Part 2 Table of contents of one proposal Section A: General Project Information Project Title: Risk factors of CKD and collaborative management of patients with chronic kidney disease Coordinating Institution Legal name: Institute of Nephrology, Peking University, Renal Division, Peking University First Hospital Address: 8 Xishiku Street Xicheng District Beijing, China 100034 Head of the Institute: Haiyan Wang Duration of the project: 5 years
Section B: Project description I. Rationale of the project Chronic kidney disease (CKD) is growing as a global public health problem. With over 1.3 billion people, China is among the world's largest and most populous countries. Understanding risk factors of CKD and establishing a collaborative management system between primary care physicians and specialists could be crucial to effectively control the burden of CKD in China. During 2006-2008, we performed a cross-sectional survey of prevalence and factors associated with CKD among a representative sample of adults in Beijing. Our results indicated that the prevalence of CKD in adults of Beijing was 13.0%, which highlighted the importance of launching preventive program of CKD in China. Furthermore, factors independently associated reduced renal function included hypertension status, nephrotoxic medication (including some Chinese herbs), high plasma uric acid, older age and so on, while diabetes was not among the lists, which are different from reports from western countries. The other two similar cross-sectional studies from China also got the similar results. However, with the understanding that cross-sectional design is not sufficient for making causal inference, and it is susceptible to reverse causation, a longitudinal cohort study is needed to further verify the preliminary results from previous cross-sectional studies. Knowledge of risk factors of CKD in China would definitely be helpful to establish future prevention strategies. Our previous study suggested that the prevalence of CKD in China is comparable to that in western countries, while the current health system is insufficient for the management for CKD patients. Currently, primary care practice in China is criticized for failing to perform a gate-keeping role: patients with CKD tend to consult specialist directly without opinion of primary care physicians; or patients with CKD are not diagnosed until reaching end stage renal disease. On the other hand, limited nephrologists are overloaded by numerous CKD patients. Establishing a collaborative management system between primary care physicians and specialists
could help to resolve unmet health care needs of CKD patient. The collaborative management system could also help to improve the quality of health care. II. Objectives of the program - To investigate the risk factors of CKD progression in China; - To explore the possibility of establishing a collaborative management model between primary care physicians and specialists in China. III. Plan of the project and methodology Study population Three thousand CKD patients (stage 3 5) would be selected as participants of the longitudinal cohort for the first part of the proposal (Risk Factors of CKD progreession). Around 15-30 nephrology centers will join this cohort. For the study population of the second part of the proposal (Collaborative Management of CKD Patients), two communities would be chosen from urban area and the other two communities would be chose from rural area due to the disparities of CKD prevalence between urban area and rural area. Selection of communities would base on the stability of the population. Their primary care physicians and nephrologists under our institute would constitute the collaborative clinical team. Part I. Risk factors of CKD Covariates collection For each participant, the following information would be collected biannually via in-person interview. General information and medical history. All participants would complete a questionnaire documenting lifestyle behavior (e.g. diet, smoking, alcohol consumption, and physical activity), as well as personal and family health history (e.g. hypertension, diabetes, cardiovascular disease and current treatment). Treatment of other chronic disease such as hypertension and diabetes would be documented. Information of nephrotoxic medications (include NSAIDS and herbs containing
aristolochic acid, which might relate to interstitial nephritis) would also be recorded. A nutritional questionnaire for 3 days intakes. Physical examination. Each participant would undergo measurements of weight, height, and blood pressure (3 times). Laboratory tests. Fasting blood would be collected and tested for glucose, LDL-cholesterol, HDL-cholesterol, triglyceride, uric acid and creatinine. Urinary albumin-to-creatinine ratio would be measured using morning urine sample. Albuminuria would be measured by immunoturbidimetic methods, and urine creatinine would be measured by Jaffe s kinetic method. DNA, serum and urinary samples will collect and store at central lab. Part II. Collaborative management of CKD patients. Contents of collaborative management Interactive communication between specialists and primary care physicians. The updated pertinent clinical information would be shared by specialists and primary care physicians. Pathways of communication would include face-to-face meeting every 3 months, and email exchanges. Contents of communication would be adjusted according to request of primary care physicians. Clinical pathways for CKD management. Clinical pathways would be developed and followed by both specialists and primary care physicians. The contents would include controlling risk factors of CKD, treatment of comorbidities of CKD, and treatment of complications of CKD. Clinical pathways would be updated every 6 months. Continuous joint care. The long-term monitoring, health education, management of common complications and comorbidities would mostly be accomplished by primary care physicians, following clinical pathways. Treatment of severe or uncommon complications would be achieved by specialists. Patients would be continuously managed by the team. Outcome variables Questionnaire about the patients attitude toward current health care service and
unmet needs would be administered at baseline and every 2 years. Treatment of common comorbidities like hypertension and diabetes, as well as common complications of CKD would be assessed at baseline and every 2 years. The baseline data would be used for comparison to evaluate the effectiveness of the collaborative management. Furthermore, analysis of health care expenditure would be performed, using historical data as control. IV. Expected outcomes First, we could longitudinally identify risk factors of CKD in Chinese population; therefore provide the basis for further interventional studies. Second, establishing collaborative management model between primary care physicians and specialists will improve quality of health care for CKD in China. V. Description of the applicants institution. Section C: Relevant references to the project Section D: Detailed budget for the action Section E: Short summary of the project Understanding risk factors of CKD and establishing a collaborative management system between primary care physicians and specialists could be crucial to effectively control the burden of CKD in China. Our previous research sponsored by International Society of Nephrology Research Committee Prevention Program provided basis for this proposal. In the first part of this proposal, we would establish a community-based cohort to longitudinally investigated risk factors of CKD. Participants would come from the 4 communities of the previous study. Factors suggested to associate with CKD in previous cross-sectional study would be
intensively monitored. Participants would be followed by in-person interview biennially. The second part of this proposal focuses on the current unsatisfied healthcare status of CKD patients in China. CKD patients detected by the previous study would be included in the study. A collaborative management system between primary care physicians and nephrologists though multiple procedures would be established. The patients satisfaction, healthcare expenditure, and clinical parameters would used to evaluate the system. By this program, we expected to identify the risk factors of CKD in China and therefore to guide future prevention programs. Furthermore, we expected to establish a healthcare model to improve the quality of healthcare for CKD patients in China.
Section F: Informed consent document 知情同意书项目名称 : 中国慢性肾脏病的危险因素及合作医疗服务项目目的 : 为了解北京地区慢性肾脏病 高血压 糖尿病的患病情况和您的健康状况, 进行本次大规模的人群调查, 为今后开展慢性肾脏病 高血压 糖尿病 心脑血管疾病等的防治提供科学依据, 同时对您的健康状况进行评估 如果发现慢性疾病将为您提出保健方法和给予医疗指导 项目内容 : 本次调查的方法是自愿参加, 由医务人员向您询问部分个人信息, 以前和明确的健康状况 ; 进行体格检查 ; 采取尿样做尿常规检查 ; 采取空腹血样作肾功能 血糖 血脂及尿酸的检查 所有的检查结果均将以书面形式送达给您 参加这些检查能够给您带来的益处是 : 1 通过此次检查可以了解您的健康状况 ; 2 所有检查项目不收取费用 ; 3 检查结果由有关专家做出健康评估, 发现异常由相应的专家提供医疗保健指导 参加检查时, 除采取血样时有轻微的针刺痛感外, 无其他风险, 也不影响对其他疾病的治疗
我理解本次研究的目的 参与研究的获益及潜在风险 关于此次研究的问题已经得到合理解答, 因此我自愿参加本次研究 我持有本知情同意书的副本 我理解签署本知情同意书即表示为保证研究过程或研究数据的真实性, 我授权研究人员 授权伦理委员会或其他医疗机构审阅我的病历记录 我理解本次研究的信息 ( 包括检测结果 ) 均会以纸质和电子形式储存, 但不涉及姓名信息 我理解我可以在任何时间 无需理由地退出研究, 并且不会影响未来的医疗诊治 参与者签名 : 日期 : 参与者姓名 : 我已向该参与者详细解释了本次研究的相关细节, 医生签名 : 日期 : 医生姓名 : 本知情同意书的副本必须交付参与者