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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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COOrdinating CaRDIology CliNics RAndomized Trial of Interventions to Improve OutcomEs (COORDINATE) - Diabetes

Conditions
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Diabetes Mellitus, Type 2, Cardiovascular Diseases

Intervention / Treatment
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* Other: Intense Education Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old Diagnosis of Type 2 diabetes mellitus (T2DM) History of at least one of the following conditions: Coronary artery disease (defined as prior MI, coronary revascularization (CABG or PCI), and/or obstructive CAD (≥50%) as documented by angiography or CTA) Stroke and/or carotid artery stenosis (≥50%) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Clinics in the control arm will be encouraged to follow guideline-based care. | |
| Active Comparator: Intervention<br>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. | Other: Intense Education Intervention<br>* Intervention will involve guideline-based care education.<br>* Other names: Intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementing a clinic-level multifaceted intervention | Proportion of patients achieving guideline-recommended management for T2DM and CVD at last follow-up visit. | Up to 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients on guideline recommended therapies at last follow-up visit. |  | Up to 12 Months | 
| Changes in cholesterol levels at last follow-up visit. |  | Baseline and last follow-up visit (up to 12 months) | 
| Changes in blood pressure control at last follow-up visit. |  | Baseline and last follow-up visit (up to 12 months) | 
| Changes in glycemic control at last follow-up visit. |  | Baseline and last follow-up visit (up to 12 months) | 
| Measurement of average time from baseline to patient event. |  | Up to 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COORDINATE-DIABETES, COORDINATE, T2DM, Diabetes Mellitus, Type 2, Cardiovascular Disease, Prevention