An evidence-base for the implementation of hospital-based palliative care programs in routine cancer practice: A systematic review.

BACKGROUND: Despite global support, there remain gaps in the integration of early palliative care into cancer care. The methods of implementation whereby evidence of benefits of palliative care is translated into practice deserve attention. AIM: To identify implementation frameworks utilised in integrated palliative care in hospital-based oncology services and to describe the associated enablers and barriers to service integration. DESIGN: Systematic review with a narrative synthesis including qualitative, mixed methods, pre-post and quasi experimental designs following the guidance by the Centre for Reviews and Dissemination (PROSPERO registration CRD42021252092). DATA SOURCES: Six databases searched in 2021: EMBASE, EMCARE, APA PsycINFO, CINAHL, Cochrane Library and Ovid MEDLINE searched in 2023. Included were qualitative or quantitative studies, in English language, involving adults >18 years, and implementing hospital-based palliative care into cancer care. Critical appraisal tools were used to assess the quality and rigour. RESULTS: Seven of the 16 studies explicitly cited the use of frameworks including those based on RE-AIM, Medical Research Council evaluation of complex interventions and WHO constructs of health service evaluation. Enablers included an existing supportive culture, clear introduction to the programme across services, adequate funding, human resources and identification of advocates. Barriers included a lack of communication with the patients, caregivers, physicians and palliative care team about programme goals, stigma around the term 'palliative', a lack of robust training, or awareness of guidelines and undefined staff roles. CONCLUSIONS: Implementation science frameworks provide a method to underpin programme development and evaluation as palliative care is integrated within the oncology setting.

Comparing health gains, costs and cost-effectiveness of 100s of interventions in Australia and New Zealand: an online interactive league table.

BACKGROUND: This study compares the health gains, costs, and cost-effectiveness of hundreds of Australian and New Zealand (NZ) health interventions conducted with comparable methods in an online interactive league table designed to inform policy. METHODS: A literature review was conducted to identify peer-reviewed evaluations (2010 to 2018) arising from the Australia Cost-Effectiveness research and NZ Burden of Disease Epidemiology, Equity and Cost-Effectiveness Programmes, or using similar methodology, with: health gains quantified as health-adjusted life years (HALYs); net health system costs and/or incremental cost-effectiveness ratio; time horizon of at least 10 years; and 3% to 5% discount rates. RESULTS: We identified 384 evaluations that met the inclusion criteria, covering 14 intervention domains: alcohol; cancer; cannabis; communicable disease; cardiovascular disease; diabetes; diet; injury; mental illness; other non-communicable diseases; overweight and obesity; physical inactivity; salt; and tobacco. There were large variations in health gain across evaluations: 33.9% gained less than 0.1 HALYs per 1000 people in the total population over the remainder of their lifespan, through to 13.0% gaining > 10 HALYs per 1000 people. Over a third (38.8%) of evaluations were cost-saving. CONCLUSIONS: League tables of comparably conducted evaluations illustrate the large health gain (and cost) variations per capita between interventions, in addition to cost-effectiveness. Further work can test the utility of this league table with policy-makers and researchers.

Care plus study: a multi-site implementation of early palliative care in routine practice to improve health outcomes and reduce hospital admissions for people with advanced cancer: a study protocol.

BACKGROUND: Current international consensus is that 'early' referral to palliative care services improves cancer patient and family carer outcomes. In practice, however, these referrals are not routine. An approach which directly addresses identified barriers to early integration of palliative care is required. This protocol details a trial of a standardized model of early palliative care (Care Plus) introduced at key defined, disease-specific times or transition points in the illness for people with cancer. Introduced as a 'whole of system' practice change for identified advanced cancers, the key outcomes of interest are population health service use change. The aims of the study are to examine the effect of Care Plus implementation on (1) acute hospitalisation days in the last 3 months of life; (2) timeliness of access to palliative care; (3) quality and (4) costs of end of life care; and (5) the acceptability of services for people with advanced cancer. METHODS: Multi-site stepped wedge implementation trial testing usual care (control) versus Care Plus (practice change). The design stipulates 'control' periods when usual care is observed, and the process of implementing Care Plus which includes phases of planning, engagement, practice change and evaluation. During the practice change phase, all patients with targeted advanced cancers reaching the transition point will, by default, receive Care Plus. Health service utilization and unit costs before and after implementation will be collated from hospital records, and state and national health service administrative datasets. Qualitative data from patients, consumers and clinicians before and after practice change will be gathered through interviews and focus groups. DISCUSSION: The study outcomes will detail the impact and acceptability of the standardized integration of palliative care as a practice change, including recommendations for ongoing sustainability and broader implementation. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN 12619001703190 . Registered 04 December 2019.

Interventions for mitigating occupational stress for professional dementia caregivers in residential aged care: A systematic review with meta-analysis.

OBJECTIVE: Occupational stress in professional dementia caregivers in residential aged care facilities has adverse effects on care quality, caregivers' health, and workforce sustainability. The purpose of this study was to examine the evidence regarding interventions to mitigate occupational stress for this population. METHODS: A systematic review of CINAHL, PsycINFO, PubMed and MEDLINE databases was conducted to identify original RCT research reporting on stress interventions, published in English between 1995 and March 2022. Search results were screened by two independent reviewers. Quality and risk of bias were appraised using the Downs and Black Checklist and Risk of Bias by two reviewers. Meta-analysis and subgroup analysis examined the pooled intervention effects on stress compared to control. RESULTS: 10 studies met the inclusion criteria, and these reported on 15 interventions and 28 outcomes from 92 facilities, involving 1,397 caregivers. We found a small and insignificant effect of interventions on caregiver stress (g = -.27, p = .16). Heterogeneity was partially explained by subgroup analysis. Interventions can mitigate stress and burden not attributed to client behaviour (n = 3) (g = -.85, p < .001), and improve caregivers' self-efficacy (n = 4) (g = -.35, p = .07). We were unable to determine the most effective type of intervention, although organisation focused interventions showed the greatest potential (g = -.58, p = .08). CONCLUSION: Interventions that improve caregivers' personal and organisational resources can reduce non-client associated stress and burden and increase self-efficacy. Aged care providers are recommended to prioritise education with organisational support interventions. Research on longitudinal effects and high-risk caregivers is required. Limitations are discussed. PROSPERO REGISTRATION NUMBER: CRD42022313715 (registered April 2022).

ParkinSong Online: Feasibility of Telehealth Delivery and Remote Data Collection for a Therapeutic Group Singing Study in Parkinson's.

BACKGROUND: Parkinson's disease can negatively affect vocal functioning and social wellbeing, particularly in the latter stages of disease progression. Face-to-face group singing interventions can improve communication and wellbeing outcomes, yet not all people can access in-person sessions. To help overcome barriers to participation, exploration of the feasibility and utility of online therapeutic singing programs is needed. OBJECTIVES: To evaluate the feasibility, acceptability, and preliminary efficacy of a 12-week ParkinSong Online intervention on speech and wellbeing for people with Parkinson's disease. METHODS: A total of 28 participants with idiopathic Parkinson's disease were recruited to a single-arm feasibility study. Weekly 90-minute online sessions were co-facilitated by a music therapist and speech pathologist. Speech and wellbeing assessments were conducted pre and post intervention. Participant and facilitator surveys were administered after each session, with focus group interviews at the end of the program. RESULTS: The recruitment rate was high (90%) with no attrition, adverse events, or safety issues. There was good intervention fidelity, attendance (average 89%), and positive participant experience. Feasibility was good, with technology reported as the main challenge (connecting and navigating Zoom). No improvements were seen in voice measures or wellbeing outcomes in this small trial. The online format used in this study did not provide the same benefits as in-person ParkinSong sessions. CONCLUSIONS: ParkinSong Online is feasible for recreational purposes and social engagement provided that people have adequate technological knowledge or support. The optimal online delivery format to achieve communication improvements in Parkinson's awaits confirmation.

The HOMESIDE Study-A Research Project to Support People Living With Dementia and Their Family Caregivers: Preliminary Report on Reading Intervention.

The behavioral and psychological symptoms of dementia (BPSD) can be challenging for family caregivers to cope with, leading to distress and fatigue. It is therefore important to offer effective strategies to reduce the impact of BPSD. The HOMESIDE randomized controlled trial (RCT) was testing purposefully developed interventions to improve the quality of life and wellbeing of dyads of people with dementia and family caregivers as a result of reduction of BPSD. HOMESIDE RCT was conducted in Australia, Germany, Norway, Poland and the United Kingdom between 2019 and 2022. The study design was a three-arm parallel-group single-blinded, pragmatic RCT with a sample size of 432 dyads. Dyads were randomly allocated to one of three treatment conditions: Music Intervention plus Standard Care; or Reading Intervention plus Standard Care; or Standard Care only. The Reading Intervention (RI) within the HOMESIDE RCT aimed to evoke shared discussion, reminiscence, meaningful shared experiences and consequently enrich everyday life, interaction and the emotional connection between the caregiver (CG) and carereceiver (CR); as well as to enhance activities of daily living and to promote relaxation or stimulation as appropriate. This paper describes the underlying conceptual framework, the content, and delivery of the Reading Intervention within the HOMESIDE RCT.

The Influence of Home-Based Music Therapy Interventions on Relationship Quality in Couples Living with Dementia-An Adapted Convergent Mixed Methods Study.

Relationship quality is important for well-being and quality of life in couples living with dementia. Home-based music therapy interventions may be conducted with the aim of enhancing relationship quality. However, the effects or influences of such interventions are only briefly investigated in previous studies. This study's aim was to identify how a 12-week home-based music therapy intervention may influence relationship quality in couples living with dementia, through an adapted convergent mixed methods design. In this case, 68 participating couples from the HOMESIDE RCT study, and four individually recruited couples, received the music therapy intervention. Relationship quality for all participants was measured by the standardized Quality of Caregiver-Patient Relationship scale, and qualitative interviews were conducted with the four individually recruited participants at baseline and post intervention. Quantitative analysis indicated no statistically significant intervention effect. However, relationship quality remained stable over the intervention period. The qualitative analysis identified that the music therapy interventions primarily led to positive emotions, closeness, intimacy, and communication between the persons with dementia and their care partners. Intervention influences could also be ambiguous, as sharing music experiences might involve a risk of evoking vulnerabilities or negative emotional responses.

Statistical analysis plan for HOMESIDE: a randomised controlled trial for home-based family caregiver-delivered music and reading interventions for people living with dementia.

BACKGROUND: Most people with dementia live in the community, not in residential care. Therefore, quality informal care for them is critical for managing behavioural and psychological symptoms of dementia (BPSD). Music therapy has been shown to reduce BPSD. However, no randomised controlled trial has examined the effects of music interventions delivered by caregivers in home settings. The HOME-based caregiver-delivered music intervention for people living with dementia (HOMESIDE) trial aims to evaluate the effectiveness of a 12-week music intervention in addition to standard care for BPSD. This article describes the statistical analysis plan. METHODS AND ANALYSIS: HOMESIDE is a large, pragmatic international three-arm parallel-group randomised controlled trial. Dyads (persons with dementia and caregiver) in Australia, Germany, the UK, Poland and Norway were randomised to receive music and standard care, reading and standard care or standard care alone. The primary outcome is BPSD (proxy) of the person living with dementia, measured using the Neuropsychiatric Inventory-Questionnaire (NPI-Q) at 90 and 180 days post-randomisation. Longitudinal analysis will compare NPI-Q severity between music and standard care versus standard care alone. Secondary outcomes include quality of life and depression (both person with dementia and caregiver), cognition (person with dementia only), distress, resilience, competence and caregiver-patient relationship (caregiver only). Treatment effects will be obtained at 90 and 180 days post-randomisation, where applicable. Safety outcomes (adverse events, hospitalisations, deaths) will be summarised. DISCUSSION: This statistical analysis plan provides a detailed methodology for the analysis of HOMESIDE and will improve the validity of the study and reduce the potential for bias. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12618001799246. Registered on November 05, 2018. CLINICALTRIALS: gov NCT03907748. Registered on April 09, 2019.

Content development and validation for a mobile application designed to train family caregivers in the use of music to support care of people living with dementia.

Background: Music therapy is increasingly recognized as an effective support for people living with dementia. However, with incidences of dementia increasing, and limited availability of music therapists, there is a need for affordable and accessible ways that caregivers can learn to use music-therapy based strategies to support the people they care for. The MATCH project aims to address this by creating a mobile application that can train family caregivers in the use of music to support people living with dementia. Methods: This study details the development and validation of training material for the MATCH mobile application. Training modules developed based on existing research were assessed by 10 experienced music therapist clinician-researchers, and seven family caregivers who had previously completed personalized training in music therapy strategies via the HOMESIDE project. Participants reviewed the content and scored each training module based on content (music therapists) and face (caregivers) validity scales. Descriptive statistics were used to calculate scores on the scales, while thematic analysis was used to analyze short-answer feedback. Results: Participants scored the content as valid and relevant, however, they provided additional suggestions for improvement via short-answer feedback. Conclusion: The content developed for the MATCH application is valid and will be trailed by family caregivers and people living with dementia in a future study.

Recruitment approaches and profiles of consenting family caregivers and people living with dementia: A recruitment study within a trial.

Background: While studies have identified strategies that are useful for recruiting people living with dementia, none have focused on psychosocial interventions involving arts therapies, or have examined the profiles of older people living in the community who consent or decline participation, particularly during a global pandemic. We aimed to identify the most effective recruitment strategies according to participant characteristics and transnational differences and develop a profile of consenting and non-consenting participants. Methods: Recruitment teams in Australia, Norway, Germany, Poland, and the United Kingdom, recorded participants' source of study awareness and characteristics of consenting and non-consenting participants. Distributions of participants 'consenting to participate' were compared and logistic regressions were used to estimate the odds ratios. Results: Consenting female caregivers were disproportionally represented. Study awareness differed between countries but overall, most expressions of interest to participate were derived from referrals from professionals or organisations, or from databases of people wanting to participate in research. Troughs in recruitment rates occurred during Northern Hemisphere summer vacation periods, and during Christmas periods. Conclusions: This study found that recruiting for a trial with community-dwelling family caregivers and people living with dementia is challenging, especially during a global pandemic. While spousal caregivers comprised the highest proportion of dyads recruited, overall spousal caregivers were more reluctant to consent to participate than adult child caregivers. More targeted recruitment strategies designed for minority groups are also needed to ensure broader representation in dementia treatment studies.

Home-based family caregiver-delivered music and reading interventions for people living with dementia (HOMESIDE trial): an international randomised controlled trial.

Background: Music interventions provided by qualified therapists within residential aged care are effective at attenuating behavioural and psychological symptoms (BPSD) of people with dementia (PwD). The impact of music interventions on dementia symptom management when provided by family caregivers is unclear. Methods: We implemented a community-based, large, pragmatic, international, superiority, single-masked randomised controlled trial to evaluate if caregiver-delivered music was superior to usual care alone (UC) on reducing BPSD of PwD measured by the Neuropsychiatric Inventory-Questionnaire (NPI-Q). The study included an active control (reading). People with dementia (NPI-Q score ≥6) and their caregiver (dyads) from one of five countries were randomly allocated to caregiver-delivered music, reading, or UC with a 1:1:1 allocation stratified by site. Caregivers received three online protocolised music or reading training sessions delivered by therapists and were recommended to provide five 30-min reading or music activities per week (minimum twice weekly) over 90-days. The NPI-Q severity assessment of PwD was completed online by masked assessors at baseline, 90- (primary) and 180-days post-randomisation and analysed on an intention-to-treat basis using a likelihood-based longitudinal data analysis model. ACTRN12618001799246; ClinicalTrials.govNCT03907748. Findings: Between 27th November 2019 and 7th July 2022, we randomised 432 eligible of 805 screened dyads (music n = 143, reading n = 144, UC n = 145). There was no statistical or clinically important difference in the change from baseline BPSD between caregiver-delivered music (-0.15, 95% CI -1.41 to 1.10, p = 0.81) or reading (-1.12, 95% CI -2.38 to 0.14, p = 0.082) and UC alone at 90-days. No related adverse events occurred. Interpretation: Our findings suggested that music interventions and reading interventions delivered by trained caregivers in community contexts do not decrease enduring BPSD symptoms. Funding: Our funding was provided by National Health and Medical Research Council, Australia; The Research Council of Norway; Federal Ministry of Education and Research, Germany; National Centre for Research and Development, Poland; Alzheimer's Society, UK, as part of the Joint Programme for Neurodegenerative Diseases consortia scheme.

Therapeutic music interventions with people with dementia living in residential aged care: Perspectives of residents, family members and care home staff from a cluster randomised controlled trial.

BACKGROUND: Despite growing support for the benefits of music interventions in dementia care, the perspectives of people with dementia, their families and carers are often missing from the research. This study explored multiple perspectives and first-person experiences of group music interventions delivered within a large cluster randomised controlled trial examining the effectiveness of group music therapy (GMT) and recreational choir singing (RCS) with people with dementia living in residential-aged care (RAC) settings. METHODS: Focus group and individual interviews with residents with dementia (n = 4), family members (n = 5) and care home staff (n = 15) were conducted following completion of the 6-month GMT and/or RCS intervention and analysed using inductive thematic analysis. FINDINGS: Three main themes were identified as follows: (1) direct and indirect intrapersonal benefits, (2) direct and indirect interpersonal benefits and (3) therapeutic music interventions versus entertainment. GMT and RCS supported residents' mood, enjoyment, engagement and connectedness to self and others within and post-sessions, with flow-on effects to family members, care staff and the care home environment. Participants differentiated GMT and RCS from other forms of music engagement in the RAC facilities and described feelings of post-programme loss, highlighting ongoing meaning in active therapeutic music interventions. CONCLUSION: This research highlights the need for increased access to sustainable and meaningful activities, such as purposefully designed therapeutic music interventions in RAC. Improving knowledge about the distinct benefits of therapeutic music interventions compared with other forms of music engagement in RAC may assist nursing staff to make appropriate treatment planning decisions regarding therapeutic music programmes to meet the complex needs of residents with dementia.

Demographic and clinical profile of residents living with dementia and depressive symptoms in Australian private residential aged care: Data from the Music Interventions for Dementia and Depression in ELderly care (MIDDEL) cluster-randomised controlled trial.

OBJECTIVES: 1) To describe the demographic and clinical characteristics of residents with dementia and depressive symptoms in the Australian private residential aged care (RAC) context; and 2) to investigate the association between neuropsychiatric symptoms, depression and quality of life and their interactions with dementia severity. METHODS: This study examined the baseline demographic and clinical data from the Australian arm of the Music Interventions for Dementia and Depression in ELderly care (MIDDEL) study, a multinational, cluster-randomised controlled trial. Demographic characteristics, neuropsychiatric symptoms, depression, quality of life and dementia severity were collected in 330 residents of 12 private RAC facilities across Melbourne, Australia. Descriptive statistics, the Kruskal-Wallis test and the Pearson Χ2 test were used to describe and compare the demographic and clinical characteristics according to dementia severity. The association between clinical characteristics and dementia severity was examined using linear regression analyses. RESULTS: Residents' mean age was 86.5 years, 69% were female, and 44.2% had severe dementia. There were no significant differences between the dementia severity groups on age, sex and education. Residents with severe dementia were more likely to have a diagnosis of Alzheimer's disease (40.3%) and be born overseas (46.8%). Higher levels of neuropsychiatric symptoms, distress and depressive symptoms, and lower quality of life were associated with more severe dementia. CONCLUSIONS: The findings from our study highlight the diverse and complex care needs of people living with dementia in the Australian private RAC setting, which can be used to inform targeted, person-centred dementia care planning, staff training and allocation of resources.

Clinical effectiveness of music interventions for dementia and depression in elderly care (MIDDEL): Australian cohort of an international pragmatic cluster-randomised controlled trial.

BACKGROUND: Dementia and depression are highly prevalent and comorbid conditions among older adults living in care homes and are associated with individual distress and rising societal costs. Effective, scalable, and feasible interventions are needed. Music interventions have shown promising effects, but the current evidence base is inconclusive. The present study aimed to determine the effectiveness of two different music interventions on the depressive symptoms of people with dementia living in residential aged care. METHODS: We implemented a 2 × 2 factorial cluster-randomised controlled trial to determine whether group music therapy (GMT) is more effective than no GMT with standard care, or recreational choir singing (RCS) is more effective than no RCS with standard care, for reducing depressive symptoms and other secondary outcomes in people with dementia with mild to severe depressive symptoms living in residential aged care. Care home units with at least ten residents were allocated to GMT, RCS, GMT plus RCS, or standard care, using a computer-generated list with block randomisation (block size four). The protocolised interventions were delivered by music therapists (GMT) and community musicians (RCS). The primary outcome was Montgomery-Åsberg Depression Rating Scale score at 6 months, assessed by a masked assessor and analysed on an intention-to-treat basis using linear mixed-effects models, which examined the effects of GMT versus no-GMT and RCS versus no-RCS, as well as interaction effects of GMT and RCS. We report on the Australian cohort of an international trial. This trial is registered with ClinicalTrials.gov, NCT03496675, and anzctr.org.au, ACTRN12618000156280. FINDINGS: Between June 15, 2018, and Feb 18, 2020, we approached 12 RAC facilities with 26 eligible care home units and, excluding six units who could not be enrolled due to COVID-19 lockdowns, we screened 818 residents. Between July 18, 2018, and Nov 26, 2019, 20 care home units were randomised (318 residents). Recruitment ceased on March 17, 2020, due to COVID-19. The primary endpoint, available from 20 care home units (214 residents), suggested beneficial effects of RCS (mean difference -4·25, 95% CI -7·89 to -0·62; p=0·0221) but not GMT (mean difference -0·44, -4·32 to 3·43; p=0·8224). No related serious adverse events occurred. INTERPRETATION: Our study supports implementing recreational choir singing as a clinically relevant therapeutic intervention in reducing depressive symptoms for people with dementia in the Australian care home context. FUNDING: National Health and Medical Research Council, Australia.

ParkinSong Online: protocol for a telehealth feasibility study of therapeutic group singing for people with Parkinson's disease.

INTRODUCTION: Parkinson's disease can be associated with speech deterioration and low communication confidence which in turn compromises social interaction. Therapeutic singing is an engaging method for combatting speech decline; however, face-to-face delivery can limit access to group singing. The aim of this study is to test the feasibility and acceptability of an online mode of delivery for a Parkinson's singing intervention (ParkinSong) as well as remote data collection procedures. METHODS AND ANALYSIS: This ParkinSong Online feasibility trial is a single-arm, pre-post study of online singing delivery and remote data collection for 30 people living with Parkinson's. The primary outcome measure is feasibility: recruitment, retention, attendance, safety, intervention fidelity, acceptability and associated costs. Secondary outcomes are speech (loudness, intelligibility, quality, communication-related quality of life) and wellbeing (apathy, depression, anxiety, stress, health-related quality of life). This mode of delivery aims to increase the accessibility of singing interventions. ETHICS AND DISSEMINATION: Ethics approval was obtained from The University of Melbourne Human Research Ethics Committee (2021-14465-16053-3) and the trial has been prospectively registered. Results will be presented at national and international conferences, published in a peer-reviewed journal, and disseminated to the Parkinson's community, researchers and policymakers. TRIAL REGISTRATION NUMBER: ACTRN12621000940875.

From phone use to speeding and driving under influence: Identifying clusters of driving risk behaviors as an opportunity for targeted interventions.

Identifying the profile of risky behaviors among drivers is central to propose effective interventions. Due to the multidimensional and overlapping aspects of risky driving behaviors, cluster analysis can provide additional insights in order to identify specific subgroups of risk. This study aimed to identify clusters of driving risk behavior (DRB) among car drivers, and to verify intra-cluster differences concerning clinical and sociodemographic variables. We approached a total of 12,231 drivers and we included 6392 car drivers. A cluster algorithm was used to identify groups of car drivers in relation to the DRB: driving without a seat belt (SB), exceeding the speed limit (SPD), using a cell phone while driving (CELL), and driving after drinking alcohol (DUI). The algorithm classified drivers within five different DRB profiles. In cluster 1 (20.1%), subjects with a history of CELL. In cluster 2 (41.4%), drivers presented no DRB. In cluster 3 (9.3%), all drivers presented SPD. In cluster 4 (12.5%), drivers presented all DRB. In cluster 5 (16.6%), all drivers presented DUI. Clusters with DUI-related offenses (4 and 5) comprised more men (81.9 and 78.8%, respectively) than the overall sample (63.4%), with more binge drinking (50.9 and 45.7%) and drug use in the previous year (13.5 and 8.6%). Cluster 1 had a high years of education (14.4 ± 3.4) and the highest personal income (Md = 3000 IQR [2000-5000]). Cluster 2 had older drivers (46.6 ± 15), and fewer bingers (10.9%). Cluster 4 had the youngest drivers (34.4 ± 11.4) of all groups. Besides reinforcing previous literature data, our study identified five unprecedented clusters with different profiles of drivers regarding DRB. We identified an original and heterogeneous group of drivers with only CELL misuse, as well as other significant differences among clusters. Hence, our findings show that targeted interventions must be developed for each subgroup in order to effectively produce safe behavior in traffic.

Promoting Independence Through quality dementia Care at Home (PITCH): a research protocol for a stepped-wedge cluster-randomised controlled trial.

BACKGROUND: Home care service providers are increasingly supporting clients living with dementia. Targeted and comprehensive dementia-specific training for home care staff is necessary to meet this need. This study evaluates a training programme delivered to care staff (paid personal carers) of clients living with dementia at home. METHODS: This study is a pragmatic stepped-wedge cluster-randomised controlled trial (SW-CRT). Home care workers (HCWs) from seven home care service providers are grouped into 18 geographical clusters. Clusters are randomly assigned to intervention or control groups. The intervention group receives 7 h of a dementia education and upskilling programme (Promoting Independence Through quality dementia Care at Home [PITCH]) after baseline measures. The control group receives PITCH training 6 months after baseline measures. This approach will ensure that all participants are offered the program. Home care clients living with dementia are also invited to participate, as well as their family carers. The primary outcome measure is HCWs' sense of competence in dementia care provision. DISCUSSION: Upskilling home care staff is needed to support the increasing numbers of people living with dementia who choose to remain at home. This study uses a stepped-wedge cluster-randomised trial to evaluate a training programme (PITCH) for dementia care that is delivered to front-line HCWs. TRIAL REGISTRATION: anzctr.org.au ; ACTRN12619000251123. Registered on 20 February 2019.

Resource assessment in trials undertaken in residential care homes: Experiences from the Australian MIDDEL cluster randomised controlled trial research team.

BACKGROUND: The resources involved in delivering a clinical trial in residential aged care facilities (RACFs) are significant and the success of a trial is dependent upon adequate planning, including appropriate timelines for each component of the study and the required budget. This paper describes process and resource assessment during recruitment, collection of outcome measures and intervention delivery, and presents learnings and considerations for conducting trials in RACFs with people living with dementia. METHODS: Data were collected across 24 clusters in 12 RACFs over 18 months during a cluster randomised controlled trial which was testing the effectiveness of music interventions in people living with dementia. Data were collected on resources required for recruitment and assessment of baseline data, as well as reasons for participant non-attendance at the interventions. RESULTS: Time between contacting next of kin and receiving formal consent often exceeded 45 days. The ratio of time between direct and indirect research activity was approximately 1:2. Participant intervention adherence is at risk from unplanned RACF lockdowns and reasons for non-attendance include those both related directly to the participant and to staff resources, scheduling or other practical considerations. CONCLUSIONS: Research planning should focus on building relationships with RACF staff and resident families, factor in adequate time for recruitment in the study timeline and consider budgeting for backfill of RACF staff during data collection phases to expedite the process and ensure adherence to study protocol timelines. TRIAL REGISTRATION AUSTRALIAN AND NEW ZEALAND CLINICAL TRIAL REGISTRY ANZCTR12618000156280 1/02/2018 HTTP//ANZCTRORGAU/TRIAL/REGISTRATION/TRIALREVIEWASPX?ACTRN=12618000156280: A.

Drug use and driving behaviors among drivers with and without alcohol-related infractions.

INTRODUCTION: Brazil is one of the countries with the highest rates of alcohol-related traffic infractions, but little is known about the profile of the drivers who commit them. Identifying the characteristics of impaired drivers is essential for planning preventive actions. OBJECTIVE: To compare drug use and driving behavior profiles of drivers with and without alcohol-related infractions. METHODS: 178 drivers stopped at routine roadblocks were assessed by traffic agents who conducted standard roadblock procedures (document verification; request of a breathalyzer test [BT]). Drug use and driving behavior data were collected through semi-structured interviews. Subjects were divided into three groups: drivers who refused the BT (RDs, n = 72), drivers who tested positive on the BT (PDs, n = 34), and drivers who had committed other infractions (ODs, n = 72). RESULTS: The proportion of alcohol use in the last year was higher among RDs (100%) than in the PD and OD groups (97.1% and 72.2% respectively, p < 0.001). Lifetime prevalence of cannabis and cocaine use for the overall sample was 44.3% and 18.2%, respectively. Fewer individuals in the OD group (31.5%) reported having been stopped at roadblocks in the previous year compared to the PDs (55.9%) and RDs (48.6%, p = 0.03). However, a higher proportion of RDs reported drunk driving in the same period (87.5%; PD 69.7%; OD 26.9%; p < 0.001). CONCLUSION: Essential differences among groups were observed. RDs had a higher proportion of alcohol use and drunk driving in the previous year; drivers who fit into this particular group may be unresponsive or less responsive to social deterrence and enforcement actions.

User experience and operational feasibility of four point-of-collection oral fluid drug-testing devices according to Brazilian traffic agents.

OBJECTIVE: Traffic fatalities in Brazil still rank among the highest worldwide, with an overall rate of 23.4 deaths/100,000 inhabitants/year. Although alcohol and drug use play an important role in traffic accidents, national data about their relative influence are scarce. Drug screening is not routinely performed by traffic agents because alcohol is the only substance regularly investigated in roadblocks. Therefore, we aimed to describe the initial traffic agent user experience for 4 handheld point-of-collection oral fluid drug testing devices used in routine roadblocks in Brazil, focusing on usage perceptions in hopes of generalizing this approach for other developing countries. METHODS: Four different oral fluid collection devices were evaluated: The DDS2, the DOA MultiScreen, the Dräger DrugTest 5000, and the Multi-Drug Multi-Line Twist Screen Device. Fourteen trained traffic agents obtained oral fluid from 164 drivers and performed 37 qualitative evaluations of the devices. Traffic agents filled out a questionnaire focusing on 9 feasibility criteria: Overall simplicity for roadside operation; operational success; saliva sample collection time; sample analysis time; ease of sample preparation and analysis; agreement with observed clinical signs; overall hygiene and safety; sufficient operating instructions; and hygiene of saliva collection. These were weighted based on an expert panel and yielded an overall composite device experience score that ranged from 1 (poor) to 100 (excellent). RESULTS: Ease of use, operational success, and acceptable collection and analysis time were considered the most important criteria by the expert panel. The results ranged from 27.3 to 88.9% for simplicity of use; 45.5 to 100.0% for operational success; 27.3 to 100% for acceptable collection time; and 36.4 to 100.0% for acceptable analysis time. The final device scores, based on the agents' user experiences, ranked as follows: DOA MultiScreen: 49.3/100; Dräger DrugTest 5000: 82.4/100; Multi-Drug Multi-Line Twist Screen Device: 84.3/100; DDS2: 88.4/100. CONCLUSION: Based on the selected criteria, 3 of the 4 devices were considered useful by traffic agents in routine roadblock operations. The weighted evaluations suggest that their ease of use (handling, sampling analysis, and reliability), as well as their agreement with findings obtained by other means, defined their utility to traffic agents, although such appraisals must be further analyzed in future studies.