Medicamentos SGLT2i y GLP-1 RA recomendados por las guías para pacientes con T2DM y ASCVD comórbidas
Este estudio tiene como objetivo determinar el porcentaje de individuos con Diabetes Mellitus Tipo 2 (T2DM) y Enfermedad Cardiovascular Aterosclerótica (ASCVD) que comienzan a utilizar medicamentos inhibidores de SGLT2 (SGLT2i) o agonistas del receptor de péptido similar al glucagón-1 (GLP-1 RA), los cuales ofrecen beneficios cardiovasculares, tal como lo recomiendan las guías.
Educational Intervention
Diabetes Mellitus Tipo 2+3
+ Enfermedades Cardiovasculares
+ Enfermedades del Sistema Endocrino
Estudio de Investigación en servicios de salud
Resumen
Fecha de inicio: 18 de agosto de 2021
Fecha en la que se inscribió al primer participante.This study focuses on improving the health of individuals who have both type 2 diabetes mellitus (T2DM) and a history of atherosclerotic cardiovascular disease (ASCVD), and who have not used certain recommended medications in the past year. The goal is to help these patients manage their conditions better. The study identifies primary care providers and assigns them randomly to either an intervention group or a control group. All eligible patients under the care of these providers are included. Specialist providers, such as cardiologists and endocrinologists, are also identified and contacted. The importance of this study lies in its potential to enhance patient care by promoting the use of guideline-recommended medications, potentially reducing cardiovascular risk. The study involves a multi-faceted approach to support providers in caring for their patients. This includes sharing recent treatment recommendations based on guidelines and providing patients with information on reducing their cardiovascular risk. The study does not require active enrollment or recruitment. The primary outcome measured is the percentage of individuals with T2DM and ASCVD who start using SGLT2i or GLP-1 RA medications. These medications have cardiovascular benefits, excluding combination products. This is determined by reviewing administrative claims data for pharmacy claims.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 4197 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Investigación en Servicios de Salud
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 85 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: Patient * Patients with T2DM defined as ≥2 outpatient diagnoses of T2DM in any position on separate days; OR ≥1 inpatient diagnosis T2DM in any position; OR ≥1 outpatient diagnosis in any position AND ≥1 medication claim for T2DM * ≥1 diagnosis code for ASCVD (coronary artery disease diagnoses or procedures, cerebrovascular disease, peripheral artery disease of atherosclerotic origin) on any claim type in any position within the 24-month period prior to identification * Enrolled in a Humana Medicare Advantage Prescription Drug plan with ≥12 months pre-identification continuous enrollment (no more than a 31 day gap) as of the identification date and currently enrolled as of the identification date * Age 18-85 years at time of identification * Patients residing in Kentucky (KY), West Virginia (WV), Pennsylvania (PA), and 6 counties in south New Jersey (NJ) (Burlington, Camden, Cumberland, Gloucester, Mercer, Salem) (United States) Provider * Primary care providers of the identified patients Exclusion Criteria: Patients * ≥1 diagnosis or procedure code for end-stage kidney disease, renal transplant, dialysis or kidney failure * Any hospice or long-term care residence * ≥1 code for pregnancy/childbirth * Patients with any use of SGLT2i or GLP-1 RA medications in the pre-identification period * Patients without an attributed primary care provider * Patients on do not contact lists * Patients without valid addresses and telephone numbers * Patients with ≥1 diagnosis for type 1 diabetes pre-identification Primary care providers * Providers on do not contact lists * Providers without valid fax/mailing address and phone number * Providers with \<3 or \>50 eligible patients
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Comparador ActivoObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación