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Trials
Published in: Trials 1/2023

Open Access 01-12-2023 | Peritoneal Dialysis | Methodology

Multi-center, pragmatic, cluster-randomized, controlled trial of standardized peritoneal dialysis (PD) training versus usual care on PD-related infections (the TEACH-PD trial): trial protocol

Authors: Josephine S. F. Chow, Neil Boudville, Yeoungjee Cho, Suetonia Palmer, Elaine M. Pascoe, Carmel M. Hawley, Donna M. Reidlinger, Laura E. Hickey, Ruth Stastny, Andrea Valks, Liza Vergara, Ramya Movva, Charani Kiriwandeniya, Hayley Candler, Gabor Mihala, Bernadette Buisman, Keri-Lu Equinox, Ana E. Figueiredo, Trudi Fuge, Kirsten Howard, Martin Howell, Allison Jaure, Matthew D. Jose, Anna Lee, Susana S. Miguel, Jo-anne Moodie, Thu T. Nguyen, Geraldine Pinlac, Annie Reynolds, Walaa W. M. Saweirs, Genevieve Z. Steiner-Lim, Bronwen TeWhare, Melinda Tomlins, Megan Upjohn, David Voss, Rachael C. Walker, Joanne Wilson, David W. Johnson

Published in: Trials | Issue 1/2023

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Abstract

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.
Appendix
Available only for authorised users
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Metadata
Title
Multi-center, pragmatic, cluster-randomized, controlled trial of standardized peritoneal dialysis (PD) training versus usual care on PD-related infections (the TEACH-PD trial): trial protocol
Authors
Josephine S. F. Chow
Neil Boudville
Yeoungjee Cho
Suetonia Palmer
Elaine M. Pascoe
Carmel M. Hawley
Donna M. Reidlinger
Laura E. Hickey
Ruth Stastny
Andrea Valks
Liza Vergara
Ramya Movva
Charani Kiriwandeniya
Hayley Candler
Gabor Mihala
Bernadette Buisman
Keri-Lu Equinox
Ana E. Figueiredo
Trudi Fuge
Kirsten Howard
Martin Howell
Allison Jaure
Matthew D. Jose
Anna Lee
Susana S. Miguel
Jo-anne Moodie
Thu T. Nguyen
Geraldine Pinlac
Annie Reynolds
Walaa W. M. Saweirs
Genevieve Z. Steiner-Lim
Bronwen TeWhare
Melinda Tomlins
Megan Upjohn
David Voss
Rachael C. Walker
Joanne Wilson
David W. Johnson
Publication date
01-12-2023
Publisher
BioMed Central
Published in
Trials / Issue 1/2023
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-023-07715-0

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