NAV-KIDS2 trial: protocol for a multi-centre, staggered randomised controlled trial of a patient navigator intervention in children with chronic kidney disease
Abstract 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 amo...
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BMC
2019-04-01
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Series: | BMC Nephrology |
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Online Access: | http://link.springer.com/article/10.1186/s12882-019-1325-y |
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record_format |
Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Anita van Zwieten Patrina Caldwell Kirsten Howard Allison Tong Jonathan C. Craig Stephen Alexander Martin Howell Teixeira-Pinto Armando Carmel Hawley Shilpa Jesudason Amanda Walker Fiona Mackie Sean Kennedy Steve McTaggart Hugh McCarthy Simon Carter Siah Kim Sam Crafter Reginald Woodleigh Chandana Guha Germaine Wong |
spellingShingle |
Anita van Zwieten Patrina Caldwell Kirsten Howard Allison Tong Jonathan C. Craig Stephen Alexander Martin Howell Teixeira-Pinto Armando Carmel Hawley Shilpa Jesudason Amanda Walker Fiona Mackie Sean Kennedy Steve McTaggart Hugh McCarthy Simon Carter Siah Kim Sam Crafter Reginald Woodleigh Chandana Guha Germaine Wong NAV-KIDS2 trial: protocol for a multi-centre, staggered randomised controlled trial of a patient navigator intervention in children with chronic kidney disease BMC Nephrology Chronic kidney disease Dialysis Kidney transplantation Children Adolescents Patient navigator |
author_facet |
Anita van Zwieten Patrina Caldwell Kirsten Howard Allison Tong Jonathan C. Craig Stephen Alexander Martin Howell Teixeira-Pinto Armando Carmel Hawley Shilpa Jesudason Amanda Walker Fiona Mackie Sean Kennedy Steve McTaggart Hugh McCarthy Simon Carter Siah Kim Sam Crafter Reginald Woodleigh Chandana Guha Germaine Wong |
author_sort |
Anita van Zwieten |
title |
NAV-KIDS2 trial: protocol for a multi-centre, staggered randomised controlled trial of a patient navigator intervention in children with chronic kidney disease |
title_short |
NAV-KIDS2 trial: protocol for a multi-centre, staggered randomised controlled trial of a patient navigator intervention in children with chronic kidney disease |
title_full |
NAV-KIDS2 trial: protocol for a multi-centre, staggered randomised controlled trial of a patient navigator intervention in children with chronic kidney disease |
title_fullStr |
NAV-KIDS2 trial: protocol for a multi-centre, staggered randomised controlled trial of a patient navigator intervention in children with chronic kidney disease |
title_full_unstemmed |
NAV-KIDS2 trial: protocol for a multi-centre, staggered randomised controlled trial of a patient navigator intervention in children with chronic kidney disease |
title_sort |
nav-kids2 trial: protocol for a multi-centre, staggered randomised controlled trial of a patient navigator intervention in children with chronic kidney disease |
publisher |
BMC |
series |
BMC Nephrology |
issn |
1471-2369 |
publishDate |
2019-04-01 |
description |
Abstract 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-KIDS2 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). |
topic |
Chronic kidney disease Dialysis Kidney transplantation Children Adolescents Patient navigator |
url |
http://link.springer.com/article/10.1186/s12882-019-1325-y |
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doaj-f5cee3ffe233462aa82ccfbf89c6e2d02020-11-25T02:21:56ZengBMCBMC Nephrology1471-23692019-04-012011910.1186/s12882-019-1325-yNAV-KIDS2 trial: protocol for a multi-centre, staggered randomised controlled trial of a patient navigator intervention in children with chronic kidney diseaseAnita van Zwieten0Patrina Caldwell1Kirsten Howard2Allison Tong3Jonathan C. Craig4Stephen Alexander5Martin Howell6Teixeira-Pinto Armando7Carmel Hawley8Shilpa Jesudason9Amanda Walker10Fiona Mackie11Sean Kennedy12Steve McTaggart13Hugh McCarthy14Simon Carter15Siah Kim16Sam Crafter17Reginald Woodleigh18Chandana Guha19Germaine Wong20Centre for Kidney Research at The Children’s Hospital at WestmeadCentre for Kidney Research at The Children’s Hospital at WestmeadSydney School of Public Health, University of SydneyCentre for Kidney Research at The Children’s Hospital at WestmeadCollege of Medicine and Public Health, Flinders University, AdelaideCentre for Kidney Research at The Children’s Hospital at WestmeadCentre for Kidney Research at The Children’s Hospital at WestmeadCentre for Kidney Research at The Children’s Hospital at WestmeadFaculty of Medicine, Princess Alexandra Hospital Southside Clinical UnitDepartment of Renal Medicine, Royal Adelaide HospitalDepartment of Renal Medicine, Royal Children’s Hospital in MelbourneDepartment of Renal Medicine, Sydney Children’s HospitalDepartment of Renal Medicine, Sydney Children’s HospitalDepartment of Renal Medicine, Lady Cilento Children’s HospitalCentre for Kidney Research at The Children’s Hospital at WestmeadCentre for Kidney Research at The Children’s Hospital at WestmeadCentre for Kidney Research at The Children’s Hospital at WestmeadDepartment of Renal Medicine, Women’s and Children’s HospitalCanCare, Prostate and Breast Cancer FoundationCentre for Kidney Research at The Children’s Hospital at WestmeadCentre for Kidney Research at The Children’s Hospital at WestmeadAbstract 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-KIDS2 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).http://link.springer.com/article/10.1186/s12882-019-1325-yChronic kidney diseaseDialysisKidney transplantationChildrenAdolescentsPatient navigator |