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Psoriatic Arthritis D2P Screening

Primary Purpose

Psoriatic Arthritis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Direct to patient PsA Screening Questionnaire
Sponsored by
Jessica Walsh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Psoriatic Arthritis focused on measuring Psoriasis

Eligibility Criteria

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

Inclusion Criteria:

  • Have an International Classification of Diseases (ICD) code diagnosis of psoriasis but without a confirmed diagnosis of Psoriatic Arthritis prior to study initiation
  • Be age 18 or older
  • Be geographically located within a reasonable proximity to the Rheumatology study site

Exclusion Criteria:

  • Have psoriasis and a confirmed diagnosis of psoriatic arthritis made or confirmed by a rheumatologist

Sites / Locations

  • University of PennsylvaniaRecruiting
  • University of UtahRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Intervention with Direct Access to Rheumatologist

Intervention with Standard of Care Referral

Control

Arm Description

Psoriasis patients with no prior diagnosis of PsA randomized to receive intervention PsA questionnaire, including instructions on how to directly schedule a rheumatologic evaluation

Psoriasis patients with no prior diagnosis of PsA randomized to receive intervention PsA questionnaire, including instructions to talk with their doctor about a referral to a rheumatologist

Psoriasis patients with no prior diagnosis of PsA randomized to not receive an intervention PsA questionnaire

Outcomes

Primary Outcome Measures

Percentage of patients with a new PsA diagnosis
The percentage of psoriasis patients with a new diagnosis of PsA will be compared between the Experimental Arms and the Control Arm, and compared between the two Experimental Arms (intervention with direct access to rheumatologist and intervention with standard of care referral)
Symptom duration
Average duration of baseline symptoms prior to PsA diagnosis in the Experimental Arms (intervention with direct access to rheumatologist and intervention with standard of care referral) will be compared to the average duration of baseline symptoms prior to PsA diagnosis in the Control Arm

Secondary Outcome Measures

Percentage of patients who complete a rheumatologic evaluation
The percentage of psoriasis patients who complete a rheumatologic evaluation will be compared between the Experimental Arms and the Control Arm, and compared between the two Experimental Arms (intervention with direct access to rheumatologist and intervention with standard of care referral)
Time to initial PsA diagnosis after questionnaire dissemination
The average time to PsA diagnosis after dissemination of the questionnaire in the Intervention with Direct Access to Rheumatologist arm compared to the Intervention with Standard of Care Referral Arm
Time to rheumatologic evaluation after questionnaire dissemination
The average time to rheumatologic evaluation after dissemination of the questionnaire in the Intervention with Direct Access to Rheumatologist arm compared to the Intervention with Standard of Care Referral Arm
Severity of PsA Disability
Average work disability in PsA, as measured by the Work Productivity and Activity Impairment questionnaire score will be compared between the Experimental ams (intervention with direct access to rheumatologist and intervention with standard of care referral) and the Control Arm
Physical function level in PsA
Average physical function level in PsA, as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) questionnaire score will be compared between the Experimental Arms (intervention with direct access to rheumatologist and intervention with standard of care referral) and the Control Arm.
Severity of PsA radiographic damage
Average number of psoriatic arthritis inflammatory changes per rheumatology provider's judgement after review of all relevant available imaging data using scale of yes/no/unsure will be compared between the Experimental Arms (intervention with direct access to rheumatologist and intervention with standard of care referral) and the Control Arm.
PsA Activity by Joint Count
Average number of swollen/tender joints in PsA using the 66/68 joint count assessment by rheumatology provider physical exam will be compared between the Experimental Arms (intervention with direct access to rheumatologist and intervention with standard of care referral) and the Control Arm.
PsA Activity by Enthesitis
Average number of joint insertions with enthesitis in PsA as determined by the Leeds enthesitis index as assessed by rheumatology provider physical exam will be compared between the Experimental Arms (intervention with direct access to rheumatologist and intervention with standard of care referral) and the Control Arm.
PsA Activity by Dactilitis Count
Average number of digits with dactylitis in PsA using a dactylitis count (yes/no for each finger or toe) as assessed by rheumatology provider physical exam will be compared between the Experimental Arms (intervention with direct access to rheumatologist and intervention with standard of care referral) and the Control Arm.

Full Information

First Posted
September 13, 2019
Last Updated
January 13, 2023
Sponsor
Jessica Walsh
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1. Study Identification

Unique Protocol Identification Number
NCT04110522
Brief Title
Psoriatic Arthritis D2P Screening
Official Title
Accelerating Psoriatic Arthritis Detection in Patients With Psoriasis: Direct-to-patient Administration of Screening Questionnaires (D2P Screening)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2019 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jessica Walsh

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 overarching goal of this study is to develop a direct-to-patient screening approach that will improve early Psoriatic Arthritis (PsA) detection in patients with psoriasis. Previously developed screening questionnaires were intended for use in the setting of a doctor's office to assist providers with referral decisions. However, these screening questionnaires are infrequently used in routine practice because of limitations with time and resources. The study will aim to develop a practical screening strategy that does not require involvement from dermatologists (or other non-rheumatology providers) and can systematically reach a broad range of psoriasis patients, including patients not attending dermatology clinics. The researchers hypothesize that disseminating questionnaires directly to patients outside of a clinic setting (direct-to-patient approach) will educate patients about their PsA risk and improve early PsA diagnoses.
Detailed Description
Electronic medical record (EMR) systems will be used to identify psoriasis patients without a PsA diagnosis. Patients will be randomized to receive a PsA screening questionnaire (intervention group) or not receive a questionnaire (control group). Rates of rheumatologic evaluations and new PsA diagnoses will be compared between the groups, using EMRs to longitudinally track outcomes. Intervention group patients who through the completion of the PsA Screening questionnaire positively self-screen for an elevated PsA risk will either be randomly invited to directly access a rheumatology appointment or instructed to talk with their doctor about a rheumatology referral. We will compare rates of rheumatologic evaluations and new PsA diagnoses between these groups to identify the best method for accessing rheumatology appointments. To determine if PsA patients diagnosed after receiving a screening questionnaire differ from patients diagnosed via usual care; investigators will examine disease duration, severity, and comorbidities in patients receiving and not receiving the screening questionnaire.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
Psoriasis

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention with Direct Access to Rheumatologist
Arm Type
Experimental
Arm Description
Psoriasis patients with no prior diagnosis of PsA randomized to receive intervention PsA questionnaire, including instructions on how to directly schedule a rheumatologic evaluation
Arm Title
Intervention with Standard of Care Referral
Arm Type
Experimental
Arm Description
Psoriasis patients with no prior diagnosis of PsA randomized to receive intervention PsA questionnaire, including instructions to talk with their doctor about a referral to a rheumatologist
Arm Title
Control
Arm Type
No Intervention
Arm Description
Psoriasis patients with no prior diagnosis of PsA randomized to not receive an intervention PsA questionnaire
Intervention Type
Other
Intervention Name(s)
Direct to patient PsA Screening Questionnaire
Intervention Description
Patients randomized to an intervention group will be asked to complete and score the 5-item Psoriasis Epidemiology Screening Tool (PEST) questionnaire. Those patients with an elevated score (PEST ≥3 out of 5) will be advised to complete a rheumatologic evaluation for PsA.
Primary Outcome Measure Information:
Title
Percentage of patients with a new PsA diagnosis
Description
The percentage of psoriasis patients with a new diagnosis of PsA will be compared between the Experimental Arms and the Control Arm, and compared between the two Experimental Arms (intervention with direct access to rheumatologist and intervention with standard of care referral)
Time Frame
6 months
Title
Symptom duration
Description
Average duration of baseline symptoms prior to PsA diagnosis in the Experimental Arms (intervention with direct access to rheumatologist and intervention with standard of care referral) will be compared to the average duration of baseline symptoms prior to PsA diagnosis in the Control Arm
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percentage of patients who complete a rheumatologic evaluation
Description
The percentage of psoriasis patients who complete a rheumatologic evaluation will be compared between the Experimental Arms and the Control Arm, and compared between the two Experimental Arms (intervention with direct access to rheumatologist and intervention with standard of care referral)
Time Frame
6 months
Title
Time to initial PsA diagnosis after questionnaire dissemination
Description
The average time to PsA diagnosis after dissemination of the questionnaire in the Intervention with Direct Access to Rheumatologist arm compared to the Intervention with Standard of Care Referral Arm
Time Frame
6 months
Title
Time to rheumatologic evaluation after questionnaire dissemination
Description
The average time to rheumatologic evaluation after dissemination of the questionnaire in the Intervention with Direct Access to Rheumatologist arm compared to the Intervention with Standard of Care Referral Arm
Time Frame
6 months
Title
Severity of PsA Disability
Description
Average work disability in PsA, as measured by the Work Productivity and Activity Impairment questionnaire score will be compared between the Experimental ams (intervention with direct access to rheumatologist and intervention with standard of care referral) and the Control Arm
Time Frame
6 months
Title
Physical function level in PsA
Description
Average physical function level in PsA, as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) questionnaire score will be compared between the Experimental Arms (intervention with direct access to rheumatologist and intervention with standard of care referral) and the Control Arm.
Time Frame
6 months
Title
Severity of PsA radiographic damage
Description
Average number of psoriatic arthritis inflammatory changes per rheumatology provider's judgement after review of all relevant available imaging data using scale of yes/no/unsure will be compared between the Experimental Arms (intervention with direct access to rheumatologist and intervention with standard of care referral) and the Control Arm.
Time Frame
6 months
Title
PsA Activity by Joint Count
Description
Average number of swollen/tender joints in PsA using the 66/68 joint count assessment by rheumatology provider physical exam will be compared between the Experimental Arms (intervention with direct access to rheumatologist and intervention with standard of care referral) and the Control Arm.
Time Frame
6 months
Title
PsA Activity by Enthesitis
Description
Average number of joint insertions with enthesitis in PsA as determined by the Leeds enthesitis index as assessed by rheumatology provider physical exam will be compared between the Experimental Arms (intervention with direct access to rheumatologist and intervention with standard of care referral) and the Control Arm.
Time Frame
6 months
Title
PsA Activity by Dactilitis Count
Description
Average number of digits with dactylitis in PsA using a dactylitis count (yes/no for each finger or toe) as assessed by rheumatology provider physical exam will be compared between the Experimental Arms (intervention with direct access to rheumatologist and intervention with standard of care referral) and the Control Arm.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have an International Classification of Diseases (ICD) code diagnosis of psoriasis but without a confirmed diagnosis of Psoriatic Arthritis prior to study initiation Be age 18 or older Be geographically located within a reasonable proximity to the Rheumatology study site Exclusion Criteria: Have psoriasis and a confirmed diagnosis of psoriatic arthritis made or confirmed by a rheumatologist
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Walsh, M.D.
Phone
801-581-4333
Email
jessica.walsh@hsc.utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Walsh, M.D.
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
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
Alexis Ogdie, M.D.
Phone
215-662-2454
First Name & Middle Initial & Last Name & Degree
Alexis Ogdie, M.D.
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia Ibrahim
Phone
801-581-8300
Email
sonia.ibrahim@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Jessica Walsh, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Psoriatic Arthritis D2P Screening

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