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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
1,049
Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.
Number of Participants Prescribed All 3 Groups of Recommended Evidence-based Medications
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%.
Time frame: Up to 12 Months
Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit.
Number of participants prescribed each of the 3 recommended therapies at the last follow-up visit.
Time frame: Up to 12 Months
Change in Average LDL-C From Baseline to Last Follow-up Visit.
Average change in LDL-C values between baseline visit and last follow-up visit.
Time frame: Baseline and last follow-up visit (up to 12 months)
Number of Participants With LDL-C < 70 mg/dL
Change in number of participants with LDL-C \< 70 mg/dL at baseline visit vs. last follow-up visit.
Time frame: Baseline and last follow-up visit (up to 12 months)
Change in Average Blood Pressure From Baseline to Last Follow-up Visit.
Change in systolic and diastolic blood pressure from baseline to last follow-up visit.
Time frame: Baseline and last follow-up visit (up to 12 months)
Number of Participants With sBP < 130 mmHg
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 34 more locations
Proportion of participants achieving sBP \< 130 mmHg at baseline vs. last follow-up visit
Time frame: Baseline and last follow-up visit (up to 12 months)
Number of Participants With dBP < 180 mmHg
Change in number of participants with dBP \< 180 mmHg from baseline to last follow-up visit
Time frame: Baseline and last follow-up visit (up to 12 months)
Change in Average HbA1c From Baseline to Last Follow-up Visit.
Change in hemoglobin A1c (HbA1c) between baseline and last follow-up visit.
Time frame: Baseline and last follow-up visit (up to 12 months)
Number of Participants With HbA1c < 7%
Change in number of participants with HbA1c \< 7% from baseline to last follow-up visit.
Time frame: Baseline and last follow-up visit (up to 12 months)
Number of Participants Experiencing an Event Within 1 Year
Number of participants experiencing an event within 12 months of enrollment. Also known as cumulative incidence of events.
Time frame: Up to 12 Months