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

• Conditions: Disparities in Treatment of Aortic Valve Stenosis; Aortic Valve Stenosis
• Interventions: Other: Patient Questionnaire; Other: Provider Questionnaire

• Registration Number: NCT04525937
• Lead Sponsor: Minneapolis Heart Institute Foundation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-04
• Study First Submitted: 2020-08-20
• Study First Submitted QC: 2020-08-21
• Study First Posted: 2020-08-25
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-07
• Last Update Posted: 2022-04-08
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Exclusion Criteria

• Age < 18
• Patients who do not allow their records to be used for research

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Severe Aortic Stenosis with Disparities	Patient Questionnaire	Patients will complete a survey and their aortic stenosis will be clinically followed at 30 days and one year
Medical Providers with Disparities	Provider Questionnaire	Referring primary care providers complete a questionnaire on their referral practices for patients with severe aortic stenosis

Primary Outcome Measures

Name	Time	Method
MACE (Major Adverse Cardiac Event)	30 days and 1 year
Patient Mortality	30 days and 1 year

Secondary Outcome Measures

Name	Time	Method
Referring physician- related barriers/biases.	through study completion, an average of 1 year	Secondary outcomes (Providers): referring physician-related barriers/biases against routine guideline-driven care for members of disparate groups with severe aortic stenosis.

Trial Locations

Locations (1)

Minneapolis Heart Institute Foundation; 🇺🇸 Minneapolis, Minnesota, United States