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Trial registered on ANZCTR


Registration number
ACTRN12618001152213
Ethics application status
Approved
Date submitted
9/07/2018
Date registered
12/07/2018
Date last updated
30/08/2019
Date data sharing statement initially provided
9/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient navigators in children with chronic kidney disease
Scientific title
A multi-centre, staggered entry, waitlist randomised controlled trial of patient navigators to improve the overall self-rated health in children with chronic kidney disease
Secondary ID [1] 295469 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
NAVKIDS2 trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children with chronic kidney disease 308730 0
Condition category
Condition code
Renal and Urogenital 307670 307670 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A patient navigator program. The navigator will work with patients, caregivers, health professionals to achieve better care and health through involvement in the social, community and health organisational network. It is a complex intervention and will be individualised, tailored to the needs of the patients and families. The navigator will first identify the needs of the individuals and family, and then design the management plan. The navigator may work with the child and family on a daily basis (either face to face, or via telephone) or less frequently, depending upon the needs of the child and family. The navigator will be available to families during business hours on weekdays. Considering their overall caseload, the time navigators will allocate to each family will be approximately 1 hour per week. The family will have access to the navigator for 24 weeks.
The navigator will follow a four-by-four matrix of tasks and network plan:
1. Identification of task categories for a specific patient and family: navigating tasks may consist of identifying and mitigating barriers with patients and healthcare professionals. They may include telling (explaining where and when a renal biopsy will be done), inquiring (asking about the potential barriers, such as language barriers to attend the next appointment after the biopsy), supporting (listening to the fears about the interventions) and coaching (discussing the potential questions the patients and families may wish to ask in the next appointment).
2. Facilitation for a specific patient and families: the navigator may coordinate communication, seek advice from non-medical and medical staff and help to bring patients in for the appointments.
For example, the patient navigator may help the caregivers to keep track of appointments, particularly when the organisational and executive skills of the child are affected, provide social support, interpret health information provided by the clinicians and facilitate communication within the families when parents are separated. Navigators may help patients to forge a more participatory dialogue with their clinicians, and guiding the patients to ask the right questions, enhancing patient autonomy. Patient navigators can also provide support for caregivers; e.g. managing transport to and from the hospital or coping with the complex organisational network within the hospital, particularly for those of lower literacy, low SES and families from non-English speaking backgrounds.

3. Identification of networks: the navigators will identify all potential network interactions that are relevant to the patients and their families. These may include: the health service providers, the non-clinical staff (administrators and receptionist), and other social support services such as the social workers, community-based services, transportation, and the maintenance of activities and system tasks for patients.
These potential networks will be given to patients and family, ensuring they have full understanding and access to all the services required.
4. Document and review: the navigator will record their own actions (for example: steps taken with or on behalf of the patients and record other activities that are relevant to the navigator role).
Intervention code [1] 301787 0
Other interventions
Comparator / control treatment
The waitlist control is standard care. The control arm (standard care) involved the provision of general care provided by the healthcare professionals in the hospital and outpatient settings without the support of a patient navigator. The waitlist, controlled design has the benefit of allowing all eligible participants to be enrolled and receive the same intervention for the same duration of time, but staggered entry at different time points (different waves) such that participants with delayed entry will serve as controls.
Control group
Active

Outcomes
Primary outcome [1] 306655 0
Self rated health of the children with CKD. The self-rated health is a patient-reported health outcome, is a validated composite measure of the children’s global health status, including both physical and quality of life construct. It is a 5-point Likert scale ranging from (poor health, fair, good, very good and excellent health)
Timepoint [1] 306655 0
The primary study end-point is SRH of the child at the end of 6-month follow-up.
The primary outcome will be collected at baseline, 1, 3, 6, and 12 months.
Secondary outcome [1] 349157 0
Utility based quality of life, measured using the Health Utility Index (HUI-3)
Timepoint [1] 349157 0
Collected at baseline, 1, 3, 6, and 12 month follow-ups.
Secondary outcome [2] 349294 0
The number of hospitalisations (measured using a study-specific questionnaire)
Timepoint [2] 349294 0
Collected at 1, 3, 6, 12 month follow-ups.
Secondary outcome [3] 349295 0
Number of missed school days (measured using a study specific questionnaire)
Timepoint [3] 349295 0
Collected at baseline, 1, 3, 6, and 12 months.
Secondary outcome [4] 349297 0
All-cause, cardiovascular (CV) and other cause-specific mortality: One-year (short), 5-year (medium) and 10-year (longer) term all-cause, CV and non-CV related mortality will be obtained using data linkage with the National Death Index, housed within the Australia Institute and Health and Welfare (AIHW).
Timepoint [4] 349297 0
1, 5 and 10-year
Secondary outcome [5] 349298 0
Direct health care costs and resource use. Healthcare resource use will be estimated using linked data including hospitalisation records, and Medicare Australia data for outpatient healthcare use (Pharmaceutical Benefit Scheme (PBS) and Medicare Benefits Schedule (MBS). Cost will be estimated by applying DRG or Medicare unit costs and will also include the costs of the patient navigator program.
Timepoint [5] 349298 0
Linkage will occur 12 month after completion of the study.
Secondary outcome [6] 349365 0
Caregiver satisfaction with healthcare including perceived access to care (study specific questionnaire).
Timepoint [6] 349365 0
Collected at baseline, 1, 3, 6, and 12 months.
Secondary outcome [7] 372222 0
Biomarker measured using blood samples - estimated glomerular filtration rate (eGFR*)

*eGFR calculated using a modified Schwartz equation for the estimated glomerular filtration rate.
Timepoint [7] 372222 0
Collected at baseline and 6 months.
Secondary outcome [8] 372223 0
Biomarker measured from blood sample – urea.
Timepoint [8] 372223 0
Collected at baseline and 6 months.
Secondary outcome [9] 372224 0
Biomarker measured from blood sample - albumin.
Timepoint [9] 372224 0
Collected at baseline and 6 months.
Secondary outcome [10] 372225 0
Biomarker measured from blood sample - bilirubin
Timepoint [10] 372225 0
Collected at baseline and 6 months.
Secondary outcome [11] 372226 0
Biomarker measured from blood sample - alanine transaminase.
Timepoint [11] 372226 0
Collected at baseline and 6 months.
Secondary outcome [12] 372227 0
Biomarker measured from blood sample - alkaline phosphatase.
Timepoint [12] 372227 0
Collected at baseline and 6 months.
Secondary outcome [13] 372228 0
Biomarker measured from blood sample – gamma glutamyl transferase
Timepoint [13] 372228 0
Collected at baseline and 6 months.
Secondary outcome [14] 372229 0
Biomarker measured from blood sample – haemoglobin.
Timepoint [14] 372229 0
Collected at baseline and 6 months.
Secondary outcome [15] 372230 0
Biomarker measured from blood sample – white cell count.
Timepoint [15] 372230 0
Collected at baseline and 6 months.
Secondary outcome [16] 372231 0
Biomarker measured from blood sample – platelets.
Timepoint [16] 372231 0
Collected at baseline and 6 months.

Eligibility
Key inclusion criteria
Specifically, to be eligible for the study, participants must satisfy all of the below criteria:
1. Children with CKD (3-5), or CKD-D or CKD-T,
2. Aged 3-17 years, and
3. Low SES background. Low SES families are defined as the following: a. Weekly household income (less than the median gross household income, $1250 (AUD) per week), b. Poor or very poor self-perceived financial status, c. Single parenting on social benefits, d. Both parents are unemployed, e. Families living in public housing.
Minimum age
3 Years
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Limited life expectancy of less than 12 months and 2. Unable to provide consent by the caregiver (and assent– if the child is 16 years or over).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation will occur.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence is generated by a computerized random number generator, using a random permuted block design with randomly chosen block sizes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Staggered entry, wait-list randomized control trial.
(Wait-list group acts as control).
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
The sample size was calculated for the analysis of the 5-point Likert scale of the SRH (and parent-rated health for younger children) of the child using an ordinal logistic regression. Assuming a dropout rate of 20%, a total of 210 children (105 in each arm) will be required for a final sample of 168 patients . This sample size will allow us to detect an odds ratio (OR) of 2.3, with approximately 80% power and a significance level of 0.05.

Data analyses: All data will be analysed according to the intention to treat principle. The primary outcome, SRH of the child, will be compared between the intervention and waitlisted groups at 6 months post-treatment using an ordinal logistic regression model. The waitlisted cohort will also allow for a pre and post analysis. We will use robust standard errors to account for clustering within centres. In addition, we will analyse the longitudinal evaluation of SRH within the 12 month-period after the intervention, using a mixed model. The degree of change in SRH over the various time points will also be examined for association with baseline characteristics of the participants such as age, gender, CKD stage, by examining the time interaction with these variables. Secondary endpoints that are continuous data, such as utility-based quality of life and caregiver satisfaction, and count data, such as number of hospitalisations and number of school missed days, will be analysed using linear and Poisson regression, respectively, to compare the intervention and waitlisted groups. Subgroup analyses based on the different waves (i.e. the recruiting sites) and CKD stage will also be conducted. Time to event analyses will be used to estimate the rate of death between the intervention and waitlisted groups using Cox proportional hazards model, stratified by CKD stage at the time of randomisation. A p-value of 0.05 will be used to indicate statistical significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 11382 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 11384 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [3] 11385 0
Sydney Children's Hospital - Randwick
Recruitment hospital [4] 14668 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 23281 0
2145 - Westmead
Recruitment postcode(s) [2] 23282 0
4101 - South Brisbane
Recruitment postcode(s) [3] 23283 0
3052 - Parkville
Recruitment postcode(s) [4] 23284 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 300059 0
Government body
Name [1] 300059 0
National Health and Medical Research Council Medical Research Future Fund
Address [1] 300059 0
16 Marcus Clarke St, Canberra ACT 2601, NSW, Australia
Country [1] 300059 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia, Brisbane, QLD 4072, Australia
Country
Australia
Secondary sponsor category [1] 299455 0
None
Name [1] 299455 0
Address [1] 299455 0
Country [1] 299455 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300906 0
The Sydney Children’s Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 300906 0
The Children's Hospital at Westmead, Corner of Hawkesbury and Hainsworth Street, Westmead, NSW 2145
Ethics committee country [1] 300906 0
Australia
Date submitted for ethics approval [1] 300906 0
27/06/2018
Approval date [1] 300906 0
27/11/2018
Ethics approval number [1] 300906 0
HREC/18/SCHN/325

Summary
Brief summary
The NAVKID2 trial is a multi-centre, staggered entry, waitlisted randomised controlled trial that assesses the health benefits and costs of a patient navigator program in children with chronic kidney disease (CKD) stages 3-5, on dialysis (CKD-D) and with kidney transplants (CKD-T) and of low socioeconomic backgrounds. CKD is a devastating illness associated with increased mortality, reduced quality of life, impaired growth, neurocognitive impairment and psychosocial maladjustment in children. The overall annual mortality rate for children on dialysis is 35 per 1000 population and is thirty-fold higher than children without CKD. Such large discrepancies in mortality rates remain unchanged despite medical advances over the past two decades. The key findings of our observational KCAD study indicated that poor health in children with CKD is not only attributed to the direct influence of the chronic illness but also reflects outcomes of the complex pathway that defines equitable access to healthcare. We found that children with CKD of the lowest and second lowest socioeconomic status (SES) quartiles were at least 3 and 2 times more likely to experience poorer overall health compared to the highest SES quartile.
Patient navigators are trained non-medical personnel who assist patients with complex and/or chronic conditions journey through the continuum of care and transit across different care settings. They help the vulnerable and underserved populations with chronic illness to better understand their diagnoses, treatment options, and available resources, to guide them through the very complex medical system and to overcome barriers to health care access and bridge gaps in transitions of care. Using a staggered entry, waitlist randomised control design, this study will aim to: 1. Assesses the impact of a patient navigator program on the overall health and well-being of children with CKD in a multi-centre, staggered-entry, waitlisted randomised controlled trial.
2. Determine the cost-effectiveness of a patient-navigator program compare with standard care.
3. Identify the barriers and facilitators of developing and implementing a patient navigator program in clinical practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85230 0
A/Prof Germaine Wong
Address 85230 0
Centre for Kidney Research, Kids Research Institute, The Children's Hospital at Westmead, Corner of Hawkesbury Road and Hainsworth Street, Westmead 2145, NSW
Country 85230 0
Australia
Phone 85230 0
+612 8890 6962
Fax 85230 0
+ 612 9633 9351
Email 85230 0
germaine.wong@health.nsw.gov.au
Contact person for public queries
Name 85231 0
A/Prof Germaine Wong
Address 85231 0
Centre for Kidney Research, Kids Research Institute, The Children's Hospital at Westmead, Corner of Hawkesbury Road and Hainsworth Street, Westmead 2145, NSW
Country 85231 0
Australia
Phone 85231 0
+612 8890 6962
Fax 85231 0
+ 612 9633 9351
Email 85231 0
germaine.wong@health.nsw.gov.au
Contact person for scientific queries
Name 85232 0
A/Prof Germaine Wong
Address 85232 0
Centre for Kidney Research, Kids Research Institute, The Children's Hospital at Westmead, Corner of Hawkesbury Road and Hainsworth Street, Westmead 2145, NSW
Country 85232 0
Australia
Phone 85232 0
+612 8890 6962
Fax 85232 0
+ 612 9633 9351
Email 85232 0
germaine.wong@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This requirement was not considered/included in the ethics application and approval. However, study level data will be published and publicly available.
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 889 0
Study protocol
Citation [1] 889 0
Link [1] 889 0
Email [1] 889 0
Other [1] 889 0
It is important to note that the statistical plan is also included in the study protocol.
Type [2] 892 0
Informed consent form
Citation [2] 892 0
Link [2] 892 0
Email [2] 892 0
Other [2] 892 0
Type [3] 893 0
Ethical approval
Citation [3] 893 0
Link [3] 893 0
Email [3] 893 0
Other [3] 893 0
Type [4] 894 0
Ethical approval
Citation [4] 894 0
Link [4] 894 0
Email [4] 894 0
Other [4] 894 0
This is the HREA ethics form.
Summary results
No Results