Psoriatic Arthritis D2P Screening

Psoriatic Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04110522
• Other study ID #: IRB_00117215
• Status: Recruiting
• Phase: N/A
• Start date: July 22, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: University of Utah
• Contact: Jessica Walsh, M.D.
• Phone: 801-581-4333
• Email: jessica.walsh[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Jessica Walsh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with a new PsA diagnosis	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)	6 months
Primary	Symptom duration	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	6 months
Secondary	Percentage of patients who complete a rheumatologic evaluation	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)	6 months
Secondary	Time to initial PsA diagnosis after questionnaire dissemination	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	6 months
Secondary	Time to rheumatologic evaluation after questionnaire dissemination	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	6 months
Secondary	Severity of PsA Disability	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	6 months
Secondary	Physical function level in PsA	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 months
Secondary	Severity of PsA radiographic damage	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.	6 months
Secondary	PsA Activity by Joint Count	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.	6 months
Secondary	PsA Activity by Enthesitis	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.	6 months
Secondary	PsA Activity by Dactilitis Count	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.	6 months