Duke University
Durham, North Carolina, 27707, United States
NCT Number: NCT04025125
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.
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Notify Me40 year and older
All sexes
Observational
Durham, North Carolina, 27707, United States
To identify factors associated with cardiology referral in under-represented racial and ethnic minority (URM) populations with HIV and elevated cardiovascular risk
Only the study team can determine whether someone qualifies for participation.
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:
Exclusion criteria
Time frame: 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.
Time frame: 5 years
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
Incidence of first stroke event will be determined from diagnosis and/or procedure codes from electronic health record data.
Time frame: 5 years
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: Approximately 60 minutes
Qualitative information will be assessed from semi-structured interviews conducted with participating healthcare providers
Time frame: Approximately 60 minutes
Qualitative information will be assessed from semi-structured interviews conducted with participating patients
Time frame: Longitudinal evaluation during 5 years of follow up.
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.
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.
Duke University
Other
Pathways to Cardiovascular Disease Prevention and Impact of Specialty Referral in Underrepresented Racial/Ethnic Minorities With HIV (Coordinating Center)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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