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Multi-center, pragmatic, cluster-randomized, controlled trial of standardized peritoneal dialysis (PD) training
Josephine S F Chow1,2,3,4,5, Neil Boudville6,7, Yeoungjee Cho8,9
1South Western Sydney Local Health District, Liverpool, NSW, Australia. Josephine.Chow@health.nsw.gov.au.
Insights
The Targeted Education ApproaCH to improve Peritoneal Dialysis outcomes (TEACH-PD) trial investigates if standardized training reduces peritoneal dialysis (PD) infections. This approach aims to improve PD sustainability and patient outcomes by implementing ISPD guidelines.
Area of Science:
- Nephrology
- Clinical Trials
- Infectious Disease Prevention
Background:
- Peritoneal dialysis (PD)-related infections are a major challenge to the long-term success of PD therapy.
- Standardized PD training curricula are lacking, potentially contributing to infection rates.
- The Targeted Education ApproaCH to improve Peritoneal Dialysis outcomes (TEACH-PD) trial addresses this gap.
Purpose of the Study:
- To evaluate if a standardized training curriculum, based on International Society for Peritoneal Dialysis (ISPD) guidelines, reduces PD-related infections compared to usual training.
- To assess the impact of standardized training on various secondary outcomes including infection-associated catheter removal, transfer to hemodialysis, quality of life, hospitalization, and mortality.
Main Methods:
- A registry-based, pragmatic, open-label, multi-center, binational, cluster-randomized controlled trial involving 42 PD treatment units in Australia and New Zealand.
- Recruitment of adult patients (≥18 years) new to PD training between July 2019 and June 2023.
- Randomization of clusters to either the standardized TEACH-PD training or usual training practice, with a minimum follow-up of 12 months (average 2 years).
Main Results:
- Primary outcome: time to the first occurrence of any PD-related infection (exit site, tunnel, or peritonitis).
- Secondary outcomes: individual infection components, catheter removal, transfer to hemodialysis, quality of life, hospitalization, all-cause death, and cost-effectiveness.
- Data collected from the ANZ Dialysis and Transplant Registry (ANZDATA) and NZPD Registry.
Conclusions:
- The TEACH-PD trial is designed to provide high-certainty evidence on the effectiveness of an ISPD guideline-informed standardized PD training curriculum.
- Findings will inform best practices for PD nurse trainers and patients to prevent PD-related infections.
- The study aims to enhance the sustainability of PD and improve patient care through evidence-based training.
Background:
Peritoneal dialysis (PD)-related infections, such as peritonitis, exit site, and tunnel infections, substantially impair the sustainability of PD. Accordingly, PD-related infection is the top-priority research outcome for patients and caregivers. While PD nurse trainers teach patients to perform their own PD, PD training curricula are not standardized or informed by an evidentiary base and may offer a potential approach to prevent PD infections. The Targeted Education ApproaCH to improve Peritoneal Dialysis outcomes (TEACH-PD) trial evaluates whether a standardized training curriculum for PD nurse trainers and incident PD patients based on the International Society for Peritoneal Dialysis (ISPD) guidelines reduces PD-related infections compared to usual training practices.
Methods:
The TEACH-PD trial is a registry-based, pragmatic, open-label, multi-center, binational, cluster-randomized controlled trial. TEACH-PD will recruit adults aged 18 years or older who have not previously undergone PD training at 42 PD treatment units (clusters) in Australia and New Zealand (ANZ) between July 2019 and June 2023. Clusters will be randomized 1:1 to standardized TEACH-PD training curriculum or usual training practice. The primary trial outcome is the time to the first occurrence of any PD-related infection (exit site infection, tunnel infection, or peritonitis). The secondary trial outcomes are the individual components of the primary outcome, infection-associated catheter removal, transfer to hemodialysis (greater than 30 days and 180 days), quality of life, hospitalization, all-cause death, a composite of transfer to hemodialysis or all-cause death, and cost-effectiveness. Participants are followed for a minimum of 12 months with a targeted average follow-up period of 2 years. Participant and outcome data are collected from the ANZ Dialysis and Transplant Registry (ANZDATA) and the New Zealand Peritoneal Dialysis (NZPD) Registry. This protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines.
Discussion:
TEACH-PD is a registry-based, cluster-randomized pragmatic trial that aims to provide high-certainty evidence about whether an ISPD guideline-informed standardized PD training curriculum for PD nurse trainers and adult patients prevents PD-related infections.
Trial Registration:
ClinicalTrials.gov NCT03816111. Registered on 24 January 2019.
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