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

Chronic Kidney Disease Clinical Trial

Official title:

Patient and Provider Education for Patients With Severe Chronic Kidney Disease: Assessing the Impact on Barriers and Use of Home Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02202018
• Other study ID #: REB13-0083_MOD1
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: September 2018

Study information

• Verified date: October 2018
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 2018
• Est. primary completion date: November 2017
• 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

Exclusion Criteria:

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Active KT intervention
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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Use of home dialysis at six months after dialysis initiation
Secondary	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).	Use of home dialysis at six months after dialysis initiation in patients who have been followed by a Nephrologist

External Links

•   CANN-NET Educational Tools