Can a sick-day protocol improve outcomes in Chronic Kidney Disease?

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The benefits to CKD patients of renin angiotensin system (RAS) blockers and diuretics are well-established; however, these agents may become hazardous on “sick-days” that lead to volume depletion and increase the risk of renal function loss and acute kidney injury (AKI). It is not known how frequent significant sick-days occur in CKD patients, or whether a self-managed sick-day protocol (SDP) that temporarily holds RAS blocker and diuretics is safe or effective in preserving renal function, or preventing AKI. Hypothesis: a self- managed SDP in CKD patients will safely reduce renal function loss, AKI episodes and preventable service utilization. Study Design: 6-month pragmatic randomized trial. Study population: Stage III-V, pre-dialysis CKD patients, deemed high-risk based on treatment with a RAS blocker and loop diuretic. Study site: VA Maryland Health Care System (VAMHCS) including a network of two hospitals, and urban and rural outpatient clinics. Intervention: Intervention participants will be provided with instructions for an SDP with monthly monitoring via an interactive voice-survey dial-response system (IVSDRS) to track frequency of sick-days and self-management responses to these incidents. Usual care participants will be educated on the significance of sick-days and encouraged to call providers for guidance on therapy when sick-days occur. All participants will be asked to obtain measures of renal function when sick. Specific aims: 1) Compare the safety and effectiveness of the SDP intervention versus usual care. 2) Determine the incidence of sick-days in the intervention arm using remote IVSDRS monitoring and by end-of-study survey of all participants. 3) Evaluate intervention arm participants' usage of, and adherence to, the SDP with remote IVSDRS monitoring. Study measurements: Baseline and 6-month measures of renal function, incidental measurement of renal function and blood chemistries proximate to significant sick-days, electronic health record (EHR) review for hospitalizations and episodes of AKI (ICD-10 code-defined), IVSRDS monitoring for significant sick-days and adherence to the SDP. Outcomes: 6-month change in renal function, incidence of ICD-10 defined-AKI, frequency of serum creatinine-defined AKI in the ambulatory setting, IVSDRS detection of sick-day incidents, and intervention arm participants' cessation and timely resumption of RAS blocker and/or diuretics, Analytical plans: Comparison between intervention and usual care participants of renal function change, and frequency of AKI and hospitalization using generalized linear models and Poisson regression methods, respectively. Similar regression methods will be used to determine the adjusted frequency rate of sick-day incidents and participant response to sick-days. Expected findings: Use of a self-managed SDP in high-risk CKD patients is feasible to safely administer with preliminary evidence for preservation of renal function, and prevention of AKI.