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

19 août 2022 mis à jour par: Duke University

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

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.

Aperçu de l'étude

Statut

Complété

Description détaillée

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

Type d'étude

Observationnel

Inscription (Réel)

57

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • North Carolina
      • Durham, North Carolina, États-Unis, 27707
        • Duke University
      • Winston-Salem, North Carolina, États-Unis, 27157
        • Wake Forest University Health Sciences
    • Ohio
      • Cleveland, Ohio, États-Unis, 44106
        • University Hospitals Cleveland Medical Center
    • South Carolina
      • Charleston, South Carolina, États-Unis, 29425
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, États-Unis, 37232-2582
        • Vanderbilt University Medical Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

40 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

N/A

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Aims 1 and 2 not recruiting patients

Aims 3 population of interest:

  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 and prescription of antiretroviral therapy (ART));

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Proportion of patients with referral to a cardiology specialist (primary outcome for Aim 1)
Délai: 6 months from the date when patient met eligibility criteria for referral
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
Proportion of patients with blood pressure control (primary outcome for Aim 2)
Délai: 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.
Longitudinal evaluation during 5 years of follow up.
Proportion of patients with Cholesterol control (co-primary outcome for Aim 2)
Délai: 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.
Longitudinal evaluation during 5 years of follow up.
Patient perspective on facilitators and barriers to optimal CVD prevention (co-primary outcome for Aim 3)
Délai: Approximately 60 minutes
Qualitative information will be assessed from semi-structured interviews conducted with participating patients
Approximately 60 minutes
Provider perspective on facilitators and barriers to optimal CVD prevention (co-primary outcome for Aim 3)
Délai: Approximately 60 minutes
Qualitative information will be assessed from semi-structured interviews conducted with participating healthcare providers
Approximately 60 minutes

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Incidence of major adverse cardiovascular event, myocardial infarction (secondary outcome for Aim 2)
Délai: 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).
5 years
Incidence of Stroke (secondary outcome for Aim 2)
Délai: 5 years
Incidence of first stroke event will be determined from diagnosis and/or procedure codes from electronic health record data.
5 years
Incidence of All-cause death (secondary outcome for Aim 2)
Délai: 5 years
Incidence of all-cause death will be determined from electronic health record data and a query of the National Death Index.
5 years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

  • Chercheur principal: Gerald Bloomfield, MD, Duke Health

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

29 octobre 2019

Achèvement primaire (Réel)

30 juillet 2022

Achèvement de l'étude (Réel)

30 juillet 2022

Dates d'inscription aux études

Première soumission

2 juillet 2019

Première soumission répondant aux critères de contrôle qualité

17 juillet 2019

Première publication (Réel)

18 juillet 2019

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 août 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

19 août 2022

Dernière vérification

1 août 2022

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Pro00101104
  • 1R01MD013493-01 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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