Preventing Early Dialysis Starts

NCT02183987 | Completed

• 1 other identifier: REB13-0083_MOD1
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Knowledge Translation; Chronic Kidney Disease; Dialysis; Intent-to-defer; Early dialysis; Cluster randomized trial

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy Outcome: Proportion of patients followed by a Nephrologist ( > 3 months) who start dialysis with an eGFR > 10.5 ml/min

  Proportion of patients followed by a Nephrologist ( \> 3 months) who start dialysis with an eGFR \> 10.5 ml/min in the follow-up period. eGFR at dialysis initiation will be ascertained from the clinic clusters and confirmed by linkage with the Canadian Organ Replacement Register (CORR).

  12 month follow-up period after intervention

• Primary Safety Outcome: Proportion of patients starting dialysis as inpatients or in an emergency room

  Proportion of all incident dialysis patients originating from the randomized clinic clusters that start dialysis in a hospital or in an emergency room in the follow-up period. Patient location at dialysis initiation will be ascertained from the Canadian Organ Replacement Register (CORR) via linkage with the Canadian Institute for Health Information (CIHI)-Discharge Abstract Database.

  12 month follow-up period after intervention

Secondary Outcomes (4)

• Secondary Efficacy Outcome: Rate of change in early dialysis starts

  12 month follow-up period after intervention

• Secondary Outcome: Outcomes of all patients followed in the nephrology clinics using provincial data linkages, wherever available (presently Ontario, Manitoba and Alberta)

  12 month follow-up period after intervention

• Secondary Outcome: Quarterly proportion of new starts from each clinic, and the differences in this proportion between the two study arms.

  12 month follow-up period after intervention

• Secondary Outcome: Acceptability of the knowledge translation materials

  12 month follow-up period after intervention

Study Arms (2)

Active Knowledge Translation Group

EXPERIMENTAL

CKD clinics receiving the active knowledge translation intervention.

Other: Active Knowledge Translation Intervention

Passive Knowledge Translation Group

NO INTERVENTION

Clinics will have access to the Canadian Society of Nephrology (CSN) guidelines on the optimal timing of dialysis initiation (current practice). These guidelines have been published in the Canadian Medical Association Journal (CMAJ) and have been recently presented at the annual meeting of the Canadian Society of Nephrology.

Interventions

Active Knowledge Translation Intervention OTHER

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.

Active Knowledge Translation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Multidisciplinary clinics in Canada that provide care coordinated by a Nephrologist to patients with chronic kidney disease (CKD)
• These clinics have already been identified in a previous survey

Sponsors & Collaborators

• University of Manitoba: lead
• Manitoba Health Research Council: collaborator
• University of Calgary: collaborator
• University of Western Ontario, Canada: collaborator
• University of Ottawa: collaborator
• University of Toronto: collaborator
• Dalhousie University: collaborator
• McGill University: collaborator
• University of British Columbia: collaborator

Study Sites (2)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

Location

Related Publications (5)

• Nesrallah GE, Mustafa RA, Clark WF, Bass A, Barnieh L, Hemmelgarn BR, Klarenbach S, Quinn RR, Hiremath S, Ravani P, Sood MM, Moist LM; Canadian Society of Nephrology. Canadian Society of Nephrology 2014 clinical practice guideline for timing the initiation of chronic dialysis. CMAJ. 2014 Feb 4;186(2):112-7. doi: 10.1503/cmaj.130363. No abstract available.

  PMID: 24492525 BACKGROUND

• Ferguson TW, Garg AX, Sood MM, Rigatto C, Chau E, Komenda P, Naimark D, Nesrallah GE, Soroka SD, Beaulieu M, Alam A, Kim SJ, Dixon S, Manns B, Tangri N. Association Between the Publication of the Initiating Dialysis Early and Late Trial and the Timing of Dialysis Initiation in Canada. JAMA Intern Med. 2019 Jul 1;179(7):934-941. doi: 10.1001/jamainternmed.2019.0489.

  PMID: 31135821 BACKGROUND

• Chau EM, Manns BJ, Garg AX, Sood MM, Kim SJ, Naimark D, Nesrallah GE, Soroka SD, Beaulieu M, Dixon S, Alam A, Tangri N; Canadian Kidney Knowledge Translation and Generation Network (CANN-NET). Knowledge Translation Interventions to Improve the Timing of Dialysis Initiation: Protocol for a Cluster Randomized Trial. Can J Kidney Health Dis. 2016 Sep 14;3:2054358116665257. doi: 10.1177/2054358116665257. eCollection 2016.

  PMID: 28270916 BACKGROUND

• Tangri N, Garg AX, Ferguson TW, Dixon S, Rigatto C, Allu S, Chau E, Komenda P, Naimark D, Nesrallah GE, Soroka SD, Beaulieu M, Alam A, Kim SJ, Sood MM, Manns B. Effects of a Knowledge-Translation Intervention on Early Dialysis Initiation: A Cluster Randomized Trial. J Am Soc Nephrol. 2021 Jul;32(7):1791-1800. doi: 10.1681/ASN.2020091254. Epub 2021 Apr 15.

  PMID: 33858985 RESULT

• Manns BJ, Garg AX, Sood MM, Ferguson T, Kim SJ, Naimark D, Nesrallah GE, Soroka SD, Beaulieu M, Dixon SN, Alam A, Allu S, Tangri N. Multifaceted Intervention to Increase the Use of Home Dialysis: A Cluster Randomized Controlled Trial. Clin J Am Soc Nephrol. 2022 Apr;17(4):535-545. doi: 10.2215/CJN.13191021. Epub 2022 Mar 21.

  PMID: 35314481 RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Navdeep Tangri, MD PhD FRCPC

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Braden Manns, MD

  University of Calgary

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Nephrologist

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 8, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 19, 2022

Record last verified: 2022-04

Locations

CA (2)