A 12 Month Site Randomized Trial in Adults With Type 2 Diabetes Mellitus and History of Cardiovascular Disease
A 12 Month Site Randomized Trial in Adults With Type 2 Diabetes Mellitus and History of Cardiovascular Disease
COORDINATE-Diabetes is a cluster-randomized clinical trial to test the effectiveness of an
 innovative, clinic-level educational intervention to improve the management of patients with
 type 2 diabetes mellitus and cardiovascular disease.
Patients with Type 2 diabetes mellitus and a history of cardiovascular disease will be
 enrolled in this study. The study will randomize 46 US cardiology clinics to an intervention
 arm vs. control arm. The clinic-level multi-faceted educational intervention will include
 strategies to develop cardiology and endocrinology partnerships and guideline-recommended
 care pathways with measurement and feedback to improve the care of patients with type 2
 diabetes mellitus and cardiovascular disease.

 Patients must be enrolled during a routine visit in a cardiology clinic, and the clinic must
 have at least 3 physicians and/or APPs on staff with independent patient populations.
Inclusion Criteria:

 -  Age ≥ 18 years old

 -  Diagnosis of Type 2 diabetes mellitus (T2DM)

 -  History of at least one of the following conditions:

 1. Coronary artery disease (defined as prior MI, coronary revascularization (CABG or
 PCI), and/or obstructive CAD (≥50%) as documented by angiography or CTA)

 2. Stroke and/or carotid artery stenosis (≥50%)

 3. Peripheral Arterial disease (defined as claudication with ABI<0.9, prior
 peripheral revascularization, and/or amputation due to circulatory insufficiency)

 -  Ability to communicate with site staff and understand and provide written informed
 consent and proof of Health Insurance Portability and Accountability Act (HIPAA)
 authorization

 Exclusion Criteria:

 -  Determined to be highly unlikely to survive and/or to continue follow-up in that
 clinic for at least 1 year, as identified by site investigator

 -  GFR<30 mL/min/1.73m2

 -  Already on all guideline-recommended therapies for T2DM and CVD

 -  Absolute contraindication to any of the guideline recommended therapies for T2DM and
 CVD