If health organisations and staff engage in research, does healthcare improve? Strengthening the evidence base through systematic reviews.

BACKGROUND: There is an often-held assumption that the engagement of clinicians and healthcare organizations in research improves healthcare performance at various levels. Previous reviews found up to 28 studies suggesting a positive association between the engagement of individuals and healthcare organizations in research and improvements in healthcare performance. The current study sought to provide an update. METHODS: We updated our existing published systematic review by again addressing the question: Does research engagement (by clinicians and organizations) improve healthcare performance? The search covered the period 1 January 2012 to March 2024, in two phases. First, the formal updated search ran from 1 January 2012 to 31 May 2020, in any healthcare setting or country and focussed on English language publications. In this phase two searches identified 66 901 records. Later, a further check of key journals and citations to identified papers ran from May 2020 to March 2024. In total, 168 papers progressed to full-text appraisal; 62 were identified for inclusion in the update. Then we combined papers from our original and updated reviews. RESULTS: In the combined review, the literature is dominated by papers from the United States (50/95) and mostly drawn from the Global North. Papers cover various clinical fields, with more on cancer than any other field; 86 of the 95 papers report positive results, of which 70 are purely positive and 16 positive/mixed, meaning there are some negative elements (i.e. aspects where there is a lack of healthcare improvement) in their findings. CONCLUSIONS: The updated review collates a substantial pool of studies, especially when combined with our original review, which are largely positive in terms of the impact of research engagement on processes of care and patient outcomes. Of the potential engagement mechanisms, the review highlights the important role played by research networks. The review also identifies various papers which consider how far there is a "dose effect" from differing amounts of research engagement. Additional lessons come from analyses of equity issues and negative papers. This review provides further evidence of contributions played by systems level research investments such as research networks on processes of care and patient outcomes.

Real World Challenges in Delivering Consumer Directed Care to Enhance Nursing Home Residents' Well Being.

OBJECTIVES: The aim of this study was to use the ADKAR model of organizational change to gain an understanding of why a training program designed to equip staff with the skills to provide a Consumer Directed Care (CDC) model in nursing homes produced little change in the outcome variables, including resident quality of life. METHODS: We collected and analyzed various forms of site-specific data including CDC implementation plans developed by staff trained in 21 facilities, and their training facilitators' records. RESULTS: Staff trained in the principles of CDC produced well-developed, facility-specific plans to introduce a CDC model of care, yet they faced many barriers to the implementation of these plans. These barriers were spread across multiple stages of the ADKAR model and included staff turnover (including managers), lack of engagement by management, lack of or inconsistent availability of a CDC champion, and disruptions to the training program. CONCLUSIONS: We identified several organizational factors contributing to the failure of the training program to produce anticipated changes. CLINICAL IMPLICATIONS: Without organizational commitment and full management support, attempts to implement CDC training programs are likely to fail, leading to negative consequences for residents' autonomy and control over how they are cared for.

An evaluation of a consumer directed care training program for nursing home staff.

OBJECTIVES: This study evaluated a training program to support the delivery of consumer directed care (CDC). It was hypothesized that both interventions, compared to the control condition, would demonstrate increased levels of CDC in nursing homes, increased staff practice of CDC, and improved resident QoL. The training plus support group was expected to show greater gains, compared to the training only group. MATERIALS AND METHODS: In a cluster RCT design, 33 nursing homes were randomly allocated to one of three conditions: training plus support, training only, and care as usual. Outcome measures included level of CDC within each home, staff practice of CDC, and resident QoL. RESULTS AND DISCUSSION: Hypotheses for this study were partially supported. Nursing homes became more CDC-oriented but with minimal changes in staff practice of CDC. Resident QoL also demonstrated limited change. The findings are discussed in terms of organizational barriers to change within nursing homes.

CogTale: an online platform for the evaluation, synthesis, and dissemination of evidence from cognitive interventions studies.

Systematic reviews and meta-analyses are critical in health-related decision-making, and are considered the gold standard in research synthesis methods. However, with new trials being regularly published and with the development of increasingly rigorous standards of data synthesis, systematic reviews often require much expertise and long periods of time to be completed. Automation of some of the steps of evidence synthesis productions is a promising improvement in the field, capable of reducing the time and costs associated with the process.This article describes the development and main characteristics of a novel online repository of cognitive intervention studies entitled Cognitive Treatments Article Library and Evaluation (CogTale). The platform is currently in a Beta Release phase, as it is still under development. However, it already contains over 70 studies, and the CogTale team is continuously coding and uploading new studies into the repository. Key features include advanced search options, the capability to generate meta-analyses, and an up-to-date display of relevant published studies.

Consumer directed care in residential aged care: an evaluation of a staff training program.

Objectives: The advent of Consumer-Directed Care (CDC, or individualized care) in Residential Aged Care Facilities (RACFs, or residential care) will require a paradigm shift in service delivery. This article evaluated the six-session Resident at the Centre of Care (RCC) staff training program designed to equip staff to implement a CDC model of care among residents.Method: There were two experimental conditions: RCC training program alone, RCC training program plus support, and a 'care as usual' condition. Outcome measures were resident quality of life (QoL) and resident working relationships with staff at 3-month follow-up. At Time 1, 92 residents from RACFs participated in the program. The RCC is six sessions that focus on the development of staff skills in communicating with residents, as well as the organizational change and transformational leadership that is needed for the implementation of CDC.Results: There were significant improvements in resident QoL. There was no major difference between the RCC Program plus support condition compared to the RCC Program alone condition, but both were associated with more positive changes in resident QoL than the 'care as usual' condition.Conclusion: This study demonstrates that training staff in strategies to implement CDC in RACFs can lead to an improvement in the wellbeing of many residents, and that additional support to assist staff to implement the strategies may not be required to produce such improvements. Longer term follow-up is necessary to determine if the improvements in resident QoL are sustained.

Resident perceptions of opportunity for communication and contribution to care planning in residential aged care.

BACKGROUND AND AIM: Irrespective of age, communication is a tool of expression and a key daily activity meeting the human need for social interaction and connection. The introduction of consumer-directed care (CDC) emphasises the importance of communication to provide consumers with the opportunity to exercise choice over the care they receive. As consumer-directed care progresses, it is hypothesised that the feasibility of shared decision-making and care planning in residential aged care will be largely determined by the communication opportunities afforded to the residents. Therefore, the aim of this study was to explore resident perceptions of the opportunities they have to communicate, including the opportunity to express their care preferences and contribute opinions about their care. DESIGN: A qualitative inductive design was adopted. METHODS: An individual interview format was used to gather the perspectives of 102 residents. Data were analysed using qualitative content analysis to generate themes illustrating patterns in participant views. FINDINGS: Overall, residents desired increased involvement in their care planning and increased opportunity for more meaningful communication and social opportunities. Residents described the negative impact of the communication difficulties they face on their communication and the need for support and activities to be tailored to residents' individual communication needs. CONCLUSIONS: To facilitate resident participation in CDC and meet resident desire for increased social communication, further investment in resources to support resident-staff communication and accommodate residents' individual communication needs is required. IMPLICATIONS FOR PRACTICE: By highlighting communication as a stand-alone activity and a priority of residents, the findings of this study raise the profile of communication and demonstrate the need for explicit allocation of care time and specialist services to support resident-staff communication and social communication in residential aged care. Such support must be tailored to meet residents' individual communication needs and be coupled with increased staff training in providing communication support. Without facilitating resident communication and increasing the opportunity to communicate, shared decision-making and care planning in residential aged care consistent with person-centred and consumer-directed models of care will be limited.

A randomized controlled trial to evaluate the effectiveness of a staff training program to implement consumer directed care on resident quality of life in residential aged care.

BACKGROUND: Residential Aged Care Facilities (RACFs) are moving towards a Consumer Directed Care (CDC) model of care. There are limited examples of CDC in ageing research, and no evaluation of a comprehensive CDC intervention in residential care was located. This study will implement and evaluate a staff training program, Resident at the Center of Care (RCC), designed to facilitate and drive CDC in residential care. METHODS: The study will adopt a cluster randomized controlled design with 39 facilities randomly allocated to one of three conditions: delivery of the RCC program plus additional organizational support, delivery of the program without additional support, and care as usual. A total of 834 staff (22 in each facility, half senior, half general staff) as well as 744 residents (20 in each facility) will be recruited to participate in the study. The RCC program comprises five sessions spread over nine weeks: Session 1 clarifies CDC principles; Sessions 2 to 5 focus on skills to build and maintain working relationships with residents, as well as identifying organizational barriers and facilitators regarding the implementation of CDC. The primary outcome measure is resident quality of life. Secondary outcome measures are resident measures of choice and control, the working relationship between resident and staff; staff reports of transformational leadership, job satisfaction, intention to quit, experience of CDC, work role stress, organizational climate, and organizational readiness for change. All measures will be completed at four time points: pre-intervention, 3-months, 6-months, and 12-month follow-up. Primary analyses will be conducted on an intention to treat basis. Outcomes for the three conditions will be compared with multilevel linear regression modelling. DISCUSSION: The RCC program is designed to improve the knowledge and skills of staff and encourage transformational leadership and organizational change that supports implementation of CDC. The overarching goal is to improve the quality of life and care of older people living in residential care. TRIAL REGISTRATION: ACTRN12618000779279; Registered 9 May 2018 with the Australian and New Zealand Clinical Trials Registry (ANZCTR; http://www.anzctr.org.au/ ).

The Kids Insight into Dementia Survey (KIDS): development and preliminary psychometric properties.

OBJECTIVES: Children may have a foundational role in efforts to raise community awareness about dementia. There is some qualitative work with children with a relative with dementia, but little work into the insights of children as general citizens without affected family. One issue is an absence of measurement tools; thus the study aimed to design and pilot a psychometrically sound self-report measure of dementia attitudes for children. METHOD: Using a multi-staged scale development process, stakeholder and expert input informed a 52-item Kids Insight into Dementia Survey (KIDS). After a pretest of KIDS with 21 Australian schoolchildren aged 10-12 years, exploratory factor analysis and reliability and validity testing were run on a revised KIDS with data from 203 similar-aged schoolchildren. RESULTS: The KIDS was reduced from 52 to 14 items, and a three-factor solution identified: 'Personhood,' 'Stigma,' and 'Dementia Understanding.' A strong positive correlation with an adult measure of dementia attitudes (r = .76) and a moderate positive correlation with a child measure of attitudes towards older adults (r = .47) indicated good concurrent validity. Internal consistency of .83 indicated good reliability. CONCLUSION: Results support the use of KIDS as a tool to measure children's insight into dementia, and to evaluate dementia education initiatives targeting the youth.

What do children need to know about dementia? The perspectives of children and people with personal experience of dementia.

ABSTRACTBackground:The vision for dementia-friendly communities is challenged by limited public awareness and stigma about dementia. The study aim was to elicit stakeholder priorities for the message content of an education program to improve dementia awareness among youth; specifically, what do children need to know about dementia? METHODS: A qualitative inquiry using interviews and focus groups was used. Purposive sampling achieved maximum variation in dementia experience and participant characteristics. Focus groups with Scouts in the community aged 9-12 years old (n = 22) used innovative techniques to explore children's attitudes towards people with dementia. Participants with personal experience of dementia were five people with early-stage dementia; 12 adult primary carers; four non-primary carers; and six grandchildren of a person with dementia. They were asked what is important for children to understand about dementia and what attitudes they may like an education program to confer. Content analysis was performed using NVivo10. RESULTS: Strong themes to emerge were that children need to know the whole truth about dementia; that individuals with dementia are "still people," that it is "not the fault" of the person with dementia; and that dementia is different and typically unpredictable for everyone. Discussions also indicated a need to educate children about ways to relate to a person with dementia, and to appreciate "positives" within a relationship. CONCLUSIONS: Children are our future citizens. Developing an education program for children with this message content may be fundamental to de-stigmatizing dementia and laying the foundation to dementia-friendly communities.

Raising awareness of research evidence among health professionals delivering dementia care: Are knowledge translation workshops useful?

Providing information about the latest research via educational sessions to health professionals caring for people with dementia may be insufficient to drive change. This project explored self-reported impacts on practice change of adding information about knowledge translation (KT) to a national dementia education program. Six national workshop days were held. Each provided the option of participating in a Principles of KT and innovation implementation seminar in addition to a clinical topic update (sexualities and dementia, or managing behavioral and psychological symptoms of dementia). Six months postworkshop, 321 participants were invited to complete a research utilization survey. Seventy-five responded. KT seminar participants were more likely to report instrumental outcomes (e.g. changed policies, procedures) than those who did not participate in the KT seminar. Including KT information in educational sessions for health professionals may increase the likelihood of practice change in the field of dementia care and warrants further research.

Applying Knowledge Translation Concepts and Strategies in Dementia Care Education for Health Professionals: Recommendations From a Narrative Literature Review.

INTRODUCTION: Dementia education programs are being developed for health professionals, but with limited guidance about "what works" in design and content to promote best practice in dementia care. Knowledge translation (KT) is a conceptual framework for putting evidence to work in health care. This narrative literature review examined the question: What does the field KT offer, conceptually and practically, for education of health professionals in dementia care? It seeks to identify the types of strategies currently used within education to facilitate effective KT for the wide range of health professionals who may be involved in the care of people with dementia, plus explore enablers and barriers to KT in this context. METHODS: From 76 articles identified in academic databases and manual bibliographic searching, 22 met review criteria. RESULTS: The literature synthesis indicated four hallmarks of successful KT-oriented dementia education for health professionals: (1) multimodal delivery, (2) tailored approaches, (3) relationship building, and (4) organizational support for change in the work setting. Participatory action frameworks were also favored, based on interactive knowledge exchange (eg, blended learning) rather than passive unidirectional approaches alone (eg, lectures). DISCUSSION: The following six principles are proposed for educating health professionals in dementia care: (1) Match the education strategy to the KT goal and learner preferences; (2) Use integrated multimodal learning strategies and provide opportunities for multiple learning exposures plus feedback; (3) Build relationships to bridge the research-practice gap; (4) Use a simple compelling message with formats and technologies relevant to the audience; (5) Provide incentives to achieve KT goals; and (6) Plan to change the workplace, not just the individual health professional.

The relationship between the quality of the built environment and the quality of life of people with dementia in residential care.

While there is considerable evidence on the impact of specific design features on problems associated with dementia, the link between the quality of the built environment and quality of life of people with dementia is largely unexplored. This study explored the environmental and personal characteristics that are associated with quality of life in people with dementia living in residential aged care. Data were obtained from 275 residents of 35 aged care homes and analysed using linear regression. The quality of the built environment was significantly associated with the quality of life of the resident measured by global self-report. Environmental ratings were not associated with proxy or detailed self-report ratings. Higher quality of life is associated with buildings that facilitate engagement with a variety of activities both inside and outside, are familiar, provide a variety of private and community spaces and the amenities and opportunities to take part in domestic activities.

A Systematic Review of Interventions to Change Staff Care Practices in Order to Improve Resident Outcomes in Nursing Homes.

BACKGROUND: We systematically reviewed interventions that attempted to change staff practice to improve long-term care resident outcomes. METHODS: Studies met criteria if they used a control group, included 6 or more nursing home units and quantitatively assessed staff behavior or resident outcomes. Intervention components were coded as including education material, training, audit and feedback, monitoring, champions, team meetings, policy or procedures and organizational restructure. RESULTS: Sixty-three unique studies were broadly grouped according to clinical domain-oral health (3 studies), hygiene and infection control (3 studies), nutrition (2 studies), nursing home acquired pneumonia (2 studies), depression (2 studies) appropriate prescribing (7 studies), reduction of physical restraints (3 studies), management of behavioral and psychological symptoms of dementia (6 studies), falls reduction and prevention (11 studies), quality improvement (9 studies), philosophy of care (10 studies) and other (5 studies). No single intervention component, combination of, or increased number of components was associated with greater likelihood of positive outcomes. Studies with positive outcomes for residents also tended to change staff behavior, however changing staff behavior did not necessarily improve resident outcomes. Studies targeting specific care tasks (e.g. oral care, physical restraints) were more likely to produce positive outcomes than those requiring global practice changes (e.g. care philosophy). Studies using intervention theories were more likely to be successful. Program logic was rarely articulated, so it was often unclear whether there was a coherent connection between the intervention components and measured outcomes. Many studies reported barriers relating to staff (e.g. turnover, high workload, attitudes) or organizational factors (e.g. funding, resources, logistics). CONCLUSION: Changing staff practice in nursing homes is possible but complex. Interventionists should consider barriers and feasibility of program components to impact on each intended outcome.

The effects of humor therapy on nursing home residents measured using observational methods: the SMILE cluster randomized trial.

OBJECTIVES: To evaluate the effects of humor therapy assessed using observational methods on agitation, engagement, positive behaviors, affect, and contentment. DESIGN: Single-blind cluster randomized controlled trial. SETTING: A total of 35 Sydney nursing homes. PARTICIPANTS: All eligible residents within geographically defined areas within each nursing home were invited to participate. INTERVENTION: Professional "ElderClowns" provided 9 to 12 weekly humor therapy sessions, augmented by resident engagement by trained staff "LaughterBosses." Controls received usual care. MEASUREMENTS: The Behavior Engagement Affect Measure (BEAM) touchpad observational tool was used to capture real-time behavioral data. The tool assesses the duration in seconds of agitation, positive behavior toward others, engagement, and affect (angry, anxious, happy, neutral, sad). RESULTS: Seventeen nursing homes (189 residents) received the intervention and 18 homes (209 residents) received usual care. Over 26 weeks, in comparison with controls, the humor therapy group decreased in duration of high agitation (effect size = 0.168 and 0.129 at 13 and 26 weeks, respectively) and increased in duration of happiness (effect size = 0.4 and 0.236 at 13 and 26 weeks, respectively). CONCLUSION: We confirmed that humor therapy decreases agitation and also showed that it increases happiness. Researchers may consider evaluating impacts of nonpharmaceutical interventions on positive outcomes. Computer-assisted observational measures should be considered, particularly for residents with dementia and when the reliability of staff is uncertain.

Computer-assisted direct observation of behavioral agitation, engagement, and affect in long-term care residents.

OBJECTIVES: The objectives of the current research were (1) to test and evaluate the investigator-designed Behavior, Engagement, and Affect Measure (BEAM) touchpad direct observational data collection tool, and (2) to implement this tool to investigate residents' patterns of behavioral agitation, engagement, affect, behaviors associated with positive mood, general time-activity use, and social interactions within long-term care. DESIGN: Raters collected cross-sectional observational data and conducted semistructured interviews with participants of the Sydney Multisite Intervention of LaughterBosses and ElderClowns (SMILE) Study. Researchers tested the BEAM's reliability and validity and evaluated the instrument's discriminate validity for sampling resident behaviors. SETTING: Data were collected in 36 long-term care homes. The sample included low-care hostels, high-care nursing homes, and residential facilities offering aging-in-place. PARTICIPANTS: Participants were 406 residents aged 52 to 105 years, with and without dementia. MEASUREMENTS: Researchers collected direct observational data using the BEAM and operationalized behavioral domains based largely on concepts from Kitwood's model of person-centered care. Care staff reported on resident behavior using standardized measures of agitation, depression, quality of life, and social engagement. RESULTS: The BEAM showed moderate-to-substantial interrater reliability and slight-to-moderate correlations with staff-report data gathered through standardized questionnaire measures. Observations showed that residents spent the greatest amount of time stationary and expressing little emotion, although actively engaged with their environment. Residents were observed to be coping adequately and experiencing a positive social and/or positive care interaction in approximately half of observations; however, close to a third of ratings identified "ill-being." Residents showed more positive behavior, appeared happier and less anxious, and exhibited higher "well-being" during structured activity than during free time or meals. CONCLUSION: The BEAM is a reliable and valid observational tool for measuring behavior in long-term care. Long-term care residents expressed little emotion and experienced limited positive social interaction in their daily routine. Increased provision of structured activities may increase resident experiences of positive behavior, affect, and well-being.

Successful ingredients in the SMILE study: resident, staff, and management factors influence the effects of humor therapy in residential aged care.

OBJECTIVE: To test the hypothesis that individual and institutional-level factors influence the effects of a humor therapy intervention on aged care residents. METHODS: Data were from the humor therapy group of the Sydney Multisite Intervention of LaughterBosses and ElderClowns, or SMILE, study, a single-blind cluster randomized controlled trial of humor therapy conducted over 12 weeks; assessments were performed at baseline, week 13, and week 26. One hundred eighty-nine individuals from 17 Sydney residential aged care facilities were randomly allocated to the humor therapy intervention. Professional performers called "ElderClowns" provided 9-12 weekly humor therapy 2-hour sessions, augmented by trained staff, called "LaughterBosses." Outcome measures were as follows: Cornell Scale for Depression in Dementia, Cohen-Mansfield Agitation Inventory, Neuropsychiatric Inventory, the withdrawal subscale of Multidimensional Observation Scale for Elderly Subjects, and proxy-rated quality of life in dementia population scale. Facility-level measures were as follows: support of the management for the intervention, commitment levels of LaughterBosses, Environmental Audit Tool scores, and facility level of care provided (high/low). Resident-level measures were engagement, functional ability, disease severity, and time-in-care. Multilevel path analyses simultaneously modeled resident engagement at the individual level (repeated measures) and the effects of management support and staff commitment to humor therapy at the cluster level. RESULTS: Models indicated flow-on effects, whereby management support had positive effects on LaughterBoss commitment, and LaughterBoss commitment increased resident engagement. Higher resident engagement was associated with reduced depression, agitation, and neuropsychiatric scores. CONCLUSION: Effectiveness of psychosocial programs in residential aged care can be enhanced by management support, staff commitment, and active resident engagement.

Potential benefits to staff from humor therapy with nursing home residents.

Life in residential care can be challenging for residents and staff. Bringing humor into this setting may benefit residents, creating a more productive, enjoyable work environment for staff. The potential effect of exposure to humor therapy on staff, both as active and incidental participants, as part of a randomized controlled trial of the effect of humor therapy for aged care residents was investigated in the Sydney Multisite Intervention of LaughterBosses and ElderClowns (SMILE). The intervention involved a humor program with professional performers (ElderClowns) and trained facility staff (LaughterBosses) for a minimum of nine 2-hour sessions over 12 weeks. Methods included a staff survey at three time points, interviews with LaughterBosses, and a satisfaction rating by facility managers. There were significant positive findings for some staff subgroups, including assistants in nursing/personal care assistants and staff older than 45. LaughterBoss interviews and intervention group manager ratings of staff work enthusiasm were positive.

The Sydney Multisite Intervention of LaughterBosses and ElderClowns (SMILE) study: cluster randomised trial of humour therapy in nursing homes.

OBJECTIVES: To determine whether humour therapy reduces depression (primary outcome), agitation and behavioural disturbances and improves social engagement and quality-of-life in nursing home residents. DESIGN: The Sydney Multisite Intervention of LaughterBosses and ElderClowns study was a single-blind cluster randomised controlled trial of humour therapy. SETTING: 35 Sydney nursing homes. PARTICIPANTS: All eligible residents within geographically defined areas within each nursing home were invited to participate. INTERVENTION: Professional 'ElderClowns' provided 9-12 weekly humour therapy sessions, augmented by resident engagement by trained staff 'LaughterBosses'. Controls received usual care. MEASUREMENTS: Depression scores on the Cornell Scale for Depression in Dementia, agitation scores on the Cohen-Mansfield Agitation Inventory, behavioural disturbance scores on the Neuropsychiatric Inventory, social engagement scores on the withdrawal subscale of Multidimensional Observation Scale for Elderly Subjects, and self-rated and proxy-rated quality-of-life scores on a health-related quality-of-life tool for dementia, the DEMQOL. All outcomes were measured at the participant level by researchers blind to group assignment. RANDOMISATION: Sites were stratified by size and level of care then assigned to group using a random number generator. RESULTS: Seventeen nursing homes (189 residents) received the intervention and 18 homes (209 residents) received usual care. Groups did not differ significantly over time on the primary outcome of depression, or on behavioural disturbances other than agitation, social engagement and quality of life. The secondary outcome of agitation was significantly reduced in the intervention group compared with controls over 26 weeks (time by group interaction adjusted for covariates: p=0.011). The mean difference in change from baseline to 26 weeks in Blom-transformed agitation scores after adjustment for covariates was 0.17 (95% CI 0.004 to 0.34, p=0.045). CONCLUSIONS: Humour therapy did not significantly reduce depression but significantly reduced agitation. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry -ACTRN12611000462987.

Study protocol for a randomized controlled trial of humor therapy in residential care: the Sydney Multisite Intervention of LaughterBosses and ElderClowns (SMILE).

BACKGROUND: Humor therapy is a non-pharmacological intervention with potential to improve mood and quality of life for institutionalized older persons, including those with dementia. The primary aims of the Sydney Multisite Intervention of LaughterBosses and ElderClowns (SMILE) are to examine the effects of humor therapy on residents' mood, quality of life, social engagement, and agitation. METHODS: SMILE is a single-blinded cluster-randomized controlled trial where 398 consented residents in 35 residential aged care facilities will be allocated to receive humor therapy or usual care. Residents allocated to the intervention group will engage in humor therapy with professional performers (ElderClowns) and trained facility staff (LaughterBosses) for a minimum of nine two-hour sessions over 12 weeks as well as engaging humorously with LaughterBosses during the course of daily care. The usual care control group will not engage in any formal humor therapy. Researchers, blind to treatment allocation, will assess residents at baseline (week 0), post-intervention (week 13), and follow-up (week 26). The measurement suite includes the Cornell Scale for Depression in Dementia, the Dementia Quality of Life Scale, the Multidimensional Observation Scale for Elderly Subjects, the Cohen-Mansfield Agitation Inventory, and the Neuropsychiatric Inventory. Observations of residents' engagement will be recorded at each humor therapy session. CONCLUSIONS: SMILE is the first large rigorous study of humor therapy in aged care.