ANZCTR - Registration

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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

22/08/2022

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, waitlist randomised controlled trial of patient navigators to improve the overall self-rated health in children with chronic kidney disease

Secondary ID [1]

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

Condition category

Condition code

Renal and Urogenital

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]

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]

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]

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]

Utility based quality of life, measured using the Health Utility Index (HUI-3)

Timepoint [1]

Collected at baseline, 1, 3, 6, and 12 month follow-ups.

Secondary outcome [2]

The number of hospitalisations (measured using a study-specific questionnaire)

Timepoint [2]

Collected at 1, 3, 6, 12 month follow-ups.

Secondary outcome [3]

Number of missed school days (measured using a study specific questionnaire)

Timepoint [3]

Collected at baseline, 1, 3, 6, and 12 months.

Secondary outcome [4]

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]

1, 5 and 10-year

Secondary outcome [5]

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]

Linkage will occur 12 month after completion of the study.

Secondary outcome [6]

Caregiver satisfaction with healthcare including perceived access to care (study specific questionnaire).

Timepoint [6]

Collected at baseline, 1, 3, 6, and 12 months.

Secondary outcome [7]

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]

Collected at baseline, 6 and 12 months.

Secondary outcome [8]

Biomarker measured from blood sample – urea.

Timepoint [8]