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Preventing Early Dialysis Starts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02183987
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : December 20, 2019
Sponsor:
Collaborators:
Manitoba Health Research Council
University of Calgary
University of Western Ontario, Canada
University of Ottawa
University of Toronto
Dalhousie University
McGill University
University of British Columbia
Information provided by (Responsible Party):
Navdeep Tangri, University of Manitoba

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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Other: Active Knowledge Translation Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Knowledge Translation Interventions to Prevent the Early Initiation of Dialysis: A Cluster Randomized Trial
Study Start Date : September 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active Knowledge Translation Group
CKD clinics receiving the active knowledge translation intervention.
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.

No Intervention: Passive Knowledge Translation Group
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.



Primary Outcome Measures :
  1. Primary Efficacy Outcome: Proportion of patients followed by a Nephrologist ( > 3 months) who start dialysis with an eGFR > 10.5 ml/min [ Time Frame: 12 month follow-up period after intervention ]
    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).

  2. Primary Safety Outcome: Proportion of patients starting dialysis as inpatients or in an emergency room [ Time Frame: 12 month follow-up period after intervention ]
    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.


Secondary Outcome Measures :
  1. Secondary Efficacy Outcome: Rate of change in early dialysis starts [ Time Frame: 12 month follow-up period after intervention ]
    The rate of change in early dialysis starts will be analyzed to assess whether the effect of the active knowledge translation intervention dissipates over time, and for non-linear effects.

  2. Secondary Outcome: Outcomes of all patients followed in the nephrology clinics using provincial data linkages, wherever available (presently Ontario, Manitoba and Alberta) [ Time Frame: 12 month follow-up period after intervention ]
    Examine the outcomes of all patients followed in the nephrology clinics using provincial data linkages, wherever available (presently Ontario, Manitoba and Alberta) to examine rates of hospitalizations, deaths, and cost of pre-dialysis care in both study arms.

  3. Secondary Outcome: Quarterly proportion of new starts from each clinic, and the differences in this proportion between the two study arms. [ Time Frame: 12 month follow-up period after intervention ]
    Quarterly proportion of new starts from each clinic (new starts/total number of patients followed in the clinic), and the differences in this proportion between the two study arms.

  4. Secondary Outcome: Acceptability of the knowledge translation materials [ Time Frame: 12 month follow-up period after intervention ]
    Acceptability of the knowledge translation materials provided to the clinic measured using semi-structured interviews and surveys in the follow-up period.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02183987


Locations
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Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, R3T 2N2
Sponsors and Collaborators
University of Manitoba
Manitoba Health Research Council
University of Calgary
University of Western Ontario, Canada
University of Ottawa
University of Toronto
Dalhousie University
McGill University
University of British Columbia
Investigators
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Principal Investigator: Navdeep Tangri, MD PhD FRCPC University of Manitoba
Study Director: Braden Manns, MD University of Calgary

Additional Information:
Publications:
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Responsible Party: Navdeep Tangri, Assistant Professor, Nephrologist, University of Manitoba
ClinicalTrials.gov Identifier: NCT02183987    
Other Study ID Numbers: REB13-0083_MOD1
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Keywords provided by Navdeep Tangri, University of Manitoba:
Knowledge Translation
Chronic Kidney Disease
Dialysis
Intent-to-defer
Early dialysis
Cluster randomized trial
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency