Cardiovascular Diseases, HIV/AIDS
Conditions
Brief 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.
Detailed description
To identify factors associated with cardiology referral in under-represented racial and ethnic minority (URM) populations with HIV and elevated cardiovascular risk
Interventions
None listed
Sponsors
Duke University
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Inclusion criteria
Project is not recruiting as retrospective review of electronic health records. 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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Visit to a Cardiology Specialist From Cohort | 5 years | A binary variable, with 'yes' defined if there is documented evidence that a ambulatory visit was made with a cardiologist after becoming eligible by CVD risk score, and 'no' otherwise. Patients were followed from the date when they met eligibility criteria to the date of first encounter with a cardiology specialist or through a maximum of 5 years from their eligibility date. Follow-up was censored early at the end of data collection (December 31, 2020), or 6 months after the patient's last ambulatory visit, if earlier. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGerald Bloomfield, MD
Duke Health
Participant flow
Recruitment details
retrospective data study
Pre-assignment details
As is pre-specified in the study protocol, Aim 3 data are not reported here.
Participants by arm
| Arm | Count |
|---|---|
| Overall Overall cohort. | 2,039 |
| Total | 2,039 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 45 years |
| Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score | 5.1 10-year risk percentage |
| Ethnicity (NIH/OMB) Hispanic or Latino | 225 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1810 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 9 Participants |
| Race (NIH/OMB) Asian | 35 Participants |
| Race (NIH/OMB) Black or African American | 1755 Participants |
| Race (NIH/OMB) More than one race | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 164 Participants |
| Race (NIH/OMB) White | 65 Participants |
| Region of Enrollment United States | 2039 Participants |
| Sex: Female, Male Female | 1061 Participants |
| Sex: Female, Male Male | 978 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 137 / 2,039 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Number of Participants With Visit to a Cardiology Specialist From Cohort
A binary variable, with 'yes' defined if there is documented evidence that a ambulatory visit was made with a cardiologist after becoming eligible by CVD risk score, and 'no' otherwise. Patients were followed from the date when they met eligibility criteria to the date of first encounter with a cardiology specialist or through a maximum of 5 years from their eligibility date. Follow-up was censored early at the end of data collection (December 31, 2020), or 6 months after the patient's last ambulatory visit, if earlier.
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall | Number of Participants With Visit to a Cardiology Specialist From Cohort | 283 Participants |
Other Pre-specified
Incidence of All-cause Death
Incidence of all-cause death will be determined from electronic health record data and a query of the National Death Index.
Time frame: 5 years
Other Pre-specified
Incidence of Major Adverse Cardiovascular Event, Myocardial Infarction
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).
Time frame: 5 years
Other Pre-specified
Incidence of Stroke
Incidence of first stroke event will be determined from diagnosis and/or procedure codes from electronic health record data.
Time frame: 5 years
Other Pre-specified
Patient Perspective on Facilitators and Barriers to Optimal CVD Prevention
Qualitative information will be assessed from semi-structured interviews conducted with participating patients
Time frame: Approximately 60 minutes
Other Pre-specified
Proportion of Patients With Blood Pressure Control
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.
Time frame: Longitudinal evaluation during 5 years of follow up.
Other Pre-specified
Proportion of Patients With Cholesterol Control
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.
Time frame: Longitudinal evaluation during 5 years of follow up.
Other Pre-specified
Provider Perspective on Facilitators and Barriers to Optimal CVD Prevention
Qualitative information will be assessed from semi-structured interviews conducted with participating healthcare providers
Time frame: Approximately 60 minutes