Transform CV Risk in Diabetes (CVRiD)

This initiative supports a real-world study of practice and physician prescribing patterns and a quality improvement initiative evaluating best practices (including clinical decision support, facilitated referral to cardiometabolic team-based care model, and general educational tools/resources) to im-prove use of guideline-directed therapeutics known to lower cardiovascular risk (CV) in patients with type 2 diabetes (T2D).

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Decision support; Other: Facilitated referral to a cardiometabolic team-based center

• Study Type: Interventional
• Enrollment (Estimated): 750
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shilpa Patel; Phone Number: 2023756354; Email: SPatel@acc.org
• Study Contact Backup: Name: Jack Reilly; Phone Number: 202; Email: JReilly@acc.org

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20004
      • Recruiting
      • Multiple sites nationwide
      • Contact: Shilpa Patel; Email: SPatel@acc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• T2D diagnosis in the medical record

• ASCVD, defined as follows:

  1. Known Coronary artery disease (CAD), prior Acute coronary syndrome (ACS), or coronary artery revascularization
  2. Prior TIA/ischemic stroke or known carotid or intracerebral atherosclerosis, or prior carotid revascularization
  3. Prior Peripheral artery disease (PAD) including symptomatic claudication or pe-ripheral revascularization

Exclusion Criteria:

• Current participation in an interventional clinical assessment of an investigational drug/device (excluding assessments related to COVID-19)
• Currently receiving any SGLT2i or GLP-1RA
• Known allergy/hypersensitivity/intolerance/contraindication to SGLT2i or GLP-1RA
• Currently receiving comfort care or enrolled in hospice
• Life expectancy <1 year
• History of or plan for heart transplantation or ventricular assist device
• Current or planned hemodialysis
• Decompensated end stage liver disease
• History of Fournier's Gangrene
• Type 1 diabetes
• Prior history of diabetic ketoacidosis
• Pregnancy or active breastfeeding
• History of Pancreatitis or pancreatic cancer
• History of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Education alone
Active Comparator: Education + decision support to provide suggestions for care optimization	Other: Decision support; This implementation strategy will include the clinician education of the previous arm and apply "audit and feedback" of prior care to inform recommendations for future care. These suggestions will encompass 5 different domains based on eligibility and potential opportunity for an SGLT2i, GLP-1RA, angiotensin converting enzyme inhibitors (ACEi)/angiotensin-receptor blockers (ARB), antiplatelet or antithrombotic therapy, and statin therapy. The incorporation of clinical decision support technology will be utilized to identify tailored opportunities for each CV risk reduction based on guideline recommendations for individual patients. Clinicians will be presented prompts with patient-specific recommendation(s) for further optimization of cardioprotective agents. These prompts will be conveyed by a Study Coordinator to responsible clinicians. The follow-up clinical prompts will be based on auditing of updated clinical parameters and medication use.
Active Comparator: Education + facilitated referral to cardiometabolic team-based center for care optimization	Other: Facilitated referral to a cardiometabolic team-based center; Each site will have access to clinicians caring for patients in structured, multidisciplinary cardiometabolic centers. Clinicians caring for patients randomized to this intervention strategy will receive a facilitated referral via the EHR together). If the clinician approves the referral, the patient will be referred to this local team-based comprehensive risk factor management clinic. All patients randomized to this group will be considered in this group whether or not a visit to the cardiometabolic center is completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New prescription of a SGLT2i and/or GLP-1RA	Proportion of treatment-naïve patients who are newly prescribed a SGLT2i and/or GLP-1RA over 9 months in the facilitated referral group (Arm C) versus usual care group (Arm A)	9 months

Collaborators and Investigators

• Sponsor: American College of Cardiology
• Collaborators: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: Pro00059648

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No