Racial and Economic Disparities and Unmet Needs in Patien... | NCT04525937

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

NCT04525937

Sponsor

Minneapolis Heart Institute Foundation

Status

Unknown status

Last Update Posted

Apr 8, 2022Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Disparities in Treatment of Aortic Valve Stenosis
Aortic Valve Stenosis

Interventions

Patient Questionnaire
Provider Questionnaire

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 4, 2018Actual

Primary Completion Date

Aug 1, 2022Estimated

Completion Date

Aug 1, 2022Estimated

First Submitted Date

Aug 20, 2020

First Submission Date that Met QC Criteria

Aug 21, 2020

First Posted Date

Aug 25, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2022

Last Update Posted Date

Apr 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Patient Questionnaire	Other	Patient Questionnaire	Patients with Severe Aortic Stenosis with Disparities

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient Mortality		30 days and 1 year
MACE (Major Adverse Cardiac Event)		30 days and 1 year

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sarah Schwager, RN, BSN	Contact	612-863-6257		Sarah.Schwager@allina.com

Overall Officials

Name	Affiliation	Role
Mario Goessl, MD, PhD	Minneapolis Heart Institute Foundation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Minneapolis Heart Institute Foundation	Recruiting	Minneapolis	Minnesota	55407	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001024	Aortic Valve Stenosis

Ancestor Terms

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000073222	Patient Health Questionnaire

Ancestor Terms

ID	Term
D011795	Surveys and Questionnaires
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided