NAV-KIDS trial: protocol for a multi-centre, staggered randomised controlled trial of a patient navigator intervention in children with chronic kidney disease.

Authors:
Patrina Caldwell
Patrina Caldwell
University of Sydney
Kirsten Howard
Kirsten Howard
Sydney School of Public Health
Australia
Allison Tong
Allison Tong
The Children's Hospital at Westmead
Australia
Jonathan C Craig
Jonathan C Craig
Sydney School of Public Health
Australia
Stephen Alexander
Stephen Alexander
University of Nottingham Medical School
United Kingdom
Martin Howell
Martin Howell
The Children's Hospital at Westmead
Australia

BMC Nephrol 2019 Apr 18;20(1):134. Epub 2019 Apr 18.

Centre for Kidney Research at The Children's Hospital at Westmead, Westmead, New South Wales, Australia.

Background: Chronic kidney disease (CKD) is a devastating illness associated with increased mortality, reduced quality of life, impaired growth, neurocognitive impairment and psychosocial maladjustment in children. There is growing evidence of socioeconomic disparities in health outcomes among children with CKD. Patient navigators are trained non-medical personnel who assist patients with chronic conditions journey through the continuum of care and transit across different care settings. They help vulnerable and underserved populations to better understand their diagnosis, treatment options, and available resources, guide them through complex medical systems, and help them to overcome barriers to health care access. Given the complexity and chronicity of the disease process and concerns that current models of care may not adequately support the provision of high-level care in children with CKD from socioeconomically disadvantaged backgrounds, a patient navigator program may improve the provision of care and overall health of children with CKD.

Methods: The NAV-KIDS trial is a multi-centre, staggered entry, waitlisted randomised controlled trial assessing the health benefits and costs of a patient navigator program in children with CKD (stages 3-5, on dialysis, and with kidney transplants), who are of low socioeconomic backgrounds. Across 5 sites, 210 patients aged from 3 to 17 years will be randomised to immediate receipt of a patient navigator intervention for 24 weeks or waitlisting with standard care until receipt of a patient navigator at 24 weeks. The primary outcome is child self-rated health (SRH) 6-months after completion of the intervention. Other outcomes include utility-based quality of life, caregiver SRH, satisfaction with healthcare, progression of kidney dysfunction, other biomarkers, missed school days, hospitalisations and mortality. The trial also includes an economic evaluation and process evaluation, which will assess the cost-effectiveness, fidelity and barriers and enablers of implementing a patient navigator program in this setting.

Discussion: This study will provide clear evidence on the effectiveness and cost-effectiveness of a new intervention aiming to improve overall health and well-being for children with CKD from socioeconomically disadvantaged backgrounds, through a high quality, well-powered clinical trial.

Trial Registration: Prospectively registered (12/07/2018) on the Australian New Zealand Clinical Trials Registry ( ACTRN12618001152213 ).

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Source
https://bmcnephrol.biomedcentral.com/articles/10.1186/s12882
Publisher Site
http://dx.doi.org/10.1186/s12882-019-1325-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6471999PMC
April 2019
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