Chronic Kidney DiseaseNCT02183987
Preventing Early Dialysis Starts
A study testing Active Knowledge Translation Intervention in people with Chronic Kidney Disease, run by University of Manitoba at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Active Knowledge Translation Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Calgary
Calgary, Alberta, T2N 1N4
University of Manitoba
Winnipeg, Manitoba, R3T 2N2
About this study
Official title: Knowledge Translation Interventions to Prevent the Early Initiation of Dialysis: A Cluster Randomized Trial
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Active Knowledge Translation Intervention
- Keywords
- Knowledge Translation, Chronic Kidney Disease, Dialysis, Intent-to-defer, Early dialysis, Cluster randomized trial
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Knowledge Translation InterventionOther
- 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.
- Educational whiteboard video will be made available as a resource for clinic staff \& patients.
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Active Knowledge Translation Group | Experimental | CKD clinics receiving the active knowledge translation intervention. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 12 month follow-up period after intervention
Secondary outcomes (4)
Secondary Efficacy Outcome: Rate of change in early dialysis starts
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.
Measured: 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)
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.
Measured: 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.
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.
Measured: 12 month follow-up period after intervention
Secondary Outcome: Acceptability of the knowledge translation materials
Acceptability of the knowledge translation materials provided to the clinic measured using semi-structured interviews and surveys in the follow-up period.
Measured: 12 month follow-up period after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Navdeep Tangri, University of Manitoba
- Investigators
- Navdeep Tangri, MD PhD FRCPC, Principal investigator, University of ManitobaBraden Manns, MD, Study director, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183987
- Sponsor's protocol ID
- REB13-0083_MOD1
- Status last verified
- Apr 2022
- First submitted
- 2 Jul 2014
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24492525Ferguson 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.
PubMed 31135821Chau 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.
PubMed 28270916Tangri 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.
PubMed 33858985Manns 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.
PubMed 35314481
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge Translation Interventions to Prevent the Early Initiation of Dialysis: A Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT02183987
- Acronym / sponsor ID
- REB13-0083_MOD1
- Conditions
- Chronic Kidney Disease
- Keywords
- Knowledge Translation, Chronic Kidney Disease, Dialysis, Intent-to-defer, Early dialysis, Cluster randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- 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
- Study start
- Sep 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Knowledge Translation Group | Experimental | Other: Active Knowledge Translation InterventionCKD clinics receiving the 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Knowledge Translation Intervention1. 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. | Other | Active Knowledge Translation Group |
Primary outcome
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).
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.
4 secondary outcomes
Secondary Efficacy Outcome: Rate of change in early dialysis starts
Time frame: 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)
Time frame: 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.
Time frame: 12 month follow-up period after intervention
Secondary Outcome: Acceptability of the knowledge translation materials
Time frame: 12 month follow-up period after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Background: PubMed 24492525Nesrallah 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.
- Background: PubMed 31135821Ferguson 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.
- Background: PubMed 28270916Chau 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.
- Results publication: PubMed 33858985Tangri 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.
- Results publication: PubMed 35314481Manns 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Navdeep Tangri, MD PhD FRCPC principal investigator
University of Manitoba
Braden Manns, MD study director
University of Calgary
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Knowledge Translation Intervention in people with Chronic Kidney Disease, run by University of Manitoba at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02183987, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.