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Aboriginal HealthPhase 2NCT05629416

The Communicate Study Partnership

A Phase 2 study testing Interventions to transform the culture of healthcare systems to achieve excellence in providing culturally safe care for First Nations peoples in people with Aboriginal Health and Cultural Safety, run by Menzies School of Health Research at 4 sites in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Interventions to transform the culture of healthcare systems to achieve excellence in providing culturally safe care for First Nations peoples
Could I receive a placebo?
No, everyone receives an active treatment
How many people
340 participants
Where
4 sitesAustralia
Study dates
23 May 2022to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • None

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Victoria Kerrigan, PhD contact

+61889468600

vicki.kerrigan@menzies.edu.au

Australia4 sites, 4 recruiting
  • Royal Darwin Hospital

    Darwin, Northern Territory, 0810

    Recruiting
  • Palmerston Hospital

    Darwin, Northern Territory, 0830

    Not yet recruiting
  • Katherine Hospital

    Katherine, Northern Territory, 0850

    Not yet recruiting
  • Gove District Hospital

    Nhulunbuy, Northern Territory, 0880

    Not yet recruiting

Other trials in Australia

About this study

Official title: The Communicate Study Partnership - Improving Healthcare Experiences and Outcomes for Aboriginal Peoples Through Delivery of Culturally Safe Healthcare in First Languages

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.

Read more

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.

Read the detailed description

The goal of "The Communicate Study: partnership across the Top End to improve Aboriginal patients' experience and outcomes of healthcare" is to achieve sustainable organisational change to provide excellence in cultural and clinical safety for Aboriginal people utilising NT Health facilities.

Aim 1: Transform the culture of healthcare systems to achieve excellence in providing culturally safe care for First Nations peoples

  • Develop, implement and evaluate anti-racism training using 'Ask the specialist-Plus'. This comprises moderated discussion and reflection on 'Ask the Specialist' podcast episodes held during in-service and clinical teaching timeslots for healthcare providers

Aim 2: Strengthen the tools and strategies required underpinning culturally safe practice

  1. Improve demand for Aboriginal interpreters and Aboriginal health practitioners through improved cultural understanding and recognition of patient needs
  2. Improve supply of interpreters and Aboriginal health practitioners willing to work in the hospital environment by creating a culturally safe workplace and supporting career pathways
  3. Effectiveness strategies tailored to participating sites such as
  • positioning interpreters at points of need and embedding them in medical and surgical teams
  • Optimising workflow to facilitate efficiency and availability across hospital departments

Aim 3: Evaluate outcomes using comprehensive qualitative and quantitative measures

  1. Qualitative enquiry to assess cultural safety from patient perspectives, and understand experiences of Aboriginal and Non-Aboriginal healthcare providers and interpreters
  2. Quantitative outcomes including
  • performance across key indicators: changes in documentation of language; Interpreter bookings made; Interpreter bookings completed; % Aboriginal patients in need getting access to an interpreter
  • Impact of intervention: proportion of admissions with and without interpreters ending in self-discharge; unplanned re-admissions and changes in hospital length of stay
  • economic analysis of the costs and cost benefits of interpreter use to decrease self-discharge and re-admission rates.
Being tested
Interventions to transform the culture of healthcare systems to achieve excellence in providing culturally safe care for First Nations peoples

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interventions to transform the culture of healthcare systems to achieve excellence in providing culturally safe care for First Nations peoplesBehavioural

    1. 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.
    2. 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.
    3. Support simplified and improved strategies for booking an interpreter to increase uptake.
    4. Implement retention strategies to ensure interpreters receive workplace support.
    5. Provide training in health terminology for interpreters.
    6. Integrate interpreter supply and demand through efficiency and effectiveness strategies tailored to participating sites.
    7. Implement continuous quality improvement cycles with senior managers, using findings from qualitative and quantitative data collection and evaluation.
Study groups in NCT05629416
Study groupRoleWhat they receive
Cultural safety training and behaviour change interventionExperimental- Interventions to transform the culture of healthcare systems to achieve excellence in providing culturally safe care for First Nations peoples
Receives: Behavioral: Interventions to transform the culture of healthcare systems to achieve excellence in providing culturally safe care for First Nations peoples

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self discharge among Aboriginal inpatients at Royal Darwin Hospital, Palmerston Hospital, Katherine Hospital and Gove District Hospital

    Self discharge (also referred to as 'Discharge against medical advice,', 'take own leave' or 'incomplete care') will be assessed among all admitted Aboriginal patients every quarter as a measure of the effeciveness of hospital-level study activities

    • Measured as proportion of all admissions of Aboriginal people that end in self-discharge
    • Data source: hospital Admitted Patient Care dataset (routinely collected by health services)

    The study has a two-year baseline phase July 1 2020 - June 30 2022, and four-year intervention (activity) period July 1 2022 - June 30 2026.

    There are no individually enrolled participants followed up at given time points; instead, activities are implemented continually at the level of the health systems, and outcomes are assessed using continuous hospital data and qualitative data, summarised quarterly.

    Measured: 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)

  2. Patient experience (qualitative evaluation)

    Patient experience pre- and post-implementation of the interventions will be assessed through in-depth 30-60 minute one-on-one, face-to-face interviews of inpatients and patients who have recently (within 14 days) been discharged, by a member of the research team. The research team member will speak the patient's first language, or will work with an Aboriginal interpreter to conduct the interview.

    Some individuals with repeated contact with healthservices (such as renal dialysis patients) will be invited to participate in serial interviews over time

    Measured: 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 outcomes (5)
  1. Documentation of language in hospital medical records

    Adequacy of documentation (proportion of Aboriginal patients for whom language is documented) will be used to inform quarterly quality improvement data review meetings. Data source: hospital electronic system (currently CARESYS, transitioning during the study period to ACACIA)

    Measured: Up to 4 years. (Documentation of language will be tracked throughout the 4-year intervention period.)

  2. Access to an interpreter during admission

    Interpreter access (proportion of Aboriginal patients with a language other than English as their first language) will be used to inform quarterly quality improvement data review meetings.

    Measured: Up to 4 years. (Documentation of interpreter access will be tracked throughout the 4-year intervention period.)

  3. Healthcare provider experience

    Healthcare provider experience of working with Aboriginal interpreters (qualitative evaluation) assessed by 30 minute semi-structured one-on-one, face-to-face interviews of healthcare providers with a member of the research team.

    Measured: 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

  4. Cost

    Healthcare costs will be calculated based on variables including the top 6 ICD codes per admission and hospital length of stay. Economic evaluation will be conducted from the payer perspective and include the linked Admitted Patient Care and Aboriginal Interpreter Service datasets and NTHTE Unit expenditure reports, as well as ICD codes and Australian Refined DRGs.

    Measured: 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

  5. Unplanned readmission within 28 days

    Continuous data collated monthly

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2022
  2. Study start23 May 2022
  3. Primary completion11 May 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
Interventions to transform the culture of healthcare systems to achieve excellence in providing culturally safe care for First Nations peoples
Masking
None (open label)
Enrolment
340 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05629416
Sponsor's protocol ID
2008644
Status last verified
Feb 2023
First submitted
7 Nov 2022
Last updated
16 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 35373706
  • 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.

    PubMed 34637434
  • 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.

    PubMed 34301261
  • 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.

    PubMed 34088326
  • 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.

    PubMed 32888378
  • 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.

    PubMed 32710454
  • 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.

    PubMed 32471490
  • 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.

    PubMed 29141623

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Interventions to transform the culture of healthcare systems to achieve excellence in providing culturally safe care for First Nations peoples in people with Aboriginal Health and Cultural Safety, run by Menzies School of Health Research at 4 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anna Ralph, PhD (+618 89468647, anna.ralph@menzies.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self discharge among Aboriginal inpatients at Royal Darwin Hospital, Palmerston Hospital, Katherine Hospital and Gove District Hospital (time frame: 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05629416, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.

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