Cardiometabolic Diseases, Diabetic Cardiomyopathy, Heart Failure, Type 2 Diabetes
Conditions
Keywords
Pragmatic Clinical Trial, Heart Failure, Cardiovascular Prevention
Brief summary
A pragmatic, randomized clinical trial to evaluate the effect of a heart failure (HF) risk assessment and prevention strategy incorporating HF clinical risk scores (WATCH-DM) with cardiac biomarker (NT-proBNP) paired with a clinical decision support tool to implement an intensive prevention strategy among patients with high risk focused on implementation of evidence-based HF preventive therapies.
Detailed description
Primary care providers will be randomized to receive notifications via the electronic health record if any patients with diabetes have high heart failure risk based on a combination of clinical risk scores(WATCH-DM), and biomarkers (NT-proBNP). Providers will be provided recommendation to initiate evidence based therapies (SGLT2 inhibitors, GLP1 agonists, non-steroidal MRA) , obtain expert e-consultation, or refer the patient to a cardiometabolic risk management program.
Interventions
BEHAVIORALIntensive Prevention Strategy
Providers randomized to the intensive prevention strategy will receive notification about patients with diabetes who have high heart failure risk and recommendations for medical management, e-consultation, or referral to a cardiometabolic risk management program.
Sponsors
University of Texas Southwestern Medical Center
Roche Diagnostics GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Primary Care Provider that sees diabetes patients in clinic
Exclusion criteria
* Provider does not see patients with Diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incident Heart Failure or All-cause death | 2-year follow-up | Incident Heart Failure (based on electronic health record International Classification of Diseases codes) or all-cause death. This will be assessed via retrospective chart review. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prescription Rates of SGLT2i | 6-months from electronic health record alert. | Counts of SGLT2 inhibitor prescriptions filled |
| Prescription Rate of Finerenone | 6-months from electronic health record alert. | Counts of Finerenone prescriptions |
| Prescription Rate of GLP1 | 6-months from electronic health record alert. | Counts of GLP1 prescription |
Countries
United States
Contacts
CONTACTAmbarish Pandey, MD
CONTACTVINAYAK SUBRAMANIAN, MD
Outcome results
None listed