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

Not Applicable

Completed

Conditions: Cardiovascular Diseases
Diabetes Mellitus, Type 2

Registration Number: NCT03936660

Lead Sponsor: Duke University

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1049

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants Prescribed All 3 Groups of Recommended Evidence-based Medications	Up to 12 Months	Proportion of patients prescribed all three groups of guideline-recommended therapies for management for T2DM and CVD at last follow-up visit. Groups were defined as (1) high-intensity statins (40-80 mg/d atorvastatin or 20-40 mg/d rosuvastatin); (2) ACEIs or ARBs including angiotensin receptor-neprilysin inhibitors (ARNIs); and (3) SGLT2 inhibitors and/or GLP-1RAs with proven cardiovascular benefit (SGLT2 inhibitors: empagliflozin, dapagliflozin, or canagliflozin; GLP-1RAs: liraglutide, semaglutide, or dulaglutide), or metformin monotherapy with hemoglobin A1c \< 7%.

Secondary Outcome Measures

Name	Time	Method
Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit.	Up to 12 Months	Number of participants prescribed each of the 3 recommended therapies at the last follow-up visit.
Change in Average LDL-C From Baseline to Last Follow-up Visit.	Baseline and last follow-up visit (up to 12 months)	Average change in LDL-C values between baseline visit and last follow-up visit.
Number of Participants With LDL-C < 70 mg/dL	Baseline and last follow-up visit (up to 12 months)	Change in number of participants with LDL-C \< 70 mg/dL at baseline visit vs. last follow-up visit.
Change in Average Blood Pressure From Baseline to Last Follow-up Visit.	Baseline and last follow-up visit (up to 12 months)	Change in systolic and diastolic blood pressure from baseline to last follow-up visit.
Number of Participants With sBP < 130 mmHg	Baseline and last follow-up visit (up to 12 months)	Proportion of participants achieving sBP \< 130 mmHg at baseline vs. last follow-up visit
Number of Participants With dBP < 180 mmHg	Baseline and last follow-up visit (up to 12 months)	Change in number of participants with dBP \< 180 mmHg from baseline to last follow-up visit
Change in Average HbA1c From Baseline to Last Follow-up Visit.	Baseline and last follow-up visit (up to 12 months)	Change in hemoglobin A1c (HbA1c) between baseline and last follow-up visit.
Number of Participants With HbA1c < 7%	Baseline and last follow-up visit (up to 12 months)	Change in number of participants with HbA1c \< 7% from baseline to last follow-up visit.
Number of Participants Experiencing an Event Within 1 Year	Up to 12 Months	Number of participants experiencing an event within 12 months of enrollment. Also known as cumulative incidence of events.

Trial Locations

Locations (44): Grandview Health/Alabama Cardiovascular Group
🇺🇸
Birmingham, Alabama, United States
USA Cardiology
🇺🇸
Mobile, Alabama, United States
Alaska Heart and Vascular Institute
🇺🇸
Anchorage, Alaska, United States
Dignity Health/DHMG Specialty Medicine
🇺🇸
Phoenix, Arizona, United States
Stanford University
🇺🇸
Stanford, California, United States
Blue Coast Cardiology
🇺🇸
Vista, California, United States
Aurora Denver Cardiology
🇺🇸
Denver, Colorado, United States
Bridgeport Hospital
🇺🇸
Bridgeport, Connecticut, United States
Orlando Heart and Vascular Institute
🇺🇸
Altamonte Springs, Florida, United States
Riverside Medical Center/Synergy Healthcare
🇺🇸
Bradenton, Florida, United States
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Grandview Health/Alabama Cardiovascular Group
🇺🇸Birmingham, Alabama, United States