TY - JOUR
T1 - Coordinating Cardiology clinics randomized trial of interventions to improve outcomes (COORDINATE) – Diabetes
T2 - rationale and design
AU - Nelson, Adam J.
AU - Pagidipati, Neha J.
AU - Kelsey, Michelle D.
AU - Ardissino, Maddalena
AU - Aroda, Vanita R.
AU - Cavender, Matthew A.
AU - Lopes, Renato D.
AU - Al-Khalidi, Hussein R.
AU - Braceras, Rogelio
AU - Gaynor, Tanya
AU - Kaltenbach, Lisa A.
AU - Kirk, Julienne K.
AU - Lingvay, Ildiko
AU - Magwire, Melissa L.
AU - O'Brien, Emily C.
AU - Pak, Jonathan
AU - Pop-Busui, Rodica
AU - Richardson, Caroline R.
AU - Levya, Monica
AU - Senyucel, Cagri
AU - Webb, Laura
AU - McGuire, Darren K.
AU - Green, Jennifer B.
AU - Granger, Christopher B.
N1 - Funding Information:
The study was overseen by an academic steering committee comprised of cardiologists, endocrinologists, primary care physicians, nurses, pharmacists and quality-improvement/implementation specialists. Enrolling centers obtained site specific institutional review board approval pursuant to local regulations. All individuals were required to sign written informed consent prior to collection of any trial data. The COORDINATE-Diabetes trial is funded by Boehringer Ingelheim/Lilly through an external collaborative research program. The trial is coordinated, and the data analyzed, independently by the Duke Clinical Research Institute. The authors are solely responsible for the design and conduct of this trial, all trial analyses, the drafting and editing of the paper, and its final contents.
Publisher Copyright:
© 2022 Elsevier Inc.
PY - 2023/2
Y1 - 2023/2
N2 - Several medications that are proven to reduce cardiovascular events exist for individuals with type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular disease, however they are substantially underused in clinical practice. Clinician, patient, and system-level barriers all contribute to these gaps in care; yet, there is a paucity of high quality, rigorous studies evaluating the role of interventions to increase utilization. The COORDINATE-Diabetes trial randomized 42 cardiology clinics across the United States to either a multifaceted, site-specific intervention focused on evidence-based care for patients with T2DM or standard of care. The multifaceted intervention comprised the development of an interdisciplinary care pathway for each clinic, audit-and-feedback tools and educational outreach, in addition to patient-facing tools. The primary outcome is the proportion of individuals with T2DM prescribed three key classes of evidence-based medications (high-intensity statin, angiotensin converting enzyme inhibitor or angiotensin receptor blocker, and either a sodium/glucose cotransporter-2 inhibitor (SGLT-2i) inhibitor or glucagon-like peptide 1 receptor agonist (GLP-1RA) and will be assessed at least 6 months after participant enrollment. COORDINATE-Diabetes aims to identify strategies that improve the implementation and adoption of evidence-based therapies.
AB - Several medications that are proven to reduce cardiovascular events exist for individuals with type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular disease, however they are substantially underused in clinical practice. Clinician, patient, and system-level barriers all contribute to these gaps in care; yet, there is a paucity of high quality, rigorous studies evaluating the role of interventions to increase utilization. The COORDINATE-Diabetes trial randomized 42 cardiology clinics across the United States to either a multifaceted, site-specific intervention focused on evidence-based care for patients with T2DM or standard of care. The multifaceted intervention comprised the development of an interdisciplinary care pathway for each clinic, audit-and-feedback tools and educational outreach, in addition to patient-facing tools. The primary outcome is the proportion of individuals with T2DM prescribed three key classes of evidence-based medications (high-intensity statin, angiotensin converting enzyme inhibitor or angiotensin receptor blocker, and either a sodium/glucose cotransporter-2 inhibitor (SGLT-2i) inhibitor or glucagon-like peptide 1 receptor agonist (GLP-1RA) and will be assessed at least 6 months after participant enrollment. COORDINATE-Diabetes aims to identify strategies that improve the implementation and adoption of evidence-based therapies.
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U2 - 10.1016/j.ahj.2022.10.079
DO - 10.1016/j.ahj.2022.10.079
M3 - Article
C2 - 36279931
AN - SCOPUS:85142541430
SN - 0002-8703
VL - 256
SP - 2
EP - 12
JO - American Heart Journal
JF - American Heart Journal
ER -