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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05629416




Registration number
NCT05629416
Ethics application status
Date submitted
7/11/2022
Date registered
29/11/2022
Date last updated
16/02/2023

Titles & IDs
Public title
The Communicate Study Partnership
Scientific title
The Communicate Study Partnership - Improving Healthcare Experiences and Outcomes for Aboriginal Peoples Through Delivery of Culturally Safe Healthcare in First Languages
Secondary ID [1] 0 0
2008644
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aboriginal Health 0 0
Cultural Safety 0 0
Access to Interpreters 0 0
Healthcare Provider Training 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Interventions to transform the culture of healthcare systems to achieve excellence in providing culturally safe care for First Nations peoples

Experimental: Cultural safety training and behaviour change intervention - - Interventions to transform the culture of healthcare systems to achieve excellence in providing culturally safe care for First Nations peoples


Behaviour: Interventions to transform the culture of healthcare systems to achieve excellence in providing culturally safe care for First Nations peoples
Implement 'Ask the Specialist Plus', a structured program to promote anti-racism within Northern Territory (NT) hospitals by giving healthcare providers training in cultural safety.
Implement strategies to foster 'Clinical champions of cultural safety' through a social media chat platform and face to face meetings to discuss anti-racism practice, cultural safety and practical ways to deliver culturally safe care including interpreter use.
Support simplified and improved strategies for booking an interpreter to increase uptake.
Implement retention strategies to ensure interpreters receive workplace support.
Provide training in health terminology for interpreters.
Integrate interpreter supply and demand through efficiency and effectiveness strategies tailored to participating sites.
Implement continuous quality improvement cycles with senior managers, using findings from qualitative and quantitative data collection and evaluation.
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Self discharge among Aboriginal inpatients at Royal Darwin Hospital, Palmerston Hospital, Katherine Hospital and Gove District Hospital
Timepoint [1] 0 0
Up to 4 years. (Health system level data are collected and summarised quarterly during July 1 2022 - June 30 2026, and compared with the baseline phase July 1 2020 - June 30 2022)
Primary outcome [2] 0 0
Patient experience (qualitative evaluation)
Timepoint [2] 0 0
Up to 4 years. Interview data will be collected at regular intervals throughout the study (2022-2026) to track any change in patient experience during the course of the intervention period
Secondary outcome [1] 0 0
Documentation of language in hospital medical records
Timepoint [1] 0 0
Up to 4 years. (Documentation of language will be tracked throughout the 4-year intervention period.)
Secondary outcome [2] 0 0
Access to an interpreter during admission
Timepoint [2] 0 0
Up to 4 years. (Documentation of interpreter access will be tracked throughout the 4-year intervention period.)
Secondary outcome [3] 0 0
Healthcare provider experience
Timepoint [3] 0 0
Up to 4 years. Interview data will be collected at regular intervals throughout the study (2022-2026) to track any change in healthcare provider experience during the course of the intervention period
Secondary outcome [4] 0 0
Cost
Timepoint [4] 0 0
Up to 4 years. Continuous data (daily data, summarised monthly) will be assessed during - the two-year baseline phase July 1 2020 - June 30 2022 - the four-year intervention (activity) period July 1 2022 - June 30 2026
Secondary outcome [5] 0 0
Unplanned readmission within 28 days
Timepoint [5] 0 0
Up to 4 years. Continuous data (daily data, summarised monthly) will be assessed during - the two-year baseline phase July 1 2020 - June 30 2022 - the four-year intervention (activity) period July 1 2022 - June 30 2026

Eligibility
Key inclusion criteria
Different patient and provider participants (e.g. Aboriginal patients, Aboriginal
interpreters, healthcare providers of any ethnicity) will be invited to participate in
interviews, observations and surveys to assess effectiveness of study activities
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Health Services Research
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
340
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 0 0
Royal Darwin Hospital - Darwin
Recruitment hospital [2] 0 0
Palmerston Hospital - Darwin
Recruitment hospital [3] 0 0
Katherine Hospital - Katherine
Recruitment hospital [4] 0 0
Gove District Hospital - Nhulunbuy
Recruitment postcode(s) [1] 0 0
0810 - Darwin
Recruitment postcode(s) [2] 0 0
0830 - Darwin
Recruitment postcode(s) [3] 0 0
0850 - Katherine
Recruitment postcode(s) [4] 0 0
0880 - Nhulunbuy

Funding & Sponsors
Primary sponsor type
Other
Name
Menzies School of Health Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Northern Territory of Australia as represented by the Department of Health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Djalkiri Foundation Aboriginal Corporation
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Charles Darwin University
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
National Accreditation Authority for Translators and Interpreters
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Northern Territory Government as represented by the Department of The Chief Minister and Cabinet
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The vision of the Communicate Study Partnership is to ensure more Aboriginal patients receive
culturally safe healthcare in their first language.

The Communicate Study Partnership will implement and evaluate creative ways to embed cultural
safety training and increase use of Aboriginal Interpreters and Aboriginal Health
Practitioners at Northern Territory Top End hospitals.

Quantitative outcomes (interpreter uptake, outcomes including leave against medical advice,
costs) will be measured using time-series analysis. Qualitative outcomes derived from
interviews with patient, healthcare provider and interpreter participants, will be informed
by decolonising theory and participatory approaches.

Successful project implementation will improve experience of care and health outcomes for
Aboriginal people, build Aboriginal workforce, and improve healthcare provider satisfaction.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05629416
Trial related presentations / publications
Kerrigan V, McGrath SY, Herdman RM, Puruntatameri P, Lee B, Cass A, Ralph AP, Hefler M. Evaluation of 'Ask the Specialist': a cultural education podcast to inspire improved healthcare for Aboriginal peoples in Northern Australia. Health Sociol Rev. 2022 Jul;31(2):139-157. doi: 10.1080/14461242.2022.2055484. Epub 2022 Apr 3.
O'Connor E, Kerrigan V, Aitken R, Castillon C, Mithen V, Madrill G, Roman C, Ralph AP. Does improved interpreter uptake reduce self-discharge rates in hospitalised patients? A successful hospital intervention explained. PLoS One. 2021 Oct 12;16(10):e0257825. doi: 10.1371/journal.pone.0257825. eCollection 2021.
Kerrigan V, McGrath SY, Majoni SW, Walker M, Ahmat M, Lee B, Cass A, Hefler M, Ralph AP. "The talking bit of medicine, that's the most important bit": doctors and Aboriginal interpreters collaborate to transform culturally competent hospital care. Int J Equity Health. 2021 Jul 23;20(1):170. doi: 10.1186/s12939-021-01507-1.
Kerrigan V, McGrath SY, Majoni SW, Walker M, Ahmat M, Lee B, Cass A, Hefler M, Ralph AP. From "stuck" to satisfied: Aboriginal people's experience of culturally safe care with interpreters in a Northern Territory hospital. BMC Health Serv Res. 2021 Jun 4;21(1):548. doi: 10.1186/s12913-021-06564-4.
Mithen V, Kerrigan V, Dhurrkay G, Morgan T, Keilor N, Castillon C, Hefler M, Ralph AP. Aboriginal patient and interpreter perspectives on the delivery of culturally safe hospital-based care. Health Promot J Austr. 2021 Feb;32 Suppl 1:155-165. doi: 10.1002/hpja.415. Epub 2020 Dec 4.
Communicate Study group*. Improving communication with Aboriginal hospital inpatients: a quasi-experimental interventional study. Med J Aust. 2020 Aug;213(4):180-181. doi: 10.5694/mja2.50700. Epub 2020 Jul 25. No abstract available.
Kerrigan V, Lewis N, Cass A, Hefler M, Ralph AP. "How can I do more?" Cultural awareness training for hospital-based healthcare providers working with high Aboriginal caseload. BMC Med Educ. 2020 May 29;20(1):173. doi: 10.1186/s12909-020-02086-5.
Ralph AP, Lowell A, Murphy J, Dias T, Butler D, Spain B, Hughes JT, Campbell L, Bauert B, Salter C, Tune K, Cass A. Low uptake of Aboriginal interpreters in healthcare: exploration of current use in Australia's Northern Territory. BMC Health Serv Res. 2017 Nov 15;17(1):733. doi: 10.1186/s12913-017-2689-y.
Public notes

Contacts
Principal investigator
Name 0 0
Anna Ralph, PhD
Address 0 0
Menzies School of Health Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Anna Ralph, PhD
Address 0 0
Country 0 0
Phone 0 0
+618 89468647
Fax 0 0
Email 0 0
anna.ralph@menzies.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05629416