TY - JOUR
T1 - NAV-KIDS 2 trial
T2 - Protocol for a multi-centre, staggered randomised controlled trial of a patient navigator intervention in children with chronic kidney disease
AU - Van Zwieten, Anita
AU - Caldwell, Patrina
AU - Howard, Kirsten
AU - Tong, Allison
AU - Craig, Jonathan C.
AU - Alexander, Stephen
AU - Howell, Martin
AU - Armando, Teixeira Pinto
AU - Hawley, Carmel
AU - Jesudason, Shilpa
AU - Walker, Amanda
AU - Mackie, Fiona
AU - Kennedy, Sean
AU - McTaggart, Steve
AU - McCarthy, Hugh
AU - Carter, Simon
AU - Kim, Siah
AU - Crafter, Sam
AU - Woodleigh, Reginald
AU - Guha, Chandana
AU - Wong, Germaine
N1 - Publisher Copyright:
© 2019 The Author(s).
PY - 2019/4/18
Y1 - 2019/4/18
N2 - 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 2 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).
AB - 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 2 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).
KW - Adolescents
KW - Children
KW - Chronic kidney disease
KW - Dialysis
KW - Health disparities
KW - Kidney transplantation
KW - Patient navigator
KW - Randomised controlled trial
KW - Socioeconomic disadvantage
UR - http://www.scopus.com/inward/record.url?scp=85064518825&partnerID=8YFLogxK
U2 - 10.1186/s12882-019-1325-y
DO - 10.1186/s12882-019-1325-y
M3 - Article
C2 - 30999884
AN - SCOPUS:85064518825
SN - 1471-2369
VL - 20
JO - BMC Nephrology
JF - BMC Nephrology
IS - 1
M1 - 134
ER -