Psoriatic Arthritis D2P Screening

Jessica Walsh

Status: Enrolling

Conditions: Psoriatic Arthritis

Treatments: Other: Direct to patient PsA Screening Questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT04110522

IRB_00117215

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18,000 participants in 3 patient groups

Intervention with Direct Access to Rheumatologist

Experimental group

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

Treatment:

Other: Direct to patient PsA Screening Questionnaire

Intervention with Standard of Care Referral

Experimental group

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

Treatment:

Other: Direct to patient PsA Screening Questionnaire

Control

No Intervention group

Description:

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