- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02202018
A Cluster Randomized Trial to Assess the Impact of Patient and Provider Education on Use of Home Dialysis
Patient and Provider Education for Patients With Severe Chronic Kidney Disease: Assessing the Impact on Barriers and Use of Home Dialysis
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Alberta
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Calgary, Alberta, Kanada, T2N 4Z6
- University of Calgary
-
-
Manitoba
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Winnipeg, Manitoba, Kanada, R3T 2N2
- University of Manitoba
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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:
-
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Active KT Intervention
CKD clinics receiving the active knowledge translation intervention.
|
|
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Inget ingripande: Usual standard of care
Clinics will continue their standard of care education and approach to use of home dialysis.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Primary Efficacy Outcome: Use of home dialysis
Tidsram: 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).
|
Use of home dialysis at six months after dialysis initiation
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Secondary outcome: Use of home dialysis at six months in patients who have been followed by a Nephrologist
Tidsram: Use of home dialysis at six months after dialysis initiation 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Braden Manns, MD, University of Calgary
- Studierektor: Navdeep Tangri, MD PhD FRCPC, University of Manitoba
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- REB13-0083_MOD1
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