Chronic Kidney Disease Clinical Trial
Official title:
Knowledge Translation Interventions to Prevent the Early Initiation of Dialysis: A Cluster Randomized Trial
Verified date | April 2022 |
Source | University of Manitoba |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 55 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | University of Calgary | Calgary | Alberta |
Canada | University of Manitoba | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba | Dalhousie University, Manitoba Health Research Council, McGill University, University of British Columbia, University of Calgary, University of Ottawa, University of Toronto, University of Western Ontario, Canada |
Canada,
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. — View Citation
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. — View Citation
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 Nephro — View Citation
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. — View Citation
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 Random — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | 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. | 12 month follow-up period after intervention | |
Secondary | 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. | 12 month follow-up period after intervention | |
Secondary | 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. | 12 month follow-up period after intervention | |
Secondary | 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. | 12 month follow-up period after intervention |
Status | Clinical Trial | Phase | |
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