A novel, multidomain, primary care nurse-led and mHealth-assisted intervention for dementia risk reduction in middle-aged adults (HAPPI MIND): study protocol for a cluster randomised controlled trial.

INTRODUCTION: Middle-aged multidomain risk reduction interventions targeting modifiable risk factors for dementia may delay or prevent a third of dementia cases in later life. We describe the protocol of a cluster randomised controlled trial (cRCT), HAPPI MIND (Holistic Approach in Primary care for PreventIng Memory Impairment aNd Dementia). HAPPI MIND will evaluate the efficacy of a multidomain, nurse-led, mHealth supported intervention for assessing dementia risk and reducing associated risk factors in middle-aged adults in the Australian primary care setting. METHODS AND ANALYSIS: General practice clinics (n≥26) across Victoria and New South Wales, Australia, will be recruited and randomised. Practice nurses will be trained to implement the HAPPI MIND intervention or a brief intervention. Patients of participating practices aged 45-65 years with ≥2 potential dementia risk factors will be identified and recruited (approximately 15 patients/clinic). Brief intervention participants receive a personalised report outlining their risk factors for dementia based on Australian National University Alzheimer's Disease Risk Index (ANU-ADRI) scores, education booklet and referral to their general practitioner as appropriate. HAPPI MIND participants receive the brief intervention as well as six individualised dementia risk reduction sessions with a nurse trained in motivational interviewing and principles of behaviour change, a personalised risk reduction action plan and access to the purpose-built HAPPI MIND smartphone app for risk factor self-management. Follow-up data collection will occur at 12, 24 and 36 months. Primary outcome is ANU-ADRI score change at 12 months from baseline. Secondary outcomes include change in cognition, quality of life and individual risk factors of dementia. ETHICS AND DISSEMINATION: Project approved by Monash University Human Research Ethics Committee (ID: 28273). Results will be disseminated in peer-reviewed journals and at healthcare conferences. If effective in reducing dementia risk, the HAPPI MIND intervention could be integrated into primary care, scaled up nationally and sustained over time. TRIAL REGISTRATION NUMBER: ACTRN12621001168842.

Dementia Risk Reduction in Primary Care: A Scoping Review of Clinical Guidelines Using a Behavioral Specificity Framework.

BACKGROUND: Primary care practitioners are being called upon to work with their patients to reduce dementia risk. However, it is unclear who should do what with whom, when, and under what circumstances. OBJECTIVE: This scoping review aimed to identify clinical guidelines for dementia risk reduction (DRR) in primary care settings, synthesize the guidelines into actionable behaviors, and appraise the guidelines for specificity. METHODS: Terms related to "dementia", "guidelines", and "risk reduction" were entered into two academic databases and two web search engines. Guidelines were included if they referred specifically to clinical practices for healthcare professionals for primary prevention of dementia. Included guidelines were analyzed using a directed content analysis method, underpinned by the Action-Actor-Context-Target-Time framework for specifying behavior. RESULTS: Eighteen guidelines were included in the analysis. Together, the guidelines recommended six distinct clusters of actions for DRR. These were to 1) invite patients to discuss DRR, 2) identify patients with risk factors for dementia, 3) discuss DRR, 4) manage dementia risk factors, 5) signpost to additional support, and 6) follow up. Guidelines recommended various actors, contexts, targets, and times for performing these actions. Together, guidelines lacked specificity and were at times contradictory. CONCLUSION: Currently available guidelines allow various approaches to promoting DRR in primary care. Primary care teams are advised to draw on the results of the review to decide which actions to undertake and the locally appropriate actors, contexts, targets, and times for these actions. Documenting these decisions in more specific, local guidelines for promoting DRR should facilitate implementation.

Implementing dementia risk reduction in primary care: views of enrollees in the Preventing Dementia Massive Open Online Course.

There is a push for greater promotion of dementia risk reduction (DRR) by primary care practitioners (PCPs). The aims of this study were to understand the views of non-medically trained Australian contributors in a Massive Open Online Course (MOOC) about dementia prevention regarding the role of PCPs in promoting DRR and to consider the implications of those views for developing implementation strategies. Discussion board posts of MOOC enrollees were analysed regarding the actions that organisations, communities and/or governments should take to help people work towards DRR. Of the 1641 eligible contributors to the discussion, 160 (10%) indicated that PCPs had a role in promoting DRR. This subset of participants particularly wanted earlier identification of risk by PCPs and a discussion about DRR. Some participants thought PCPs did not currently prioritise DRR, lacked knowledge about DRR and faced Medicare and resource restrictions to promoting DRR. We suggest that PCPs need: better publicity for their role in promoting DRR; to prioritise DRR; knowledge about DRR; and to take advantage of existing opportunities to promote DRR quickly. The findings of this study should be considered when attempting to implement DRR guidelines in primary care.

General population perspectives of dementia risk reduction and the implications for intervention: A systematic review and thematic synthesis of qualitative evidence.

BACKGROUND: Evidence for the potential prevention of dementia through lifestyle risk factor modification is growing and has prompted examination of implementation approaches. Understanding the general population's perspectives regarding dementia risk reduction is key to implementation. This may provide useful insights into more effective and efficient ways to help people change relevant beliefs, motivations and behaviour patterns. We conducted a systematic review and thematic synthesis of qualitative evidence to develop an integrated model of general population dementia risk reduction perspectives and the implications for intervention in research and implementation contexts. METHODS AND FINDINGS: We searched electronic databases, supplemented by lateral search techniques, to identify studies published since 1995 reporting qualitative dementia risk reduction perspectives of the non-expert general population who do not have dementia. Thematic synthesis, incorporating an expert panel discussion, was used to identify overarching themes and develop an integrated model to guide intervention to support individuals to adopt and maintain dementia risk reduction behaviour patterns. Quality of included studies and confidence in review findings were systematically appraised. We included 50 papers, reflecting the views of more than 4,500 individuals. Main themes were: 1) The need for effective education about a complex topic to prevent confusion and facilitate understanding and empowerment; 2) Personally relevant short- and long-term benefits of dementia risk reduction behaviour patterns can generate value and facilitate action; 3) Individuals benefit from trusted, reliable and sensitive support to convert understanding to personal commitment to relevant behaviour change; 4) Choice, control and relevant self-regulatory supports help individuals take-action and direct their own progress; 5) Collaborative and empowering social opportunities can facilitate and propagate dementia risk reduction behaviour change; 6) Individual behaviour patterns occur in social contexts that influence beliefs through heuristic processes and need to be understood. Findings indicate that, for intervention: 1) education is key, but both content and delivery need to be tailored; 2) complementary interventions to support self-regulation mechanisms and social processes will increase education effectiveness; 3) co-design principles should guide intervention design and delivery processes; 4) all interventions need to be supported by context-specific data. CONCLUSIONS: This systematic review and thematic synthesis provides a comprehensive, integrated model of the dementia risk reduction perspectives of the general population and intervention approaches to support behaviour change that can be applied in clinical trial and real-world implementation settings. Findings extend existing knowledge and may assist more effective intervention design and delivery.

The CORE study-An adapted mental health experience codesign intervention to improve psychosocial recovery for people with severe mental illness: A stepped wedge cluster randomized-controlled trial.

BACKGROUND: Mental health policies outline the need for codesign of services and quality improvement in partnership with service users and staff (and sometimes carers), and yet, evidence of systematic implementation and the impacts on healthcare outcomes is limited. OBJECTIVE: The aim of this study was to test whether an adapted mental health experience codesign intervention to improve recovery-orientation of services led to greater psychosocial recovery outcomes for service users. DESIGN: A stepped wedge cluster randomized-controlled trial was conducted. SETTING AND PARTICIPANTS: Four Mental Health Community Support Services providers, 287 people living with severe mental illnesses, 61 carers and 120 staff were recruited across Victoria, Australia. MAIN OUTCOME MEASURES: The 24-item Revised Recovery Assessment Scale (RAS-R) measured individual psychosocial recovery. RESULTS: A total of 841 observations were completed with 287 service users. The intention-to-treat analysis found RAS-R scores to be similar between the intervention (mean = 84.7, SD= 15.6) and control (mean = 86.5, SD= 15.3) phases; the adjusted estimated difference in the mean RAS-R score was -1.70 (95% confidence interval: -3.81 to 0.40; p = .11). DISCUSSION: This first trial of an adapted mental health experience codesign intervention for psychosocial recovery outcomes found no difference between the intervention and control arms. CONCLUSIONS: More attention to the conditions that are required for eight essential mechanisms of change to support codesign processes and implementation is needed. PATIENT AND PUBLIC INVOLVEMENT: The State consumer (Victorian Mental Illness Awareness Council) and carer peak bodies (Tandem representing mental health carers) codeveloped the intervention. The adapted intervention was facilitated by coinvestigators with lived-experiences who were coauthors for the trial and process evaluation protocols, the engagement model and explanatory model of change for the trial.

Dementia risk reduction in practice: the knowledge, opinions and perspectives of Australian healthcare providers.

This study examined Australian primary healthcare providers' knowledge about dementia risk factors and risk reduction and their perspectives on barriers and enablers to risk reduction in practice. Primary healthcare providers were recruited through Primary Health Networks across Australia (n=51). Participants completed an online survey that consisted of fixed-responses and free-text components to assess their knowledge, attitudes and current practices relating to dementia risk factors and risk reduction techniques. The results showed that Australian primary healthcare providers have good knowledge about the modifiable risk factors for dementia; however, face several barriers to working with patients to reduce dementia risk. Commonly reported barriers included low patient motivation and healthcare system level limitations. The most commonly reported recommendations to helping primary healthcare providers to work with patients to reduce dementia risk included increasing resources and improving dementia awareness and messaging. While the results need to be interpreted in the context of the limitations of this study, we conclude that collaborative efforts between researchers, clinicians, policy makers and the media are needed to support the uptake of risk reduction activities in primary care settings.

Refined conceptual model for implementing dementia risk reduction: incorporating perspectives from Australian general practice.

Dementia is now a global health priority. With no known cure, the best way to reduce the number of people who will be living with dementia is by promoting dementia risk reduction (DRR). However, despite evidence-based guidelines, DRR is not yet routinely promoted in Australian general practice. Previously, we proposed a preliminary conceptual model for implementing DRR in primary care based on our scoping review of practitioners' views. The present study aimed to refine this model for the Australian context by incorporating the current perspectives of Australian general practitioners (GPs) and general practice nurses (GPNs) about DRR. Interviews with 17 GPs and GPNs were analysed using the framework method, underpinned by the Consolidated Framework for Implementation Research (CFIR). We identified 12 barriers to promoting DRR in Australian general practice, along with five facilitators. Using the CFIR-Expert Recommendations for Implementing Change (ERIC) Matching Tool to select prioritised implementation strategies from the ERIC project, the findings were incorporated into a refined conceptual model. The refined model points to an implementation intervention that uses educational materials and meetings to reach consensus with GPs and GPNs on the importance of promoting DRR and an appropriate approach. Champion GPs and GPNs should be prepared to drive the agreed implementation forward, and general practices should share successes and lessons learned. This model is a crucial step in bridging the gap between DRR guidelines and routine practice.

Implementing dementia risk reduction in primary care: a preliminary conceptual model based on a scoping review of practitioners' views.

Primary care practitioners (PCPs) do not routinely promote dementia risk reduction. The purpose of this study was to map the published literature on the views of PCPs about dementia risk reduction, in order to identify implementation constructs and strategies crucial to the development of an implementation intervention to support dementia risk reduction in primary care. We undertook a scoping review of the PCPs' views about promoting brain health for reducing dementia risk. We searched MEDLINE, PsycINFO, CINAHL, and Embase for English-language articles published between 1995 and December 2017. We then applied the Consolidated Framework for Implementation Research (CFIR) and matched Expert Recommendations for Implementing Change to the scoping review findings in order to develop a preliminary implementation model. Eight articles reported views of PCPs about dementia prevention. Study findings were mapped to 5 of the 39 CFIR constructs: (i) knowledge and beliefs about dementia risk reduction, (ii) evidence strength and quality, (iii) relative priority, (iv) available resources, and (v) external policy and incentives. The findings suggest implementation strategies to consider in our preliminary model include (i) educational meetings, (ii) identifying and preparing champions, (iii) conducting local consensus discussions, (iv) altering incentive structures, and (v) capturing and sharing local knowledge. There have been few studies about the views of PCPs about dementia risk reduction. Implementation in the primary care setting is fundamental to early identification of risk and supporting preventive practices, but it needs to focus on more than just education for PCPs. We need more up-to-date and in-depth data on the views of PCPs about dementia risk reduction and context-specific analyses of implementation needs. Further research into effective primary care interventions to reduce dementia risk is expected to support implementation efforts.

Advancing engagement methods for trials: the CORE study relational model of engagement for a stepped wedge cluster randomised controlled trial of experience-based co-design for people living with severe mental illnesses.

BACKGROUND: Engagement is essential in trials research but is rarely embedded across all stages of the research continuum. The development, use, effectiveness and value of engagement in trials research is poorly researched and understood, and models of engagement are rarely informed by theory. This article describes an innovative methodological approach for the development and application of a relational model of engagement in a stepped wedge designed cluster randomised controlled trial (RCT), the CORE study. The purpose of the model is to embed engagement across the continuum of the trial which will test if an experience-based co-design intervention improves psychosocial recovery for people affected by severe mental illness. METHODS: The model was developed in three stages and used a structured iterative approach. A context mapping assessment of trial sites was followed by a literature review on recruitment and retention of hard-to-reach groups in complex interventions and RCTs. Relevant theoretical and philosophical underpinnings were identified by an additional review of literature to inform model development and enactment of engagement activities. RESULTS: Policy, organisational and service user data combined with evidence from the literature on barriers to recruitment provided contextual information. Four perspectives support the theoretical framework of the relational model of engagement and this is organised around two facets: the relational and continuous. The relational facet is underpinned by relational ethical theories and participatory action research principles. The continuous facet is supported by systems thinking and translation theories. These combine to enact an ethics of engagement and evoke knowledge mobilisation to reach the higher order goals of the model. CONCLUSIONS: Engagement models are invaluable for trials research, but there are opportunities to advance their theoretical development and application, particularly within stepped wedge designed studies where there may be a significant waiting period between enrolment in a study and receipt of an intervention.

The CORE study protocol: a stepped wedge cluster randomised controlled trial to test a co-design technique to optimise psychosocial recovery outcomes for people affected by mental illness in the community mental health setting.

INTRODUCTION: User engagement in mental health service design is heralded as integral to health systems quality and performance, but does engagement improve health outcomes? This article describes the CORE study protocol, a novel stepped wedge cluster randomised controlled trial (SWCRCT) to improve psychosocial recovery outcomes for people with severe mental illness. METHODS: An SWCRCT with a nested process evaluation will be conducted over nearly 4 years in Victoria, Australia. 11 teams from four mental health service providers will be randomly allocated to one of three dates 9 months apart to start the intervention. The intervention, a modified version of Mental Health Experience Co-Design (MH ECO), will be delivered to 30 service users, 30 carers and 10 staff in each cluster. Outcome data will be collected at baseline (6 months) and at completion of each intervention wave. The primary outcome is improvement in recovery score using the 24-item Revised Recovery Assessment Scale for service users. Secondary outcomes are improvements to user and carer mental health and well-being using the shortened 8-item version of the WHOQOL Quality of Life scale (EUROHIS), changes to staff attitudes using the 19-item Staff Attitudes to Recovery Scale and recovery orientation of services using the 36-item Recovery Self Assessment Scale (provider version). Intervention and usual care periods will be compared using a linear mixed effects model for continuous outcomes and a generalised linear mixed effects model for binary outcomes. Participants will be analysed in the group that the cluster was assigned to at each time point. ETHICS AND DISSEMINATION: The University of Melbourne, Human Research Ethics Committee (1340299.3) and the Federal and State Departments of Health Committees (Project 20/2014) granted ethics approval. Baseline data results will be reported in 2015 and outcomes data in 2017. TRIAL REGISTRATION NUMBER: Australian and New Zealand Clinical Trials Registry ACTRN12614000457640.

Comprehension of sarcasm, metaphor and simile in Williams syndrome.

BACKGROUND: Although people with Williams syndrome (WS) are often characterized as friendly and sociable with relatively good general language abilities, there is emerging evidence of pragmatic difficulties and trouble comprehending aspects of non-literal language. AIMS: The main aim was to investigate the comprehension of sarcasm, metaphor and simile in WS relative to typically developing controls. A secondary aim was to examine the association between non-literal language comprehension and a range of other cognitive abilities, both in WS and in the typically developing population. METHODS & PROCEDURES: Twenty-six participants with WS were compared with 26 typically developing chronological age-matched controls (TDCA) and 26 typically developing mental age-matched controls (TDMA). Participants listened to stories in which characters made non-literal comments. They were then asked what each character meant by their comment. In order to investigate the second aim of the study, cognitive abilities were also assessed using the Woodcock-Johnson (Revised) Tests of Cognitive Ability, including expressive vocabulary, verbal working memory, perceptual integration, inferential reasoning and overall cognitive ability. OUTCOMES & RESULTS: Comprehension of non-literal language in WS was significantly below TDCA levels, but was not significantly different to TDMA levels. For typically developing controls, each of the cognitive measures was strongly correlated with each of the measures of non-literal language comprehension. The same relationships were not always found for participants with WS. In particular, sarcasm comprehension in WS was not significantly correlated with any of the assessed cognitive abilities, and expressive vocabulary was not significantly correlated with any measure of non-literal comprehension. CONCLUSIONS & IMPLICATIONS: Comprehension of simile in WS is below TDCA levels but seems on par with their mental age level. It appears that comprehension of sarcasm and metaphors is above the cognitive capabilities and mental age level of most individuals with WS. Further, the pattern of correlations between non-literal comprehension and cognitive abilities in WS relative to controls suggests that perhaps the linguistic and cognitive systems that underpin non-literal language comprehension in typically developing individuals interact and integrate in different ways in WS.

Revision of a method quality rating scale for single-case experimental designs and n-of-1 trials: the 15-item Risk of Bias in N-of-1 Trials (RoBiNT) Scale.

Recent literature suggests a revival of interest in single-case methodology (e.g., the randomised n-of-1 trial is now considered Level 1 evidence for treatment decision purposes by the Oxford Centre for Evidence-Based Medicine). Consequently, the availability of tools to critically appraise single-case reports is of great importance. We report on a major revision of our method quality instrument, the Single-Case Experimental Design Scale. Three changes resulted in a radically revised instrument, now entitled the Risk of Bias in N-of-1 Trials (RoBiNT) Scale: (i) item content was revised and increased to 15 items, (ii) two subscales were developed for internal validity (IV; 7 items) and external validity and interpretation (EVI; 8 items), and (iii) the scoring system was changed from a 2-point to 3-point scale to accommodate currently accepted standards. Psychometric evaluation indicated that the RoBiNT Scale showed evidence of construct (discriminative) validity. Inter-rater reliability was excellent, for pairs of both experienced and trained novice raters. Intraclass correlation coefficients of summary scores for individual (experienced) raters: ICC(TotalScore) = .90, ICC(IVSubscale) = .88, ICC(EVISubscale) = .87; individual (novice) raters: ICC(TotalScore)= .88, ICC(IVSubscale) = .87, ICC(EVISubscale) = .93; consensus ratings between experienced and novice raters (ICC(TotalScore) = .95, ICC(IVSubscale) = .93, ICC(EVISubscale) = .93. The RoBiNT Scale thus shows sound psychometric properties and provides a comprehensive yet efficient examination of important features of single-case methodology.

A systematic review of assessment tools for adults used in traumatic brain injury research and their relationship to the ICF.

BACKGROUND AND AIMS: Good assessment is an essential component of effective patient management. Yet the sheer volume of available assessment instruments presents a barrier for the clinician or researcher to (a) be knowledgeable about suitable measures and (b) keep up-to-date with new measures that are published. In order to create a resource of currently-used measures, we conducted a systematic review of assessment tools used in the research literature on traumatic brain injury (TBI). METHODS: We used two electronic databases (Medline and PsycINFO) to identify full-length, English-language articles published between 2000 and 2012 in which outcome in adults with TBI was assessed with behavioural tests or questionnaires. RESULTS: The searches yielded 5,735 articles and after deletion of duplicates (n = 1,383) and articles not meeting selection criteria (n = 1,759), 2,593 articles were further examined. The articles contained 910 behavioural instruments, with a final set of 728 unique instruments. Each instrument was classified against the International Classification of Functioning, Disability and Health (ICF). Half of the instruments (n = 370, 50.8%) evaluated the mental functions domain of the ICF body functions component, with a substantially smaller proportion (n = 64, 8.8%) examining specific motor-sensory and other body functions. Instruments also covered domains of activities/participation (n = 109, 15.0%), environmental factors (n = 22, 3.0%) and personal factors (n = 36, 4.9%). A substantial number of scales (n = 93, 12.8%) were multidimensional across the body function domains (n = 32), as well as the functioning and disability part of the ICF (n = 60). The remaining 5% of instruments addressed concepts not covered by the ICF, including quality of life (n = 19, 2.6%) and rehabilitation process tools (such as therapeutic alliance). The 728 instruments were listed and more than 70 of the most common, spread across 20 domains, were highlighted. CONCLUSION: These data provide a comprehensive and up-to-date resource that gives the researcher or clinician a very large selection of assessment instruments covering the major areas of function pertinent to TBI.

Attribution of negative intention in Williams syndrome.

People with Williams syndrome (WS) are said to have sociable and extremely trusting personalities, approaching strangers without hesitation. This study investigated whether people with WS are less likely than controls to attribute negative intent to others when interpreting a series of ambiguous pictures. This may, at least partially, explain their hypersociability toward strangers. Twenty-seven individuals with WS and 54 typically developing controls (27 matched to WS participants on sex and chronological age and 27 matched on sex and mental age) viewed 10 ambiguous pictures, where one person in the picture may be seen as having a negative objective. Participants were asked to describe what was happening in the picture. Responses were scored for negative intention attribution (NIA). NIA was reduced in WS individuals relative to typically developing controls of the same chronological age, but was similar to typically developing controls of the same mental age. Findings are discussed in relation to possible underlying neurological and cognitive mechanisms and practical implications for understanding and teaching stranger danger to people with WS.