Psoriatic Arthritis
Conditions
Keywords
Psoriasis
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.
Interventions
OTHERDirect 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.
Sponsors
Jessica Walsh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with a new PsA diagnosis | 6 months | 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) |
| Symptom duration | 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients who complete a rheumatologic evaluation | 6 months | 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) |
| Time to initial PsA diagnosis after questionnaire dissemination | 6 months | 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 |
| Time to rheumatologic evaluation after questionnaire dissemination | 6 months | 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 |
| Severity of PsA Disability | 6 months | 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 |
| Physical function level in PsA | 6 months | 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. |
| Severity of PsA radiographic damage | 6 months | 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. |
| PsA Activity by Joint Count | 6 months | 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. |
| PsA Activity by Enthesitis | 6 months | 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. |
| PsA Activity by Dactilitis Count | 6 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJessica Walsh, M.D.
University of Utah
Outcome results
None listed