Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001241628
Ethics application status
Approved
Date submitted
29/07/2021
Date registered
30/11/2023
Date last updated
30/11/2023
Date data sharing statement initially provided
30/11/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Return to Country: A national platform study to return Aboriginal and Torres Strait Islander renal patients home
Scientific title
Return to Country: Effect of increasing health service awareness of cultural safety on perceptions of care and time to return home in Aboriginal and/or Torres Strait Islander dialysis and/or kidney transplant patients
Secondary ID [1] 300321 0
Nil
Universal Trial Number (UTN)
Trial acronym
RTC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End-stage kidney disease 315927 0
Cultural safety 315928 0
Barriers for returning home models of care for renal patients 330984 0
The impact of racism on patient experience during renal medical care 330986 0
Patient reported experience when navigating the renal health-care system 330987 0
The miscommunication during medical care and treatment 330988 0
Wellbeing 330989 0
Condition category
Condition code
Renal and Urogenital 314199 314199 0 0
Kidney disease
Public Health 321246 321246 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
4
Target follow-up type
Years
Description of intervention(s) / exposure
Study Part 2 (observation)
Clinician leaders, patient-facing staff and patients from tertiary renal services/units participating in this study will participate in the following activities at baseline and after a minimum of two (and maximum of three) years:
i) an organisational policies and procedures audit relevant to culturally safe practice for Aboriginal and/or Torres Strait Islander patients, adapted from National Safety and Quality of Health Care guidelines;
ii) an on-line voluntary and anonymous staff survey designed to measure staff attitudes and beliefs toward Aboriginal and/or Torres Strait Islander patients, as well as self-reported communication styles and strategies staff use with patients. 20 minutes;
iii) a report of relevant one year patient outcomes (death, treatment modality, return to postcode of original residence) for each centre using national renal (ANZDATA) registry data over the previous five years;
iv) qualitative feedback from Aboriginal and/or Torres Strait Islander patient groups (ideally involving patients who are within one year of starting treatment) about their perceptions of treatment and care in five broad domains, as well as their responses to summaries of the information provided through activities (i), (ii) and (iii) above; and their willingness to be involved in a process of health service quality improvement - talking circles/focus group up to 10 renal patients in session, duration 2-3hr
v) qualitative feedback from key staff informants at each centre about their responses to a report including data from activities (i), (ii), (iii) and (iv) above, including a qualitative assessment from them of the degree to which they feel their centre/service is providing adequate care, and their willingness to be involved in a process of health service quality improvement. Report presentation to renal executive, to renal staff through in-service and summary posters

If the responses from patients (in activity (iv)) and key staff informants (in activity (v)) support engagement in health service quality improvement at the involved centre/service, a group (Study Part 3 - Change Phase: Community of Practice, CoP) including both will be convened and consent gained from the group for Return To Country researchers to observe the meetings and make suggestions for change when invited to do so. This will be the only "intervention" in the study (besides the provision of data from activities (i)-(v) above.

Regardless of the involvement of the renal centre/service in the process of patient-staff health service quality improvement as part of the Return To Country Study, the initial activities (i)-(v) above will be repeated for each service after a minimum of two and maximum of three years since the initial activity. This will provide data about changes in processes, attitudes and outcomes of care.
Intervention code [1] 316600 0
Not applicable
Comparator / control treatment
The control group will be non-Indigenous patients receiving care at the participating renal centre/service.
Control group
Active

Outcomes
Primary outcome [1] 322581 0
Renal health outcomes (patients): the proportion of Aboriginal and/or Torres Strait Islander patients receiving treatment at home or in their community of origin, as assessed by residential data in records (provided by renal centre/service to the ANZDATA registry, and also documented in hospital administrative data). The primary outcome will be measured at one, two and three years after starting treatment.
Timepoint [1] 322581 0
From start of treatment and every 12 months thereafter (for a minimum of 2 years and up to 3 years). Trends over time in the proportion of patients accessing care at home or in their community of origin at each renal centre/service will be assessed, particularly in relation to changes to national policy (November 2018) and in relation to the date of provision of the initial Return To Country report (containing data from observational activities (i)-(v) as outlined above).
Secondary outcome [1] 378992 0
Staff attitudes, beliefs and self-reported communication behaviours, as reported in the anonymous on-line staff survey for each renal service/centre.
Timepoint [1] 378992 0
Baseline and at 2 years after baseline
Secondary outcome [2] 378995 0
Organisational policies and documented procedures relevant to cultural safety as assessed by a policies and procedures audit (adapted from Cultural Respect Framework 2016-2026)
Timepoint [2] 378995 0
Baseline and at 2 years after baseline
Secondary outcome [3] 425103 0
Understanding of the extent to the renal unit willingness to respond to identified areas of development in cultural safety and patient centred care will be assessed through active participation in Study Part 3 (change phase) with the formation of Community of Practice and the development and implementation of site specific strategies to improve cultural safety in one or more of the cultural safety domains AND follow-up organisational audits and staff surveys, that is repeating steps Study Part 2 (observational) steps i), ii), iii)
Timepoint [3] 425103 0
2 years after baseline

Eligibility
Key inclusion criteria
Renal health services coordinating care for at least five Aboriginal and/or Torres Strait Islander patients starting renal replacement therapy every year. Since this is health services research, both service staff and patients will be involved, but the primary unit of recruitment and interest is the health service not individual patients.

Inclusion criteria for patient participants in surveys, interviews, focus groups, CoP:
- For part 1: within 12 months of starting RRT, language experts and cultural advisors, patients who identify as Aboriginal and/or Torres Strait Islander.
-For part 2 & 3: patients' receiving treatment at one of the participating renal health services

Inclusion criteria for staff participants in the surveys, interviews, focus groups, CoP:
- Medical staff, including medical doctors, Registered nurses, allied health staff employed at the participating renal health services
- Any non-medical staff employed at the participating renal health services (such as personal care assistants, receptionist, ward clerk, transport officers)

Inclusion criteria for key informants participating in the interviews/focus groups:
- Key renal unit staff, including the head of unit, nursing director, Aboriginal Health Practitioner or Worker, Aboriginal Liaison Officer, transplant coordinator, allied health professionals.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For renal health service:
- Does not comply with the Service Site Agreement; or
- Requesting removal from the study

For renal patients and staff:
- Requestion removal from the study
- Children under 18 years
- Cognitively impaired
- Being in acute pain or severe mental distress
- Unable to provide informed consent

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Relationships between collected variables will be examined using bivariate correlations and multivariable regression. A conceptual model of the hypothesised causal chain will guide more detailed analysis of the longitudinal dataset.
Time-to-event methods will be used for analysis of the effect of interventions, with more complex methods ultimately using Cox proportional hazards regression, stratified by centre and clustered at the individual level, with the introduction of one or more interventions incorporated as time-dependent variables.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/08/2020
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
13
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,WA
Recruitment hospital [1] 20103 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [2] 20104 0
Alice Springs Hospital - Alice Springs
Recruitment hospital [3] 20105 0
Cairns Base Hospital - Cairns
Recruitment hospital [4] 20106 0
The Townsville Hospital - Douglas
Recruitment hospital [5] 20107 0
John Hunter Hospital - New Lambton
Recruitment hospital [6] 20108 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 20109 0
Royal Perth Hospital - Perth
Recruitment hospital [8] 20110 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [9] 20111 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [10] 20112 0
Westmead Hospital - Westmead
Recruitment hospital [11] 20113 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [12] 20114 0
Dubbo Base Hospital - Dubbo
Recruitment postcode(s) [1] 34811 0
0810 - Tiwi
Recruitment postcode(s) [2] 34812 0
0870 - Alice Springs
Recruitment postcode(s) [3] 34821 0
2050 - Camperdown
Recruitment postcode(s) [4] 34820 0
2145 - Westmead
Recruitment postcode(s) [5] 34815 0
2305 - New Lambton
Recruitment postcode(s) [6] 34822 0
2830 - Dubbo
Recruitment postcode(s) [7] 34814 0
4814 - Douglas
Recruitment postcode(s) [8] 34813 0
4870 - Cairns
Recruitment postcode(s) [9] 34816 0
5000 - Adelaide
Recruitment postcode(s) [10] 34817 0
6000 - Perth
Recruitment postcode(s) [11] 34819 0
6009 - Nedlands
Recruitment postcode(s) [12] 34818 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 304746 0
Government body
Name [1] 304746 0
National Health and Medical Research Council
Country [1] 304746 0
Australia
Primary sponsor type
Other
Name
Menzies School of Health Research
Address
Darwin (Royal Darwin Hospital Campus)John Mathews Building (JMB)Building 58, Royal Darwin Hospital CampusRocklands Drive, Casuarina,Northern Territory, 0810
Country
Australia
Secondary sponsor category [1] 305060 0
None
Name [1] 305060 0
Address [1] 305060 0
Country [1] 305060 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305166 0
Northern Territory (NT) Department of Health and Menzies School of Health Research
Ethics committee address [1] 305166 0
John Matthews Building, Royal Darwin Hospital CampusRocklands Drive, Casuarina, NT, 0810
Ethics committee country [1] 305166 0
Australia
Date submitted for ethics approval [1] 305166 0
25/09/2019
Approval date [1] 305166 0
12/12/2019
Ethics approval number [1] 305166 0
HREC 2019-3530
Ethics committee name [2] 309113 0
Central Australian Human Research Ethics Committee
Ethics committee address [2] 309113 0
PO Box 4066 Alice SpringsNT 0871
Ethics committee country [2] 309113 0
Australia
Date submitted for ethics approval [2] 309113 0
04/09/2019
Approval date [2] 309113 0
19/11/2019
Ethics approval number [2] 309113 0
CA-19-3518
Ethics committee name [3] 314007 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [3] 314007 0
North Terrace, Adelaide, SA, 5000
Ethics committee country [3] 314007 0
Australia
Date submitted for ethics approval [3] 314007 0
08/08/2023
Approval date [3] 314007 0
12/09/2023
Ethics approval number [3] 314007 0
2023/HRE00209
Ethics committee name [4] 314199 0
Central Adelaide Local Health Network
Ethics committee address [4] 314199 0
North Terrace, Adelaide, SA 5000
Ethics committee country [4] 314199 0
Australia
Date submitted for ethics approval [4] 314199 0
10/08/2023
Approval date [4] 314199 0
12/09/2023
Ethics approval number [4] 314199 0
2023/HRE00209

Summary
Brief summary
End-stage kidney disease (ESKD), when dialysis or a kidney transplant is required to maintain life, has a devastating impact on Indigenous patients and their families. In remote communities, rates of ESKD are 15 or more times higher than amongst non-Indigenous Australians of the same age and sex, and people need to relocate to distant urban centres to take up dialysis. Community-based dialysis or a kidney transplant allows a patient to return to live in their community. However, Indigenous Australians have very low rates of such community-based treatment. This multicentre prospective interventional study will investigate why this is, and test if interventions to address these identified barriers can get more people home for treatment.
Trial website
https://www.menzies.edu.au/page/Research/Projects/Kidney/Return_to_Country/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99462 0
Prof Paul Lawton
Address 99462 0
Alfred Health & Monash University, 55 Commercial Road Melbourne Victoria , Victoria 3004
Country 99462 0
Australia
Phone 99462 0
+61399038939
Fax 99462 0
Email 99462 0
paul.lawton@menzies.edu.au
Contact person for public queries
Name 99463 0
Ms Yomei Jones
Address 99463 0
John Mathews Building (Bldg 58), Royal Darwin Hospital Campus, Rocklands Drive, Casuarina NT 0810
Country 99463 0
Australia
Phone 99463 0
+61889468637
Fax 99463 0
Email 99463 0
yomei.jones@menzies.edu.au
Contact person for scientific queries
Name 99464 0
Prof Paul Lawton
Address 99464 0
Alfred Health & Monash University, 55 Commercial Road Melbourne Victoria , Victoria 3004
Country 99464 0
Australia
Phone 99464 0
+61438335152
Fax 99464 0
Email 99464 0
paul.lawton@menzies.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Sensitive data will be collected (about staff and patients' experiences of racism), and data will be collated about and for each participating unit with the explicit understanding that these data will not be released in a way that identifies patients, staff or participating units.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.