Prevention of Cardiovascular Disease and Mortality in Patients With Psoriasis or Psoriatic Arthritis

Study Overview
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Brief Summary
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The goal of this research is to test a novel centralized care coordinator program to assist patients with psoriatic disease in lowering their risk of cardiovascular disease through the application of standard of care approaches to improving modifiable cardiovascular risk factors.

Detailed Description
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Psoriasis patients have an increased risk of cardiovascular disease and mortality but are less likely to have traditional cardiovascular risk factors identified or adequately managed. Care coordinators have previously been demonstrated to improve outcomes in patients with chronic diseases (such as comorbid diabetes and depression) and are now routinely embedded in primary care practices in integrated health systems. The goal of this research is to test a novel centralized care coordinator program to assist patients with psoriatic disease in lowering their risk of cardiovascular disease through the application of standard of care approaches to improving modifiable cardiovascular risk factors.

Official Title
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Prevention of Cardiovascular Disease and Mortality in Patients With Psoriasis or Psoriatic Arthritis: Translating Guidelines of Care to Better Outcomes for Patients With Psoriatic Disease

Conditions
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Psoriasis, Psoriatic Arthritis, Psoriatic Conditions, Cardiovascular Diseases

Intervention / Treatment
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* Other: Care Coordinator Model


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to provide informed consent Male or female aged 40-75 Being seen by a dermatology provider in routine care for the primary encounter diagnosis of psoriasis Exclusion Criteria: Currently taking a prescription lipid lowering medication Pregnant or planning pregnancy in the next 6 months Has a known history of cardiovascular disease (MI, Stroke, coronary artery, cerebrovascular, or peripheral vascular disease)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 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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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Care Coordination<br> | Other: Care Coordinator Model<br>* A centralized care coordinator at the National Psoriasis Foundation will provide evidence-based education regarding a heart healthy lifestyle (i.e., diet, exercise, smoking cessation) and guidance from the American Heart Association/American College of Cardiology regarding management of dyslipidemia and hypertension. This information will be conveyed to a primary care provider of the patient's preference.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LDL | Change in LDL cholesterol | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Addition of new medication | Percent newly using lipid lowering, hypertension (HTN), or diabetes (DM) medications | 6 months | 
| Change in 10-year cardiovascular (CV) risk | Change in predicted 10-year risk of atherosclerotic cardiovascular disease (ASCVD) among patients with baseline 10-year risk greater than or equal to 5% measured by the American College of Cardiology ASCVD risk estimator tool for predicting percent risk for atherosclerotic cardiovascular disease. | 6 months | 
| 30% LDL reduction | Percent with 7.5% to 20% risk who achieve a 30% or greater reduction in LDL on follow up testing | 6 months | 
| 50% LDL reduction | Percent with greater than or equal to 20% risk who achieve LDL reduction of greater than or equal to 50% | 6 months | 
| LDL reduction under 100 | Percent who achieve LDL less than 100 mg/dL or non-HDL less than 130 mg/dL | 6 months | 
| Change in blood pressure | Change in systolic blood pressure (mm Hg) | 6 months | 
| Change in cholesterol | Change in total cholesterol (mg/dL) | 6 months | 
| Change in HDL | Change in HDL cholesterol (mg/dL) | 6 months | 
| Change in non-HDL | Change in non-HDL cholesterol (mg/dL) | 6 months | 
| Change in HbA1c | Change in hemoglobin A1c level measured in percent. | 6 months | 
| Change in Weight | Change in weight calculated by BMI (kg/m2) | 6 months | 
| Smoking status change | Percent of patients who quit smoking measured by self-reported response to survey question. | 6 months | 
| Percent undergoing additional CV testing | Percent undergoing additional cardiovascular (CV) risk testing such as stress test, coronary calcium score or related imaging. | 6 months | 
| Change in Body Surface Area (BSA) psoriasis severity | Change in percent of body surface area affected by psoriasis will be assessed. | 6 months | 
| Change in Physicians Global Assessment (PGA) psoriasis severity | Change in PGA score measured from 0-5 with 5 being the most severe psoriasis and 0 being the least severe. | 6 months | 
| Change in dermatology life quality index (DLQI) | Patient reported quality of life outcomes will be assessed using DLQI. The DLQI is calculated by summing the score of 10 questions regarding impact of skin condition on daily life resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. | 6 months | 
| Change in general health | EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a scale ranging from 1 (no health state problem) to 3 (extreme health state problems). The EQ VAS records the patient's self-rated health on a vertical visual analogue scale ranging from 0, worst health state, to 100, best health state. A scoring function is used to assign a value (i.e., EQ-5D™ index score) to self-reported health states from a set of population-based preference weights. For the U.S. general population, the possible EQ-5D index scores range from -0.11 to 1.0 where 0.0 = death and 1.0 = perfect health. | 6 months | 
| Change in reported psoriasis medication use | Proportion of patients who have reported any change in medications taken for psoriatic disease measured through a patient reported survey. | 6 months | 
| Change in physical activity days active | Change in patient reported physcial activity level through the Physical Activity Questionnaire measuring the number of days active for at least 30 minutes over the past month | 6 months | 
| Change in physical activity level | Change in patient reported physcial activity level through the Physical Activity Questionnaire measuring the patient reported level of physical activity on a likert scale from seldom active to vigorously active. | 6 months | 
| Patient experience with Care Coordinator Model | Patient experience with the care coordinator will be measured through the Patient Experience Survey with a likert scale from strongly agree to strongly disagree. | 6 months |