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Psoriatic Arthritis D2P Screening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110522
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Jessica Walsh, University of Utah

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.

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Other: Direct to patient PsA Screening Questionnaire Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Accelerating Psoriatic Arthritis Detection in Patients With Psoriasis: Direct-to-patient Administration of Screening Questionnaires (D2P Screening)
Actual Study Start Date : July 22, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention with Direct Access to Rheumatologist
Psoriasis patients with no prior diagnosis of PsA randomized to receive intervention PsA questionnaire, including instructions on how to directly schedule a rheumatologic evaluation
Other: Direct to patient PsA Screening Questionnaire
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.

Experimental: Intervention with Standard of Care Referral
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
Other: Direct to patient PsA Screening Questionnaire
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.

No Intervention: Control
Psoriasis patients with no prior diagnosis of PsA randomized to not receive an intervention PsA questionnaire



Primary Outcome Measures :
  1. Percentage of patients with a new PsA diagnosis [ Time Frame: 6 months ]
    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)

  2. Symptom duration [ Time Frame: 6 months ]
    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 :
  1. Percentage of patients who complete a rheumatologic evaluation [ Time Frame: 6 months ]
    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)

  2. Time to initial PsA diagnosis after questionnaire dissemination [ Time Frame: 6 months ]
    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

  3. Time to rheumatologic evaluation after questionnaire dissemination [ Time Frame: 6 months ]
    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

  4. Severity of PsA Disability [ Time Frame: 6 months ]
    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

  5. Physical function level in PsA [ Time Frame: 6 months ]
    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.

  6. Severity of PsA radiographic damage [ Time Frame: 6 months ]
    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.

  7. PsA Activity by Joint Count [ Time Frame: 6 months ]
    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.

  8. PsA Activity by Enthesitis [ Time Frame: 6 months ]
    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.

  9. PsA Activity by Dactilitis Count [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110522


Contacts
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Contact: Jessica Walsh, M.D. 801-581-4333 jessica.walsh@hsc.utah.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Alexis Ogdie, M.D.    215-662-2454      
Principal Investigator: Alexis Ogdie, M.D.         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Sonia Ibrahim    801-581-8300    sonia.ibrahim@hsc.utah.edu   
Principal Investigator: Jessica Walsh, M.D.         
Sponsors and Collaborators
Jessica Walsh
Investigators
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Principal Investigator: Jessica Walsh, M.D. University of Utah
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Responsible Party: Jessica Walsh, Assistant Professor, Rheumatology, University of Utah
ClinicalTrials.gov Identifier: NCT04110522    
Other Study ID Numbers: IRB_00117215
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jessica Walsh, University of Utah:
Psoriasis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases