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A Cluster Randomized Trial to Assess the Impact of Patient and Provider Education on Use of Home Dialysis

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Active KT intervention
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Kidney Disease focused on measuring Knowledge Translation, Chronic Kidney Disease, Dialysis, Home dialysis, Cluster randomized trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Exclusion Criteria:

-

Sites / Locations

  • University of Calgary
  • University of Manitoba

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Active KT Intervention

Usual standard of care

Arm Description

CKD clinics receiving the active knowledge translation intervention.

Clinics will continue their standard of care education and approach to use of home dialysis.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

First Posted
July 11, 2014
Last Updated
October 9, 2018
Sponsor
University of Calgary
Collaborators
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT02202018
Brief Title
A Cluster Randomized Trial to Assess the Impact of Patient and Provider Education on Use of Home Dialysis
Official Title
Patient and Provider Education for Patients With Severe Chronic Kidney Disease: Assessing the Impact on Barriers and Use of Home Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
University of Manitoba

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Knowledge Translation, Chronic Kidney Disease, Dialysis, Home dialysis, Cluster randomized trial

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active KT Intervention
Arm Type
Experimental
Arm Description
CKD clinics receiving the active knowledge translation intervention.
Arm Title
Usual standard of care
Arm Type
No Intervention
Arm Description
Clinics will continue their standard of care education and approach to use of home dialysis.
Intervention Type
Other
Intervention Name(s)
Active KT intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Efficacy Outcome: Use of home dialysis
Description
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).
Time Frame
Use of home dialysis at six months after dialysis initiation
Secondary Outcome Measure Information:
Title
Secondary outcome: Use of home dialysis at six months in patients who have been followed by a Nephrologist
Description
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).
Time Frame
Use of home dialysis at six months after dialysis initiation in patients who have been followed by a Nephrologist

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Navdeep Tangri, MD PhD FRCPC
Organizational Affiliation
University of Manitoba
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Braden Manns, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3T 2N2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
35314481
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 Nephrol. 2022 Apr;17(4):535-545. doi: 10.2215/CJN.13191021. Epub 2022 Mar 21.
Results Reference
derived

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A Cluster Randomized Trial to Assess the Impact of Patient and Provider Education on Use of Home Dialysis

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