Supplementary Material for: Medication Intervention for Chronic Kidney Disease Patients Transitioning from Hospital to Home: Study Design and Baseline Characteristics

Background: The hospital readmission rate in the population with chronic kidney disease (CKD) is high and strategies to reduce this risk are urgently needed. Methods: The CKD-Medication Intervention Trial (CKD-MIT; www.clinicaltrials.gov; NCTO1459770) is a single-blind (investigators), randomized, clinical trial conducted at Providence Health Care in Spokane, Washington. Study participants are hospitalized patients with CKD stages 3-5 (not treated with kidney replacement therapy) and acute illness. The study intervention is a pharmacist-led, home-based, medication management intervention delivered within 7 days after hospital discharge. The primary outcome is a composite of hospital readmissions and visits to emergency departments and urgent care centers for 90 days following hospital discharge. Secondary outcomes are achievements of guideline-based targets for CKD risk factors and complications. Results: Enrollment began in February 2012 and ended in May 2015. At baseline, the age of participants was 69 ± 11 years (mean ± SD), 50% (77 of 155) were women, 83% (117 of 141) had hypertension and 56% (79 of 141) had diabetes. At baseline, the estimated glomerular filtration rate was 41 ± 14 ml/min/1.73 m2 and urine albumin-to-creatinine ratio was 43 mg/g (interquartile range 8-528 mg/g). The most frequent diagnosis category for the index hospital admission was cardiovascular diseases at 34% (53 of 155), but the most common single diagnosis for admission was community-acquired acute kidney injury at 10% (16 of 155). Conclusion: Participants in CKD-MIT are typical of acutely ill hospitalized patients with CKD. A medication management intervention after hospital discharge is under study to reduce post-hospitalization acute care utilization and to improve CKD management.

背景：慢性肾脏病（CKD）患者群体中的医院再入院率较高，亟需采取策略以降低这一风险。方法：CKD-Medication 干预试验（CKD-MIT；www.clinicaltrials.gov；NCTO1459770）是一项由普罗维登斯医疗保健公司在华盛顿州斯波坎进行的单盲（研究者盲法）、随机、临床试验。研究参与者为患有CKD 3-5期（未接受肾脏替代疗法）及急性疾病的住院患者。研究干预措施是由药剂师主导的、基于家庭的药物管理干预，在出院后7天内实施。主要结局指标为出院后90天内医院再入院和急诊科及紧急护理中心的就诊情况。次要结局指标为CKD风险因素及并发症的基于指南的目标达成情况。结果：招募工作始于2012年2月，并于2015年5月结束。在基线时，参与者的平均年龄为69 ± 11岁（均值 ± 标准差），其中50%（77名/155名）为女性，83%（117名/141名）患有高血压，56%（79名/141名）患有糖尿病。基线时，估计的肾小球滤过率为41 ± 14 ml/min/1.73 m2，尿液白蛋白与肌酐比值为43 mg/g（四分位数范围8-528 mg/g）。首次住院的最常见诊断类别为心血管疾病，占34%（53名/155名），但最常见的单一诊断是社区获得性急性肾损伤，占10%（16名/155名）。结论：CKD-MIT的参与者典型地代表了患有急性疾病的住院CKD患者。研究出院后的药物管理干预，旨在降低出院后急性护理的利用率，并改善CKD的管理。