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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: Chow, Josephine S F
Boudville, Neil
Cho, Yeoungjee 
Palmer, Suetonia
Pascoe, Elaine M
Hawley, Carmel M
Reidlinger, Donna M
Hickey, Laura E
Stastny, Ruth
Valks, Andrea
Vergara, Liza
Movva, Ramya
Kiriwandeniya, Charani
Candler, Hayley
Mihala, Gabor
Buisman, Bernadette
Equinox, Keri-Lu 
Figueiredo, Ana E
Fuge, Trudi
Howard, Kirsten 
Howell, Martin
Jaure, Allison
Jose, Matthew D
Lee, Anna
Miguel, Susana S
Moodie, Jo-Anne
Nguyen, Thu-Anh 
Pinlac, Geraldine
Reynolds, Annie
Saweirs, Walaa W M
Steiner-Lim, Genevieve Z
TeWhare, Bronwen
Tomlins, Melinda 
Upjohn, Megan
Voss, David
Walker, Rachael C
Wilson, Joanne
Johnson, David W
Issue Date: 2023
Source: Chow JSF, Boudville N, Cho Y, Palmer S, Pascoe EM, Hawley CM, Reidlinger DM, Hickey LE, Stastny R, Valks A, Vergara L, Movva R, Kiriwandeniya C, Candler H, Mihala G, Buisman B, Equinox KL, Figueiredo AE, Fuge T, Howard K, Howell M, Jaure A, Jose MD, Lee A, Miguel SS, Moodie JA, Nguyen TT, Pinlac G, Reynolds A, Saweirs WWM, Steiner-Lim GZ, TeWhare B, Tomlins M, Upjohn M, Voss D, Walker RC, Wilson J, Johnson DW. 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. Trials. 2023 Nov 14;24(1):730. doi: 10.1186/s13063-023-07715-0. PMID: 37964367; PMCID: PMC10647147.
Journal: Trials
Abstract: 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. 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. 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. NCT03816111. Registered on 24 January 2019.
Description: Cairns & Hinterland Hospital and Health Service (CHHHS) affiliated author: Keri-Lu Equinox
DOI: 10.1186/s13063-023-07715-0
Keywords: Cluster randomized controlled trial;Competency assessment;Cost-effectiveness;Outcomes;Patient education;Peritoneal dialysis;Peritonitis;Standardized training
Type: Article
Appears in Sites:Cairns & Hinterland HHS Publications

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