NAVKIDS2 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
Anita van Zwieten,
Elizabeth G. Ryan,
Patrina Caldwell,
Kirsten Howard,
Allison Tong,
Jonathan C. Craig,
Stephen I. Alexander,
Martin Howell,
Armando Teixeira-Pinto,
Carmel M. Hawley,
Shilpanjali Jesudason,
Amanda Walker,
Fiona Mackie,
Sean E. Kennedy,
Steven McTaggart,
Hugh J. McCarthy,
Simon A. Carter,
Siah Kim,
Reginald Woodleigh,
Anna Francis,
Alistair R. Mallard,
Amélie Bernier-Jean,
David W. Johnson,
Deirdre Hahn,
Donna Reidlinger,
Elaine Pascoe,
Julie Varghese,
Charani Kiriwandeniya,
Liza Vergara,
Nicholas Larkins,
Luke Macauley,
Michelle Irving,
Rabia Khalid,
Chandana Guha,
Germaine Wong
Affiliations
Anita van Zwieten
Centre for Kidney Research at The Children’s Hospital at Westmead
Elizabeth G. Ryan
Australasian Kidney Trials Network, University of Queensland
Patrina Caldwell
Centre for Kidney Research at The Children’s Hospital at Westmead
Kirsten Howard
Sydney School of Public Health, University of Sydney
Allison Tong
Centre for Kidney Research at The Children’s Hospital at Westmead
Jonathan C. Craig
College of Medicine and Public Health, Flinders University
Stephen I. Alexander
Centre for Kidney Research at The Children’s Hospital at Westmead
Martin Howell
Centre for Kidney Research at The Children’s Hospital at Westmead
Armando Teixeira-Pinto
Centre for Kidney Research at The Children’s Hospital at Westmead
Carmel M. Hawley
Australasian Kidney Trials Network, University of Queensland
Shilpanjali Jesudason
Central Northern Adelaide Renal and Transplantation Service (CNARTS), Royal Adelaide Hospital
Amanda Walker
Department of Nephrology, Royal Children’s Hospital
Fiona Mackie
Department of Nephrology, Sydney Children’s Hospital
Sean E. Kennedy
Department of Nephrology, Sydney Children’s Hospital
Steven McTaggart
Children’s Health Queensland Hospital and Health Service
Hugh J. McCarthy
Centre for Kidney Research at The Children’s Hospital at Westmead
Simon A. Carter
Centre for Kidney Research at The Children’s Hospital at Westmead
Siah Kim
Centre for Kidney Research at The Children’s Hospital at Westmead
Reginald Woodleigh
Prostate and Breast Cancer Foundation (CanCare)
Anna Francis
Children’s Health Queensland Hospital and Health Service
Alistair R. Mallard
School of Human Movement and Nutrition Sciences, University of Queensland
Amélie Bernier-Jean
Centre de Recherche du CIUSSS du Nord-de-l’Île de Montréal, University of Montréal
David W. Johnson
Australasian Kidney Trials Network, University of Queensland
Deirdre Hahn
Centre for Kidney Research at The Children’s Hospital at Westmead
Donna Reidlinger
Australasian Kidney Trials Network, University of Queensland
Elaine Pascoe
Australasian Kidney Trials Network, University of Queensland
Julie Varghese
Australasian Kidney Trials Network, University of Queensland
Charani Kiriwandeniya
Australasian Kidney Trials Network, University of Queensland
Liza Vergara
Australasian Kidney Trials Network, University of Queensland
Nicholas Larkins
Perth Children’s Hospital
Luke Macauley
Kidney Health Australia
Michelle Irving
Menzies Centre for Health Policy, The University of Sydney
Rabia Khalid
Centre for Kidney Research at The Children’s Hospital at Westmead
Chandana Guha
Centre for Kidney Research at The Children’s Hospital at Westmead
Germaine Wong
Centre for Kidney Research at The Children’s Hospital at Westmead
Abstract Background This update summarises key changes made to the protocol since the publication of the original protocol for the NAVKIDS2 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
