Culturally safe, trauma-informed approach to cognitive impairment and dementia in older Aboriginal and Torres Strait Islander people.

BACKGROUND: The population of older (age ≥50 years) Aboriginal and Torres Strait Islander people is increasing, and the rate of dementia in this group is three to fivefold higher than in the general population. A high prevalence of risk factors across the life course likely contributes to these rates. OBJECTIVE: This paper highlights practical ways to apply best practice principles when addressing the detection of cognitive impairment and dementia in older Aboriginal and Torres Strait Islander people and its management in the context of a person's family, carers and community. DISCUSSION: Recognising culture, the collective nature of family and community decision making for a person, the ways to uphold respect for Elders and a trauma-informed approach are fundamental to the care of older Aboriginal and Torres Strait Islander people with cognitive impairment and dementia.

Murru Minya-informing the development of practical recommendations to support ethical conduct in Aboriginal and Torres Strait Islander health research: a protocol for a national mixed-methods study.

INTRODUCTION: Conducting ethical and high-quality health research is crucial for informing public health policy and service delivery to reduce the high and inequitable burden of disease experienced by Aboriginal and Torres Strait Islander people. Ethical guidelines and principles specifically for health research with Aboriginal and Torres Strait Islander people have been developed for use since 1987. However, there has been limited examination of how these are being applied to the conduct of research. METHODS AND ANALYSIS: Murru Minya will be a large-scale national study to examine the implementation of ethical processes in Aboriginal and Torres Strait Islander health research. A mixed-methods design will be used in four baarra (steps). The first three baarra will collect knowledge, experiences and wisdom from three key groups: Aboriginal and Torres Strait Islander communities, research academics, and Human Research Ethics Committees using online surveys, yarning, and semistructured interviews. This knowledge will inform the final baarra of developing a set of practical recommendations to support ethical conduct in Aboriginal and Torres Strait Islander health research into the future. ETHICS AND DISSEMINATION: Ethical approval for this research project has been granted by National, State and Territory Human Research Ethics Committees. This research has been developed in collaboration with Aboriginal and Torres Strait Islander researchers, Aboriginal Community Controlled Health Organisation representatives, Aboriginal community members, the National Health Leadership Forum, and Aboriginal and Torres Strait Islander research team. The knowledge translation plan will be integrated and revised throughout the project as partnerships and engagement with Aboriginal and Torres Strait Islander communities continue. All findings will be shared with peak Aboriginal research bodies and Aboriginal and Torres Strait Islander communities in ways that are meaningful to them.

Risk of severe illness from COVID-19 among Aboriginal and Torres Strait Islander adults: the construct of 'vulnerable populations' obscures the root causes of health inequities.

OBJECTIVE: To quantify the prevalence of known health-related risk factors for severe COVID-19 illness among Aboriginal and Torres Strait Islander adults, and their relationship with social determinants. METHODS: Weighted cross-sectional analysis of the 2018-19 National Aboriginal and Torres Strait Islander Health Survey; Odds Ratios for cumulative risk count category (0, 1, or ≥2 health-related risk factors) by social factors calculated using ordered logistic regression. RESULTS: Of the adult population, 42.9%(95%CI:40.6,45.2) had none of the examined health-related risk factors; 38.9%(36.6,41.1) had 1, and 18.2%(16.7,19.7) had ≥2. Adults experiencing relative advantage across social indicators had significantly lower cumulative risk counts, with 30-70% lower odds of being in a higher risk category. CONCLUSIONS: Aboriginal and Torres Strait Islander peoples must continue to be recognised as a priority population in all stages of pandemic preparedness and response as they have disproportionate exposure to social factors associated with risk of severe COVID-19 illness. Indigeneity itself is not a 'risk' factor and must be viewed in the wider context of inequities that impact health Implications for public health: Multi-sectoral responses are required to improve health during and after the COVID-19 pandemic that: enable self-determination; improve incomes, safety, food security and culturally-safe healthcare; and address discrimination and trauma.

Access to Aboriginal Community-Controlled Primary Health Organizations Can Explain Some of the Higher Pap Test Participation Among Aboriginal and Torres Strait Islander Women in North Queensland, Australia.

BACKGROUND: Aboriginal and Torres Strait Islander Community-Controlled Health Organisations (ACCHOs) provides culturally appropriate primary care for Aboriginal and Torres Strait Islander people in Australia. The population of North Queensland has a higher proportion of Aboriginal and Torres Strait Islander people, a greater population coverage of ACCHOs, and higher cervical screening participation than the Rest of Queensland. The association between regional differences in the use of ACCHOs for cervical screening and variations in screening participation among Aboriginal and Torres Strait Islander women is currently unknown. METHODS: This is a population-based study of 1,107,233 women, aged 20-69 years who underwent cervical screening between 2013 and 2017. Of these women, 132,972 (12%) were from North Queensland, of which 9% were identified as Aboriginal and Torres Strait Islander women (2% Rest of Queensland) through linkage to hospital records. Regional differentials in screening by Aboriginal and Torres Strait Islander status were quantified using participation rate ratios (PRRs) with 95% confidence intervals (CIs) from negative binomial regression models. Logistic regression was used to identify factors associated with Aboriginal and Torres Strait Islander women being screened at ACCHOs. RESULTS: Aboriginal and Torres Strait Islander women from North Queensland (versus) Rest of Queensland had higher odds of screening at ACCHOs after adjusting for age and area-level variables. After adjustment for non-ACCHO variables, the regional differential in screening among Aboriginal and Torres Strait Islander women was significantly higher (PRR 1.28, 95% CI 1.20-1.37) than that among other Australian women [PRR = 1.11 (1.02-1.18)], but was attenuated on further adjustment for ACCHO variables, [PRR = 1.15, (1.03-1.28)] to become similar to the corresponding point estimate for other Australian women [PRR = 1.09, (1.01-1.20)]. However, the significant interaction between Aboriginal and Torres Strait Islander status and region (p < 0.001) remained, possibly reflecting the large cohort size. Screening participation increased with better access to health services for all women. CONCLUSIONS: Improving access to primary health care for Aboriginal and Torres Strait Islander women, especially through ACCHOs, may reduce existing disparities in cervical screening participation. Further gains will require greater levels of local community engagement and understanding of the experiences of screened Aboriginal and Torres Strait Islander women to inform effective interventions.

Improving systems of prenatal and postpartum care for hyperglycemia in pregnancy: A process evaluation.

OBJECTIVE: To identify successes to date and opportunities for improvement in the implementation of a complex health systems intervention aiming to improve prenatal and postpartum care and health outcomes for women with hyperglycemia in pregnancy in regional and remote Australia. METHODS: A qualitative evaluation, underpinned by the RE-AIM framework (reach, effectiveness, adoption, implementation, maintenance), was conducted mid-intervention. Semi-structured interviews were conducted with the participants, who included clinicians, regional policymakers and managers, and study implementation staff. RESULTS: Interviewees (n = 45) reported that the early phase of the intervention had resulted in the establishment of a clinician network, increased clinician awareness of hyperglycemia in pregnancy, and improvements in management, including earlier referral for specialist care and a focus on improving communication with women. Enablers of implementation included existing relationships with stakeholders and alignment of the intervention with health service priorities. Challenges included engaging remote clinicians and the labor-intensive nature of maintaining a clinical register of women with hyperglycemia in pregnancy. CONCLUSION: The early phase of this health systems intervention has had a positive perceived impact on systems of care for women with hyperglycemia in pregnancy. Findings have informed modifications to the intervention, including the development of a communication and engagement strategy.

Enablers and barriers to primary healthcare for Aboriginal and Torres Strait Islander adolescents: study protocol for participatory mixed-methods research that builds on WHO global standards.

INTRODUCTION: One-third of Australia's Aboriginal and Torres Strait Islander population are adolescents. Recent data highlight their health needs are substantial and poorly met by existing services. To design effective models of primary healthcare, we need to understand the enablers and barriers to care for Aboriginal and Torres Strait Islander adolescents, the focus of this study. METHODS AND ANALYSIS: This protocol was codesigned with Apunipima Cape York Health Council that supports the delivery of primary healthcare for 11 communities in Far North Queensland. We framed our study around the WHO global standards for high-quality health services for adolescents, adding an additional standard around culturally safe care. The study is participatory and mixed methods in design and builds on the recommended WHO assessment tools. Formative qualitative research with young people and their communities (exploring concepts in the WHO recommended quantitative surveys) seeks to understand demand-side enablers and barriers to care, as well as preferences for an enhanced response. Supply-side enablers and barriers will be explored through: a retrospective audit of clinic data (to identify current reasons for access and what can be strengthened); an objective assessment of the adolescent friendliness of clinical spaces; anonymous feedback from adolescent clients around quality of care received and what can be improved; and surveys and qualitative interviews with health providers to understand their perspectives and needs to provide enhanced care. This codesigned project has been approved by Apunipima Cape York Health Council and Far North Queensland Human Research Ethics Committee. DISSEMINATION AND IMPLICATIONS: The findings from this project will inform a codesigned accessible and responsive model of primary healthcare for Aboriginal and Torres Strait Islander adolescents.

Global systematic review of the effects of suicide prevention interventions in Indigenous peoples.

OBJECTIVE: Suicide rates are often higher in Indigenous than in non-Indigenous peoples. This systematic review assessed the effects of suicide prevention interventions on suicide-related outcomes in Indigenous populations worldwide. METHODS: We searched CINAHL, Embase, PubMed, PsycINFO, ProQuest Dissertations & Theses and Web of Science from database inception to April 2020. Eligible were English language, empirical and peer-reviewed studies presenting original data assessing the primary outcomes of suicides and suicide attempts and secondary outcomes of suicidal ideation, intentional self-harm, suicide or intentional self-harm risk, composite measures of suicidality or reasons for life in experimental and quasi-experimental interventions with Indigenous populations worldwide. We assessed the risk of bias with the Cochrane Risk of Bias Tool and the Risk of Bias Assessment for Non-randomised Studies. FINDINGS: We included 24 studies from Australia, Canada, New Zealand and the USA, comprising 14 before-after studies, 4 randomised controlled trials (RCTs), 3 non-randomised controlled trials, 2 interrupted time-series designs and 1 cohort study. Suicides decreased in four and suicide attempts in six before-after studies. No studies had a low risk of bias. There was insufficient evidence to confirm the effectiveness of any one suicide prevention intervention due to shortage of studies, risk of bias, and population and intervention heterogeneity. Review limitations include language bias, no grey literature search and data availability bias. CONCLUSION: For the primary outcomes of suicides and suicide attempts, the limited available evidence supports multilevel, multicomponent interventions. However, there are limited RCTs and controlled studies.

Integrating Healthcare Services for Indigenous Australian Students at Boarding Schools: A Mixed-Methods Sequential Explanatory Study.

INTRODUCTION: Many Aboriginal and Torres Strait Islander Australian adolescents from remote communities attend boarding schools, requiring integrated healthcare between home and schools. This study explored students' health status, healthcare service use and satisfaction. METHODOLOGY: A two-phased mixed-methods explanatory design was implemented. 32 Indigenous primary and 188 secondary boarding school students were asked their health status, psychological distress, use of healthcare services in community and boarding school, and service satisfaction. Results were fed back to students, parents and community members, and education and healthcare staff to elicit further explanation and interpretation. RESULTS: In the previous year, 75% of primary and 81% of secondary boarding school students had visited a doctor. More than 90% were satisfied with healthcare services used. Despite 27.1% reporting high psychological distress, students did not perceive distress as reducing their overall health, nor was distress associated with mental healthcare service use. DISCUSSION: Despite high levels of service use and satisfaction, this study highlighted the need for improved healthcare integration for Indigenous adolescents between school-based and remote community services. Further research is needed to identify students' expectations and models for healthcare integration. CONCLUSION: With resourcing, schools could play a greater role in facilitating access to healthcare.

Improving Models of Care for Diabetes in Pregnancy: Experience of Current Practice in Far North Queensland, Australia.

Aims: To map health practitioners' experiences and describe knowledge regarding screening and management of Diabetes in Pregnancy (DIP) in Far North Queensland, Australia. Methods: Mixed methods including a cross-sectional survey (101 respondents) and 8 focus groups with 61 health practitioners. All participants provided clinical care for women with DIP. Results: A wide range of healthcare professionals participated; 96% worked with Indigenous women, and 63% were from regional or remote work settings. Universal screening for gestational diabetes at 24-28 weeks gestation was reported as routine with 87% using a 75 g Oral Glucose Tolerance Test. Early screening for DIP was reported by 61% although there was large variation in screening methods and who should be screened <24 weeks. Health practitioners were confident providing lifestyle advice (88%), dietary, and blood glucose monitoring education (67%, 81%) but only 50% were confident giving insulin education. Electronic medical records were used by 80% but 55% also used paper records. Dissatisfaction with information from hospitals was reported by 40%. In the focus groups improving communication and information technology systems were identified as key areas. Other barriers described were difficulties in care coordination and access for remote women. Conclusions: Communication, information technology systems, coordination of care, and education for health professionals are key areas that will be addressed by a complex health systems intervention being undertaken by the DIP Partnership in North Queensland.

Validation and Factor Analysis of the Child and Youth Resilience Measure for Indigenous Australian Boarding School Students.

Introduction: Resilience is a strengths-based construct that is useful for understanding differences in health and wellbeing among youth. There are a range of validated survey instruments available to measure resilience for Aboriginal and Torres Strait Islander (hereafter respectfully Indigenous) youth. However, standard international instruments should only be used if they have been subjected to a rigorous cross-cultural adaptation process and psychometric evaluation in the target population to ensure their validity. The aim of the study was to validate an adapted Child and Youth Resilience Measure (CYRM-28) within a sample of Indigenous Australian boarding school students. Method: The CYRM-28, augmented with an additional 11 site specific items was administered to a purposive sample of Australian Indigenous boarding school students (n = 233) as part of the broader T4S survey instrument that captures demographic information and measures resilience, psychological distress and risk, and service usage. Confirmatory factor analysis was undertaken to verify the relationship between the observed variables with the theoretical constructs of the CYRM-28 and previous findings on the factor structure. Cronbach alpha was also calculated to assess the internal consistency of the CYRM-28 within this sample. Results: Survey data were not a good fit for any previously identified models of the CYRM-28, although the inclusion of a site-specific variable improved the overall fit statistics. Two separate scales were confirmed that capture the sources and expressions of resilience for Indigenous Australian boarding school students. This structure is different to previous findings in relation to the CYRM-28, but consistent with conceptualizations of resilience as a dynamic process. Conclusions: The findings are useful in guiding the future use of the CYRM-28 instrument, explorations of Indigenous youth resilience, and for services working with Indigenous youth in out of home care situations. They highlight contextual differences in the measurement of resilience and the importance of validating standard instruments that have been subjected to rigorous cross-cultural adaptation processes. The two scales offer practical guidance to human services working with Indigenous youth on strategies to build and monitor resilience in Indigenous Australian youth and contribute to the emergent understanding of their resilience.

Study protocol: Our Cultures Count, the Mayi Kuwayu Study, a national longitudinal study of Aboriginal and Torres Strait Islander wellbeing.

INTRODUCTION: Aboriginal and Torres Strait Islander peoples are Australia's first peoples and have been connected to the land for ≥65 000 years. Their enduring cultures and values are considered critical to health and wellbeing, alongside physical, psychological and social factors. We currently lack large-scale data that adequately represent the experiences of Aboriginal and Torres Strait Islander people; the absence of evidence on cultural practice and expression is particularly striking, given its foundational importance to wellbeing. METHOD AND ANALYSIS: Mayi Kuwayu: The National Study of Aboriginal and Torres Strait Islander Wellbeing (Mayi Kuwayu Study) will be a large-scale, national longitudinal study of Aboriginal and Torres Strait Islander adults, with linkage to health-related administrative records. The baseline survey was developed through extensive community consultation, and includes items on: cultural practice and expression, sociodemographic factors, health and wellbeing, health behaviours, experiences and environments, and family support and connection. The baseline survey will be mailed to 200 000 Aboriginal and Torres Strait Islander adults (≥16 years), yielding an estimated 16 000-40 000 participants, supplemented through face-to-face recruitment. Follow-up surveys will be conducted every 3-5 years, or as funding allows. The Mayi Kuwayu Study will contribute to filling key evidence gaps, including quantifying the contribution of cultural factors to wellbeing, alongside standard elements of health and risk. ETHICS AND DISSEMINATION: This study has received approval from national Human Research Ethics Committees, and from State and Territory committees, including relevant Aboriginal and Torres Strait Islander organisations. The study was developed and is conducted in partnership with Aboriginal and Torres Strait Islander organisations across states and territories. It will provide an enduring and shared infrastructure to underpin programme and policy development, based on measures and values important to Aboriginal and Torres Strait Islander peoples. Approved researchers can access confidentialised data and disseminate findings according to study data access and governance protocols.

Validation and recalibration of the Framingham cardiovascular disease risk models in an Australian Indigenous cohort.

Background In Australia, clinical guidelines for primary prevention of cardiovascular disease recommend the use of the Framingham model to help identify those at high risk of developing the disease. However, this model has not been validated for the Indigenous population. Design Cohort study. Methods Framingham models were applied to the Well Person's Health Check (WPHC) cohort (followed 1998-2014), which included 1448 Aboriginal and Torres Strait Islanders from remote Indigenous communities in Far North Queensland. Cardiovascular disease risk predicted by the original and recalibrated Framingham models were compared with the observed risk in the WPHC cohort. Results The observed five- and 10-year cardiovascular disease probability of the WPHC cohort was 10.0% (95% confidence interval (CI): 8.5-11.7) and 18.7% (95% CI: 16.7-21.0), respectively. The Framingham models significantly underestimated the cardiovascular disease risk for this cohort by around one-third, with a five-year cardiovascular disease risk estimate of 6.8% (95% CI: 6.4-7.2) and 10-year risk estimates of 12.0% (95% CI: 11.4-12.6) and 14.2% (95% CI: 13.5-14.8). The original Framingham models showed good discrimination ability (C-statistic of 0.67) but a significant lack of calibration (χ2 between 82.56 and 134.67). After recalibration the 2008 Framingham model corrected the underestimation and improved the calibration for five-year risk prediction (χ2 of 18.48). Conclusions The original Framingham models significantly underestimate the absolute cardiovascular disease risk for this Australian Indigenous population. The recalibrated 2008 Framingham model shows good performance on predicting five-year cardiovascular disease risk in this population and was used to calculate the first risk chart based on empirical validation using long-term follow-up data from a remote Australian Indigenous population.

Economic evaluation of Indigenous health worker management of poorly controlled type 2 diabetes in north Queensland.

OBJECTIVE: To conduct an economic evaluation of intensive management by Indigenous health workers (IHWs) of Indigenous adults with poorly controlled type 2 diabetes in rural and remote north Queensland. DESIGN: Cost-consequence analysis alongside a cluster randomised controlled trial of an intervention delivered between 1 March 2012 and 5 September 2013. SETTING: Twelve primary health care services in rural and remote north Queensland communities with predominantly Indigenous populations. PARTICIPANTS: Indigenous adults with poorly controlled type 2 diabetes (HbA1c ≥ 69 mmol/mol) and at least one comorbidity (87 people in six IHW-supported communities (IHW-S); 106 in six usual care (UC) communities). MAIN OUTCOME MEASURES: Per person cost of the intervention; differential changes in mean HbA1c levels, percentage with extremely poor HbA1c level control, quality of life, disease progression, and number of hospitalisations. RESULTS: The mean cost of the 18-month intervention trial was $10 060 per person ($6706 per year). The intervention was associated with a non-significantly greater reduction in mean HbA1c levels in the IHW-S group (-10.1 mmol/mol v -5.4 mmol/mol in the UC group; P = 0.17), a significant reduction in the proportion with extremely poor diabetes control (HbA1c ≥ 102 mmol/mol; P = 0.002), and a sub-significant differential reduction in hospitalisation rates for type 2 diabetes as primary diagnosis (-0.09 admissions/person/year; P = 0.06), with a net reduction in mean annual hospital costs of $646/person (P = 0.07). Quality of life utility scores declined in both groups (between-group difference, P = 0.62). Rates of disease progression were high in both groups (between-group difference, P = 0.73). CONCLUSION: Relative to the high cost of the intervention, the IHW-S model as implemented is probably a poor investment. Incremental cost-effectiveness might be improved by a higher caseload per IHW, a longer evaluation time frame, and improved service integration. Further approaches to improving chronic disease outcomes in this very unwell population need to be explored, including holistic approaches that address the complex psychosocial, pathophysiological and environmental problems of highly disadvantaged populations. TRIAL REGISTRATION: ANZCTR12610000812099.

Psycho-social resilience, vulnerability and suicide prevention: impact evaluation of a mentoring approach to modify suicide risk for remote Indigenous Australian students at boarding school.

BACKGROUND: The proposed study was developed in response to increased suicide risk identified in Aboriginal and Torres Strait Islander students who are compelled to attend boarding schools across Queensland when there is no secondary schooling provision in their remote home communities. It will investigate the impact of a multicomponent mentoring intervention to increase levels of psychosocial resilience. We aim to test the null hypothesis that students' resilience is not positively influenced by the intervention. The 5-year project was funded by the Australian National Health and Medical Research Council from December 2014. METHODS/DESIGN: An integrated mixed methods approach will be adopted; each component iteratively informing the other. Using an interrupted time series design, the primary research methods are quantitative: 1) assessment of change in students' resilience, educational outcomes and suicide risk; and 2) calculation of costs of the intervention. Secondary methods are qualitative: 3) a grounded theoretical model of the process of enhancing students' psychosocial resilience to protect against suicide. Additionally, there is a tertiary focus on capacity development: more experienced researchers in the team will provide research mentorship to less experienced researchers through regular meetings; while Indigenous team members provide cultural mentorship in research practices to non-Indigenous members. DISCUSSION: Australia's suicide prevention policy is progressive but a strong service delivery model is lacking, particularly for Indigenous peoples. The proposed research will potentially improve students' levels of resilience to mitigate against suicide risk. Additionally, it could reduce the economic and social costs of Indigenous youth suicide by obtaining agreement on what is good suicide prevention practice for remote Indigenous students who transition to boarding schools for education, and identifying the benefits-costs of an evidence-based multi-component mentoring intervention to improve resilience.

Aboriginal community controlled health services: leading the way in primary care.

The national Closing the Gap framework commits to reducing persisting disadvantage in the health of Aboriginal and Torres Strait Islander people in Australia, with cross-government-sector initiatives and investment. Central to efforts to build healthier communities is the Aboriginal community controlled health service (ACCHS) sector; its focus on prevention, early intervention and comprehensive care has reduced barriers to access and unintentional racism, progressively improving individual health outcomes for Aboriginal people. There is now a broad range of primary health care data that provides a sound evidence base for comparing the health outcomes for Indigenous people in ACCHSs with the outcomes achieved through mainstream services, and these data show: models of comprehensive primary health care consistent with the patient-centred medical home model; coverage of the Aboriginal population higher than 60% outside major metropolitan centres; consistently improving performance in key performance on best-practice care indicators; and superior performance to mainstream general practice. ACCHSs play a significant role in training the medical workforce and employing Aboriginal people. ACCHSs have risen to the challenge of delivering best-practice care and there is a case for expanding ACCHSs into new areas. To achieve the best returns, the current mainstream Closing the Gap investment should be shifted to the community controlled health sector.

Evaluation of the pilot phase of an Aboriginal and Torres Strait Islander Male Health Module.

This article evaluates the pilot phase of an Aboriginal and Torres Strait Islander Male Health Module. Although men experience higher levels of illness and die younger than women, educational programs to support health workers utilise a gender-based approach to increase participation of Aboriginal and Torres Strait Islander males in health care are rare and lack appropriate content. Recognising this gap in service provision, and under the guidance of a Reference Group comprising community leaders in Aboriginal and Torres Strait male health, a comprehensive and culturally appropriate Male Health Module has been developed to enhance the capacity of health workers to improve access to services for Aboriginal and Torres Strait Islander males. Methods used were: in-depth interviews with Module developers, pilot workshops for trainers and health workers, questionnaires and focus group discussions with workshop participants, and participant observations. As well as enhancing capacity to facilitate access to health services for men, the Module was deemed relevant because of its potential to promote health worker empowerment and wellbeing. Findings revealed that improving access to services for men required male and female health workers working in partnership. Despite overall enthusiasm for the Module, the findings also revealed deep fear that it would end up 'collecting dust on shelves'. Strategies to improve the Module quality and accessibility are highlighted.

Getting better at chronic care in remote communities: study protocol for a pragmatic cluster randomised controlled of community based management.

BACKGROUND: Prevalence and incidence of diabetes and other common comorbid conditions (hypertension, coronary heart disease, renal disease and chronic lung disease) are extremely high among Indigenous Australians. Recent measures to improve quality of preventive care in Indigenous community settings, while apparently successful at increasing screening and routine check-up rates, have shown only modest or little improvements in appropriate care such as the introduction of insulin and other scaled-up drug regimens in line with evidence-based guidelines, together with support for risk factor reduction. A new strategy is required to ensure high quality integrated family-centred care is available locally, with continuity and cultural safety, by community-based care coordinators with appropriate system supports. METHODS/DESIGN: The trial design is open parallel cluster randomised controlled trial. The objective of this pragmatic trial is to test the effectiveness of a model of health service delivery that facilitates integrated community-based, intensive chronic condition management, compared with usual care, in rural and remote Indigenous primary health care services in north Queensland. Participants are Indigenous adults (aged 18-65 years) with poorly controlled diabetes (HbA1c>=8.5) and at least one other chronic condition. The intervention is to employ an Indigenous Health Worker to case manage the care of a maximum caseload of 30 participants. The Indigenous Health Workers receive intensive clinical training initially, and throughout the study, to ensure they are competent to coordinate care for people with chronic conditions. The Indigenous Health Workers, supported by the local primary health care (PHC) team and an Indigenous Clinical Support Team, will manage care, including coordinating access to multidisciplinary team care based on best practice standards. Allocation by cluster to the intervention and control groups is by simple randomisation after participant enrolment. Participants in the control group will receive usual care, and will be wait-listed to receive a revised model of the intervention informed by the data analysis. The primary outcome is reduction in HbA1c measured at 18 months. Implementation fidelity will be monitored and a qualitative investigation (methods to be determined) will aim to identify elements of the model which may influence health outcomes for Indigenous people with chronic conditions. DISCUSSION: This pragmatic trial will test a culturally-sound family-centred model of care with supported case management by IHWs to improve outcomes for people with complex chronic care needs. This trial is now in the intervention phase. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTR12610000812099.