Harasemiw Oksana, Drummond Neil, Singer Alexander, Bello Aminu, Komenda Paul, Rigatto Claudio, Lerner Jordyn, Sparkes Dwight, Ferguson Thomas W, Tangri Navdeep
Chronic Disease Innovation Centre, Seven Oaks General Hospital, Winnipeg, MB, Canada.
Department of Internal Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada.
Can J Kidney Health Dis. 2019 May 29;6:2054358119841611. doi: 10.1177/2054358119841611. eCollection 2019.
A risk-based model of care for managing patients with chronic kidney disease (CKD) using the Kidney Failure Risk Equation (KFRE) has been successfully integrated into nephrology care pathways in several jurisdictions. However, as most patients with CKD can be managed in primary care, the next pertinent steps would be to integrate the KFRE into primary care pathways.
Using a risk-based approach for guiding CKD care in the primary care setting, the objective of the study is to develop, implement, and evaluate tools that can be used by patients and providers.
This study is a multicenter cluster randomized control trial.
Thirty-two primary care clinics belonging to the Canadian Primary Care Sentinel Surveillance Network (CPCSSN) across Manitoba and Alberta.
All patients at least 18 years old or older with CKD categories G3-G5 attending the participating clinics; we estimate each clinic will have an average of 185 patients with CKD.
Thirty-two primary care clinics will be randomized to receive either an active knowledge translation intervention or no intervention. The intervention involves the addition of the KFRE and decision aids to clinics' Data Presentation Tool (DPT), as well as patient-facing visual aids, a medical detailing visit, and sentinel feedback reports. Control clinics will only be exposed to current guidelines for CKD management, without active dissemination.
Data from the CPCSSN repository will be used to assess whether a risk-based care approach affected management of CKD. Primary outcomes are as follows: the proportion of patients with measured urine albumin-to-creatinine ratio, and the proportion of patients being appropriately treated with angiotensin-converting enzyme inhibitor or angiotensin receptor blockers. Secondary outcomes are as follows: the optimal management of diabetes (hemoglobin A1C <8.5%, and the use of sodium-glucose cotransporter-2 inhibitors in CKD G3 patients), hypertension (office blood pressure <130/80 for patients with diabetes, 140/90 for those without), and cardiovascular risk (statin prescription); prescriptions of nonsteroidal anti-inflammatory drugs; and decline in estimated glomerular filtration rate (eGFR). In addition, in a substudy, we will measure CKD-specific health literacy and trust in physician care via surveys administered in the clinic post-visit. At the provider level, we will measure satisfaction with the risk prediction tools. Lastly, at the health system level, outcomes include cost of CKD care, and appropriate referrals for patients at high risk of kidney failure based on provincial guidelines. Primary and secondary outcomes will be measured at the patient level and enumerated at the clinic level 1 year after the intervention implementation, except for decline in eGFR, which will be measured 2 years postintervention.
Limitations include scalability of the proposal in other health care systems.
If successful, this intervention has the potential to improve the management of patients with CKD within Canadian primary care settings, leading to health and economic benefits, and influencing practice guidelines.
ClinicalTrials.gov identifier: NCT03365063.
使用肾衰竭风险方程（KFRE）对慢性肾脏病（CKD）患者进行基于风险的护理模式已在多个司法管辖区成功纳入肾脏病护理路径。然而，由于大多数CKD患者可在初级保健机构得到管理，接下来的相关步骤将是把KFRE纳入初级保健路径。
采用基于风险的方法在初级保健环境中指导CKD护理，本研究的目的是开发、实施和评估患者及医疗服务提供者可用的工具。
本研究是一项多中心整群随机对照试验。
隶属于加拿大初级保健哨点监测网络（CPCSSN）的32家初级保健诊所，分布在曼尼托巴省和艾伯塔省。
所有年龄在18岁及以上、患有G3 - G5期CKD的患者，就诊于参与研究的诊所；我们估计每家诊所平均有185例CKD患者。
32家初级保健诊所将被随机分组，一组接受积极的知识转化干预，另一组不接受干预。干预措施包括在诊所的数据展示工具（DPT）中添加KFRE和决策辅助工具，以及面向患者的视觉辅助工具、一次医学详细讲解访视和哨点反馈报告。对照诊所仅遵循现行的CKD管理指南，不进行积极传播。
来自CPCSSN数据库的数据将用于评估基于风险的护理方法是否影响CKD的管理。主要结局如下：测量尿白蛋白与肌酐比值的患者比例，以及接受血管紧张素转换酶抑制剂或血管紧张素受体阻滞剂适当治疗的患者比例。次要结局如下：糖尿病的最佳管理（糖化血红蛋白<8.5%，以及在G3期CKD患者中使用钠 - 葡萄糖协同转运蛋白2抑制剂）、高血压（糖尿病患者诊室血压<130/80，非糖尿病患者诊室血压<140/90）和心血管风险（他汀类药物处方）；非甾体抗炎药的处方；以及估计肾小球滤过率（eGFR）的下降。此外，在一项子研究中，我们将通过就诊后在诊所进行的调查来测量CKD特异性健康素养和对医生护理的信任度。在医疗服务提供者层面，我们将测量对风险预测工具的满意度。最后，在卫生系统层面，结局包括CKD护理成本，以及根据省级指南对有肾衰竭高风险患者进行适当转诊。主要和次要结局将在患者层面进行测量，并在干预实施1年后在诊所层面进行统计，eGFR下降情况将在干预后2年进行测量。
局限性包括该方案在其他医疗系统中的可扩展性。
如果成功，这项干预措施有可能改善加拿大初级保健环境中CKD患者的管理，带来健康和经济效益，并影响实践指南。
ClinicalTrials.gov标识符：NCT03365063。
