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

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

doi:10.1186/s13063-023-07715-0

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.

Authors

Josephine S F Chow^{1

2

3

4

5}, Neil Boudville^{6

7}, Yeoungjee Cho^{8

9}, Suetonia Palmer^{10

11}, Elaine M Pascoe⁹, Carmel M Hawley^{9

12

13}, Donna M Reidlinger¹⁴, Laura E Hickey⁹, Ruth Stastny⁹, Andrea Valks⁹, Liza Vergara⁹, Ramya Movva⁹, Charani Kiriwandeniya⁹, Hayley Candler⁹, Gabor Mihala⁹, Bernadette Buisman^{15

16}, Keri-Lu Equinox¹⁷, Ana E Figueiredo¹⁸, Trudi Fuge¹⁹, Kirsten Howard^{20

21}, Martin Howell²¹, Allison Jaure²⁰, Matthew D Jose^{22

23}, Anna Lee²⁴, Susana S Miguel^{25

26}, Jo-Anne Moodie²⁷, Thu T Nguyen²⁸, Geraldine Pinlac¹⁰, Annie Reynolds²⁹, Walaa W M Saweirs¹⁵, Genevieve Z Steiner-Lim³⁰, Bronwen TeWhare³¹, Melinda Tomlins³², Megan Upjohn²⁸, David Voss³³, Rachael C Walker³⁴, Joanne Wilson¹⁰, David W Johnson^{8

9}

Affiliations

¹ South Western Sydney Local Health District, Liverpool, NSW, Australia. [email protected].
² Ingham Institute for Applied Medical Research, Liverpool, NSW, Australia. [email protected].
³ University of New South Wales, Kennington, NSW, Australia. [email protected].
⁴ Western Sydney University, Sydney, NSW, Australia. [email protected].
⁵ University of Tasmania, Hobart, TAS, Australia. [email protected].
⁶ Medical School, University of Western Australia, Crawley, WA, Australia.
⁷ Department of Renal Medicine, Sir Charles Gairdner Hospital, Nedlands, WA, Australia.
⁸ Department of Kidney and Transplant Service, Princess Alexandra Hospital, Brisbane, QLD, Australia.
⁹ Australasian Kidney Trials Network, Centre for Health Services Research, The University of Queensland, Brisbane, QLD, Australia.
¹⁰ Department of Medicine, University of Otago, Christchurch, New Zealand.
¹¹ Te Whatu Ora Health New Zealand, Hamilton, New Zealand.
¹² Translational Research Institute, Brisbane, QLD, Australia.
¹³ Metro South Kidney and Transplant Service, Princess Alexandra Hospital, Brisbane, QLD, Australia.
¹⁴ Centre for Health Services Research, The University of Queensland, Brisbane, QLD, Australia.
¹⁵ Health New Zealand, Te Whatu Ora Te Tai Tokerau, Hamilton, New Zealand.
¹⁶ University of Auckland, Te Tai Tokerau Northtec, Auckland, New Zealand.
¹⁷ Cairns Hospital, Cairns, QLD, Australia.
¹⁸ School of Nursing, Escola de Ciências da Saúde E da Vida, Pontifícia Universidade Católica Do Rio Grande Do Sul, Porto Alegre, Brazil.
¹⁹ , Wollongong, Australia.
²⁰ Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.
²¹ Menzies Centre for Health Policy and Economics, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
²² University of Tasmania, Hobart, TAS, Australia.
²³ Renal Unit, Royal Hobart Hospital, Hobart, TAS, Australia.
²⁴ , Shoalhaven, Australia.
²⁵ South Western Sydney Local Health District, Liverpool, NSW, Australia.
²⁶ Ingham Institute for Applied Medical Research, Liverpool, NSW, Australia.
²⁷ Royal Melbourne Hospital, Parkville, VIC, Australia.
²⁸ Health New Zealand, Te Whatu Ora Te Toka Tumai, Hamilton, New Zealand.
²⁹ Health New Zealand, Te Whatu Ora Te Matua a Māui Hawkes Bay, Hamilton, New Zealand.
³⁰ NICM Health Research Institute, Western Sydney University Sydney, Campbelltown, NSW, Australia.
³¹ Health New Zealand, Te Whatu Ora Taranaki, Hamilton, New Zealand.
³² Department of Nephrology, Hunter New England Local Health District, New Lambton, NSW, Australia.
³³ Health New Zealand, Te Whatu Ora Counties Manukau, Hamilton, New Zealand.
³⁴ Te Pukenga Eastern Institute of Technology, Christchurch, New Zealand.

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.

Keywords: Cluster randomized controlled trial; Competency assessment; Cost-effectiveness; Outcomes; Patient education; Peritoneal dialysis; Peritonitis; Standardized training.

Publication types

Clinical Trial Protocol

MeSH terms

Adult
Curriculum
Humans
Multicenter Studies as Topic
Peritoneal Dialysis* / adverse effects
Peritonitis* / diagnosis
Peritonitis* / etiology
Peritonitis* / prevention & control
Pragmatic Clinical Trials as Topic
Quality of Life
Randomized Controlled Trials as Topic

Associated data

ClinicalTrials.gov/NCT03816111

Abstract

Publication types

MeSH terms

Associated data

Grants and funding