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出境医 / 临床实验 / A 12 Month Site Randomized Trial in Adults With Type 2 Diabetes Mellitus and History of Cardiovascular Disease (COORDINATE)

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

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Cardiovascular Diseases Other: Intense Education Intervention Not Applicable

Detailed Description:

Patients with Type 2 diabetes mellitus and a history of cardiovascular disease will be enrolled in this study. The study will randomize 46 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: COOrdinating CaRDIology CliNics RAndomized Trial of Interventions to Improve OutcomEs (COORDINATE) - Diabetes
Actual Study Start Date : July 18, 2019
Estimated Primary Completion Date : March 30, 2022
Estimated Study Completion Date : March 30, 2027
Arms and Interventions
Arm Intervention/treatment
No Intervention: Control
Clinics in the control arm will be encouraged to follow guideline-based care.
Active Comparator: Intervention
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
Intervention will involve guideline-based care education.
Other Name: Intervention
Outcome Measures
Primary Outcome Measures :
  1. Implementing a clinic-level multifaceted intervention [ Time Frame: 12 Months ]
    Proportion of patients achieving guideline-recommended management for T2DM and CVD at 12 months as prescribed by a cardiologist.


Secondary Outcome Measures :
  1. Proportion of patients on guideline recommended therapies at 12 months. [ Time Frame: 12 Months ]
  2. Changes in cholesterol levels over 12 months. [ Time Frame: Baseline and 12 Months ]
  3. Changes in blood pressure control over 12 months. [ Time Frame: Baseline and 12 Months ]
  4. Changes in glycemic control over 12 months [ Time Frame: Baseline and 12 Months ]
  5. Measurement of average time from baseline to patient event. [ Time Frame: 12 Months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Laura Webb 9196688977 laura.webb@duke.edu
Contact: Nina Hines 9196683637 nina.hines@duke.edu

Locations
Show Show 49 study locations
Sponsors and Collaborators
Duke University
Boehringer Ingelheim
Eli Lilly and Company
Investigators
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Principal Investigator: Christopher Granger, MD Duke Clinical Research Institute
Tracking Information
First Submitted Date  ICMJE May 1, 2019
First Posted Date  ICMJE May 3, 2019
Last Update Posted Date March 8, 2021
Actual Study Start Date  ICMJE July 18, 2019
Estimated Primary Completion Date March 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2019) 		Implementing a clinic-level multifaceted intervention [ Time Frame: 12 Months ]
Proportion of patients achieving guideline-recommended management for T2DM and CVD at 12 months as prescribed by a cardiologist.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2019)
  • Proportion of patients on guideline recommended therapies at 12 months. [ Time Frame: 12 Months ]
  • Changes in cholesterol levels over 12 months. [ Time Frame: Baseline and 12 Months ]
  • Changes in blood pressure control over 12 months. [ Time Frame: Baseline and 12 Months ]
  • Changes in glycemic control over 12 months [ Time Frame: Baseline and 12 Months ]
  • Measurement of average time from baseline to patient event. [ Time Frame: 12 Months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 12 Month Site Randomized Trial in Adults With Type 2 Diabetes Mellitus and History of Cardiovascular Disease
Official Title  ICMJE COOrdinating CaRDIology CliNics RAndomized Trial of Interventions to Improve OutcomEs (COORDINATE) - Diabetes
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 46 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • Cardiovascular Diseases
Intervention  ICMJE Other: Intense Education Intervention
Intervention will involve guideline-based care education.
Other Name: Intervention
Study Arms  ICMJE
  • No Intervention: Control
    Clinics in the control arm will be encouraged to follow guideline-based care.
  • Active Comparator: Intervention
    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: Other: Intense Education Intervention
Publications *
  • 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.
  • 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.
  • 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. Review.
  • 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.
  • 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. Review.
  • 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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 1, 2019) 		1380
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 30, 2027
Estimated Primary Completion Date March 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laura Webb 9196688977 laura.webb@duke.edu
Contact: Nina Hines 9196683637 nina.hines@duke.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03936660
Other Study ID Numbers  ICMJE Pro00101556
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE
  • Boehringer Ingelheim
  • Eli Lilly and Company
Investigators  ICMJE
Principal Investigator: Christopher Granger, MD Duke Clinical Research Institute
PRS Account Duke University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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