Targeted Education ApproaCH to Improve Peritoneal Dialysis Outcomes Trial
- Conditions
- Kidney Disease, ChronicPeritoneal Dialysis Catheter-Associated PeritonitisPeritoneal Dialysis Catheter Exit Site InfectionPeritoneal Dialysis Catheter Tunnel Infection
- Interventions
- Behavioral: Current standard PD trainingBehavioral: TEACH-PD Training Curriculum
- Registration Number
- NCT03816111
- Lead Sponsor
- The University of Queensland
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- Patients new to PD;
- Patients > 18 years of age,
- Need to undergo PD training;
- Are able to provide informed consent
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Current Standard PD Training Current standard PD training All patients at sites randomized to this arm will receive the unit's current PD training materials and plan TEACH-PD Training Curriculum TEACH-PD Training Curriculum All patients at sites randomized to this arm will receive the TEACH-PD Training Curriculum
- Primary Outcome Measures
Name Time Method Time to the first occurrence of any PD-related infection From the PD start date until first PD-related infection, assessed up to 4 years Time to the first occurrence of any PD-related infection including exit site infection, tunnel infection or peritonitis
- Secondary Outcome Measures
Name Time Method Time to first exit site infection From the PD start date until first exit site infection, assessed up to 4 years Time to first exit site infection
Time to first episode of peritonitis From the PD start date until first peritonitis episode, assessed up to 4 years Time to first episode of peritonitis
Participant Quality of Life questionnaire Completed at baseline, 6, 12, 18 and 24 months 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).Time to first tunnel infection From the PD start date until first tunnel infection, assessed up to 4 years Time to first tunnel infection
Time to infection-associated catheter removal From the PD start date until first infection-associated catheter removal, assessed up to 4 years Time to infection-associated catheter removal
Incidence of technique failure - 180 days Assessed at 180 days after transfer to HD or if death occurs within this period Incidence of technique failure defined as transfer to haemodialysis for greater than 180-days and/or death within this time
Incidence of technique failure - 30 days Assessed at 30 days after transfer to HD or if death occurs within this period Incidence of technique failure defined as transfer to haemodialysis for greater than 30-days and/or death within this time
Incidence of all-cause hospitalization Assessed from the PD start date, over up to 4 years Incidence of all-cause hospitalization collected via health department hospitalization data linkage
Incidence of all-cause mortality Assessed from the PD start date, over up to 4 years Incidence of all-cause mortality
Health-care cost-effectiveness analysis Assessed from the PD start date, over up to 4 years Difference in the incremental cost per Quality Adjusted Life Years gained between treatment arms
Trial Locations
- Locations (48)
Royal Brisbane and Women's Hospital
🇦🇺Herston, Queensland, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Gosford Hospital
🇦🇺Gosford, New South Wales, Australia
St Vincent's Hospital Sydney
🇦🇺Darlinghurst, New South Wales, Australia
Orange Hospital
🇦🇺Orange, New South Wales, Australia
Cairns Hospital
🇦🇺Cairns, Queensland, Australia
The Tweed Hospital
🇦🇺Tweed Heads, New South Wales, Australia
Logan Hospital
🇦🇺Meadowbrook, Queensland, Australia
Lismore Hospital
🇦🇺Lismore, New South Wales, Australia
Liverpool Hospital
🇦🇺Sydney, New South Wales, Australia
St George Hospital
🇦🇺Sydney, New South Wales, Australia
Royal North Shore Hospital
🇦🇺St Leonards, New South Wales, Australia
Mackay Base Hospital
🇦🇺Mackay, Queensland, Australia
Royal Prince Alfred/Concord Hospital
🇦🇺Sydney, New South Wales, Australia
Royal Hobart Hospital
🇦🇺Hobart, Tasmania, Australia
Royal Melbourne Hospital
🇦🇺Melbourne, Victoria, Australia
Taranaki Hospital
🇳🇿New Plymouth, New Zealand
Gold Coast University Hospital
🇦🇺Southport, Queensland, Australia
Toowoomba Hospital
🇦🇺Toowoomba, Queensland, Australia
Launceston General Hospital
🇦🇺Launceston, Tasmania, Australia
Waitakere Hospital
🇳🇿Auckland, New Zealand
Barwon Health
🇦🇺Geelong, Victoria, Australia
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Fiona Stanley Hospital
🇦🇺Murdoch, Western Australia, Australia
Waikato Hospital
🇳🇿Hamilton, New Zealand
North Shore Hospital
🇳🇿Auckland, New Zealand
Auckland Hospital
🇳🇿Auckland, New Zealand
Wairau Hospital
🇳🇿Blenheim, New Zealand
Nelson Hospital
🇳🇿Nelson, New Zealand
Palmerston North/Whanganui Hospital
🇳🇿Palmerston North, New Zealand
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
St Vincent's Hospital Melbourne
🇦🇺Fitzroy, Victoria, Australia
Nepean/Blacktown Hospital
🇦🇺Sydney, New South Wales, Australia
Prince of Wales Hospital
🇦🇺Sydney, New South Wales, Australia
Wellington Hospital
🇳🇿Wellington, New Zealand
Gisborne Hospital
🇳🇿Gisborne, New Zealand
Hawke's Bay Hospital
🇳🇿Hastings, New Zealand
Dunedin Hospital
🇳🇿Dunedin, New Zealand
Whangarei Hospital
🇳🇿Whangarei, New Zealand
Tamworth Hospital
🇦🇺Tamworth, New South Wales, Australia
Middlemore Hospital
🇳🇿Auckland, New Zealand
Canberra Hospital
🇦🇺Canberra, Australian Capital Territory, Australia
Princess Alexandra Hospital
🇦🇺Brisbane, Queensland, Australia
Sunshine Coast University Hospital
🇦🇺Nambour, Queensland, Australia
Monash Health
🇦🇺Dandenong, Victoria, Australia
Austin Health
🇦🇺Heidelberg, Victoria, Australia
Royal Darwin Hospital
🇦🇺Darwin, Northern Territory, Australia