Background: End Stage Renal Disease (ESRD) requiring chronic dialysis treatment is associated with poor health outcomes and high costs. Recent data shows that early initiation of dialysis, defined as starting dialysis with an estimated glomerular filtration rate >10.5 ml/min/1.73m2 (eGFR; the measure of kidney function used in practice), has risen rapidly in the last two decades. In 2010, a large randomized trial was published that evaluated the effect of early vs. late initiation, noting no health benefits but higher costs. Despite this, in a recent national cohort study, the investigators noted substantial practice pattern variation in the timing dialysis initiation in Canada, noting that > 40% of all patients started dialysis "early", ranging from 10% to 57% across regions.
The Canadian Society of Nephrology has recently released clinical practice guidelines on the timing of dialysis initiation, recommending an "intent-to-defer" over an "intent-to-start early" approach for the initiation of chronic dialysis. Since simply releasing guidelines does not ensure that the evidence practice gap is bridged, the Canadian Kidney Knowledge Translation and Generation Network (CANN-NET), a national network of clinicians, researchers and knowledge users, was established to ensure best practices for patients with chronic kidney disease (CKD). On behalf of CANN-NET, we propose a cluster randomized controlled trial (RCT) of a knowledge translation (KT) strategy to reduce early initiation of dialysis in patients with severe CKD. Informed by careful survey work, the knowledge translation intervention will consist of patient- and provider-directed educational tools based on the recent published clinical practice guidelines, and will include compelling visual aids (infographic and whiteboard video), audit and feedback, and in-person medical detailing. The control group will have access to the published clinical practice guidelines, consistent with current clinical practice.
The investigators' hypothesis and specific aims are as follows:
Hypothesis: The investigators hypothesize that the clinics randomized to the active KT strategy will start a greater proportion of patients on dialysis later (eGFR below 10.5 ml/min/1.73m2) compared to the control.
Aim 1 - Efficacy: To compare the impact of an active KT intervention with passive guideline release on the proportion of patients followed by a Nephrologist ( > 3 months) who start dialysis with an eGFR >10.5ml/min/1.73 m2 across the randomized CKD clinics (clusters) in Canada.
Aim 2 - Safety: To compare the impact of an active KT intervention with passive guideline release on safe dialysis initiation (acute unplanned dialysis starts) across the randomized CKD clinics in Canada.
Study Design: A cluster randomized trial of CKD clinics across Canada comparing the efficacy and safety of a KT intervention targeting early initiation of dialysis in patients with advanced CKD. The unit of observation will be the patient (i.e., outcomes will be measured at the level of an individual patient), and the unit of randomization will be at the level of the multidisciplinary CKD clinic.
Team: The investigators' study team includes experts in the clinical epidemiology of CKD and kidney failure, local opinion leaders from every province/region, as well experts in knowledge translation and cluster randomized design. As such, the team is well positioned to carry out the proposed study.
Research Significance: Early initiation of dialysis leads to uncertain benefit and potential harm to patients with CKD, with an increase in health care costs. This topic was deemed the highest priority area for knowledge translation intervention by regional and provincial kidney health administrators across Canada in a 2010 survey. If successful, the investigators' intervention will reduce the practice pattern variation in dialysis initiation, provide a successful framework for future KT interventions, and could have significant health and economic benefits.
