Breaking the cycle: Effect of a multi-agency maternity service redesign on reducing the over-representation of Aboriginal and Torres Strait Islander newborns in out-of-home care: A prospective, non-randomised, intervention study in urban Australia.

BACKGROUND: Strategies to reduce over-representation of Indigenous children in out-of-home care must start in pregnancy given Indigenous babies are 6 % of infants (<1 year), yet 43 % of infants in out-of-home care. OBJECTIVE: To determine if an Indigenous-led, multi-agency, partnership redesign of maternity services decreases the likelihood of babies being removed at birth. PARTICIPANTS AND SETTING: Women carrying an Indigenous baby/babies who gave birth at the Mater Mothers' Public Hospital, Brisbane (2013-2019). METHODS: A prospective, non-randomised, intervention trial evaluated a multi-agency service redesign. Women pregnant with an Indigenous baby birthing at a tertiary hospital were offered standard care or Birthing in Our Community (BiOC) service. We compared likelihood of babies being removed by Child Protection Services (CPS) at birth by model of care. Inverse probability of treatment propensity score weighting controlled baseline confounders and calculated treatment effect. Standardized differences were calculated to assess balance of risk factors for each copy of multiple imputation. Australian New Zealand Clinical Trial Registry, ACTRN12618001365257. RESULTS: In 2013-2019, 1988 women gave birth to 2044 Indigenous babies, with 40 women having babies removed at birth (9 BiOC, 31 standard care). Adjusted odds of baby removal were significantly lower for mothers in BiOC compared to standard care (AOR 0.37, 95 % CI 0.16, 0.84). In total, 2.0 % of Indigenous babies were removed by CPS; eight times higher than non-Indigenous babies at the same hospital (0.25 %). CONCLUSIONS: BiOC reduced removals of newborn Indigenous babies likely disrupting generational cycles of CPS contact, trauma, and maltreatment, and contributing to short and long-term health and wellbeing benefits for mothers and babies.

Using EMPOWER in daily life: a qualitative investigation of implementation experiences.

BACKGROUND: Digital self-management tools blended with clinical triage and peer support have the potential to improve access to early warning signs (EWS) based relapse prevention in schizophrenia care. However, the implementation of digital interventions in psychosis can be poor. Traditionally, research focused on understanding how people implement interventions has focused on the perspectives of mental health staff. Digital interventions are becoming more commonly used by patients within the context of daily life, which means there is a need to understand implementation from the perspectives of patients and carers. METHODS: Semi-structured one-on-one interviews with 16 patients who had access to the EMPOWER digital self-management intervention during their participation in a feasibility trial, six mental health staff members who supported the patients and were enrolled in the trial, and one carer participant. Interviews focused on understanding implementation, including barriers and facilitators. Data were coded using thematic analysis. RESULTS: The intervention was well implemented, and EMPOWER was typically perceived positively by patients, mental health staff and the carer we spoke to. However, some patients reported negative views and reported ideas for intervention improvement. Patients reported valuing that the app afforded them access to things like information or increased social contact from peer support workers that went above and beyond that offered in routine care. Patients seemed motivated to continue implementing EMPOWER in daily life when they perceived it was creating positive change to their wellbeing, but seemed less motivated if this did not occur. Mental health staff and carer views suggest they developed increased confidence patients could self-manage and valued using the fact that people they support were using the EMPOWER intervention to open up conversations about self-management and wellbeing. CONCLUSIONS: The findings from this study suggest peer worker supported digital self-management like EMPOWER has the potential to be implemented. Further evaluations of these interventions are warranted, and conducting qualitative research on the feasibility gives insight into implementation barriers and facilitators, improving the likelihood of interventions being usable. In particular, the views of patients who demonstrated low usage levels would be valuable.

Work Stress, Vicarious Trauma and the Public Mental Health Framework: Kozarov v Victoria [2022] HCA 12 and Its Aftermath.

The Public Mental Health Framework argues that law and policy are important in preventing mental ill-health and promoting wellbeing. Therefore, the 2022 decision of the Australian High Court in Kozarov v Victoria (Kozarov), in which a lawyer from the Office of Public Prosecutions (OPP) who worked in the Specialist Sex Offences Unit successfully claimed damages for vicarious trauma, has significant implications for the legal profession and those who are employed in emotionally demanding work. This article provides commentary on the Kozarov decision, within the context of other Australian case law including subsequent cases. It explores the significance of Kozarov and post-Kozarov authority for the development of (1) the law in "work stress" cases; (2) employers in the wake of the decision, including the OPP; and (3) the Public Mental Health Framework in relation to work stress and sexual violence as social determinants of health and mental health.

Psychiatric advance directives and consent to electroconvulsive therapy (ECT) in Australia: A legislative review and suggestions for the future.

Psychiatric Advance Directives (PADs) have been adopted in many jurisdictions around the world and in most Australian states and territories. They are seen as a less restrictive and patient-centered approach to the provision of mental health care. Electroconvulsive therapy (ECT) is a restricted treatment in most jurisdictions in Australia and across the world. This paper explores the history, regulation and use of ECT and PADs and the intersections between them. It provides an overview of the legislative framework in each Australian state and territory and explores some of the issues which have arisen such as complexity of the regulatory framework, making PADs binding for refusing and consenting to ECT, involving treating teams in how PADs are made, using restrictive interventions to implement PADs, and the role of the Tribunal. While PADs are often framed as an important legal tool for allowing patients to refuse psychiatric treatment (especially ECT), the paper emphasizes that they can also be an innovative way for people to consent to psychiatric treatment in advance and an empowering option to access mental health care. It then makes some suggestions for future reform.

Effect of a Birthing on Country service redesign on maternal and neonatal health outcomes for First Nations Australians: a prospective, non-randomised, interventional trial.

BACKGROUND: There is an urgency to redress unacceptable maternal and infant health outcomes for First Nations families in Australia. A multi-agency partnership between two Aboriginal Community-controlled health services and a tertiary hospital in urban Australia designed, implemented, and evaluated the new Birthing in Our Community (BiOC) service. In this study, we aimed to assess and report the clinical effectiveness of the BiOC service on key maternal and infant health outcomes compared with that of standard care. METHODS: Pregnant women attending the Mater Mothers Public Hospital (Brisbane, QLD, Australia) who were having a First Nations baby were invited to receive the BiOC service. In this prospective, non-randomised, interventional trial of the service, we specifically enrolled women who intended to birth at the study hospital, and had a referral from a family doctor or Aboriginal Medical Service. Participants were offered either standard care services or the BiOC service. Prespecified primary outcomes to test the effectiveness of the BiOC service versus standard care were the proportion of women attending five or more antenatal visits, smoking after 20 weeks of gestation, who had a preterm birth (<37 weeks), and who were exclusively breastfeeding at discharge from hospital. We used inverse probability of treatment weighting to balance confounders and calculate treatment effect. This trial is registered with the Australian New Zealand Clinical Trial Registry, ACTRN12618001365257. FINDINGS: Between Jan 1, 2013, and June 30, 2019, 1867 First Nations babies were born at the Mater Mothers Public Hospital. After exclusions, 1422 women received either standard care (656 participants) or the BiOC service (766 participants) and were included in the analyses. Women receiving the BiOC service were more likely to attend five or more antenatal visits (adjusted odds ratio 1·54, 95% CI 1·13-2·09; p=0·0064), less likely to have an infant born preterm (0·62, 0·42-0·93; p=0·019), and more likely to exclusively breastfeed on discharge from hospital (1·34, 1·06-1·70; p=0·014). No difference was found between the two groups for smoking after 20 weeks of gestation, with both showing a reduction compared with smoking levels reported at their hospital booking visit. INTERPRETATION: This study has shown the clinical effectiveness of the BiOC service, which was co-designed by stakeholders and underpinned by Birthing on Country principles. The widespread scale-up of this new service should be prioritised. Dedicated funding, knowledge translation, and implementation science are needed to ensure all First Nations families can access Birthing on Country services that are adapted for their specific contexts. FUNDING: Australian National Health and Medical Research Council.

Perspectives of Trial Staff on the Barriers to Recruitment in a Digital Intervention for Psychosis and How to Work Around Them: Qualitative Study Within a Trial.

BACKGROUND: Recruitment processes for clinical trials of digital interventions for psychosis are seldom described in detail in the literature. Although trial staff have expertise in describing barriers to and facilitators of recruitment, a specific focus on understanding recruitment from the point of view of trial staff is rare, and because trial staff are responsible for meeting recruitment targets, a lack of research on their point of view is a key limitation. OBJECTIVE: The primary aim of this study was to understand recruitment from the point of view of trial staff and discover what they consider important. METHODS: We applied pluralistic ethnographic methods, including analysis of trial documents, observation, and focus groups, and explored the recruitment processes of the EMPOWER (Early Signs Monitoring to Prevent Relapse in Psychosis and Promote Well-being, Engagement, and Recovery) feasibility trial, which is a digital app-based intervention for people diagnosed with schizophrenia. RESULTS: Recruitment barriers were categorized into 2 main themes: service characteristics (lack of time available for mental health staff to support recruitment, staff turnover, patient turnover [within Australia only], management styles of community mental health teams, and physical environment) and clinician expectations (filtering effects and resistance to research participation). Trial staff negotiated these barriers through strategies such as emotional labor (trial staff managing feelings and expressions to successfully recruit participants) and trying to build relationships with clinical staff working within community mental health teams. CONCLUSIONS: Researchers in clinical trials for digital psychosis interventions face numerous recruitment barriers and do their best to work flexibly and to negotiate these barriers and meet recruitment targets. The recruitment process appeared to be enhanced by trial staff supporting each other throughout the recruitment stage of the trial.

The COVID-19 pandemic and the human rights of persons with mental and cognitive impairments subject to coercive powers in Australia.

The purpose of this paper is to explore the effect of the COVID-19 pandemic on the human rights of persons with mental and cognitive impairments subject to coercive powers in Australia. It sets out the relevant human rights in the Convention on the Rights of Persons with Disabilities which have been engaged by the COVID-19 pandemic and the government's response to it. It examines the effect of emergency legislation on the relaxation of human rights safeguards in mental health laws, with a focus on mental health tribunals (although it is limited by a lack of published decisions and gaps in publicly available information). However, some of the issues created for persons with disabilities during the COVID-19 pandemic are evident in some decisions published by the New South Wales Guardianship Tribunal. The paper critically analyses two guardianship decisions UZX [2020] NSWCATGD 3 (3 April, 2020) and GZK [2020] NSWCATGD 5 (23 April, 2020) and some emergency South Australian legislation COVID-19 Emergency Response Act, 2020 (SA) Schedule 1 to demonstrate the ways in which the human rights of persons with mental and cognitive impairments can be more at risk than those of the general population, even when the general population is itself in "lockdown."

Early Signs Monitoring to Prevent Relapse in Psychosis and Promote Well-Being, Engagement, and Recovery: Protocol for a Feasibility Cluster Randomized Controlled Trial Harnessing Mobile Phone Technology Blended With Peer Support.

BACKGROUND: Relapse in schizophrenia is a major cause of distress and disability and is predicted by changes in symptoms such as anxiety, depression, and suspiciousness (early warning signs [EWSs]). These can be used as the basis for timely interventions to prevent relapse. However, there is considerable uncertainty regarding the implementation of EWS interventions. OBJECTIVE: This study was designed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) against treatment as usual (TAU). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings. We will assess the feasibility of candidate primary outcomes, candidate secondary outcomes, and candidate mechanisms for a definitive trial. METHODS: We will randomize CMHSs to EMPOWER or TAU. We aim to recruit up to 120 service user participants from 8 CMHSs and follow them for 12 months. Eligible service users will (1) be aged 16 years and above, (2) be in contact with local CMHSs, (3) have either been admitted to a psychiatric inpatient service or received crisis intervention at least once in the previous 2 years for a relapse, and (4) have an International Classification of Diseases-10 diagnosis of a schizophrenia-related disorder. Service users will also be invited to nominate a carer to participate. We will identify the feasibility of the main trial in terms of recruitment and retention to the study and the acceptability, usability, safety, and outcome signals of the EMPOWER intervention. EMPOWER is a mobile phone app that enables the monitoring of well-being and possible EWSs of relapse on a daily basis. An algorithm calculates changes in well-being based on participants' own baseline to enable tailoring of well-being messaging and clinical triage of possible EWSs. Use of the app is blended with ongoing peer support. RESULTS: Recruitment to the trial began September 2018, and follow-up of participants was completed in July 2019. Data collection is continuing. The database was locked in July 2019, followed by analysis and disclosing of group allocation. CONCLUSIONS: The knowledge gained from the study will inform the design of a definitive trial including finalizing the delivery of our digital health intervention, sample size estimation, methods to ensure successful identification, consent, randomization, and follow-up of participants, and the primary and secondary outcomes. The trial will also inform the final health economic model to be applied in the main trial. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 99559262; http://isrctn.com/ISRCTN99559262. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/15058.

The Abolition or Reform of Mental Health Law: How Should the Law Recognise and Respond to the Vulnerability of Persons with Mental Impairment?

Vulnerability theory challenges the assumption that human beings are abstract and invulnerable liberal subjects and insists that any decent and just society must create law that takes into account and tries to ameliorate human vulnerability. In this article, I explore how vulnerability might apply in the context of the debate about the future of mental health law that has arisen since the entry into force of the Convention on the Rights of Persons with Disabilities (CRPD) in 2008; namely, whether mental health law should be abolished or reformed. In doing so, this article addresses three key issues: (i) how to conceptualise vulnerability; (ii) whether persons with mental impairments really are vulnerable and in what ways; and (iii) how the law should respond to the vulnerability of persons with mental impairments post-CRPD. It describes and compares three different approaches with respect to how well they address vulnerability: the Abolition with Support, Mental Capacity with Support, and the Support Except Where There is Harm Models. It argues that the law should try to accurately capture and ameliorate the vulnerability of those who are subject to it as much as possible. It also argues that from a vulnerability perspective, the reform of mental health law may be better than its abolition and that decreasing the vulnerability of persons with mental impairment requires systemic reform, resources, and cultural change.

The Indigenous Birthing in an Urban Setting study: the IBUS study : A prospective birth cohort study comparing different models of care for women having Aboriginal and Torres Strait Islander babies at two major maternity hospitals in urban South East Queensland, Australia.

BACKGROUND: With persisting maternal and infant health disparities, new models of maternity care are needed to meet the needs of Aboriginal and Torres Strait Islander people in Australia. To date, there is limited evidence of successful and sustainable programs. Birthing on Country is a term used to describe an emerging evidence-based and community-led model of maternity care for Indigenous families; its impact requires evaluation. METHODS: Mixed-methods prospective birth cohort study comparing different models of care for women having Aboriginal and Torres Strait Islander babies at two major maternity hospitals in urban South East Queensland (2015-2019). Includes women's surveys (approximately 20 weeks gestation, 36 weeks gestation, two and six months postnatal) and infant assessments (six months postnatal), clinical outcomes and cost comparison, and qualitative interviews with women and staff. DISCUSSION: This study aims to evaluate the feasibility, acceptability, sustainability, clinical and cost-effectiveness of a Birthing on Country model of care for Aboriginal and Torres Strait Islander families in an urban setting. If successful, findings will inform implementation of the model with similar communities. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry # ACTRN12618001365257 . Registered 14 August 2018 (retrospectively registered).

Birthing on Country (in Our Community): a case study of engaging stakeholders and developing a best-practice Indigenous maternity service in an urban setting.

Developing high-quality and culturally responsive maternal and infant health services is a critical part of 'closing the gap' in health disparities between Aboriginal and Torres Strait Islander people and other Australians. The National Maternity Services Plan led work that describes and recommends Birthing on Country best-practice maternity care adaptable from urban to very remote settings, yet few examples exist in Australia. This paper demonstrates Birthing on Country principles can be applied in the urban setting, presenting our experience establishing and developing a Birthing on Country partnership service model in Brisbane, Australia. An initial World Café workshop effectively engaged stakeholders, consumers and community members in service planning, resulting in a multiagency partnership program between a large inner city hospital and two local Aboriginal Community-Controlled Health Services (ACCHS). The Birthing in Our Community program includes: 24/7 midwifery care in pregnancy to six weeks postnatal by a named midwife, supported by Indigenous health workers and a team coordinator; partnership with the ACCHS; oversight from a steering committee, including Indigenous governance; clinical and cultural supervision; monthly cultural education days; and support for Indigenous student midwives through cadetships and placement within the partnership. Three years in, the partnership program is proving successful with clients, as well as showing early signs of improved maternal and infant health outcomes.

Education and training of clinical and translational study investigators and research coordinators: A competency-based approach.

INTRODUCTION: Training for the clinical research workforce does not sufficiently prepare workers for today's scientific complexity; deficiencies may be ameliorated with training. The Enhancing Clinical Research Professionals' Training and Qualifications developed competency standards for principal investigators and clinical research coordinators. METHODS: Clinical and Translational Science Awards representatives refined competency statements. Working groups developed assessments, identified training, and highlighted gaps. RESULTS: Forty-eight competency statements in 8 domains were developed. CONCLUSIONS: Training is primarily investigator focused with few programs for clinical research coordinators. Lack of training is felt in new technologies and data management. There are no standardized assessments of competence.

Enhancing Clinical Research Professionals' Training and Qualifications (ECRPTQ): Recommendations for Good Clinical Practice (GCP) training for investigators and study coordinators.

INTRODUCTION: The translation of discoveries to drugs, devices, and behavioral interventions requires well-prepared study teams. Execution of clinical trials remains suboptimal due to varied quality in design, execution, analysis, and reporting. A critical impediment is inconsistent, or even absent, competency-based training for clinical trial personnel. METHODS: In 2014, the National Center for Advancing Translational Science (NCATS) funded the project, Enhancing Clinical Research Professionals' Training and Qualifications (ECRPTQ), aimed at addressing this deficit. The goal was to ensure all personnel are competent to execute clinical trials. A phased structure was utilized. RESULTS: This paper focuses on training recommendations in Good Clinical Practice (GCP). Leveraging input from all Clinical and Translational Science Award hubs, the following was recommended to NCATS: all investigators and study coordinators executing a clinical trial should understand GCP principles and undergo training every 3 years, with the training method meeting the minimum criteria identified by the International Conference on Harmonisation GCP. CONCLUSIONS: We anticipate that industry sponsors will acknowledge such training, eliminating redundant training requests. We proposed metrics to be tracked that required further study. A separate task force was composed to define recommendations for metrics to be reported to NCATS.

The concept of capacity in Australian mental health law reform: Going in the wrong direction?

The six Australian states and two territories each have legislation that enables the involuntary detention and treatment of individuals diagnosed with mental illness who are considered in need of treatment and where there is evidence of a risk of harm to self or others. A number of governments have undertaken or are currently undertaking reviews of mental health laws in light of the Australian Government's ratification of the Convention on the Rights of Persons with Disabilities. While United Nations bodies have made it clear that laws which enable the detention of and substituted decision-making for persons with disabilities should be abolished, debates in Australia about the reform of mental health legislation have largely focused on Article 12 of the CRPD and what is meant by the right of persons with disabilities to enjoy legal capacity on an equal basis with others. It is argued that a more holistic view of the CRPD rather than the current narrow focus on Article 12 would best serve the needs of persons with mental impairments.

Detention and treatment down under: human rights and mental health laws in Australia and New Zealand.

Mental health law reform in recent decades has drawn on the international human rights movement. The entering into force of the Convention on the Rights of Persons with Disabilities (CRPD) on May 3 2008 has been hailed by some as signalling a new era in relation to how domestic mental health laws should be reformed. Both Australia and New Zealand have ratified the CRPD and Australia has acceded to its Optional Protocol. New Zealand and the Australian Capital Territory and Victoria have statutory bills of rights which have an interpretive effect, but are unable to render other statutes invalid. Drawing on the results of interviews conducted with fifty-two representatives of consumer and carer organisations, lawyers, and mental health professionals across Australia and New Zealand, this paper examines the current thinking on human rights and mental health laws in these countries and outlines what changes, if any, may be brought to domestic legislation in light of the Convention.