Public involvement in Australian clinical trials: A systematic review.

BACKGROUND: Public involvement enhances the relevance, quality, and impact of research. There is some evidence that public involvement in Australian research lags other countries, such as the United Kingdom. The purpose of the systematic review was to establish the rates and describe the characteristics of public involvement in Australian clinical trials. METHODS: We reviewed evidence of public involvement in all Australian randomised controlled trials published in the first 6 months of 2021. To determine the quality of public involvement, we used the five-item short-form version of the Guidance of Reporting Involvement Patients and the Public, version 2. RESULTS: In total, 325 randomised controlled trials were included, of which 17 (5%) reported any public involvement. Six trials reported public involvement in setting the research aim and seven in developing study methods. The authors of one study reflected on the overall role and influence of public involvement in the research. CONCLUSION: Rate of public involvement in Australian clinical trials is seemingly substantially lower than those reported in countries with similar advanced public health care systems, notably the United Kingdom. Our observations may be explained by a lack of researcher skills in how to involve the public and the failure by major funding agencies in Australia to mandate public involvement when deciding on how to award grant funding.

Creating "an oasis of hope, inclusion and connection": students and stakeholders' experiences of a pilot Recovery College.

BACKGROUND: Recovery Colleges are an innovative approach to promoting personal recovery for people experiencing mental illness. AIMS: This study was to explore experiences of students, supporters, staff, educators and external stakeholders (i.e. partner organisations) of a pilot Recovery College in the Australian Capital Territory (ACTRC), and the impact of participation in the College for students and supporters. METHODS: ACTRC students, supporters, staff and educators, and external stakeholders were invited to participate in a mixed-method evaluation via an online survey, interviews and/or focus groups. The survey included questions regarding experiences and recovery-orientation of the College environment, and for students and supporters only, satisfaction with the College. Qualitative data from interviews and focus groups was inductively coded, thematically analysed and triangulated with survey responses. RESULTS: The findings suggest that the ACTRC provides a safe space, promotes meaningful connections within and beyond the college, and offers steppingstones supporting recovery and growth. Participants spoke positively about cross institutional partnerships and collaboration with several organisations within the ACT. CONCLUSIONS: This evaluation reiterates the role of Recovery Colleges as an innovative approach to promoting personal recovery for people living with mental illness. Adequate resourcing and collaboration are essential in realising the value of co-production whilst ensuring sustainability.

Constructing recovery: A Lived Experience and post-structuralist exploration of how the meaning of personal recovery and rehabilitation has changed over time.

OBJECTIVE: This article explores how the concept of 'recovery' has been much debated and often sits at odds with our notion of rehabilitation. METHOD: This article provides a Lived Experience and post-structural commentary on the ever-changing meaning of recovery and rehabilitation. RESULTS: Building on the contemporary Consumer Movement's use of the term recovery, this article explores how constructions of recovery try to create a boundary which stops people being invalidated based on their experience, or perceived experience, of mental distress. The concept of recovery has insufficiently influenced rehabilitation practices. Recovery is also frequently reappropriated, often with no or minimal consumer input, and reconstructed in line with notions of progress and improvement. CONCLUSION: People with Lived Experience have challenged the concept of rehabilitation; however, rehabilitation may still have relevance if it is redefined according to Lived Experience values and recovery-oriented practice.

Community-based models of care facilitating the recovery of people living with persistent and complex mental health needs: a systematic review and narrative synthesis.

Objective: This study aims to assess the effectiveness of community-based models of care (MoCs) supporting the recovery of individuals who experience persistent and complex mental health needs. Method: We conducted a systematic review and narrative synthesis of MoC studies reporting clinical, functional, or personal recovery from October 2016 to October 2021. Sources were Medline, EMBASE, PsycInfo, CINAHL, and Cochrane databases. Studies were grouped according to MoC features. The narrative synthesis was led by our researchers with lived experience. Results: Beneficial MoCs ranged from well-established to novel and updated models and those explicitly addressing recovery goals and incorporating peer support: goal-focused; integrated community treatment; intensive case management; partners in recovery care coordination; rehabilitation and recovery-focused; social and community connection-focused; supported accommodation; and vocational support. None of our diverse group of MoCs supporting recovery warranted a rating of best practice. Established MoCs, such as intensive case management, are promising practices regarding clinical and functional recovery, with potential for enhancements to support personal recovery. Emerging practice models that support personal and functional recovery are those where consumer goals and priorities are central. Conclusion: Evidence for established models of care shows that there is a need for inevitable evolution and adaptation. Considering the high importance of effective MoCs for people experiencing persistent and complex mental health needs, further attention to service innovation and research is required. Greater emphasis on the inclusion of lived and living experience in the design, delivery, implementation, and research of MoCs is needed, to enhance MOCs' relevance for achieving individual consumer recovery outcomes.

Community-based social interventions for people with severe mental illness: a systematic review and narrative synthesis of recent evidence.

People living with severe mental illness (SMI) are one of the most marginalized groups in society. Interventions which aim to improve their social and economic participation are of crucial importance to clinicians, policy-makers and people with SMI themselves. We conducted a systematic review of the literature on social interventions for people with SMI published since 2016 and collated our findings through narrative synthesis. We found an encouragingly large amount of research in this field, and 72 papers met our inclusion criteria. Over half reported on the effectiveness of interventions delivered at the service level (supported accommodation, education or employment), while the remainder targeted individuals directly (community participation, family interventions, peer-led/supported interventions, social skills training). We identified good evidence for the Housing First model of supported accommodation, for the Individual Placement and Support model of supported employment, and for family psychoeducation, with the caveat that a range of models are nonetheless required to meet the varied housing, employment and family-related needs of individuals. Our findings also highlighted the importance of contextual factors and the need to make local adaptations when "importing" interventions from elsewhere. We found that augmentation strategies to enhance the effectiveness of social interventions (particularly supported employment and social skills training) by addressing cognitive impairments did not lead to transferable "real life" skills despite improvements in cognitive function. We also identified an emerging evidence base for peer-led/supported interventions, recovery colleges and other interventions to support community participation. We concluded that social interventions have considerable benefits but are arguably the most complex in the mental health field, and require multi-level stakeholder commitment and investment for successful implementation.

Peer support work for people experiencing mental distress attending the emergency department: Exploring the potential.

OBJECTIVE: This study explored the benefits and limitations of employing peer support workers, who utilise their own lived experience of mental distress and recovery, to support people experiencing mental distress who are attending the ED. METHODS: This co-produced qualitative study utilised four phases: (i) assemble a collaborative multi-disciplinary research team and Expert Panel, of which at least half identified as having lived experience; (ii) a site visit to an ED; (iii) focus groups with consumers, support persons and ED staff; and (iv) a learning workshop for peer workers. RESULTS: Focus groups were run for consumers (n = 7), support persons (n = 5) and ED staff (n = 7). Eleven consumer peer workers participated in the learning workshop. Four themes were identified and triangulated: the individual in distress, peer support work, a 'Peers in EDs' service and the ED context. Overall, findings suggest that peer support workers contribute important skills including listening, de-escalation, relationship-building and empathy. CONCLUSIONS: This study identified that peer support workers would bring important skills to an ED (e.g. empathetic support, de-escalation). However, significant workforce and organisational support would be required.

Adapting Peer Researcher Facilitated Strategies to Recruit People Receiving Mental Health Services to a Tobacco Treatment Trial.

Introduction: One of the most challenging aspects of conducting intervention trials among people who experience severe mental illness (SMI) and who smoke tobacco, is recruitment. In our parent "QuitLink" randomized controlled trial (RCT), slower than expected peer researcher facilitated recruitment, along with the impact of COVID-19 pandemic restrictions, necessitated an adaptive recruitment response. The objectives of the present study were to: (i) describe adaptive peer researcher facilitated recruitment strategies; (ii) explore the effectiveness of these strategies; (iii) investigate whether recruitment strategies reached different subgroups of participants; and (iv) examine the costs and resources required for implementing these strategies. Finally, we offer experience-based lessons in a Peer Researcher Commentary. Methods: People were included in the RCT if they smoked at least 10 cigarettes a day and were accessing mental health support from the project's two partnering mental health organizations in Victoria, Australia. The majority of people accessing these services will have been diagnosed with SMI. Recruitment occurred over 2 years. We began with peer facilitated recruitment strategies delivered face-to-face, then replaced this with direct mail postcards followed by telephone contact. In the final 4 months of the study, we began online recruitment, broadening it to people who smoked and were accessing support or treatment (including from general practitioners) for mental health and/or alcohol or other drug problems, anywhere in the state of Victoria. Differences between recruitment strategies on key participant variables were assessed. We calculated the average cost per enrolee of the different recruitment approaches. Results: Only 109 people were recruited from a target of 382: 29 via face-to-face (March 2019 to April 2020), 66 from postcards (May 2020 to November 2020), and 14 from online (November to December 2020 and January to March 2021) strategies. Reflecting our initial focus on recruiting from supported independent living accommodation facilities, participants recruited face-to-face were significantly more likely to be living in partially or fully supported independent living (n = 29, <0.001), but the samples were otherwise similar. After the initial investment in training and equipping peer researchers, the average cost of recruitment was AU$1,182 per participant-~US$850. Face-to-face recruitment was the most expensive approach and postcard recruitment the least (AU$1,648 and AU$928 per participant). Discussion: Peer researcher facilitated recruitment into a tobacco treatment trial was difficult and expensive. Widely dispersed services and COVID-19 restrictions necessitated non-face-to-face recruitment strategies, such as direct mail postcards, which improved recruitment and may be worthy of further research. Clinical Trial Registration: The trial is registered with ANZCTR (www.anzctr.org.au): ACTRN12619000244101 prior to the accrual of the first participant and updated regularly as per registry guidelines. The trial sponsor was the University of Newcastle, NSW, Australia.

The value of compassionate support to address smoking: A qualitative study with people who experience severe mental illness.

Introduction: People experiencing severe mental illness (SMI) smoke at much higher rates than the general population and require additional support. Engagement with existing evidence-based interventions such as quitlines and nicotine replacement therapy (NRT) may be improved by mental health peer worker involvement and tailored support. This paper reports on a qualitative study nested within a peer researcher-facilitated tobacco treatment trial that included brief advice plus, for those in the intervention group, tailored quitline callback counseling and combination NRT. It contextualizes participant life experience and reflection on trial participation and offers insights for future interventions. Methods: Qualitative semi-structured interviews were conducted with 29 participants in a randomized controlled trial (intervention group n = 15, control group n = 14) following their 2-month (post-recruitment) follow-up assessments, which marked the end of the "Quitlink" intervention for those in the intervention group. Interviews explored the experience of getting help to address smoking (before and during the trial), perceptions of main trial components including assistance from peer researchers and tailored quitline counseling, the role of NRT, and other support received. A general inductive approach to analysis was applied. Results: We identified four main themes: (1) the long and complex journey of quitting smoking in the context of disrupted lives; (2) factors affecting quitting (desire to quit, psychological and social barriers, and facilitators and reasons for quitting); (3) the perceived benefits of a tailored approach for people with mental ill-health including the invitation to quit and practical resources; and (4) the importance of compassionate delivery of support, beginning with the peer researchers and extended by quitline counselors for intervention participants. Subthemes were identified within each of these overarching main themes. Discussion: The findings underscore the enormity of the challenges that our targeted population face and the considerations needed for providing tobacco treatment to people who experience SMI. The data suggest that a tailored tobacco treatment intervention has the potential to assist people on a journey to quitting, and that compassionate support encapsulating a recovery-oriented approach is highly valued. Clinical trial registration: The Quitlink trial was registered with ANZCTR (www.anzctr.org.au): ACTRN12619000244101 prior to the accrual of the first participant and updated regularly as per registry guidelines.

Reporting of patient and public involvement and engagement (PPIE) in clinical trials published in nursing science journals: a descriptive study.

BACKGROUND: Patient and Public Involvement and Engagement (PPIE) in research positively affects the relevance, quality, and impact of research. Around 11% of studies published in leading medical journals demonstrate PPIE. The extent of PPIE in nursing research has not been previously studied. METHODS: A descriptive study of PPIE in clinical trials published in general nursing science journals between 1st January and 31st August 2021. Data were extracted from included studies against the five items of the Guidance for Reporting Involvement of Patients and the Public (GRIPP2) short form reporting checklist. RESULTS: We searched 27 journals and identified 89 randomised controlled clinical trials. There was no statement or evidence of PPIE in any of the included trials. CONCLUSION: Nurse researchers need to ensure that they purposefully involve patients in their research and report this in papers describing study findings.

Patient involvement in research may improve the quality and relevance of the work. The British Medical Journal­one of the top medical research journals in the world­has developed a patient partnership plan. Part of this plan requires papers sent to the journal for publication to include a statement about how patients were involved in the research. If patients were not involved in the research, this should be stated in the paper. Most papers published in the British Medical Journal now include a statement about patient involvement. We wanted to check if nurses were reporting patient involvement in the research they do. We read 89 randomised controlled trials (RCTs) published in 27 general nursing journals. We focused on RCTs because they are widely considered the gold standard for evaluating interventions and therefore are most likely to impact on patient care. Unlike the British Medical Journal, there was no evidence that nursing journals required authors to say how patients were engaged or involved in the research they published. There was no evidence of patient involvement in any of the nursing research articles that we looked at. The implication of our work is that nurse researchers need to be developing ways for effective engagement of patients in all aspects of their research and explaining how they did this in the papers they publish in nursing journals.

Engaging with Transformative Paradigms in Mental Health.

When graduates of Australian social work courses embark on a career in mental health, the systems they enter are complex, fragmented and evolving. Emerging practitioners will commonly be confronted by the loneliness, social exclusion, poverty and prejudice experienced by people living with mental distress; however, social work practice may not be focused on these factors. Instead, in accordance with the dominant biomedical perspective, symptom and risk management may predominate. Frustration with the limitations evident in this approach has seen the United Nations call for the transformation of mental health service delivery. Recognising paradigmatic influences on mental health social work may lead to a more considered enactment of person centred, recovery and rights-based approaches. This paper compares and contrasts influences of neo-liberalism, critical theory, human rights and post-structuralism on mental health social work practice. In preparing social work practitioners to recognise the influence of, and work more creatively with, intersecting paradigms, social work educators strive to foster a transformative approach to mental health practice that straddles discourses.

Design features that reduce the use of seclusion and restraint in mental health facilities: a rapid systematic review.

Increasing efforts are being made to prevent and/or eliminate the use of seclusion and restraint in mental health facilities. Recent literature recognises the importance of the physical environment in supporting better outcomes in mental health services. This rapid review scoped the existing literature studying what physical design features of mental health facilities can reduce the use of seclusion and physical restraint. DESIGN: A rapid review of peer-reviewed literature. METHODS: Peer-reviewed literature was searched for studies on architectural design and the use of restraint and seclusion in mental health facilities. The following academic databases were searched: Cochrane Library, Medline, PsycINFO, Scopus and Avery for English language literature published between January 2010 and August 2019. The Joanna Briggs Institute's critical appraisal tool was used to assess the quality of included studies. RESULTS: We identified 35 peer-reviewed studies. The findings revealed several overarching themes in design efforts to reduce the use of seclusion and restraint: a beneficial physical environment (eg, access to gardens or recreational facilities); sensory or comfort rooms; and private, uncrowded and calm spaces. The critical appraisal indicated that the overall quality of studies was low, as such the findings should be interpreted with caution. CONCLUSION: This study found preliminary evidence that the physical environment has a role in supporting the reduction in the use of seclusion and restraint. This is likely to be achieved through a multilayered approach, founded on good design features and building towards specific design features which may reduce occurrences of seclusion and restraint. Future designs should include consumers in a codesign process to maximise the potential for change and innovation that is genuinely guided by the insights of lived experience expertise.

The Stroke and Carer Optimal Health Program (SCOHP) to enhance psychosocial health: study protocol for a randomized controlled trial.

BACKGROUND: Stroke is a leading cause of disability and distress, and often profoundly affects the quality of life of stroke survivors and their carers. With the support of carers, many stroke survivors are returning to live in the community despite the presence of disability and ongoing challenges. The sudden and catastrophic changes caused by stroke affects the mental, emotional and social health of both stroke survivors and carers. The aim of this study is to evaluate a Stroke and Carer Optimal Health Program (SCOHP) that adopts a person-centred approach and engages collaborative therapy to educate, support and improve the psychosocial health of stroke survivors and their carers. METHODS: This study is a prospective randomised controlled trial. It will include a total of 168 stroke survivors and carers randomly allocated into an intervention group (SCOHP) or a control group (usual care). Participants randomised to the intervention group will receive nine (8 + 1 booster) sessions guided by a structured workbook. The primary outcome measures for stroke survivors and carers will be health-related quality of life (AQoL-6D and EQ-5D) and self-efficacy (GSE). Secondary outcome measures will include: anxiety and depression (HADS); coping (Brief COPE); work and social adjustment (WSAS); carer strain (MCSI); carer satisfaction (CASI); and treatment evaluation (TEI-SF and CEQ). Process evaluation and a health economic cost analysis will also be conducted. DISCUSSION: We believe that this is an innovative intervention that engages the stroke survivor and carer and will be significant in improving the psychosocial health, increasing independence and reducing treatment-related costs in this vulnerable patient-carer dyad. In addition, we expect that the intervention will assist carers and stroke survivors to negotiate the complexity of health services across the trajectory of care and provide practical skills to improve self-management. TRIAL REGISTRATION: ACTRN12615001046594 . Registered on 7 October 2015.