision aid as measured by satisfaction survey
Description
Satisfaction survey to rate the decision aid and shared decision-making process
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Number of times decision aid was used in consultation for patients switching therapies or starting a new treatment.
Description
Rates of of the decision aid use
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or older Diagnosis of psoriasis (as confirmed by dermatologist) or psoriatic arthritis (as confirmed by rheumatologist) Treated at Penn In addition to the above, for the observation and implementation phases of the study: 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: Unable to give informed consent Youth, under the age of 18 years Patients without psoriasis or psoriatic arthritis Not being treated at a Penn clinic In addition to the above, for the observation and implementation phases of the study: Not starting or switching to a new medication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathleen Bush
Phone
215-662-6332
Email
katbu@upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexis Ogdie-Beatty, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital at the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Bush, BS
Phone
215-662-6332
Email
katbu@upenn.edu
First Name & Middle Initial & Last Name & Degree
Alexis Ogdie-Beatty, MD, MSCE

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Participant data will be used to create the decision aids which will then be made available to patients, researchers, and medical centers. Physicians and researchers may request de-identified data from the PI and research plans will be reviewed on a case by case basis.

Learn more about this trial

Psoriatic Arthritis and Psoriasis Treatment Decision Aid

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