Psoriatic Arthritis D2P Screening

NCT ID: NCT04110522

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-22
• Study Completion Date: 2025-12-31

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.

Conditions

Psoriatic Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Direct to patient PsA Screening Questionnaire

Intervention Type: OTHER

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.

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

Group Type: EXPERIMENTAL

Direct to patient PsA Screening Questionnaire

Intervention Type: OTHER

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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jessica Walsh

OTHER

Sponsor Role: lead

Responsible Party

Jessica Walsh

Assistant Professor, Rheumatology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jessica Walsh, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

University of Utah

Salt Lake City, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jessica Walsh, M.D.

Role: CONTACT

jessica.walsh@hsc.utah.edu

801-581-4333

Facility Contacts

Sarah Gillespie, M.D.

Role: primary

sarah.hopkins@pennmedicine.upenn.edu

215-614-1840

Nadia Grant

Role: primary

nadia.grant@hsc.utah.edu

801-585-0798

Other Identifiers

IRB_00117215

Identifier Type: -

Identifier Source: org_study_id