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

NCT04525937 | Unknown

• 1 other identifier: Racial Disparities
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Disparities in Treatment of Aortic Valve Stenosis; Aortic Valve Stenosis

Keywords

Aortic Valve Stenosis; Disparities

Outcome Measures

Primary Outcomes (2)

• Patient Mortality

  30 days and 1 year

• MACE (Major Adverse Cardiac Event)

  30 days and 1 year

Secondary Outcomes (1)

• Referring physician- related barriers/biases.

  through study completion, an average of 1 year

Study Arms (2)

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

Other: Patient Questionnaire

Medical Providers with Disparities

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

Other: Provider Questionnaire

Interventions

Patient Questionnaire OTHER

Patient Questionnaire

Patients with Severe Aortic Stenosis with Disparities

Provider Questionnaire OTHER

Provider Questionnaire

Medical Providers with Disparities

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients: \- Over 18 years of age with echocardiographic diagnosis of severe, symptomatic AS and intermediate to high surgical risk per Society of Thoracic Surgeons (STS) mortality risk-score who have a disparate condition Providers: \- Referring primary care providers, cardiologists and cardiovascular surgeons at the study sites.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Minneapolis Heart Institute Foundation: lead

Study Sites (1)

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Patient Health Questionnaire

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Mario Goessl, MD, PhD

  Minneapolis Heart Institute Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Schwager, RN, BSN

CONTACT

612-863-6257; Sarah.Schwager@allina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 25, 2020
• Study Start: June 4, 2018
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: April 8, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)