COOrdinating CaRDIology CliNics RAndomized Trial of Interventions to Improve OutcomEs (COORDINATE) - Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,049
- 试验地点
- 88
- 主要终点
- Number of Participants Prescribed All 3 Groups of Recommended Evidence-based Medications
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of Participants Prescribed All 3 Groups of Recommended Evidence-based Medications
时间窗: Up to 12 Months
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%.
次要结局
- Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit.(Up to 12 Months)
- Change in Average LDL-C From Baseline to Last Follow-up Visit.(Baseline and last follow-up visit (up to 12 months))
- Number of Participants With LDL-C < 70 mg/dL(Baseline and last follow-up visit (up to 12 months))
- Change in Average Blood Pressure From Baseline to Last Follow-up Visit.(Baseline and last follow-up visit (up to 12 months))
- Number of Participants With sBP < 130 mmHg(Baseline and last follow-up visit (up to 12 months))
- Number of Participants With dBP < 180 mmHg(Baseline and last follow-up visit (up to 12 months))
- Change in Average HbA1c From Baseline to Last Follow-up Visit.(Baseline and last follow-up visit (up to 12 months))
- Number of Participants With HbA1c < 7%(Baseline and last follow-up visit (up to 12 months))
- Number of Participants Experiencing an Event Within 1 Year(Up to 12 Months)