An Observational Study of Patients With Autoimmune Disease

Study Overview
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Brief Summary
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TARGET-AUTOIMMUNE is an observational research study to conduct a comprehensive review of outcomes for patients with autoimmune and related diseases. .

Official Title
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An Observational Study of Patients With Autoimmune Disease

Conditions
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Autoimmune Diseases

Participation Criteria
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Eligibility Criteria
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Disease Cohort Inclusion Criteria: - Adult patients at the time of enrollment with a diagnosis autoimmune disease by select ICD-10 codes in the EHR interface Exclusion Criteria: Death Manual removal (sponsor or site request) No EHR interface encounter > 3 years Engaged Cohort Inclusion Criteria: Adult patients diagnosed and managed for these conditions invited to participate Ability to provide written informed consent Exclusion Criteria: Patient expressed desire to withdraw consent to complete PROs Failure to complete PROs within 24 weeks of initial invitation Greater than 24 months lapse of survey completion after baseline surveys completed Additionally, the criteria detailed for Disease Cohort apply to the Engaged Cohort

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Disease Cohort<br>Observational | |
| Engaged Cohort<br>Observational | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the natural history of disease in patients with autoimmune disease of various etiologies. |  | 15 Years | 
| To assess safety and effectiveness of autoimmune disease treatments and treatments for complications of any related conditions |  | 20 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate provider management practices in the treatment of patients with autoimmune diseases | Health care provider type, clinic setting, reason for initiating/not initiating/adjusting dosing of treatments, reason for discontinuing/switching treatments, and monitoring outcomes on and off treatment, will be captured as available in the provided EHR and/or through linked data. Disease-specific quality measures will be selected and evaluated. | 15 Years | 
| To evaluate longitudinal and patient reported outcomes in patients with autoimmune diseases | Longitudinal clinical outcomes and disease progression will be assessed. Self-reported patient health measures collect information directly from patients to measure physical, mental, and social health. These measures can help clinicians better understand how the disease state and/or various treatments affect what patients are able to do and the symptoms they experience beyond what is typically derived and reported in the EHR as part of traditional clinical evaluations. The information can also be used to help patients make informed decisions about their healthcare and treatment options. | 15 Years | 
| To select and evaluate quality of care measures for patients with autoimmune diseases | Identify and select best practices in care of patients with autoimmune diseases Develop a technology infrastructure to evaluate quality measures to support clinicians. | 15 Years |