Clinical trial NCT04110522: 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
Overall status: RECRUITING
Phase: NA
Conditions: Psoriatic Arthritis
Keywords: Psoriasis
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 18000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Percentage of patients with a new PsA diagnosis
timeFrame: 6 months
measure: Symptom duration
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of patients who complete a rheumatologic evaluation
timeFrame: 6 months
measure: Time to initial PsA diagnosis after questionnaire dissemination
timeFrame: 6 months
measure: Time to rheumatologic evaluation after questionnaire dissemination
timeFrame: 6 months
measure: Severity of PsA Disability
timeFrame: 6 months
measure: Physical function level in PsA
timeFrame: 6 months
measure: Severity of PsA radiographic damage
timeFrame: 6 months
measure: PsA Activity by Joint Count
timeFrame: 6 months
measure: PsA Activity by Enthesitis
timeFrame: 6 months
measure: PsA Activity by Dactilitis Count
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Jessica Walsh, M.D.
role: PRINCIPAL_INVESTIGATOR
References: