Integrating Risk-Based Care for Patients With Chronic Kidney Disease in the Community: Study Protocol for a Cluster Randomized Trial

Abstract

Background: 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. Objective: 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. Design: This study is a multicenter cluster randomized control trial. Setting: Thirty-two primary care clinics belonging to the Canadian Primary Care Sentinel Surveillance Network (CPCSSN) across Manitoba and Alberta. Patients: 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. Methods: 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. Measurements: 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 albuminto-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: Limitations include scalability of the proposal in other health care systems. Conclusions: If successful, this intervention has the potential to improve the ...

Impact of Using Risk-Based Stratification on Referral of Patients With Chronic Kidney Disease From Primary Care to Specialist Care in the United Kingdom

“…In some Canadian provinces, a risk threshold of >3% is being used in current clinical practice and this is being evaluated in improvement programs. 11 , 12 , 13 A further weakness of the study included the exclusion of patients with an eGFR of ≥60 ml/min per 1.73 m 2 and abnormal urinalysis. However, only young patients with nephrotic range proteinuria (ACR >300 mg/mmol) and an eGFR ≥60 ml/min per 1.73 m 2 will have a risk of progression to ESRD of >3% at 5 years.…”

“…CKD populations globally have contributed to this model’s extensive external validation, 9 including CKD cohorts within the United Kingdom, 9 , 10 and it is being evaluated in improvement programs in Canada. 11 , 12 , 13 The equation can easily be imbedded into electronic medical records where patients’ clinical and laboratory data can be incorporated and it is also readily available online. 14 There may be scope to improve the accuracy of the equation and studies have investigated the addition of other variables 15 , 16 , 17 , 18 , 19 , 20 or recalibrated to local populations, 10 and have also explored broadening its use by validating certain populations such as renal transplant recipients 21 , 22 and children.…”

The Kidney Failure Risk Equation Score and CKD Care Delivery Measures: A Cross-sectional Study

“…A study designed to assess the clinical impact of KFRE implementation in a primary care CKD study cohort in the United Kingdom, found that application of a KFRE-based cutoff of greater than 5% 5year risk expands eligibility for nephrology referral compared to existing guidelines [12]. An ongoing multicenter cluster randomized controlled trial plans to assess the impact of a risk-based care approach on management of CKD, including use of ACE-I/ARBs, sodium-glucose cotransporter 2 inhibitors, hypertension management, and cardiovascular risk mitigation [14].…”

“…The KFRE has been studied in the context of risk-based triage for nephrology referrals in order to optimize health system capacity, and proposals for primary care adoption of CKD risk-stratification have been published [11][12][13][14]. Importantly, it has been recognized that albuminuria measurement represents a limitation to risk-based approaches, given historically low rates of completion of this test [15].…”

Making Sense of Chronic Kidney Disease in Primary Care – Identification, Evaluation and Monitoring

“…A trial aimed at determining if KRFE risk-based approach improves CKD management in the primary care pathways is in progress. 28 Rapid progression is defined as a sustained declined in eGFR of > 5 mL/min/1.73m 2 per year. These patients are at an increased risk of rapid progression to ESKD and also an increased risk of death and vascular disease-related events 7 and will benefit from consulting a Nephrologist.…”