Racial and Economic Disparities and Unmet Needs in Patients With Severe Aortic Valvular Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-04

Study Completion Date

2022-08-01

Brief Summary

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Common barriers to receiving appropriate guideline-driven care for patients with severe aortic stenosis include referral biases by primary care providers (lack of provider education), patient comorbidities (degree of fragility), as well as psychosocial issues and cultural barriers. Additionally, race, ethnicity, socioeconomic status (SES) and education level are shown to be persistent barriers to accessing healthcare services and healthcare systems, creating a significant practice gap between various patient populations. The most recent transcatheter valve therapies (TVT) registry data show that \>94% of TAVR recipients are Caucasian, followed by less than 4% of African-Americans and Hispanics, respectively. There is a critical need to understand the barriers to treatment and care among severe aortic valve disease patients of disparate groups. This study is a multi-center, retrospective and prospective cohort study of patients diagnosed with severe aortic stenosis. Additionally, we will be surveying referring primary care providers, cardiologists and cardiovascular surgeons to assess their current referral practices for patients with severe aortic stenosis.

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Detailed Description

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Conditions

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Disparities in Treatment of Aortic Valve Stenosis Aortic Valve Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Severe Aortic Stenosis with Disparities

Patients will complete a survey and their aortic stenosis will be clinically followed at 30 days and one year

Patient Questionnaire

Intervention Type OTHER

Patient Questionnaire

Medical Providers with Disparities

Referring primary care providers complete a questionnaire on their referral practices for patients with severe aortic stenosis

Provider Questionnaire

Intervention Type OTHER

Provider Questionnaire

Interventions

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Patient Questionnaire

Intervention Type OTHER

Provider Questionnaire

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Disparity/Diversity background (either race/ethnicity, low SES (adults with incomes at or below the federal poverty level (family income to poverty ratio, ≤1), language (non-English speaker) or education (≤9 years of education))
* Patient scheduled for transcatheter aortic valve replacement using the Edwards Sapien valve, OR recently implanted with Edwards Sapien valve (up to 1 year post-TAVR)
* Echocardiographic diagnosis of severe, symptomatic AS and intermediate to high surgical risk per Society of Thoracic Surgeons (STS) mortality risk-score