Preventing Early Dialysis Starts

Summary

Chronic kidney disease (CKD) and its end stage of kidney failure requiring dialysis are important contributors to morbidity, mortality and health care costs. Over the last two decades, there has been a strong secular trend in the earlier initiation of dialysis for treatment of kidney failure from progressive CKD. These trends have occurred in spite of evidence showing harms with early dialysis initiation and increased health care costs. Recently, investigators from the Canadian Society of Nephrology, including study co-investigators, have proposed clinical practice guidelines to recommend an "intent-to-defer" approach for dialysis initiation. Whether these guidelines require an active knowledge translation strategy or they will simply translate through passive dissemination is unknown.

In the investigators' proposed national cluster parallel group randomized clinical trial, we will randomize CKD clinics across Canada to an active knowledge translation strategy to defer dialysis initiation or passive dissemination of guidelines (current practice). 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. The investigators will then evaluate the kidney function (estimated glomerular filtration rate - eGFR) at dialysis initiation for all dialysis starts originating from these clinics to examine whether our KT strategy is safe and effective at delaying dialysis initiation. Our active KT strategy, if effective, will have a significant impact on patient morbidity and health care costs.

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.

Conditions

• Chronic Kidney Disease

Interventions

OTHER

Active Knowledge Translation Intervention

1. Access to CSN guidelines, \& provider- \& patient-directed infographics recommending an intent-to-defer dialysis initiation strategy will be displayed in prominent clinic wall space \& disseminated to patients. 2. Educational whiteboard video will be made available as a resource for clinic staff \& patients. 3. Each clinic will receive reports from the Canadian Organ Replacement Register (CORR) outlining the proportion of patients followed by a Nephrologist (\>3 months) starting dialysis early (eGFR \>10.5 ml/min), for all incident dialysis patients from the clinic, with provincial \& national average comparisons. These reports, \& the CSN guideline on timing of dialysis initiation recommendation, will be delivered to the medical lead for each CKD clinic. 4. Each clinic will receive an in-person visit from one of the study investigators/collaborators highlighting the clinical practice guidelines \& evidence supporting an intent-to-defer strategy, \& will receive follow-up.

Sponsors & Collaborators

• Manitoba Health Research Council

  collaborator UNKNOWN

• University of Calgary

  collaborator OTHER

• University of Western Ontario, Canada

  collaborator OTHER

• University of Ottawa

  collaborator OTHER

• University of Toronto

  collaborator OTHER

• Dalhousie University

  collaborator OTHER

• McGill University

  collaborator OTHER

• University of British Columbia

  collaborator OTHER

• University of Manitoba

  lead OTHER

Principal Investigators

• Navdeep Tangri, MD PhD FRCPC · University of Manitoba

• Braden Manns, MD · University of Calgary

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-09-30

Primary Completion

2016-12-31

Completion

2016-12-31

Countries

• Canada

Study Locations