Recruiting

CV Risk

Sponsor:

American College of Cardiology

Code:

NCT05948969

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Decision support

Facilitated referral to a cardiometabolic team-based center

Study Details

Brief summary:

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).

Conditions

Type 2 Diabetes

Study ID

NCT05948969

Start date

Sep 1, 2023

Status verified date

Jul, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Jul 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

750 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Education alone

active comparator: Education + decision support to provide suggestions for care optimization

active comparator: Education + facilitated referral to cardiometabolic team-based center for care optimization

Interventions

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.

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.

Primary outcome measure

  • New prescription of a SGLT2i and/or GLP-1RA [ Time Frame: 9 months ]

Central Contacts and Locations

Central contacts

Locations

Multiple sites nationwide

Recruiting

Washington, District of Columbia, United States, 20004

Contacts

Shilpa Patel

SPatel@acc.org

More Information

Sponsor

American College of Cardiology

Last update posted

Jul 17, 2023

Last verified

Jul, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by American College of Cardiology on 2023-07-17.