Supporting Guideline-recommended SGLT2i and GLP-1 RA Medications for Patients with Comorbid T2DM and ASCVD
This study aims to determine the percentage of individuals with Type 2 Diabetes Mellitus (T2DM) and Atherosclerotic Cardiovascular Disease (ASCVD) who start using SGLT2 inhibitor (SGLT2i) or Glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications, which offer cardiovascular benefits, as recommended by guidelines.
Educational Intervention
Cardiovascular Diseases+4
+ Diabetes Mellitus
+ Diabetes Mellitus, Type 2
Services Research Study
Summary
Study start date: August 18, 2021
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.4197 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Services Research Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location