NAVKIDS trial: a multi-centre, waitlisted randomised controlled trial of a patient navigator intervention in children with chronic kidney disease - statistical analysis plan and update to the protocol.

Julie Varghese, Siah Kim, Reginald Woodleigh, Anna Francis, Alistair R Mallard, Amélie Bernier-Jean, David W Johnson, Deirdre Hahn, Elaine Pascoe, Simon A Carter, Charani Kiriwandeniya, Liza Vergara, Nicholas Larkins, Luke Macauley, Michelle Irving, Rabia Khalid, Chandana Guha, Germaine Wong, Armando Teixeira-Pinto, Kirsten Howard, Donna Reidlinger, Anita van Zwieten, Elizabeth G Ryan, Patrina Caldwell, Allison Tong, Stephen I Alexander, Martin Howell, Jonathan C Craig, Carmel M Hawley, Shilpanjali Jesudason, Amanda Walker, Fiona Mackie, Sean E Kennedy, Steven McTaggart, Hugh J McCarthy

Journal: Trials 2022;23(1):824

PMID: 36175942

Free Full Text on BioMed Central View on PubMed

Abstract

BACKGROUND

This update summarises key changes made to the protocol since the publication of the original protocol for the NAVKIDS trial of patient navigators for children with chronic kidney disease (CKD) experiencing social disadvantage and provides the statistical analysis plan (SAP) which has not previously been published.

METHODS/DESIGN

The original protocol was published in BMC Nephrology ( https://doi.org/10.1186/s12882-019-1325-y ) prior to the commencement of trial recruitment. During the course of the trial, some key methodological changes needed to be made including changes to eligibility criteria (addition of patients with CKD stages 1-2, broadening of financial status eligibility criterion, addition of patients living in rural/remote areas, modification of age eligibility to 0-16 years, addition of limits related to the language spoken by family, guidance regarding families with multiple eligible children), changes to sites, reduction of sample size, addition of virtual options for consent and study procedures in response to the COVID-19 pandemic, removal of staggered recruitment across sites, addition of outcomes, and changes to the timing and number of assessments. This update summarises the changes made and their rationale and provides the detailed plan for statistical analysis of the trial. These changes have been finalised prior to the completion of study follow-up and the commencement of data analysis.

TRIAL REGISTRATION

Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618001152213 . Prospectively registered on 12 July 2018.

Address: Centre for Kidney Research at The Children's Hospital at Westmead, Westmead, New South Wales, Australia. [email protected].; Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia. [email protected].; Australasian Kidney Trials Network, University of Queensland, Brisbane, Australia.; QCIF Facility for Advanced Bioinformatics, Institute for Molecular Bioscience, The University of Queensland, Brisbane, Australia.; Centre for Kidney Research at The Children's Hospital at Westmead, Westmead, New South Wales, Australia.; Discipline of Child and Adolescent Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.; Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia.; College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.; Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.; Translational Research Institute, Brisbane, Australia.; Central Northern Adelaide Renal and Transplantation Service (CNARTS), Royal Adelaide Hospital, Adelaide, South Australia, Australia.; Department of Nephrology, Royal Children's Hospital, Melbourne, Victoria, Australia.; Department of Nephrology, Sydney Children's Hospital, Randwick, New South Wales, Australia.; School of Clinical Medicine, Faculty of Medicine & Health, University of New South Wales, Sydney, Australia.; Children's Health Queensland Hospital and Health Service, Brisbane, Queensland, Australia.; Nephrology Department, The Children's Hospital at Westmead, Westmead, New South Wales, Australia.; Prostate and Breast Cancer Foundation (CanCare), Hurstville, Australia.; School of Human Movement and Nutrition Sciences, University of Queensland, Brisbane, Queensland, Australia.; Centre de Recherche du CIUSSS du Nord-de-l'Île de Montréal, University of Montréal, Montréal, Canada.; Perth Children's Hospital, Perth, Australia.; Kidney Health Australia, Melbourne, Australia.; Menzies Centre for Health Policy, The University of Sydney, Camperdown, NSW, 2006, Australia.; Centre for Evidence and Implementation, Carlton, Victoria, Australia.; Centre for Kidney Research at The Children's Hospital at Westmead, Westmead, New South Wales, Australia. [email protected].; Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia. [email protected].; Department of Renal Medicine, Westmead Hospital, Westmead, New South Wales, Australia. [email protected].

DOI: 10.1186/s13063-022-06783-y

Link outs

Free resources

Full Text Sources:

Medical:

https://medlineplus.gov/covid19coronavirusdisease2...

Miscellaneous:

https://assays.cancer.gov/non-CPTAC-3671

MeSH Terms: Australia, COVID-19, Child, Humans, Multicenter Studies as Topic, Pandemics, Patient Navigation, Randomized Controlled Trials as Topic, Renal Insufficiency, Chronic, SARS-CoV-2, Treatment Outcome