Pathways to Cardiovascular Disease Prevention (DCRI Central and Statistical Coordinating Center)

Cardiovascular Diseases Clinical Trial

Official title:

Pathways to Cardiovascular Disease Prevention and Impact of Specialty Referral in Underrepresented Racial/Ethnic Minorities With HIV (Coordinating Center)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04025125
• Other study ID #: Pro00101104
• Secondary ID: 1R01MD013493-01
• Status: Completed
• Start date: October 29, 2019
• Est. completion date: July 30, 2022

Study information

• Verified date: August 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this research is to generate evidence-based recommendations for the management of cardiovascular disease (CVD) risk in People Living with HIV (PLWH). The overall objectives of this application are to demonstrate the effect of cardiology referral on CVD outcomes in a racially/ethnically diverse cohort of PLWH, and to generate qualitative data with which to develop of a future intervention. Our central hypothesis is that cardiology referral reduces incident CVD events in underrepresented racial/ethnic minority (URM) populations with HIV compared to nonreferral. Our hypothesis has been formulated based on our own work identifying that race and provider specialty impact cardiovascular risk management. The rationale for our research is that, once it is known how URM populations with HIV access cardiology referrals, and the impact on CVD outcomes, an intervention can be appropriately designed resulting in new and innovative approaches to the management of URM PLWH at elevated CVD risk.

Description:

Aim 1. To identify factors associated with cardiology referral in under-represented racial and ethnic minority (URM) populations with HIV and elevated cardiovascular risk Aim 2. To evaluate the association between cardiology referral and CVD outcomes in under-represented racial and ethnic populations with HIV and elevated cardiovascular risk Sub-Aim 2a. To evaluate the association between cardiology referral and guideline-based CVD prevention measures in URM populations with HIV and elevated CVD risk

Note: Aims 1 and 2-retrospective analysis with anticipated 8000 EHR records to be reviewed.

Aim 3. To identify facilitators and barriers to optimal CVD prevention

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2022
• Gender: All
• Age group: 40 Years and older

Eligibility

Aims 1 and 2 are not recruiting as retrospective review of electronic health records.

Aims 1 and 2 Inclusion Criteria:

Patient health records may be accessed from subjects who meet the following criteria:

1. Race equals Black/African-American, American Indian/Alaska Native, Asian, Native Hawaiian/Pacific Islander, or More than one race, and/or Ethnicity equals Hispanic or Latino;

2. Documented evidence of HIV positive status (HIV positive diagnosis (ICD10 codes B20-B24, or ICD9 codes 042, V08) and prescription of antiretroviral therapy (ART));

3. Documented evidence of elevated AtheroSclerotic CardioVascular Disease risk (ACC/AHA ASCVD 10 year risk =5%24, or Framingham Cardiovascular Disease 10 year risk =5%25) after HIV diagnosis. The date when the patient first meets either of these CVD risk thresholds and with 1 prior encounter not having CVD risk score defines the index time-point for Aim 1 of this study. These risk calculations depend on sex, age, body mass index, diabetes, current smoking, total cholesterol, HDL cholesterol, systolic blood pressure, and treatment for hypertension (defined from diagnosis codes). If cholesterol measures are not available, then body mass index may be used in place of lipids in the Framingham risk calculation; NOTE: must have a prior encounter within 365 days within health system prior to index

4. Presence of a modifiable risk factor: hypertension, diabetes, elevated total cholesterol, elevated LDL cholesterol and/or tobacco use.

Aims 1 and 2 Exclusion criteria:

1. Age <18 years of age or >99 years of age at index event;

2. Pre-existing ASCVD prior to index event, including a previous diagnosis of any acute myocardial infarction, heart failure, acute coronary syndromes, stable or unstable angina, arterial revascularization (includes coronary arterial or peripheral), stroke, transient ischemic attack or peripheral arterial disease presumed to be of atherosclerotic origin determined by ICD codes;

3. Encounter with cardiology specialist within 1 year prior to index

4. Evidence of ART for pre-exposure prophylaxis (i.e., Truvada [emtricitabine/tenofovir disoproxil fumarate] or post-exposure prophylaxis (e.g., Truvada plus raltegravir) without HIV diagnosis.

Aim 3 Inclusion Criteria:

• Patients:

1. under-represented racial and ethnic minority (URM) populations with HIV > 40 years of age, with

2. a modifiable risk factor for Cardiovascular disease (CVD) (such as hypertension, diabetes, elevated total cholesterol, high LDL cholesterol, or currently use tobacco), and/or known CVD

• Providers

1. HIV providers will include infectious disease physicians, Internists or advance practice practitioners who report having seen > 1 person living with HIV under their care in the last 6 months; AND

2. Cardiology providers (physicians or advance practice providers) will be required to have taken care of at least 1 HIV-positive patient in the past 3 years;

Aim 3 Exclusion Criteria:

• Patients

1. Unwilling or unable to provide oral informed consent;

2. Unable to perform an interview in English;

3. Diminished capacity to give oral consent;

4. Unwilling to be interviewed.

• Providers

1. Unable to perform an interview in English;

2. Unwilling to be interviewed.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• HIV/AIDS

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Duke University	Durham	North Carolina
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with referral to a cardiology specialist (primary outcome for Aim 1)	A binary variable, with 'yes' defined if there is documented evidence that a referral is made within 6 months of becoming eligible by CVD risk score and kept within 3 months of referral, and 'no' otherwise. Cardiology referrals with kept appointments will be ascertained from electronic health record data.	6 months from the date when patient met eligibility criteria for referral
Primary	Proportion of patients with blood pressure control (primary outcome for Aim 2)	Blood pressure control will be defined based on prevailing guidelines during the study period (blood pressure <140/90 mmHg) and will be evaluated based on blood pressures recorded in electronic health record data.	Longitudinal evaluation during 5 years of follow up.
Primary	Proportion of patients with Cholesterol control (co-primary outcome for Aim 2)	Cholesterol control will be defined based on prevailing guidelines during the study period and will be evaluated based on cholesterol laboratory measures recorded in electronic health record data.	Longitudinal evaluation during 5 years of follow up.
Primary	Patient perspective on facilitators and barriers to optimal CVD prevention (co-primary outcome for Aim 3)	Qualitative information will be assessed from semi-structured interviews conducted with participating patients	Approximately 60 minutes
Primary	Provider perspective on facilitators and barriers to optimal CVD prevention (co-primary outcome for Aim 3)	Qualitative information will be assessed from semi-structured interviews conducted with participating healthcare providers	Approximately 60 minutes
Secondary	Incidence of major adverse cardiovascular event, myocardial infarction (secondary outcome for Aim 2)	Incidence of first major adverse cardiovascular event (composite of cardiovascular death and myocardial infarction) will be determined from diagnosis and/or procedure codes from electronic health record data and a query of the National Death Index (Plus).	5 years
Secondary	Incidence of Stroke (secondary outcome for Aim 2)	Incidence of first stroke event will be determined from diagnosis and/or procedure codes from electronic health record data.	5 years
Secondary	Incidence of All-cause death (secondary outcome for Aim 2)	Incidence of all-cause death will be determined from electronic health record data and a query of the National Death Index.	5 years