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.

Psoriatic Arthritis D2P Screening

Psoriatic Arthritis

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.

Direct to patient PsA Screening Questionnaire

Accelerating Psoriatic Arthritis Detection in Patients With Psoriasis: Direct-to-patient Administration of Screening Questionnaires (D2P Screening)

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)

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

Assistant Professor, Rheumatology

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)

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

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

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

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.

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.

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.

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.

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.

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

Psoriatic Arthritis D2P Screening

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status