Chronic Kidney DiseaseNCT02202018
A Cluster Randomized Trial to Assess the Impact of Patient and Provider Education on Use of Home Dialysis
A study testing Active KT intervention in people with Chronic Kidney Disease, run by University of Calgary at 2 sites in Canada.
Trial summary
Patients with severe kidney failure require dialysis or transplantation to survive. For those in whom a transplant is not an option, there are two main dialysis options: hemodialysis (either incenter or at home) or home peritoneal dialysis. 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 KT intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2014to Sep 2018
- 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
- -
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Calgary
Calgary, Alberta, T2N 4Z6
University of Manitoba
Winnipeg, Manitoba, R3T 2N2
About this study
Official title: Patient and Provider Education for Patients With Severe Chronic Kidney Disease: Assessing the Impact on Barriers and Use of Home Dialysis
Patients with severe kidney failure require dialysis or transplantation to survive. For those in whom a transplant is not an option, there are two main dialysis options: hemodialysis (either incenter or at home) or home peritoneal dialysis. Home-based therapies (peritoneal and home hemodialysis) are under-utilized in many Canadian jurisdictions with the proportion of home-based therapies varying between 10 and 40% across centres. Studies show that the low use of home dialysis is due to a variety of factors, though patient and provider awareness and knowledge of home dialysis are major factors. In this cluster randomized trial, the investigators will determine whether a standardized modality education program directed at patients, in combination with a provider-directed intervention, can increase the use of home dialysis in incident dialysis patients in Canada.
Read the detailed description
Background: Patients with severe kidney failure require dialysis or transplantation to survive. For those in whom a transplant is not an option, there are two main dialysis options: hemodialysis (either incenter or at home) or home peritoneal dialysis. Home-based therapies (peritoneal and home hemodialysis) are under-utilized in many Canadian jurisdictions with the proportion of home-based therapies varying between 10 and 40% across centres. The use of home dialysis remains lower than expected due to combination of patient, caregiver, provider, and health system barriers. Previous studies have highlighted several potential patient and caregiver barriers to use of home therapies including knowledge, skills, personal circumstances, and social supports. Provider barriers have been reported to include lack of training in peritoneal dialysis, lack (or perceived lack) in skills and knowledge, bias, and possibly inadequate physician reimbursement for home dialysis.
The Canadian Kidney Knowledge Translation and Generation Network (CANN-NET), a national network of clinicians, researchers and knowledge users that was established to ensure best practices for patients with chronic kidney disease (CKD), recently created dialysis modality educational tools aimed at patients and kidney health care providers. On behalf of CANN-NET, the investigators propose a cluster randomized controlled trial (with clusters consisting of severe CKD clinics) of a knowledge translation (KT) strategy to increase use of home dialysis in patients with end-stage renal disease. Informed by careful survey work, clinics randomized to the knowledge translation intervention will receive patient and provider directed educational tools, including the MATCH D tool, compelling visual aids (infographic, white board animated video, and an educational video on dialysis modality options), audit and feedback, and in-person medical detailing. Control clinics will continue with their usual practice with respect to dialysis modality education.
Primary Objective To determine whether a standardized modality education program directed at patients, in combination with provider-directed interventions can increase the use of home dialysis in incident dialysis patients in Canada
Study Design: A cluster randomized trial of CKD clinics across Canada comparing the efficacy and safety of a KT intervention aiming to increase use of home 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 investigative 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 investigators are well positioned to carry out the proposed study.
Research Significance: Home dialysis, in comparison to incenter hemodialysis, is associated with increased patient independence, better clinical outcomes, and lower health care costs. Due to a variety of factors, home dialysis use remains variable across Canada. This study will test the effectiveness of a KT strategy to increase the use of home dialysis.
- Conditions
- Chronic Kidney Disease
- Being tested
- Active KT intervention
- Keywords
- Knowledge Translation, Chronic Kidney Disease, Dialysis, Home 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 KT interventionOther
- Provider \& patient-directed infographics educating patients about home dialysis will be displayed in prominent clinic wall space
- Educational white board presentations promoting home dialysis
- Each clinic will receive reports outlining their current use of home dialysis in incident ESRD patients compared with provincial \& national averages
- A Canadian version of the MATCH D tool will be provided to clinic staff, to help evaluate patient appropriateness for home dialysis.
- Each clinic will receive an in-person visit from one of the study investigators/collaborators detailing the benefits of home dialysis, and the educational tools being offered to support care within their clinic.
| Study group | Role | What they receive |
|---|---|---|
| Active KT Intervention | Experimental | CKD clinics receiving the active knowledge translation intervention. Receives: Other: Active KT intervention |
| Usual standard of care | No intervention | Clinics will continue their standard of care education and approach to use of home dialysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Outcome: Use of home dialysis
Proportion of patients with incident end-stage renal disease initiating dialysis after the intervention who are using home dialysis (home hemodialysis or peritoneal dialysis) six months after dialysis initiation. Use of home dialysis will be ascertained from the clinic clusters and confirmed by linkage with the Canadian Organ Replacement Register (CORR).
Measured: Use of home dialysis at six months after dialysis initiation
Secondary outcomes (1)
Secondary outcome: Use of home dialysis at six months in patients who have been followed by a Nephrologist
Proportion of patients with incident end-stage renal disease initiating dialysis after the intervention who were followed by a Nephrologist prior to dialysis initiation who are using home dialysis (home hemodialysis or peritoneal dialysis) six months after dialysis initiation. Use of home dialysis will be ascertained from the clinic clusters and confirmed by linkage with the Canadian Organ Replacement Register (CORR).
Measured: Use of home dialysis at six months after dialysis initiation in patients who have been followed by a Nephrologist
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2017
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manitoba
- Responsible party
- Principal investigator, Braden Manns, University of Calgary
- Investigators
- Navdeep Tangri, MD PhD FRCPC, Study director, University of ManitobaBraden Manns, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202018
- Sponsor's protocol ID
- REB13-0083_MOD1
- Status last verified
- Oct 2018
- First submitted
- 11 Jul 2014
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35314481
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient and Provider Education for Patients With Severe Chronic Kidney Disease: Assessing the Impact on Barriers and Use of Home Dialysis
- ClinicalTrials.gov ID
- NCT02202018
- Acronym / sponsor ID
- REB13-0083_MOD1
- Conditions
- Chronic Kidney Disease
- Keywords
- Knowledge Translation, Chronic Kidney Disease, Dialysis, Home dialysis, Cluster randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- University of Manitoba
- Study start
- Sep 2014 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 28 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.
Patients with severe kidney failure require dialysis or transplantation to survive. For those in whom a transplant is not an option, there are two main dialysis options: hemodialysis (either incenter or at home) or home peritoneal dialysis. Home-based therapies (peritoneal and home hemodialysis) are under-utilized in many Canadian jurisdictions with the proportion of home-based therapies varying between 10 and 40% across centres. Studies show that the low use of home dialysis is due to a variety of factors, though patient and provider awareness and knowledge of home dialysis are major factors. In this cluster randomized trial, the investigators will determine whether a standardized modality education program directed at patients, in combination with a provider-directed intervention, can increase the use of home dialysis in incident dialysis patients in Canada.
Detailed description
Background: Patients with severe kidney failure require dialysis or transplantation to survive. For those in whom a transplant is not an option, there are two main dialysis options: hemodialysis (either incenter or at home) or home peritoneal dialysis. Home-based therapies (peritoneal and home hemodialysis) are under-utilized in many Canadian jurisdictions with the proportion of home-based therapies varying between 10 and 40% across centres. The use of home dialysis remains lower than expected due to combination of patient, caregiver, provider, and health system barriers. Previous studies have highlighted several potential patient and caregiver barriers to use of home therapies including knowledge, skills, personal circumstances, and social supports. Provider barriers have been reported to include lack of training in peritoneal dialysis, lack (or perceived lack) in skills and knowledge, bias, and possibly inadequate physician reimbursement for home dialysis.
The Canadian Kidney Knowledge Translation and Generation Network (CANN-NET), a national network of clinicians, researchers and knowledge users that was established to ensure best practices for patients with chronic kidney disease (CKD), recently created dialysis modality educational tools aimed at patients and kidney health care providers. On behalf of CANN-NET, the investigators propose a cluster randomized controlled trial (with clusters consisting of severe CKD clinics) of a knowledge translation (KT) strategy to increase use of home dialysis in patients with end-stage renal disease. Informed by careful survey work, clinics randomized to the knowledge translation intervention will receive patient and provider directed educational tools, including the MATCH D tool, compelling visual aids (infographic, white board animated video, and an educational video on dialysis modality options), audit and feedback, and in-person medical detailing. Control clinics will continue with their usual practice with respect to dialysis modality education.
Primary Objective To determine whether a standardized modality education program directed at patients, in combination with provider-directed interventions can increase the use of home dialysis in incident dialysis patients in Canada
Study Design: A cluster randomized trial of CKD clinics across Canada comparing the efficacy and safety of a KT intervention aiming to increase use of home 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 investigative 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 investigators are well positioned to carry out the proposed study.
Research Significance: Home dialysis, in comparison to incenter hemodialysis, is associated with increased patient independence, better clinical outcomes, and lower health care costs. Due to a variety of factors, home dialysis use remains variable across Canada. This study will test the effectiveness of a KT strategy to increase the use of home dialysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active KT Intervention | Experimental | Other: Active KT interventionCKD clinics receiving the active knowledge translation intervention. |
| Usual standard of care | No intervention | –Clinics will continue their standard of care education and approach to use of home dialysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 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 (1 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 KT intervention1. Provider \& patient-directed infographics educating patients about home dialysis will be displayed in prominent clinic wall space 2. Educational white board presentations promoting home dialysis 3. Each clinic will receive reports outlining their current use of home dialysis in incident ESRD patients compared with provincial \& national averages 4. A Canadian version of the MATCH D tool will be provided to clinic staff, to help evaluate patient appropriateness for home dialysis. 5. Each clinic will receive an in-person visit from one of the study investigators/collaborators detailing the benefits of home dialysis, and the educational tools being offered to support care within their clinic. | Other | Active KT Intervention |
Primary outcome
Primary Efficacy Outcome: Use of home dialysis
Time frame: Use of home dialysis at six months after dialysis initiation
Proportion of patients with incident end-stage renal disease initiating dialysis after the intervention who are using home dialysis (home hemodialysis or peritoneal dialysis) six months after dialysis initiation. Use of home dialysis will be ascertained from the clinic clusters and confirmed by linkage with the Canadian Organ Replacement Register (CORR).
1 secondary outcome
Secondary outcome: Use of home dialysis at six months in patients who have been followed by a Nephrologist
Time frame: Use of home dialysis at six months after dialysis initiation in patients who have been followed by a Nephrologist
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 10 Oct 2018.
- Derived from this study: 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 study director
University of Manitoba
Braden Manns, MD principal investigator
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 KT intervention in people with Chronic Kidney Disease, run by University of Calgary 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 1 inclusion and 1 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 10 Oct 2018. 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: Use of home dialysis (time frame: Use of home dialysis at six months after dialysis initiation). 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 NCT02202018, which also lists 1 linked publication.
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 10 Oct 2018.