Effects of a Knowledge-Translation Intervention on Early Dialysis Initiation: A Cluster Randomized Trial

Abstract

BackgroundThe Initiating Dialysis Early and Late (IDEAL) trial, published in 2009, found no clinically measurable benefit with respect to risk of mortality or early complications with early dialysis initiation versus deferred dialysis start. After these findings, guidelines recommended an intent-to-defer approach to dialysis initiation, with the goal of deferring it until clinical symptoms arise.MethodsTo evaluate a four-component knowledge translation intervention aimed at promoting an intent-to-defer strategy for dialysis initiation, we conducted a cluster randomized trial in Canada between October 2014 and November 2015. We randomized 55 clinics, 27 to the intervention group and 28 to the control group. The educational intervention, using knowledge-translation tools, included telephone surveys from a knowledge-translation broker, a 1-year center-specific audit with feedback, delivery of a guidelines package, and an academic detailing visit. Participants included adults who had at least 3 months of predialysis care and who started dialysis in the first year after the intervention. The primary efficacy outcome was the proportion of patients who initiated dialysis early (at eGFR >10.5 ml/min per 1.73 m2). The secondary outcome was the proportion of patients who initiated in the acute inpatient setting.ResultsThe analysis included 3424 patients initiating dialysis in the 1-year follow-up period. Of these, 509 of 1592 (32.0%) in the intervention arm and 605 of 1832 (33.0%) in the control arm started dialysis early. There was no difference in the proportion of individuals initiating dialysis early or in the proportion of individuals initiating dialysis as an acute inpatient.ConclusionsA multifaceted knowledge translation intervention failed to reduce the proportion of early dialysis starts in patients with CKD followed in multidisciplinary clinics.Clinical Trial registry name and registration number:ClinicalTrials.gov, NCT02183987. Available at: https://clinicaltrials.gov/ct2/show/NCT02183987

Timing of dialysis initiation to reduce mortality and cardiovascular events in advanced chronic kidney disease: nationwide cohort study

“…For many patients, the modest survival benefit may not outweigh this increased time on dialysis. Our results further suggest that in the absence of symptoms or strong indications, initiation of dialysis may be postponed until lower eGFR values are reached (intent to defer), 40 67 without a large increase in mortality or cardiovascular events. From a societal perspective, the higher costs associated with earlier dialysis initiation make these strategies even less desirable.…”

“… 33 This is reflected in subsequent guidelines, which recommend starting dialysis when symptoms and signs attributable to kidney failure arise rather than at a specific kidney function. 34 35 36 37 38 39 40 However, IDEAL compared only two strategies, from which an optimal eGFR cannot be derived. In addition, the achieved eGFR separation in IDEAL was 1.8 (9.0 v 7.2) mL/min/1.73 m 2 by the Modification of Diet in Renal Disease equation.…”

Multifaceted Intervention to Increase the Use of Home Dialysis

“…It may be that future cluster randomized controlled trials should focus on randomizing clusters with low performance on the outcome of interest for the study to avoid a possible ceiling effect. It is possible that our intervention was simply not effective-of particular relevance given that the primary focus of the intervention and cluster randomized controlled trial was on improving appropriateness of the timing of dialysis initiation (also a negative study) (21). It was also relevant to study the intervention's effect on the use of home dialysis because the tools all emphasized the use of home dialysis, and decision making on dialysis modality is being made at the same time as consideration around timing of initiation.…”

“…As noted in Figure 2 and described in more detail in Supplemental Appendix, the combined intervention consisted of audit and feedback, patient- and provider-directed educational tools, and a comprehensive in-person medical detailing visit (21,22).…”

“…In this stratified cluster randomized study, the unit of observation was the patient (i.e., outcomes were measured at the level of an individual patient), and the unit of randomization was the cluster. As described in a related paper (21), we performed constrained randomization using software for random number generation with allocation concealment, stratifying on province/region and size of the cluster (,200, 200-600, or .600 patients). A simulation of the randomization was completed to ensure balance on prespecified cluster-level variables.…”