Targeted Education ApproaCH to Improve Peritoneal Dialysis Outcomes Trial

Study Overview
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Brief Summary
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For many patients peritoneal dialysis (PD) is the preferred form of dialysis to treat kidney disease as it provides greater flexibility and the ability to dialyse at home. However, PD use in Australia has been decreasing over the last 10 years. A big reason for this drop is the risk of infection. The best way to prevent PD related infections is to make sure that patients have good training in PD techniques. The researchers of this study have developed TEACH-PD, a new education package for training both PD nurses and PD patients. The aim of this study is to find out whether TEACH-PD training reduces the number of PD related infections.

Detailed Description
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End stage kidney disease is fatal unless treated with dialysis or transplant. Peritoneal dialysis (PD) is a core dialysis modality offering home-based care for patients. PD utilization is frequently threatened beyond 5 years for most patients due to PD-related infections. Patient training is a critical cornerstone of mitigating infection risk and maximizing PD durability (technique survival), but training practices are characterized by a lack of standardization and severe heterogeneity. There is no high-level evidence to inform PD training. Accordingly, a structured program encompassing how and what to teach PD patients at the inception of PD treatment has the potential to reduce serious PD-related infections, extend the longevity of PD, support cost-effective home-based dialysis care, and reduce costs and health service utilization associated with hospitalization and transition to haemodialysis. TEACH-PD is a standardised modular curriculum for both PD nurse trainers and patients that has been collaboratively developed by renal nurses, doctors, educationalists and patients, aligned to current International Society for Peritoneal Dialysis (ISPD) guidelines, utilizing modern adult learning principles. The TEACH-PD program is feasible and acceptable, as demonstrated in a successful pilot study. The primary objective of TEACH-PD CRCT (Targeted Education ApproaCH to improve Peritoneal Dialysis outcomes - a Cluster Randomised Controlled Trial) is to determine whether implementation of standardised training modules based on ISPD guidelines targeting both PD trainers and patients results in a longer time to the composite end-point of exit site infections, tunnel infections and peritonitis in incident PD patients compared to existing training practices. TEACH-PD is a registry-based, pragmatic, multi-center, multinational trial, randomising PD units to implementing TEACH-PD training modules targeted at PD trainers and incident PD patients versus standard existing practices. An estimated 1,500 patient new to PD will be recruited from at least approximately 42-44 PD units in Australia and New Zealand.The study is being coordinated by the University of Queensland (operating through the Australasian Kidney Trial Network). The TEACH-PD training modules have been developed by a core group of renal nurses from the HOME Network in conjunction with senior medical clinicians from the Australasian Kidney Trials Network, eLearning curriculum developers, consumer representatives, and education experts, in line with the ISPD guidelines, utilizing modern adult learning principles and best practice eLearning techniques. The modules will be implemented at PD units in Australia and New Zealand to formally evaluate whether, compared with standard care, a standardised training curriculum will reduce the rate of PD-related infections and improve technique survival, resulting in better outcomes for patients receiving PD and significant cost-savings to the community.

Official Title
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A Pragmatic, Registry-based, International, Cluster-randomized Controlled Trial Examining the Use of TEACH-PD Training Modules for Incident PD Patients Versus Existing Practices on the Rate of PD-related Infections

Conditions
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Kidney Disease, Chronic, Peritoneal Dialysis Catheter-Associated Peritonitis, Peritoneal Dialysis Catheter Exit Site Infection, Peritoneal Dialysis Catheter Tunnel Infection

Intervention / Treatment
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* Behavioral: TEACH-PD Training Curriculum
* Behavioral: Current standard PD training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients new to PD; Patients > 18 years of age, Need to undergo PD training; Are able to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TEACH-PD Training Curriculum<br>All patients at sites randomized to this arm will receive the TEACH-PD Training Curriculum | Behavioral: TEACH-PD Training Curriculum<br>* The TEACH-PD training modules have been developed by a core group of renal nurses from the HOME Network in conjunction with senior medical clinicians from the Australasian Kidney Trials Network, eLearning curriculum developers, consumer representatives, and education experts, in line with the International Society for Peritoneal Dialysis guidelines, utilizing modern adult learning principles and best practice eLearning techniques.<br>|
| Active Comparator: Current Standard PD Training<br>All patients at sites randomized to this arm will receive the unit's current PD training materials and plan | Behavioral: Current standard PD training<br>* Current PD training materials and plan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to the first occurrence of any PD-related infection | Time to the first occurrence of any PD-related infection including exit site infection, tunnel infection or peritonitis | From the PD start date until first PD-related infection, assessed up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first exit site infection | Time to first exit site infection | From the PD start date until first exit site infection, assessed up to 4 years | 
| Time to first tunnel infection | Time to first tunnel infection | From the PD start date until first tunnel infection, assessed up to 4 years | 
| Time to first episode of peritonitis | Time to first episode of peritonitis | From the PD start date until first peritonitis episode, assessed up to 4 years | 
| Time to infection-associated catheter removal | Time to infection-associated catheter removal | From the PD start date until first infection-associated catheter removal, assessed up to 4 years | 
| Incidence of technique failure - 30 days | Incidence of technique failure defined as transfer to haemodialysis for greater than 30-days and/or death within this time | Assessed at 30 days after transfer to HD or if death occurs within this period | 
| Incidence of technique failure - 180 days | Incidence of technique failure defined as transfer to haemodialysis for greater than 180-days and/or death within this time | Assessed at 180 days after transfer to HD or if death occurs within this period | 
| Incidence of all-cause hospitalization | Incidence of all-cause hospitalization collected via health department hospitalization data linkage | Assessed from the PD start date, over up to 4 years | 
| Incidence of all-cause mortality | Incidence of all-cause mortality | Assessed from the PD start date, over up to 4 years | 
| Participant Quality of Life questionnaire | Participant-reported Quality of Life measured using EQ-5D-5L (EuroQol-5 dimensions questionnaire). EQ-5D-5L measures quality of life using 2 methods - a descriptive scale and a Visual Analogue Scale. The descriptive scale comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/ depression). Each dimension has 5 measurement levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5). Numbers associated with levels can be used to report an index score. The VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0). | Completed at baseline, 6, 12, 18 and 24 months | 
| Health-care cost-effectiveness analysis | Difference in the incremental cost per Quality Adjusted Life Years gained between treatment arms | Assessed from the PD start date, over up to 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Training