Dr Rachael Kelley

Background: A quarter of people in general hospitals have dementia. Limited existing studies suggest that hospital care experiences of people living with dementia, and the involvement of their families in care, may be suboptimal. Objectives: The objectives of this study were to explore how family involvement impacts upon experiences of hospital care for people living with dementia. Design: A qualitative ethnographic study. Methods: Ethnographic data were collected from two care of older people general hospital wards. Data were collected via observations, conversations and interviews with people living with dementia, families and staff. In total, 400 hours of observation and 46 interviews were conducted across two 7-9 month periods. Results: People living with dementia could experience a lack of connection on multiple levels - from pre-hospital life as well as life on the wards - where they could spend long periods of time without interacting with anyone. There was great variation in the degree to which staff used opportunities to involve families in improving connections and care. When used, the knowledge and expertise of families played a crucial role in facilitating more meaningful interactions, demonstrating how person-centred connections and care are possible in busy hospital settings. Despite such benefits, the involvement of families and their knowledge was not routine. Care was required to ensure that family involvement did not override the needs and wishes of people living with dementia. Conclusions: This study demonstrates the benefits of involving families and their knowledge in care, advocating for family involvement, alongside the involvement of people living with dementia, to become a more routine component of hospital care.

Background and Objectives: Important decisions about the future care of people living with dementia are routinely made in hospitals. Very little is known about how the care needs of hospitalized people with dementia are understood, or how the perspectives of the person, families, and staff intersect to inform decision-making. This study explores how the care needs of people with dementia are understood by the person, their family, and hospital staff (the care triad), and how these perspectives shape decision-making. Research Design and Methods: Ethnographic data were collected from 2 care-of-older-people general hospital wards via observations, conversations, and interviews with people with dementia, families, and staff. In total, 400 hr of observation and 46 interviews were conducted across two 7- to 9-month periods. Results: The person’s care needs were often understood differently between and within arms of the care triad. A lack of consistent engagement with families and people with dementia reduced opportunities to recognize and integrate this range of views, leading to delays or difficulties in decision-making. People with dementia, particularly those lacking capacity, were most likely to have their perspectives overlooked. Discussion and Implications: Early engagement with people with dementia and their families is required to ensure that all perspectives on the person’s current and future care needs are understood and represented during decision-making. Particular attention should be paid to involving people living with dementia in discussions and decisions about their care, and to the assessment and involvement of people who may lack capacity.

Purpose: People with Persistent Physical Symptoms experience physical symptoms that are not wholly explained by a medical disorder or disease. Multidisciplinary treatment is recommended for people with severe difficulties and is provided in a small number of specialist centres in the UK. Only brief descriptions of this treatment are available, and the experiences of people receiving this treatment as an inpatient have not been explored. This study aimed to explore how people with persistent physical symptoms experience inpatient treatment from a specialist multidisciplinary team, and to identify which factors facilitated their engagement in the rehabilitation. Materials and Methods: 18 people who had received inpatient multidisciplinary treatment for persistent physical symptoms participated in semi-structured interviews. The transcripts were analysed using reflexive thematic analysis. Results: Participants’ experiences were influenced by whether they felt believed by the healthcare team, and whether they could place their own trust and belief in the staff team and the treatment approach. Their experiences involved a series of transitions; both in environment and understanding. Conclusions: Improvements are possible for people receiving inpatient multidisciplinary treatment for severe PPS. Trusting relationships between patients and staff members take time to develop but play a major role in patients’ experiences of treatment.

Background: Delirium is common and distressing for hospice in-patients. Hospital-based research shows delirium may be prevented by targeting its risk factors. Many preventative strategies address patients’ fundamental care needs. However, there is little research regarding how interventions need to be tailored to the in-patient hospice setting. Aim: To explore the behaviours of hospice in-patient staff in relation to delirium prevention, and the influences that shape these behaviours. Design: Focused ethnography supported by behaviour change theory. Observation, semi-structured interviews and document review were conducted. Setting/participants: A total of 89 participants (multidisciplinary staff, volunteers, patients and relatives) at two UK in-patient hospice units. Results: Hospice clinicians engaged in many behaviours associated with prevention of delirium as part of person-centred fundamental care, without delirium prevention as an explicit aim. Carrying out essential care tasks was highly valued and supported by adequate staffing levels, multidisciplinary team engagement and role clarity. Patients’ reduced physical capability limited some delirium prevention behaviours, as did clinicians’ behavioural norms related to prioritising patient comfort. Delirium prevention was not embedded into routine assessment and care decision-making, despite its potential to reduce patient distress. Conclusions: The value placed on fundamental care in hospices supports delirium prevention behaviours but these require adaptation as patients become closer to death. There is a need to increase clinicians’ understanding of the potential for delirium prevention to reduce patient distress during illness progression; to support inclusion of delirium prevention in making decisions about care; and to embed routine review of delirium risk factors in practice.

Background Characteristics of self-harm differ across ages, but there is little work identifying age-related differences in younger people. Young people entering adolescence face emotionally and developmentally different challenges to those entering adulthood. This study investigates how Emergency Department (ED) presentations and management of self-harm differ through adolescence and early adulthood. Methods 3782 consecutive self-harm episodes involving 2559 people aged 12–25 years were identified from an existing database of Leeds ED attendances from 2004–2007. Odds ratios for each of four age bands were compared to the remaining young people. Results The female to male ratio was 6.3:1 at 12–14 years old, decreasing with successive age groups to 1.2:1 at 22–25 years old. Self-poisoning was commoner in those under 18 years old. 18–25 year olds were more likely to self-poison with prescribed medications, mixed overdoses, alcohol or recreational drugs. 18–25 year olds more often required medical treatment for the effects of the self-harm. 12–14 year olds were more often seen urgently by ED medical staff and offered high intensity mental health aftercare. Repetition of self-harm was commonest in 12–14 year olds, although multiple repetition of self-harm was commonest in 22–25 year olds. Limitations Data were not collected on whether the aftercare offered was received. The study sample included hospital attenders only. Conclusions The large excess of females over males in young people’s self-harm is only true at the younger age range. Older adolescents present with more severe acts of self-harm, yet receive the lowest intensity of assessment and after care.

BACKGROUND: Self-poisoning and self-injury have widely differing incidences in hospitals and in the community, which has led to confusion about the concept of self-harm. Categorising self-harm simply by a method may be clinically misleading because many hospital-attending patients switch from one method of harm to another on subsequent episodes. The study set out to determine the frequency, pattern, determinants and characteristics of method-switching in self-harm episodes presenting to the general hospital. METHODS: The pattern of repeated self-harm was established from over 33,000 consecutive self-harm episodes in a multicentre English cohort, categorising self-harm methods as poisoning, cutting, other injury, and combined methods. RESULTS: Over an average of 30 months of follow-up, 23% of people repeated self-harm and one-third of them switched method, often rapidly, and especially where the person was male, younger, or had self-harmed previously. Self-poisoning was far less likely than other methods to lead on to switching. LIMITATIONS: Self-harm episodes that do not lead to hospital attendance are not included in these findings but people who self-harmed and went to hospital but were not admitted from the emergency department to the general hospital, or did not receive designated psychosocial assessment are included. People in the study were a mix of prevalent as well as incident cases. CONCLUSIONS: Method of self-harm is fluctuating and unpredictable. Clinicians should avoid false assumptions about people׳s risks or needs based simply on the method of harm.

Background: Nonfatal self-harm is the strongest predictor of suicide, with some of the risk factors for subsequent suicide after nonfatal self-harm being similar to those for suicide in general. However, we do not have sufficient information regarding the medical care provided to nonfatal self-harm episodes preceding suicide. Aims: Our study sought to explore hospital care and predictive characteristics of the risk of suicide after nonfatal self-harm. Method: Individuals with history of nonfatal self-harm who died by suicide were compared with those who had a nonfatal self-harm episode but did not later die by suicide. Cases were identified by cross-linking data collected through a self-harm monitoring project, 2000-2007, and comprehensive local data on suicides for the same period. Results: Dying by suicide after nonfatal self-harm was more common for male subjects than for female subjects (OR = 3.3, 95% CI = 1.7-6.6). Self-injury as the method of nonfatal self-harm was associated with higher risk of subsequent suicide than was self-poisoning (OR = 2.0, 95% CI = 1.04-3.9). More urgent care at the emergency department (OR = 2.7, 95% CI = 1.1-6.3) and admission to hospital (OR = 2.0, 95% CI = 1.0-4.0) at the index episode were related to a heightened risk of suicide. Conclusion: The findings of our study could help services to form assessment and aftercare policies.

Background: Processing personal data for research purposes and the requirement of anonymity has been the subject of recent debate. We aimed to determine the proportion of individuals who present to emergency departments with non-fatal suicidal behavior where an NHS number has been successfully traced and to investigate the characteristics of patients associated with non-capture. Method: This was a descriptive study of people attending after self-harm using allocation of NHS numbers as main outcome measurement. Data from the Multicentre Monitoring of Self-Harm Project from 3 centres in England were used to identify consecutive patients (N = 3000) who were treated in six emergency departments in Oxford, Manchester and Leeds in 2004 and 2005 following self-harm. Results: NHS number was available between 55–73% of individuals across centres. Characteristics associated with non-recording of NHS number in more than one centre included those from ethnic minority groups (Oxford: chi-squared statistic = 13.6, df = 3, p = 0.004; Manchester: chi-squared statistic = 13.6, df = 3, p ≤0.001) and the homeless or living in a hostel or other institution (Oxford: chi-squared statistic = 40.9, df = 7, p = <0.001; Manchester: chi-squared statistic = 23.5, df = 7, p = 0.001). Individual centre characteristics included being of male gender (Leeds: chi-squared statistic = 4.1, df = 1, p = 0.4), those under 25 years (Oxford: chi-squared statistic = 10.6, df = 2, p = 0.005), not being admitted to general hospital (Leeds: chi-squared statistic = 223.6, df = 1, p ≤0.001) and using self-injury as a method of harm (Leeds: chi-squared statistic = 41.5, df = 2, p ≤0.001). Conclusion: Basing research studies on NHS number as the unique identifier, as suggested by the Data Protection Act 1998 and the Patient Information Advisory Group, would exclude some of the most vulnerable groups for further self-harm or suicide. This bias may also affect other research registers.

Background: Quantitative research about self-harm largely deals with self-poisoning, despite the high incidence of self-injury. Aims: We compared patterns of hospital care and repetition associated with self-poisoning and self-injury. Method: Demographic and clinical data were collected in a multicentre, prospective cohort study, involving 10 498 consecutive episodes of self-harm at six English teaching hospitals. Results: Compared with those who self-poisoned, people who cut themselves were more likely to have self-harmed previously and to have received support from mental health services, but they were far less likely to be admitted to the general hospital or receive a psychosocial assessment. Although only 17% of people repeated self-harm during the 18 months of study, survival analysis that takes account of all episodes revealed a repetition rate of 33% in the year following an episode: 47% after episodes of self-cutting and 31% after self-poisoning (P<0.001). Of those who repeated, a third switched method of self-harm. Conclusions: Hospital services offer less to people who have cut themselves, although they are far more likely to repeat, than to those who have self-poisoned. Attendance at hospital should result in psychosocial assessment of needs regardless of method of self-harm.

BACKGROUND: Self-harm is a major healthcare problem in the United Kingdom, but monitoring of hospital presentations has largely been done separately in single centres. Multicentre monitoring of self-harm has been established as a result of the National Suicide Prevention Strategy for England. METHOD: Data on self-harm presentations to general hospitals in Oxford (one hospital), Manchester (three hospitals) and Leeds (two hospitals), collected through monitoring systems in each centre, were analysed for the 18-month period March 2000 to August 2001. RESULTS: The findings were based on 7344 persons who presented following 10,498 episodes of self-harm. Gender and age patterns were similar in the three centres, 57.0% of patients being female and two-thirds (62.9%) under 35 years of age. The largest numbers by age groups were 15-19 year-old females and 20-24 year-old males. The female to male ratio decreased with age. Rates of self-harm were higher in Manchester than Oxford or Leeds, in keeping with local suicide rates. The proportion of patients receiving a specialist psychosocial assessment varied between centres and was strongly associated with admission to the general hospital. Approximately 80% of self-harm involved self-poisoning. Overdoses of paracetamol, the most frequent method, were more common in younger age groups, antidepressants in middle age groups, and benzodiazepines and sedatives in older age groups. Alcohol was involved in more than half (54.9%) of assessed episodes. The most common time of presentation to hospital was between 10 pm and 2 am. CONCLUSIONS: Multicentre monitoring of self-harm in England has demonstrated similar overall patterns of self-harm in Oxford, Manchester and Leeds, with some differences reflecting local suicide rates. Diurnal variation in time of presentation to hospital and the need for assessment of non-admitted patients have implications for service provision.

Background: Psychosocial assessment is central to the management of self-harm, but not all individuals receive an assessment following presentation to hospital. Research exploring the factors associated with assessment and non-assessment is sparse. It is unclear how assessment relates to subsequent outcome. Methods: We identified episodes of self-harm presenting to six hospitals in the UK cities of Oxford, Leeds, and Manchester over an 18-month period (1st March 2000 to 31st August 2001). We used established monitoring systems to investigate: the proportion of episodes resulting in a specialist assessment in each hospital; the factors associated with assessment and non-assessment; the relationship between assessment and repetition of self-harm. Results: A total of 7344 individuals presented with 10,498 episodes of self-harm during the study period. Overall, 60% of episodes resulted in a specialist psychosocial assessment. Factors associated with an increased likelihood of assessment included age over 55 years, current psychiatric treatment, admission to a medical ward, and ingestion of antidepressants. Factors associated with a decreased likelihood of assessment included unemployment, self-cutting, attending outside normal working hours, and self-discharge. We found no overall association between assessment and self-harm repetition, but there were differences between hospitals – assessments were protective in one hospital but associated with an increased risk of repetition in another. Limitations: Some data may have been more likely to be recorded if episodes resulted in a specialist assessment. This was a non-experimental study and so the findings relating specialist assessment to repetition should be interpreted cautiously. Conclusion: Many people who harm themselves, including potentially vulnerable individuals, do not receive an adequate assessment while at hospital. Staff should be aware of the organizational and clinical factors associated with non-assessment. Identifying the active components of psychosocial assessment may help to inform future interventions for self-harm.

Effective intervention following self-harm is vital because of the strong link between self-harm and suicide. Unfortunately, services for people who self-harm have been poor in the UK and elsewhere. In 2004, the National Institute for Health and Clinical Excellence issued a guideline setting out clear standards for care following self-harm, many of which are included in this article. Whether this guideline has led to much needed improvements in care is not clear; there are few published experiences concerning implementation of the guidance but some studies suggest that care continues to be unsatisfactory. The barriers to implementation of self-harm guidelines are not clear, but the lack of definitive research evidence for effective treatments is a potential candidate. Several systematic reviews have failed to demonstrate a statistically significant reduction in fatal or non-fatal repetition following intervention after self-harm. Recent studies have, however, shown clear benefits for some psychological therapies – in particular for cognitive behavioural therapy with a problem-solving element. Promising results have also been demonstrated for some brief interventions designed to encourage uptake of aftercare following self-harm. This article sets out a little of the evidence for these potentially beneficial interventions, including recent developments in research evidence and implications for future research.

Background: Medical students consistently report low rates of interest in psychiatry as a career over time with negative perceptions of the specialty. Only 3–6% of students enter the specialty. Aim: To explore medical students’ current career choices and attitudes to psychiatry and factors affecting these. Methods: Medical students at four UK medical schools completed a questionnaire related to career specialty choices and psychiatry and their psychiatry placement experiences. Results: A total of 905 questionnaires were returned. Psychiatry was first career specialty choice in 4% but in the top three choices in 14%. The students in this group who had undertaken clinical placements were more positively inclined towards psychiatry, given more opportunities to practice and receive feedback on psychiatric skills, and more inclined to practice psychiatry later. Conclusion: One in seven students is interested in psychiatry. Psychiatrists need to find ways to identify these students and target them with individually tailored interventions to help recruitment into the specialty.

BACKGROUND: Assessment and aftercare for people who self-harm needs to be related to an understanding of risks of adverse outcomes. We aimed to determine whether self-harm by a combination of methods and its early repetition are associated with adverse outcomes - especially non-fatal repetition and suicide. METHOD: 10,829 consecutive general hospital attendances due to self-harm in one large English city were monitored, through scrutiny of Emergency Department attendances, over three years and followed up to determine the incidence of non-fatal repetition. Subsequent deaths, by any cause and by suicide, were determined from national statistical records. RESULTS: 6155 patients accounted for the 10,829 episodes: 72% by self-poisoning, 21% self-injury, and 746 episodes (7%) due to a combination of methods. After a combined-methods index episode, non-fatal repetition (P=0.001) and suicide (P=0.002) occurred sooner and more frequently than it did among those who had self-poisoned. Further hospital attendance due to self-harm within a month was associated with a 3.7-fold (95% CI 2.1-6.4) risk of subsequent suicide. LIMITATIONS: The data exclude self-harm episodes that do not result in a hospital attendance. Index episodes in the study are not generally life-time first episodes so follow-up data are based on an arbitrary start-point. Both of these limitations are common to all studies of this kind. CONCLUSIONS: At psychosocial assessment and the making of aftercare arrangements, combined methods of self-harm or another recent episode should be considered 'red-flag' indicators for attention to care.

This month's BJPsych publishes two important studies concerned with the use of risk assessment scales after self-harm, one a systematic review and the other a multicentre cohort study. We agree with the authors: that each study adds weight to the existing evidence that points towards avoiding the use of such scales in clinical practice.

Ethnographic approaches to health and care research are invaluable. They offer rich insight into contextual and cultural factors that influence the health service, as well as the delivery of care within any given community, and recognise the centrality of the researcher in the process. Understanding the unfolding of real-life events, as well as interactions between people, space, technology and other affordances, is crucial to developing impactful and contextually sensitive interventions. Information derived from ethnography may also be unreachable by other, retrospective research approaches. By combining a collection of ten researchers’ diverse first-hand experiences relating to past studies, with collaborative reflections on conceptual, theoretical, methodological, and ethical issues pertaining to ethnographic inquiry in health and care research, this paper offers a unique, accessible and revealing ‘backstage’ introduction to ethnographic approaches. It aims to de-mystify ethnography and prepare researchers planning to adopt ethnographic approaches to health research, by describing how it can look and feel in practice with empirical illustrations. This is perhaps particularly valuable for researchers new to ethnographic approaches across disciplines and expertise levels (e.g., clinical researchers and PhD students), as well as any stakeholder who may wish to be involved, or support such work in health and care settings.

Background: This trial investigated the (cost) effectiveness of Dementia Care Mapping (DCM™) for reducing agitation in care home residents with dementia compared to usual care (DCM™ EPIC trial). Methods: Pragmatic, cluster randomised controlled trial, with follow-up at 6- and 16-months. Stratified randomisation of 50 care homes to intervention (n=31) or control (n=19). Care home eligibility included recruitment of =10 residents, not subject to improvement notices or using DCM™ in the previous 18-months. At baseline and 16-months, 726 and 261 residents were recruited, respectively. Resident eligibility included: permanent residence; diagnosis of dementia/score of =4 on the Functional Assessment Staging of Alzheimer's Disease; not at end-of-life/permanently cared for in bed. Clusters were not blinded to allocation. Three DCM™ cycles, delivered by two trained care home staff were scheduled, mirroring standard procedures; supported during cycle one by a DCM™ expert. The primary outcome was agitation (Cohen-Mansfield Agitation Inventory (CMAI)) at 16-months. Secondary outcomes included neuropsychiatric symptoms and quality of life. Findings: DCMTM was not superior to control on any primary or secondary outcomes (n=675 residents: 287 control, 388 intervention). The adjusted mean difference in CMAI score was -2.11 points in the intervention versus control (95% CI -4.66 to 0.44, p = .104, adjusted ICC control=0, intervention 0.001). Sensitivity analyses supported the primary analysis. Intervention adherence was problematic; only 26% of homes completed >1 DCM™ cycle. Incremental cost per unit improvement in CMAI for baseline recruited residents (n=726, 418 intervention, 308 control) was £289 for intervention versus control. Interpretation: There was no evidence of benefit of DCM™; an important finding given its wide, international use. Further research should urgently consider modifications to existing DCM™implementation models, or other approaches to reducing agitation in care home residents. Trial Registration Number: Registered with the International Standard Randomised Controlled Trial Register (ISRCTN) reference 82288852. Funding Statement: National Institute for Health Research Health Technology Assessment programme (project number 11/15/13). Declaration of Interests: Claire A Surr was previously employed by the University of Bradford, who own the IP to the DCM™ intervention tested in this trial. In this role she held responsibility for DCM training and method development. She was a technical author on the British Standards Institute PAS 800 guide on implementing DCM™ in health and social care provider organizations. She declares personal fees from Hawker publications outside the submitted work. David Meads reports being a member of the NIHR HTA Elective and Emergency Specialist Care Panel (EESC) being a member of the NIHR PGfAR funding panel. Clive Ballard reports grants and personal fees from Acadia pharmaceutical company, grants and personal fees from Lundbeck, personal fees from Roche, personal fees from Otusaka, personal fees from Novartis, personal fees from Eli Lilly, personal fees from Pfizer, outside the submitted work. Murna Downs works at the University of Bradford which holds the Intellectual Property for DCM™ and runs courses for practitioners and professionals who wish to learn how to use the method. Louise Robinson reports grants from NIHR Senior Investigator Award, grants from NIHR Translational Professorship Award, outside the submitted work; and NIHR board membership of the Primary Care Themed Call board. Amanda Farrin reports membership of the NIHR HTA Funding Boards Policy group, the NIHR HTA Clinical Evaluation and Trials board and, previously, the NIHR HTA Themed Call board. All other authors have no conflicts to declare Ethics Approval Statement: The study was granted ethical approval by NRES Committee Yorkshire & The Humber - Bradford Leeds REC ref 13/YH/0016. The trial will be performed in accordance with the recommendations guiding physicians in biomedical research involving human subjects adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964, amended at the 52nd World Medical Association General Assembly, Edinburgh, Scotland, 1996. Informed written consent will be obtained from the care homes, staff and residents prior to entry into the trial.

Background Discussing pharmaceutical treatment for dementia is challenging because of variation in disease progression, lack of curative treatments, and communication difficulties. Research in the context of dementia suggests shared decision making is limited, this study examined how dementia medications are discussed in practice. Methods Focused video/audio ethnography of clinical appointments (n = 14), semi-structured interviews with patients/supporters (n = 23) and clinicians (n = 5) were employed to examine communication practices. Results Two themes developed; Framing and understanding of information in the context of uncertainty explores how uncertainties around risks and benefits are understood. ‘Not worth the risk’ or ‘nothing to lose’ presents how patients/supporters and clinicians balance individuals’ contexts/perceived risks/benefits. In the absence of certainty around potential benefits, risk often informed decision-making, particularly for frailer or more vulnerable patients. Conclusions Clinicians should be aware of their influence on decision-making and be cognisant of the way that they frame opinions, which are largely based on clinical experience. Prescribers would benefit from a standardised information source which enables them to describe the likelihood and magnitude of benefits and side effects in a universal way. Accessible information for patients and relatives about the same is also recommended. Patients and relatives make their decisions to take medications in the context of relative uncertainty about the likelihood of benefits, with risk playing a pivotal role in decision making for some.

Dementia Care Mapping (DCM) is an observational tool set within a practice development process. Following training in the method, DCM is implemented via a cyclic process of briefing staff, conducting mapping observations, data analysis and report preparation, feedback to staff and action planning. Recent controlled studies of DCM’s efficacy have found heterogeneous results and variability in DCM implementation has been indicated as a potential contributing factor. This review aimed to examine the primary research evidence on the processes, barriers and facilitators to implementing DCM as a practice development method within formal dementia care settings. PUBMED, PsycINFO, CINAHL, The Cochrane Library-Cochrane reviews, HMIC (Ovid), Web of Science and Social Care Online were searched using the term “Dementia Care Mapping”. Inclusion criteria was primary research studies, in any formal dementia care settings where DCM was used as a practice development tool and which included discussion/critique of implementation processes. Assessment of study quality was conducted using the Mixed Methods Appraisal Tool (MMAT). Twelve papers were included in the review, representing nine research studies. The papers included discussion of various components of the DCM process including mapper selection and preparation; mapping observations; data analysis, report writing and feedback; and action planning. However, robust evidence on requirements for successful implementation of these components was limited. Barriers and facilitators to mapping were also discussed. The review found some consensus that DCM is more likely to be successfully implemented if the right people are selected to be trained as mappers, with appropriate mapper preparation and ongoing support, with effective leadership for DCM within the implementing organisation/unit and in organizations that already have a person-centred culture or ethos. Future development of the DCM tool should consider ways to save on time taken to conduct DCM cycles. More research to understand the ingredients for effective DCM implementation is needed.

Background: Behaviours such as agitation impact on the quality of life of care home residents with dementia and increase health care use. Interventions to prevent these behaviours have little evidence supporting their effectiveness or cost-effectiveness. We conducted an economic evaluation alongside a trial assessing Dementia Care Mapping™ (DCM) versus usual care for reducing agitation and highlight methodological challenges of conducting evaluations in this population and setting. Methods: RCT data over 16 months from English care home residents with dementia (intervention n = 418; control n = 308) were analysed. We conducted a cost-utility analysis from the healthcare provider perspective. We gathered resource use and utility (EQ-5D-5L and DEMQoL-Proxy-U) from people living with dementia and proxy informants (staff and relatives). Data were analysed using seemingly unrelated regression, accounting for care home clustering and bootstrapping used to capture sampling uncertainty. Results: Costs were higher in the intervention arm than control arm (incremental = £1,479) due in part to high cost outliers. There were small QALY gains (incremental = 0.024) in favour of DCM. The base case ICER (£64,380 per QALY) suggests DCM is not cost-effective versus usual care. With the exception of analyses excluding high cost outliers, which suggested a potential for DCM to be cost-effective, sensitivity analyses corroborated the base case findings. Bootstrapped estimates suggested DCM had a low probability (p<0.20 where λ=£20,000) of being cost-effective versus control. Conclusion: DCM does not appear to be a cost-effective intervention versus usual care in this group and setting. The evaluation highlighted several methodological challenges relating to validity of utility assessments, loss to follow-up and compliance. Further research is needed on handling high cost individuals and capturing utility in this group.

This study explored intervention implementation within a pragmatic, cluster randomised controlled trial of Dementia Care MappingTM (DCM) in UK care homes. DCM is a practice development tool comprised of a five component cycle (staff briefing, mapping observations, data analysis and reporting, staff feedback, action planning) that supports delivery of person-centred care. Two staff from the 31 intervention care homes were trained in DCM and asked to deliver three cycles over a 15-month period, supported by a DCM expert during cycle 1. Implementation data were collected after each mapping cycle. There was considerable variability in DCM implementation fidelity, dose and reach. Not all homes trained two mappers on schedule and some found it difficult to retain mappers. Only 26% of homes completed more than one cycle. Future DCM trials in care home settings should consider additional methods to support intervention completion including intervention delivery being conducted with ongoing external support.

Background: Cancer and dementia are common in older people and management of the conditions as comorbidities can be challenging, yet little is known about the size or characteristics of this group. We aimed to estimate the prevalence, characteristics and general practice resource usage of people living with both conditions in England. Methods: Anonymised electronic healthcare records from 391 National Health Service general practices across England using the TPP SystmOne general practice system were obtained from ResearchOne. Data included demographic and clinical characteristics, and general practice healthcare useage (appointments, prescriptions, referrals and secondary care contacts) for people aged 50 and over with a cancer and/or dementia diagnosis consistent with the Quality and Outcomes Framework between 2005 and 2016. Multi-level negative binomial regression was used to analyse the number of general practice appointments. Results: Data from 162,371 people with cancer and/or dementia were analysed; 3,616 (2.2%) people were identified as having comorbid cancer and dementia. Of people with cancer, 3.1% also had dementia, rising to 7.5% (1 in 13 people) in those aged 75 and over. Fewer people with both conditions were female (50.7%) compared to those with dementia alone (65.6%) and those with comorbid cancer and dementia were older than those with cancer alone [mean ages 83 (sd=7), 69 (sd=12) respectively]. Those with both conditions were less likely to have lung cancer than those with cancer alone (7.5% vs. 10.3%) but more likely to have prostate cancer (20.9% vs. 15.8%). Additional comorbidities were more prevalent for those with both conditions than those with cancer or dementia alone (68.4% 54 vs. 50.2% vs. 54.0%). In the year following the first record of either condition, people with cancer and dementia had 9% more general practice appointments (IRR:1.09, 95% 56 CI:1.01-1.17) than those with cancer alone and 37% more appointments than those with dementia alone (IRR: 1.37, 95% CI: 1.28-1.47). Conclusions: A significant number of people are living with comorbid cancer and dementia in England. This group have additional comorbidity and higher general practice usage than those with cancer/dementia alone. The needs of this group should be considered in future general practice care planning and research.

Background: Quality of care for people with dementia in care homes is of concern. Interventions that can improve care outcomes are required. Objective: To investigate the clinical and cost-effectiveness of Dementia Care MappingTM (DCM™) for reducing agitation, and improving care outcomes for people living with dementia in care homes, versus usual care. Design: A pragmatic, cluster randomised controlled trial with open-cohort design, follow-up at 6- and 16-months, integrated cost-effectiveness analysis and process evaluation. Clusters were not blinded to allocation. Primary endpoint was completed by staff-proxy and independent assessors. Setting: Stratified randomisation of 50 care homes to intervention/control on a 3:2 ratio by type, size, staff exposure to dementia training and recruiting hub. Participants: Fifty care homes were randomised (31 intervention, 19 control), with 726 residents recruited at baseline and a further 261 at 16-months. Care homes were eligible if they recruited a minimum of 10 residents, were not subject to improvement notices, had not used DCM™ in the previous 18-months and were not participating in conflicting research. Residents were eligible if they lived there permanently, had a formal diagnosis of dementia/score of 4+ on the Functional Assessment Staging of Alzheimer’s Disease, were proficient in English, not at end-of-life/permanently cared for in bed. All homes were audited on delivery of dementia and person-centred care awareness training. Those not reaching a minimum standard were provided training ahead of randomisation. Eighteen homes took part in the process evaluation. Intervention: Two staff from each intervention home were trained to use DCM™ and requested to carry out three DCM™ cycles; the first supported by an external expert. Main outcome measures: The primary outcome was agitation (Cohen-Mansfield Agitation Inventory) at 16-months. Secondary outcomes included resident behaviours and quality of life. Results: There were 675 residents in the final analysis (287 control, 388 intervention). There was no evidence of difference in agitation levels between arms. The adjusted mean difference in CMAI score was -2.11 points, lower in the intervention group than control (95% CI -4.66 to 0.44, p=0.104, adjusted ICC control=0, intervention 0.001). The sensitivity analyses results supported the primary analysis. No differences were detected in any of the secondary outcomes. The health economic analyses indicated DCM™ was not cost-effective. Intervention adherence was problematic; only 26% of homes completed more than their first DCM™ cycle. Impacts of and barriers and facilitators to DCM™ implementation were identified. Limitations: Primary completion of resident outcomes was by staff proxy due to self-report difficulties for residents with advanced dementia. Clusters were not blinded to allocation although supportive analyses suggested any reporting bias was not clinically important. Conclusions: There was no benefit of DCM™ over control on any outcomes. Implementation of DCM™ by care home staff was sub-optimal compared to protocol in the majority of homes. Future work: Alternative models of DCM™ implementation should be considered, which do not rely solely on leadership by care home staff. Trial registration: Current Controlled Trials ISRCTN82288852 Funding: This project was funded by the National Institute for Health Research Health Technology Assessment programme (project number 11/15/13).

Background: Psychosocial interventions offer opportunities to improve care for people with dementia in care homes. However, implementation is often led by staff who are not well prepared for the role. Some interventions use external experts to support staff. However little is known about external expert, care home staff and manager perceptions of such support. This paper addresses this gap. Methods: Multi-methods study within a process evaluation of a cluster randomised controlled trial of Dementia Care MappingTM (DCM). Interviews were conducted with six external experts who also completed questionnaires, 17 care home managers and 25 care home staff responsible for DCM implementation. Data were analysed using descriptive statistics and template analysis. Results: Three themes were identified: the need for expert support, practicalities of support and broader impacts of providing support. Expert support was vital for successful DCM implementation, although the five-days provided was felt to be insufficient. Some homes felt the support was inflexible and did not consider their individual needs. Practical challenges of experts being located at a geographical distance from the care homes, limited when and how support was available. Experts gained knowledge they were able to then apply in delivering DCM training. Experts were not able to accurately predict which homes would be able to implement DCM independently in future cycles. Conclusions: An external expert may form a key component of successful implementation of psychosocial interventions in care home settings. Future research should explore optimal use of the expert role.

Abstract

Background: Managing multiple conditions is difficult for patients and their families, increasing complexity in care. Two of the most common long-term conditions, cancer and dementia, both disproportionately affect older adults. However, little is known about the needs and experiences of those living with both conditions, which could inform practice in the area. Objectives: This focused ethnographic study sought to understand how oncology services balance the unique and complex needs of these patients with those of the service more widely. Design: Focused ethnography. Setting: Two NHS trusts. Participants: Seventeen people with dementia and cancer, 22 relatives and 19 staff members participated. Methods: Participant observation, informal conversations, semi-structured interviews, and medical notes review. Results: Improved satisfaction and outcomes of care were reported when staff were delivering person-centred care. Staff tried to balance the need for personalised and flexible support for individuals with dementia with managing targets and processes of cancer care and treatment. The importance of continuity of people, places, and processes was consistently highlighted. Conclusion: Navigating and managing the delicate balance between the needs of the individual and the needs of services more widely was difficult for both staff and patients. Improved awareness, identification and documentation of dementia would help to ensure that staff are aware of any specific patient needs. Consistency in staffing and appointment locations should develop familiarity and routine for people with dementia.

A growing number of people live with cancer and dementia. Dementia creates a particular set of challenges in all aspects of cancer treatment and care, including diagnosis, decision-making, access to appointments, monitoring of signs and symptoms of cancer and side effects of cancer treatment, and management of self-care tasks. People with cancer and dementia often require extensive support from family carers, and those without family support face additional challenges. This article uses the emerging UK evidence base on cancer and dementia to discuss the challenges that arise when providing cancer treatment and care to people with dementia and their families, and to make research-based recommendations on how to improve service provision for that population.

Background: Dementia Care Mapping™ (DCM) is a widely used, staff-led, psychosocial intervention to support the implementation of person-centred care. Efficacy evaluations in care homes have produced mixed outcomes, with implementation problems identified. Understanding the experiences of staff trained to lead DCM implementation is crucial to understanding implementation challenges, yet this has rarely been formally explored. This study aimed to examine the experiences of care home staff trained to lead DCM implementation, within a large cluster randomised controlled trial. Methods: Process evaluation including, semi-structured interviews with 27 trained mappers from 16 intervention allocated care homes. Data were analysed using template variant of thematic analysis. Results: Three main themes were identified 1) Preparedness to lead - While mappers overwhelmingly enjoyed DCM training, many did not have the personal attributes required to lead practice change and felt DCM training did not adequately equip them to implement it in practice. For many their expectations of the mapper role at recruitment contrasted with the reality once they began to attempt implementation; 2) Transferring knowledge into practice – Due to the complex nature of DCM, developing mastery required regular practice of DCM skills, which was difficult to achieve within available time and resources. Gaining engagement of and transferring learning to the wider staff team was challenging, with benefits of DCM largely limited to the mappers themselves, rather than realised at a care home level; and 3) Sustaining DCM - This required a perception of DCM as beneficial, allocation of adequate resources and support for the process which was often not able to be provided, for the mapper role to fit with the staff member’s usual duties and for DCM to fit with the home’s ethos and future plans for care. Conclusions: Many care homes may not have staff with the requisite skills to lead practice change using DCM, or the requisite staffing, resources or leadership support required for sustainable implementation. Adaptations to the DCM tool, process and training may be required to reduce its complexity and burden and increase chances of implementation success. Alternatively, models of implementation not reliant on care home staff may be required.

Background: Providing cancer care and treatment for ageing populations with complicating comorbidities like dementia is a growing global challenge. This study aimed to examine the hospital-based cancer care and treatment challenges and support needs of people with dementia, and identify potential ways to address these. Methods: Two-site ethnographic study in England involving semi-structured interviews, observations and accompanying conversations, and medical-record review. Participants (N=58) were people with dementia and comorbid cancer (n=17), informal caregivers (n=22) and hospital staff (n=19). Ethnographically informed thematic analysis was conducted. Results: There was an accumulated complexity of living with both illnesses simultaneously. People with dementia and families could feel confused and uninformed due to difficulties understanding, retaining and using cancer information, which impacted their informed treatment decision-making. Dementia increased the complexity and burden of travelling to and navigating unfamiliar hospital environments, frequent lengthy periods of waiting in hospital, and self-managing symptoms and side-effects at home. Oncology staff were often working without the full picture, due to variable documenting of dementia in medical-records; dementia training was limited; and time and resource pressures impeded the highly-individualised, flexible cancer care required by people with dementia. Supportive family carers were crucial in enabling people with dementia to access, navigate and undergo cancer treatment and care Conclusions: Dementia complicates cancer care in a range of ways accumulating across the cancer pathway. Our findings suggest there are several strategies and interventions, which we list here, with potential to improve cancer care and treatment for people with dementia and their families.

Objectives: The risks of developing cancer and dementia increase as we age, however this comorbidity remains relatively under-researched. This study reports on the challenges that people affected by comorbid cancer and dementia face when navigating engagement with cancer treatment within secondary care. Materials and methods: An ethnographic study recruiting 17 people with cancer and dementia, 22 relatives and 19 oncology staff in two UK National Health Service Trusts. Observations (46 hrs) and informal conversations were conducted during oncology appointments involving people with dementia. Semi-structured interviews (n=37) with people living with cancer and dementia, their relatives and staff working in various roles across oncology services were also carried out. Data were analysed using ethnographically informed thematic analysis. Results: People with cancer and dementia experienced challenges across three areas of navigating cancer treatment and care: navigating through multiple services, appointments and layers of often complex information; repeatedly navigating transport to and from hospital; and navigating non-dementia friendly hospital outpatient environments alongside the cognitive problems associated with dementia. Conclusions: Dementia impacts patients’ abilities to navigate the many practical aspects of attending hospital for cancer treatment and care. This study indicates the importance of addressing ways to improve the experience of travelling to and from hospital, alongside extending the ongoing efforts to develop ‘dementia friendly’ hospital in-patient areas and practices, to outpatient departments. Such steps will serve to improve hospital-based cancer treatment and care and more broadly outpatient appointment experiences for people with dementia and their families.

Background: Many people with dementia live in care homes, where staff can struggle to meet their complex needs. Successful practice improvement interventions in these settings require strong managerial support, but little is known about how managers can support implementation in practice, or what factors support or hinder care home managers in providing this support. Using Dementia Care Mapping™ (DCM) as an example, this study explored how care home managers can support the implementation of complex interventions, and identified factors affecting their ability to provide this support. Methods: We undertook interviews with 48 staff members (managers and intervention leads) from care homes participating in the intervention arm of the DCM EPIC trial of DCM implementation. Results: Managerial support played a key role in facilitating the implementation of a complex intervention in care home settings. Managers could provide practical and financial support in many forms. However, managerial support and leadership approaches towards implementation were highly variable in practice, and implementation was easily de-stabilised by management changes or competing managerial priorities. How well managers understood, valued and engaged with the intervention, alongside the leadership style they adopted to support implementation, were key influences on implementation success. Conclusions: For care home managers to effectively support interventions they must fully understand the proposed intervention and its potential value. This is especially important during times of managerial or practice changes, when managers lack the skills required to effectively support implementation, or when the intervention is complex. It may be unfeasible to successfully implement new interventions during times of managerial or practice instability.

Objective: Increasing numbers of people are expected to live with comorbid cancer and dementia. Cancer treatment decision-making for these individuals is complex, particularly for those lacking capacity, requiring support across the cancer care pathway. There is little research to inform practice in this area. This ethnographic study reports on the cancer decision-making experiences of people with cancer and dementia, their families, and healthcare staff. Methods: Participant observations, informal conversations, semi-structured interviews, and medical note review, in two NHS trusts. Seventeen people with dementia and cancer, 22 relatives and 19 staff members participated. Results: Decision-making raised complex ethical dilemmas and challenges and raised concerns for families and staff around whether correct decisions had been made. Whose decision it was and to what extent a person with dementia and cancer was able to make decisions was complex, requiring careful and ongoing consultation and close involvement of relatives. The potential impact dementia might have on treatment understanding and toleration required additional consideration by clinicians when evaluating treatment options. Conclusions: Cancer treatment decision-making for people with dementia is challenging, should be an ongoing process and has emotional impacts for the individual, relatives, and staff. Longer, flexible, and additional appointments may be required to support decision-making by people with cancer and dementia. Evidence-based decision-making guidance on how dementia impacts cancer prognosis, treatment adherence and efficacy is required.

Objectives: Despite cancer and dementia being conditions in which prevalence increases with age, there remains limited research on the cancer treatment and care needs of this population. Our study aimed to address this gap and this paper reports on the role of supportive networks in enabling people with dementia to access cancer treatment and care. Materials and methods: An ethnographic study involving seventeen people with cancer and dementia, 22 relatives and nineteen oncology staff. It comprised observations (46 hrs) of and informal conversations during oncology appointments attended by people with dementia and their relatives and semi-structured interviews (n=37) with people living with cancer and dementia, their relatives and staff working in various roles across oncology services. Data were analysed using thematic analysis. Results: Patients and oncology staff relied on and expected relatives to provide practical and emotional support around cancer treatment and care. Families varied in their ability to provide required support due to extent of the family network, practical issues, knowledge of the patient and their wishes, family conflict and the patient’s willingness to accept help. Where no family network was available, support provision was complex and this could compromise access to cancer treatment. Conclusions: People with comorbid cancer and dementia rely heavily on a supportive family network to access treatment and care. Oncology services need to assess the supportive networks available to individual patients in developing cancer treatment plans. Urgent consideration needs to be given to how those with no family networks can be appropriately supported.

Background: Prevalence of cancer and dementia are strongly related to age. In the UK, 70% of care home residents have dementia. By 2040, older people (aged 65+) will account for 77% of all people living with cancer. Residents with only one of these conditions may have complex care needs. Having comorbid cancer and dementia (CCD) is likely to bring further challenges. This is the first research project to examine the care and support needs of people with CCD living in residential care homes and areas for improvement. Aims: To explore: (1) The care and support needs of people with CCD living in residential care homes. (2) What constitutes good care for people with CCD, their family/supporters, and residential care home staff. (3) Potential barriers and facilitators to providing good care for people with CCD. Methods: (1) Literature review to examine implications for cancerrelated care for people with dementia living in residential care homes. (2) Interviews with 5‐10 men and women with CCD, their family members/ supporters, and residential care home staff. (3) Ethnographic observations of 5‐10 people with CCD to further explore barriers and facilitators to good care. Results: Emergent findings from the literature review will be presented, and their implications for supporting people with CCD living in residential care homes discussed. Conclusions: Findings from this study will help improve the care and support of people with CCD and will contribute to a wider programme of research exploring the cancer care needs of people with dementia across a variety of care settings.

As many countries experience population aging, patients with cancer are becoming older and have more preexisting comorbidities, which include prevalent, age-related, chronic conditions such as dementia. People living with dementia (PLWD) are vulnerable to health disparities, and dementia has high potential to complicate and adversely affect care and outcomes across the cancer trajectory. This report offers an overview of dementia and its prevalence among patients with cancer and a summary of the research literature examining cancer care for PLWD. The reviewed research indicates that PLWD are more likely to have cancer diagnosed at an advanced stage, receive no or less extensive cancer treatment, and have poorer survival after a cancer diagnosis. These cancer disparities do not necessarily signify inappropriately later diagnosis or lower treatment of people with dementia as a group, and they are arguably less feasible and appropriate targets for care optimization. The reviewed research indicates that PLWD also have an increased risk of cancer-related emergency presentations, lower quality processes of cancer-related decision making, accessibility-related barriers to cancer investigations and treatment, higher experienced treatment burden and higher caregiver burden for families, and undertreated cancer-related pain. The authors propose that optimal cancer care for PLWD should focus on proactively minimizing these risk areas and thus must be highly person-centered, with holistic decision making, individualized reasonable adjustments to practice, and strong inclusion and support of family carers. Comprehensive recommendations are made for clinical practice and future research to help clinicians and providers deliver best and equitable cancer care for PLWD and their families.

Background The quality of care for people with dementia in care homes is of concern. Interventions that can improve care outcomes are required. Objective To investigate the clinical effectiveness and cost-effectiveness of Dementia Care Mapping™ (DCM) for reducing agitation and improving care outcomes for people living with dementia in care homes, versus usual care. Design A pragmatic, cluster randomised controlled trial with an open-cohort design, follow-up at 6 and 16 months, integrated cost-effectiveness analysis and process evaluation. Clusters were not blinded to allocation. The primary end point was completed by staff proxy and independent assessors. Setting Stratified randomisation of 50 care homes to the intervention and control groups on a 3 : 2 ratio by type, size, staff exposure to dementia training and recruiting hub. Participants Fifty care homes were randomised (intervention, n = 31; control, n = 19), with 726 residents recruited at baseline and a further 261 recruited after 16 months. Care homes were eligible if they recruited a minimum of 10 residents, were not subject to improvement notices, had not used DCM in the previous 18 months and were not participating in conflicting research. Residents were eligible if they lived there permanently, had a formal diagnosis of dementia or a score of 4+ on the Functional Assessment Staging Test of Alzheimer’s Disease, were proficient in English and were not terminally ill or permanently cared for in bed. All homes were audited on the delivery of dementia and person-centred care awareness training. Those not reaching a minimum standard were provided training ahead of randomisation. Eighteen homes took part in the process evaluation. Intervention Two staff members from each intervention home were trained to use DCM and were asked to carry out three DCM cycles; the first was supported by an external expert. Main outcome measures The primary outcome was agitation (Cohen-Mansfield Agitation Inventory), measured at 16 months. Secondary outcomes included resident behaviours and quality of life. Results There were 675 residents in the final analysis (intervention, n = 388; control, n = 287). There was no evidence of a difference in agitation levels between the treatment arms. The adjusted mean difference in Cohen-Mansfield Agitation Inventory score was –2.11 points, being lower in the intervention group than in the control (95% confidence interval –4.66 to 0.44; p = 0.104; adjusted intracluster correlation coefficient: control = 0, intervention = 0.001). The sensitivity analyses results supported the primary analysis. No differences were detected in any of the secondary outcomes. The health economic analyses indicated that DCM was not cost-effective. Intervention adherence was problematic; only 26% of homes completed more than their first DCM cycle. Impacts, barriers to and facilitators of DCM implementation were identified. Limitations The primary completion of resident outcomes was by staff proxy, owing to self-report difficulties for residents with advanced dementia. Clusters were not blinded to allocation, although supportive analyses suggested that any reporting bias was not clinically important. Conclusions There was no benefit of DCM over control for any outcomes. The implementation of DCM by care home staff was suboptimal compared with the protocol in the majority of homes. Future work Alternative models of DCM implementation should be considered that do not rely solely on leadership by care home staff. Trial registration Current Controlled Trials ISRCTN82288852. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 16. See the NIHR Journals Library website for further project information.

Background: Psychosocial person-centred interventions are considered best practice for addressing complex behaviours and care needs such as agitation and anxiety, and for improving the quality of life of people with dementia in care homes. Dementia Care Mapping (DCM™) is an established practice development tool and process aimed to help care home staff deliver more person-centred care. To date, few studies have evaluated the efficacy of DCM™ and have found mixed results. These results are suggested to be the outcome of intervention implementation, which may be impacted by a range of factors. This study reports the barriers and facilitators to DCM™ implementation in care homes found during the process evaluation conducted as part of a randomized controlled trial. Methods: Eighteen of the 31 DCM™ intervention care homes were recruited to participate in the embedded process evaluation. Semi-structured interviews were conducted with 83 participants, comprising care home managers, trained DCM™ users (mappers), expert external mappers, staff members, relatives, and residents. Results: Barriers and facilitators to DCM™ implementation were found at the mapper level (e.g. motivation and confidence), the DCM™ intervention level (e.g. understanding of DCM™) and the care home level (e.g. staffing issues, manager support). Further barriers caused by the burden of trial participation were also identified (e.g. additional paperwork). Conclusions: Implementing DCM™ is complex and a greater consideration of potential barriers and facilitators in planning future studies and in practice could help improve implementation. Trial Registation: Current Controlled Trials ISRCTN82288852, registered 16/01/2014

Objectives: Agitation is common and problematic in care home residents with dementia. This study investigated the (cost)effectiveness of Dementia Care Mapping™ (DCM) for reducing agitation in this population. Method: Pragmatic, cluster randomised controlled trial with cost-effectiveness analysis in 50 care homes, follow-up at 6- and 16-months and stratified randomisation to intervention (n=31) and control (n=19). Residents with dementia were recruited at baseline (n=726) and 16-months (n=261). Clusters were not blinded to allocation. Three DCM cycles were scheduled, delivered by two trained staff per home. Cycle one was supported by an external DCM expert. Agitation (Cohen-Mansfield Agitation Inventory (CMAI)) at 16-months was the primary outcome. Results: DCM was not superior to control on any outcomes (cross-sectional sample n=675: 287 control, 388 intervention). The adjusted mean CMAI score difference was -2.11 points (95% CI -4.66 to 0.44, p = .104, adjusted ICC control=0, intervention 0.001). Sensitivity analyses supported the primary analysis. Incremental cost per unit improvement in CMAI and QALYs (intervention versus control) on closed-cohort baseline recruited sample (n=726, 418 intervention, 308 control) was £289 and £60,627 respectively. Loss to follow-up at 16-months in the original cohort was 312/726 (43·0%) mainly (87·2%) due to deaths. Intervention dose was low with only a quarter of homes completing more than one DCM cycle. Conclusion: No benefits of DCM were evidenced. Low intervention dose indicates standard care homes may be insufficiently resourced to implement DCM. Alternative models of implementation, or other approaches to reducing agitation should be considered. Trial registration: Current Controlled Trials ISRCTN82288852.

Background: This trial investigated the (cost) effectiveness of Dementia Care Mapping (DCM™) for reducing agitation in care home residents with dementia compared to usual care (DCM™ EPIC trial). Methods: Pragmatic, cluster randomised controlled trial, with follow-up at 6- and 16-months. Stratified randomisation of 50 care homes to intervention (n=31) or control (n=19). Care home eligibility included recruitment of ≥10 residents, not subject to improvement notices or using DCM™ in the previous 18-months. At baseline and 16-months, 726 and 261 residents were recruited, respectively. Resident eligibility included: permanent residence; diagnosis of dementia/score of ≥4 on the Functional Assessment Staging of Alzheimer's Disease; not at end-of-life/permanently cared for in bed. Clusters were not blinded to allocation. Three DCM™ cycles, delivered by two trained care home staff were scheduled, mirroring standard procedures; supported during cycle one by a DCM™ expert. The primary outcome was agitation (Cohen-Mansfield Agitation Inventory (CMAI)) at 16-months. Secondary outcomes included neuropsychiatric symptoms and quality of life. Findings: DCMTM was not superior to control on any primary or secondary outcomes (n=675 residents: 287 control, 388 intervention). The adjusted mean difference in CMAI score was -2.11 points in the intervention versus control (95% CI -4.66 to 0.44, p = .104, adjusted ICC control=0, intervention 0.001). Sensitivity analyses supported the primary analysis. Intervention adherence was problematic; only 26% of homes completed >1 DCM™ cycle. Incremental cost per unit improvement in CMAI for baseline recruited residents (n=726, 418 intervention, 308 control) was £289 for intervention versus control. Interpretation: There was no evidence of benefit of DCM™; an important finding given its wide, international use. Further research should urgently consider modifications to existing DCM™ implementation models, or other approaches to reducing agitation in care home residents. Trial Number: Current Controlled Trials ISRCTN82288852 Funding Statement: National Institute for Health Research Health Technology Assessment programme (project number 11/15/13). Declaration of Interests: Claire A Surr was previously employed by the University of Bradford, who own the IP to the DCMTM intervention tested in this trial. In this role she held responsibility for DCM training and method 21 development. She was a technical author on the British Standards Institute PAS 800 guide on implementing DCMTM in health and social care provider organizations. She declares personal fees from Hawker publications outside the submitted work. David Meads reports being a member of the NIHR HTA Elective and Emergency Specialist Care Panel (EESC) being a member of the NIHR PGfAR funding panel. Clive Ballard reports grants and personal fees from Acadia pharmaceutical company, grants and personal fees from Lundbeck, personal fees from Roche, personal fees from Otusaka, personal fees from Novartis, personal fees from Eli Lilly, personal fees from Pfizer, outside the submitted work. Murna Downs works at the University of Bradford which holds the Intellectual Property for DCMTM and runs courses for practitioners and professionals who wish to learn how to use the method. Louise Robinson reports grants from NIHR Senior Investigator Award, grants from NIHR Translational Professorship Award, outside the submitted work; and NIHR board membership of the Primary Care Themed Call board. Amanda Farrin reports membership of the NIHR HTA Funding Boards Policy group, the NIHR HTA Clinical Evaluation and Trials board and, previously, the NIHR HTA Themed Call board. All other authors have no conflicts to declare. Ethics Approval Statement: The study was granted ethical approval by NRES Committee Yorkshire & The Humber - Bradford Leeds REC ref 13/YH/0016.