A 12 Month Site Randomized Trial in Adults With Type 2 Diabetes Mellitus and History of Cardiovascular Disease (COORDINATE)

Duke University

Status: Active, not recruiting

Conditions: Cardiovascular Diseases; Diabetes Mellitus, Type 2

Treatments: Other: Intense Education Intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03936660

Pro00101556

Details and patient eligibility

About

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.

Full description

Patients with Type 2 diabetes mellitus and a history of cardiovascular disease will be enrolled in this study. The study will randomize a minimum of 42 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.

Enrollment: 1,049 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,049 participants in 2 patient groups

Control

No Intervention group

Description:

Clinics in the control arm will be encouraged to follow guideline-based care.

Intervention

Active Comparator group

Description:

The cardiology clinics in the intensive educational intervention arm will receive guidance to develop an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.

Treatment:

Other: Intense Education Intervention