Accelerating Psoriatic Arthritis Detection in Patients With Psoriasis: Direct-to-patient Administration of Screening Questionnaires (D2P Screening)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 18,000
- 试验地点
- 4
- 主要终点
- Percentage of patients with a new PsA diagnosis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Have psoriasis and a confirmed diagnosis of psoriatic arthritis made or confirmed by a rheumatologist
研究组 & 干预措施
Control
Psoriasis patients with no prior diagnosis of PsA randomized to not receive an intervention PsA questionnaire
Intervention with Direct Access to Rheumatologist
Psoriasis patients with no prior diagnosis of PsA randomized to receive intervention PsA questionnaire, including instructions on how to directly schedule a rheumatologic evaluation
干预措施: Direct to patient PsA Screening Questionnaire (Other)
Intervention with Standard of Care Referral
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
干预措施: Direct to patient PsA Screening Questionnaire (Other)
结局指标
主要结局
Percentage of patients with a new PsA diagnosis
时间窗: 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
时间窗: 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
次要结局
- Severity of PsA radiographic damage(6 months)
- Percentage of patients who complete a rheumatologic evaluation(6 months)
- Time to initial PsA diagnosis after questionnaire dissemination(6 months)
- PsA Activity by Joint Count(6 months)
- Time to rheumatologic evaluation after questionnaire dissemination(6 months)
- PsA Activity by Enthesitis(6 months)
- Severity of PsA Disability(6 months)
- Physical function level in PsA(6 months)
- PsA Activity by Dactilitis Count(6 months)
研究者
Jessica Walsh
Assistant Professor, Rheumatology
University of Utah