Improving Chronic Disease Management With Pieces (ICD-Pieces)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18,268
- 试验地点
- 8
- 主要终点
- All Cause Hospitalizations for Patients With a Triad of Chronic Kidney Disease, Diabetes and Hypertension
研究概览
简要总结
ICD-Pieces (Parkland Intelligent e-Coordination and Evaluation System) trial is a National Institutes of Health (NIH) Healthcare Systems(HCS) Collaboratory demonstration project to improve management of patients with a triad of Chronic Kidney Disease, hypertension and diabetes with Pieces in four HCS including Parkland, Texas Health Resources (THR), ProHealth Physicians Incorporation and North Texas VA. Pieces is a decision support technology platform created by Parkland Center for Clinical Innovation(PCCI).
The primary objective is to test the hypothesis that a collaborative model of primary care and subspecialty care intervention enhanced by Pieces and practice facilitators compared to standard clinical practice will reduce all-cause hospitalizations in patients with coexisting chronic kidney disease, diabetes and hypertension.
Secondary objectives are: a)Test if implementation of the collaborative model will reduce 30-day readmissions, emergency room visits, cardiovascular events or deaths and disease-specific hospitalizations; b) Develop and validate risk predictive models for disease-specific hospitalizations, all-cause hospitalizations, 30-day readmissions, emergency room visits, cardiovascular events and deaths for patients with chronic kidney disease, diabetes and hypertension. c) Collect demographic and clinical data to assist phenotyping patients with chronic kidney disease, diabetes and hypertension. d) Obtain safety data including Acute Kidney Injury, progression of chronic kidney disease, electrolyte disturbances and medication errors, and drug toxicity; e) Collect resource utilization information including hospitalizations, emergency room visits, outpatient visits, and diagnostic or therapeutic procedures completed.
Candidate patients in selected clinics will be enrolled over a period of 2 years and followed for 12 months. Pieces will ascertain both primary and secondary outcomes from the Electronic Health Record supported with data from the Dallas Fort Worth Hospital Council (DFWHC), Accountable Care Organization (ACO) reports and VA database, and deaths from Social Security Index (SSI) data.
详细描述
ICD-Pieces is a randomized, pragmatic clinical trial in four large healthcare systems to improve care of patients with coexistent chronic kidney disease, diabetes and hypertension. The investigators hypothesis is that patients who receive care with a collaborative model of primary care-subspecialty care enhanced by novel information technology (Pieces) and practice facilitators will have fewer all-cause hospitalizations, readmissions, disease-specific hospitalizations, Emergency Room visits, cardiovascular events and deaths than patients receiving standard medical care. The investigators will also aim to develop a better understanding of risk predictors in patients with chronic kidney disease, diabetes and hypertension to guide future recommendations of therapies that are tailored to individual patients.
The primary objective of the study is to test the hypothesis that a collaborative model of primary care enhanced by novel information technology and practice facilitators will allow to leverage data from electronic health records to identify patients with the triad of chronic kidney disease, diabetes and hypertension using objective and reproducible criteria, and provide clinician support for implementation of best practices of care, monitoring clinical measures, adjusting treatments and reduce 12-month hospitalization rates. In this study disease-specific hospitalizations for chronic kidney disease, diabetes and hypertension include hospitalizations due to cardiovascular complications, congestive heart failure, volume overload, accelerated/malignant/uncontrolled hypertension, acute coronary syndromes, myocardial infarction, stroke, coronary/peripheral revascularization, limb ischemia/amputations, diabetes complications, uncontrolled diabetes, hypoglycemia, acute kidney injury, hyperkalemia, electrolyte disturbances, medication errors, drug toxicity, and infections.
Secondary Objectives: The study will test if implementation of the collaborative model of primary care-subspecialty care interventions will reduce 30-day readmissions (for patients who are hospitalized), emergency room visits, cardiovascular events, deaths or disease-specific hospitalizations. In this study disease-specific hospitalizations for chronic kidney disease, diabetes and hypertension include hospitalizations due to cardiovascular complications, congestive heart failure, volume overload, accelerated/malignant/uncontrolled hypertension, acute coronary syndromes, myocardial infarction, stroke, coronary/peripheral revascularization, limb ischemia/amputations, diabetes complications, uncontrolled diabetes, hypoglycemia, acute kidney injury, hyperkalemia, electrolyte disturbances, medication errors, drug toxicity, and infections.
2.) Develop and validate predictive models for risks of hospitalizations, emergency room visits, cardio vascular events and deaths for all patients with coexistent chronic kidney disease, diabetes and hypertension and predict risks of 30-day disease-specific readmissions for patients who are hospitalized.
3.) Capture data (demographic, clinical, medications, laboratories, procedures) to phenotype patients with a triad of chronic kidney disease, diabetes and hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Exclusion criteria will be minimal in this pragmatic trial. The collaborative model of care will not be implemented in patients younger than 18 years or older than 85 years of age or patients who have CKD stage 5/End Stage Renal Disease(ESRD.
- •Primary care practitioners have the option of not implementing the intervention on any of their patients if they believe benefit to be minimal or risk too high due to patient comorbidities
结局指标
主要结局
All Cause Hospitalizations for Patients With a Triad of Chronic Kidney Disease, Diabetes and Hypertension
时间窗: 12 months
Hospitalization rates at 12 months for all study participants, capturing all cause unplanned hospitalizations including both regular hospitalizations as currently defined by CMS and observation status overnight. Hospitalizations will be ascertained from Electronic Health Record of each participating healthcare system with assistance from Pieces.
次要结局
- 30-day All Cause Readmissions (for Those Patients Who Have an Index Hospitalization)(12 months)
研究者
Miguel Vazquez
Professor- Internal Medicine
University of Texas Southwestern Medical Center