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

Primary Purpose

Diabetes Mellitus, Type 2, Cardiovascular Diseases

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intense Education Intervention
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 2 focused on measuring COORDINATE-DIABETES, COORDINATE, T2DM, Diabetes Mellitus, Type 2, Cardiovascular Disease, Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Grandview Health/Alabama Cardiovascular Group
  • USA Cardiology
  • Alaska Heart and Vascular Institute
  • Dignity Health/DHMG Specialty Medicine
  • Stanford University
  • Blue Coast Cardiology
  • Aurora Denver Cardiology
  • Bridgeport Hospital
  • Orlando Heart and Vascular Institute
  • Riverside Medical Center/Synergy Healthcare
  • Lennar Foundation/Univ. of Miami
  • Citrus Cardiology
  • Baptist Health Research Institute
  • Advanced Research for Health Improvement, LLC
  • Cardiovascular Inst. of Northwest Florida
  • Bayfront Cardiovascular Associates
  • Interventional Cardiac Consultants
  • Emory/Grady Memorial Hospital
  • Advocate Heart Institute
  • Advanced Heart Care Group/Medicoricium LLC
  • Specialty Physicians of Illinois
  • UnityPoint Health Cardiovascular Services
  • Prairie Cardiovascular Consultants
  • Iowa Heart Center
  • Heart Clinic of Louisiana
  • The Johns Hopkins University
  • Endeavor Medical Research
  • Cardiology Institute of Michigan
  • Hannibal Regional Medical Group
  • Advanced Heartcare LLC
  • New Jersey Heart
  • Garden State Heart Care
  • Cardiovascular Associates of the Delaware Valley
  • Northwell Health/Lenox Hill Hospital
  • Kernodle Clinic
  • Cone Health/LeBauer Brodie Ctr for Cardiovascular Rsch
  • Cape Fear Heart Associates
  • Cardiovascular Health Clinic
  • Guthrie Medical Group
  • Advanced Cardiology Associates
  • Black Hills Cardiovascular Research
  • Univ. of Texas Southwestern
  • Lonestar Heart and Vascular
  • ProHealth Care Heart and Vascular

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Intervention

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Implementing a clinic-level multifaceted intervention
Proportion of patients achieving guideline-recommended management for T2DM and CVD at last follow-up visit.

Secondary Outcome Measures

Proportion of patients on guideline recommended therapies at last follow-up visit.
Changes in cholesterol levels at last follow-up visit.
Changes in blood pressure control at last follow-up visit.
Changes in glycemic control at last follow-up visit.
Measurement of average time from baseline to patient event.

Full Information

First Posted
May 1, 2019
Last Updated
January 19, 2023
Sponsor
Duke University
Collaborators
Boehringer Ingelheim, Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT03936660
Brief Title
A 12 Month Site Randomized Trial in Adults With Type 2 Diabetes Mellitus and History of Cardiovascular Disease
Acronym
COORDINATE
Official Title
COOrdinating CaRDIology CliNics RAndomized Trial of Interventions to Improve OutcomEs (COORDINATE) - Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 25, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Boehringer Ingelheim, Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Cardiovascular Diseases
Keywords
COORDINATE-DIABETES, COORDINATE, T2DM, Diabetes Mellitus, Type 2, Cardiovascular Disease, Prevention

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1049 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Clinics in the control arm will be encouraged to follow guideline-based care.
Arm Title
Intervention
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Intense Education Intervention
Other Intervention Name(s)
Intervention
Intervention Description
Intervention will involve guideline-based care education.
Primary Outcome Measure Information:
Title
Implementing a clinic-level multifaceted intervention
Description
Proportion of patients achieving guideline-recommended management for T2DM and CVD at last follow-up visit.
Time Frame
Up to 12 Months
Secondary Outcome Measure Information:
Title
Proportion of patients on guideline recommended therapies at last follow-up visit.
Time Frame
Up to 12 Months
Title
Changes in cholesterol levels at last follow-up visit.
Time Frame
Baseline and last follow-up visit (up to 12 months)
Title
Changes in blood pressure control at last follow-up visit.
Time Frame
Baseline and last follow-up visit (up to 12 months)
Title
Changes in glycemic control at last follow-up visit.
Time Frame
Baseline and last follow-up visit (up to 12 months)
Title
Measurement of average time from baseline to patient event.
Time Frame
Up to 12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Granger, MD
Organizational Affiliation
Duke Clinical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grandview Health/Alabama Cardiovascular Group
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
USA Cardiology
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Facility Name
Alaska Heart and Vascular Institute
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Dignity Health/DHMG Specialty Medicine
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Blue Coast Cardiology
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Aurora Denver Cardiology
City
Denver
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Bridgeport Hospital
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06610
Country
United States
Facility Name
Orlando Heart and Vascular Institute
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32714
Country
United States
Facility Name
Riverside Medical Center/Synergy Healthcare
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Lennar Foundation/Univ. of Miami
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Citrus Cardiology
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Baptist Health Research Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32258
Country
United States
Facility Name
Advanced Research for Health Improvement, LLC
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Cardiovascular Inst. of Northwest Florida
City
Panama City
State/Province
Florida
ZIP/Postal Code
32401
Country
United States
Facility Name
Bayfront Cardiovascular Associates
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Interventional Cardiac Consultants
City
Trinity
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Emory/Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Advocate Heart Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Advanced Heart Care Group/Medicoricium LLC
City
Fairview Heights
State/Province
Illinois
ZIP/Postal Code
62208
Country
United States
Facility Name
Specialty Physicians of Illinois
City
Olympia Fields
State/Province
Illinois
ZIP/Postal Code
60461
Country
United States
Facility Name
UnityPoint Health Cardiovascular Services
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61606
Country
United States
Facility Name
Prairie Cardiovascular Consultants
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Iowa Heart Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Heart Clinic of Louisiana
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
The Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Endeavor Medical Research
City
Alpena
State/Province
Michigan
ZIP/Postal Code
49707
Country
United States
Facility Name
Cardiology Institute of Michigan
City
Flint
State/Province
Michigan
ZIP/Postal Code
48507
Country
United States
Facility Name
Hannibal Regional Medical Group
City
Hannibal
State/Province
Missouri
ZIP/Postal Code
63401
Country
United States
Facility Name
Advanced Heartcare LLC
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
New Jersey Heart
City
Linden
State/Province
New Jersey
ZIP/Postal Code
07036
Country
United States
Facility Name
Garden State Heart Care
City
Manalapan
State/Province
New Jersey
ZIP/Postal Code
07726
Country
United States
Facility Name
Cardiovascular Associates of the Delaware Valley
City
Sewell
State/Province
New Jersey
ZIP/Postal Code
08080
Country
United States
Facility Name
Northwell Health/Lenox Hill Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Kernodle Clinic
City
Burlington
State/Province
North Carolina
ZIP/Postal Code
27215
Country
United States
Facility Name
Cone Health/LeBauer Brodie Ctr for Cardiovascular Rsch
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Cape Fear Heart Associates
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Cardiovascular Health Clinic
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73134
Country
United States
Facility Name
Guthrie Medical Group
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Advanced Cardiology Associates
City
Greenwood
State/Province
South Carolina
ZIP/Postal Code
29646
Country
United States
Facility Name
Black Hills Cardiovascular Research
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Univ. of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Lonestar Heart and Vascular
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
ProHealth Care Heart and Vascular
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26981940
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.
Results Reference
background
PubMed Identifier
27295427
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.
Results Reference
background
PubMed Identifier
28545639
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.
Results Reference
background
PubMed Identifier
28859942
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.
Results Reference
background
PubMed Identifier
30559235
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.
Results Reference
background
PubMed Identifier
30559236
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.
Results Reference
background

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

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