Clinical trial NCT03936660: A 12 Month Site Randomized Trial in Adults With Type 2 Diabetes Mellitus and History of Cardiovascular Disease
Official title: COOrdinating CaRDIology CliNics RAndomized Trial of Interventions to Improve OutcomEs (COORDINATE) - Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Cardiovascular Diseases
Keywords: COORDINATE-DIABETES
COORDINATE
T2DM
Diabetes Mellitus, Type 2
Cardiovascular Disease
Prevention
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
name: Eli Lilly and Company
First posted: 2019-05-03
Enrollment: 1049
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Prescribed All 3 Groups of Recommended Evidence-based Medications
timeFrame: Up to 12 Months
Secondary outcomes:
measure: Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit.
timeFrame: Up to 12 Months
measure: Change in Average LDL-C From Baseline to Last Follow-up Visit.
timeFrame: Baseline and last follow-up visit (up to 12 months)
measure: Number of Participants With LDL-C < 70 mg/dL
timeFrame: Baseline and last follow-up visit (up to 12 months)
measure: Change in Average Blood Pressure From Baseline to Last Follow-up Visit.
timeFrame: Baseline and last follow-up visit (up to 12 months)
measure: Number of Participants With sBP < 130 mmHg
timeFrame: Baseline and last follow-up visit (up to 12 months)
measure: Number of Participants With dBP < 180 mmHg
timeFrame: Baseline and last follow-up visit (up to 12 months)
measure: Change in Average HbA1c From Baseline to Last Follow-up Visit.
timeFrame: Baseline and last follow-up visit (up to 12 months)
measure: Number of Participants With HbA1c < 7%
timeFrame: Baseline and last follow-up visit (up to 12 months)
measure: Number of Participants Experiencing an Event Within 1 Year
timeFrame: Up to 12 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Grandview Health/Alabama Cardiovascular Group
state: Alabama
city: Mobile
country: United States
facility: USA Cardiology
state: Alabama
city: Anchorage
country: United States
facility: Alaska Heart and Vascular Institute
state: Alaska
city: Phoenix
country: United States
facility: Dignity Health/DHMG Specialty Medicine
state: Arizona
city: Stanford
country: United States
facility: Stanford University
state: California
city: Vista
country: United States
facility: Blue Coast Cardiology
state: California
city: Denver
country: United States
facility: Aurora Denver Cardiology
state: Colorado
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: Altamonte Springs
country: United States
facility: Orlando Heart and Vascular Institute
state: Florida
city: Bradenton
country: United States
facility: Riverside Medical Center/Synergy Healthcare
state: Florida
city: Coral Gables
country: United States
facility: Lennar Foundation/Univ. of Miami
state: Florida
city: Inverness
country: United States
facility: Citrus Cardiology
state: Florida
city: Jacksonville
country: United States
facility: Baptist Health Research Institute
state: Florida
city: Naples
country: United States
facility: Advanced Research for Health Improvement, LLC
state: Florida
city: Panama City
country: United States
facility: Cardiovascular Inst. of Northwest Florida
state: Florida
city: Saint Petersburg
country: United States
facility: Bayfront Cardiovascular Associates
state: Florida
city: Trinity
country: United States
facility: Interventional Cardiac Consultants
state: Florida
city: Atlanta
country: United States
facility: Emory/Grady Memorial Hospital
state: Georgia
city: Chicago
country: United States
facility: Advocate Heart Institute
state: Illinois
city: Fairview Heights
country: United States
facility: Advanced Heart Care Group/Medicoricium LLC
state: Illinois
city: Olympia Fields
country: United States
facility: Specialty Physicians of Illinois
state: Illinois
city: Peoria
country: United States
facility: UnityPoint Health Cardiovascular Services
state: Illinois
city: Springfield
country: United States
facility: Prairie Cardiovascular Consultants
state: Illinois
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Marrero
country: United States
facility: Heart Clinic of Louisiana
state: Louisiana
city: Baltimore
country: United States
facility: The Johns Hopkins University
state: Maryland
city: Alpena
country: United States
facility: Endeavor Medical Research
state: Michigan
city: Flint
country: United States
facility: Cardiology Institute of Michigan
state: Michigan
city: Hannibal
country: United States
facility: Hannibal Regional Medical Group
state: Missouri
city: Bridgewater
country: United States
facility: Advanced Heartcare LLC
state: New Jersey
city: Linden
country: United States
facility: New Jersey Heart
state: New Jersey
city: Manalapan
country: United States
facility: Garden State Heart Care
state: New Jersey
city: Sewell
country: United States
facility: Cardiovascular Associates of the Delaware Valley
state: New Jersey
city: Manhasset
country: United States
facility: Northwell Health/Lenox Hill Hospital
state: New York
city: Burlington
country: United States
facility: Kernodle Clinic
state: North Carolina
city: Greensboro
country: United States
facility: Cone Health/LeBauer Brodie Ctr for Cardiovascular Rsch
state: North Carolina
city: Wilmington
country: United States
facility: Cape Fear Heart Associates
state: North Carolina
city: Oklahoma City
country: United States
facility: Cardiovascular Health Clinic
state: Oklahoma
city: Sayre
country: United States
facility: Guthrie Medical Group
state: Pennsylvania
city: Greenwood
country: United States
facility: Advanced Cardiology Associates
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Cardiovascular Research
state: South Dakota
city: Dallas
country: United States
facility: Univ. of Texas Southwestern
state: Texas
city: Tomball
country: United States
facility: Lonestar Heart and Vascular
state: Texas
city: Waukesha
country: United States
facility: ProHealth Care Heart and Vascular
state: Wisconsin
Study officials:
affiliation: Duke Clinical Research Institute
name: Christopher Granger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zinman B, Lachin JM, Inzucchi SE. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2016 Mar 17;374(11):1094. doi: 10.1056/NEJMc1600827. No abstract available.
citation: Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JF, Nauck MA, Nissen SE, Pocock S, Poulter NR, Ravn LS, Steinberg WM, Stockner M, Zinman B, Bergenstal RM, Buse JB; LEADER Steering Committee; LEADER Trial Investigators. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):311-22. doi: 10.1056/NEJMoa1603827. Epub 2016 Jun 13.
citation: Sattar N, Petrie MC, Zinman B, Januzzi JL Jr. Novel Diabetes Drugs and the Cardiovascular Specialist. J Am Coll Cardiol. 2017 May 30;69(21):2646-2656. doi: 10.1016/j.jacc.2017.04.014.
citation: Vinereanu D, Lopes RD, Bahit MC, Xavier D, Jiang J, Al-Khalidi HR, He W, Xian Y, Ciobanu AO, Kamath DY, Fox KA, Rao MP, Pokorney SD, Berwanger O, Tajer C, de Barros E Silva PGM, Roettig ML, Huo Y, Granger CB; IMPACT-AF investigators. A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial. Lancet. 2017 Oct 14;390(10104):1737-1746. doi: 10.1016/S0140-6736(17)32165-7. Epub 2017 Aug 28.
citation: American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S90-S102. doi: 10.2337/dc19-S009.
citation: American Diabetes Association. 10. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S103-S123. doi: 10.2337/dc19-S010.