Baseline characteristics of participants in the NAVKIDS2 trial: a patient navigator program in children with chronic kidney disease

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

doi:10.1007/s00467-022-05772-2

Baseline characteristics of participants in the NAVKIDS² trial: a patient navigator program in children with chronic kidney disease

Pediatr Nephrol. 2023 May;38(5):1577-1590. doi: 10.1007/s00467-022-05772-2. Epub 2022 Oct 20.

Authors

Chandana Guha^{1

2}, Rabia Khalid^{1

2}, Anita van Zwieten^{1

2}, Anna Francis³, Carmel M Hawley^{4

5

6}, Allison Jauré^{1

2}, Armando Teixeira-Pinto^{1

2}, Alistair R Mallard⁷, Amelie Bernier-Jean⁸, David W Johnson^{4

5

6}, Deirdre Hahn^{2

9}, Donna Reidlinger⁵, Elaine M Pascoe⁵, Elizabeth G Ryan^{5

10

11}, Fiona Mackie¹², Hugh J McCarthy^{2

12

13}, Jonathan C Craig¹⁴, Julie Varghese⁵, Charani Kiriwandeniya⁵, Kirsten Howard¹⁵, Nicholas G Larkins^{16

17}, Luke Macauley¹⁸, Amanda Walker^{19

20}, Martin Howell^{1

2}, Michelle Irving^{21

22}, Patrina H Y Caldwell^{2

13}, Reginald Woodleigh²³, Shilpanjali Jesudason²⁴, Simon A Carter^{1

2

19}, Sean E Kennedy^{12

25}, Stephen I Alexander², Steven McTaggart^{26

27}, Germaine Wong^{28

29

30}

Affiliations

¹ Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.
² Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, NSW, Australia.
³ Child and Adolescent Renal Services, Children's Health Queensland Hospital and Health Service, Brisbane, QLD, Australia.
⁴ Department of Nephrology, Princess Alexandra Hospital, Brisbane, QLD, Australia.
⁵ Australasian Kidney Trials Network, The University of Queensland, Brisbane, QLD, Australia.
⁶ Translational Research Institute, Brisbane, QLD, Australia.
⁷ School of Human Movement and Nutrition Sciences, University of Queensland, Brisbane, QLD, Australia.
⁸ CIUSSS du Nord-de-l'Île de Montréal, University of Montréal, Montreal, Canada.
⁹ Department of Nephrology, The Children's Hospital at Westmead, Sydney, NSW, Australia.
¹⁰ QCIF Facility for Advanced Bioinformatics, Institute for Molecular Bioscience, The University of Queensland, Brisbane, Australia.
¹¹ School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
¹² Department of Nephrology, Sydney Children's Hospital, Randwick, Sydney, NSW, Australia.
¹³ Discipline of Child and Adolescent Health, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.
¹⁴ College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.
¹⁵ Menzies Centre for Health Policy and Economics and Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.
¹⁶ Department of Nephrology, Perth Children's Hospital, Perth, WA, Australia.
¹⁷ School of Medicine, University of Western Australia, Perth, WA, Australia.
¹⁸ Kidney Health Australia, Adelaide, SA, Australia.
¹⁹ Department of Nephrology, Royal Children's Hospital, Melbourne, VIC, Australia.
²⁰ Murdoch Children's Research Institute, Melbourne, VIC, Australia.
²¹ Menzies Centre for Health Policy, The University of Sydney, Camperdown, Sydney, NSW, 2006, Australia.
²² Centre for Evidence and Implementation, 33 Lincoln Square South Carlton, Melbourne, VIC, 3053, Australia.
²³ Prostate and Breast Cancer Foundation (CanCare), Sydney, NSW, Australia.
²⁴ Central Northern Adelaide Renal and Transplantation Service (CNARTS), Royal Adelaide Hospital, Adelaide, SA, Australia.
²⁵ School of Clinical Medicine, Faculty of Medicine & Health, University of New South Wales, Sydney, NSW, Australia.
²⁶ Children's Health Queensland Hospital and Health Service, Brisbane, QLD, Australia.
²⁷ The University of Queensland, Brisbane, QLD, Australia.
²⁸ Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia. [email protected].
²⁹ Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, NSW, Australia. [email protected].
³⁰ Department of Renal Medicine, Westmead Hospital, Sydney, NSW, Australia. [email protected].

Abstract

Background: Children with chronic kidney disease (CKD) require multidisciplinary care to meet their complex healthcare needs. Patient navigators are trained non-medical personnel who assist patients and caregivers to overcome barriers to accessing health services through care coordination. This trial aims to determine the effectiveness of a patient navigator program in children with CKD.

Methods: The NAVKIDS² trial is a multi-center, waitlisted, randomized controlled trial of patient navigators in children with CKD conducted at five sites across Australia. Children (0-16 years) with CKD from low socioeconomic status rural or remote areas were randomized to an intervention group or a waitlisted control group (to receive intervention after 6 months). The study primary and secondary endpoints include the self-rated health (SRH) (primary), and utility-based quality of life, progression of kidney dysfunction of the child, SRH, and satisfaction with healthcare of the caregiver at 6 months post-randomization.

Results: The trial completed recruitment in October 2021 with expected completion of follow-up by October 2022. There were 162 patients enrolled with 80 and 82 patients randomized to the immediate intervention and waitlisted groups, respectively. Fifty-eight (36%) participants were from regional/remote areas, with a median (IQR) age of 9.5 (5.0, 13.0) years, 46% were of European Australian ethnicity, and 65% were male. A total of 109 children (67%) had CKD stages 1-5, 42 (26%) were transplant recipients, and 11 (7%) were receiving dialysis.

Conclusion: The NAVKIDS² trial is designed to evaluate the effectiveness of patient navigation in children with CKD from families experiencing socioeconomic disadvantage. A higher resolution version of the Graphical abstract is available as Supplementary information.

Keywords: Adolescents; Children; Chronic kidney disease; Patient navigator; Social determinants of health; Socioeconomic status.

Publication types

Randomized Controlled Trial
Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Australia
Child
Female
Humans
Male
Patient Navigation*
Quality of Life
Renal Dialysis
Renal Insufficiency, Chronic* / therapy