RESUMEN
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 = 0.104, adjusted ICC control = 0, intervention 0.001). Sensitivity analyses supported the primary analysis. Incremental cost per unit improvement in CMAI and QALYs (intervention vs 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.
Asunto(s)
Demencia , Estudios de Cohortes , Análisis Costo-Beneficio , Estudios Transversales , Demencia/terapia , Humanos , Agitación Psicomotora/terapia , Calidad de VidaRESUMEN
Objectives: To contribute to improvements in the design and delivery of intervention research in care homes by adopting a collaborative approach that listens to the experiences of care home staff who had participated in a clinical trial aimed at optimising and evaluating a psychosocial intervention package for people with dementia.Methods: Qualitative study involving focus group discussions (FGDs) involving 41 staff across 6 care homes with the UK. Inductive thematic analysis was used to identify themes and interpret the data.Results: Three overarching themes emerged as influential: Recognising preparedness; working together and learning more than expected. The findings highlighted the need to be attentive in addressing staff expectations, the value of sustained relationships and recognition of good practice. The FGDs also identified areas of unanticipated learning that staff and managers adopted.Conclusions: The FGDs showed the importance of considering the overall experience of care home staff who are involved in research and the importance of valuing the skills and experience they hold through positive affirmation. There are often unanticipated consequences of research involvement both on staff practice and on relationships which if promoted could help sustain effective ways of working together.
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Actitud del Personal de Salud , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación/normas , Instituciones de Cuidados Especializados de Enfermería/organización & administración , Personal de Salud/organización & administración , Personal de Salud/psicología , Humanos , Investigación Cualitativa , Calidad de la Atención de Salud/organización & administraciónRESUMEN
OBJECTIVES: The study aims to understand the factors that care home staff felt enabled or hindered them in continuing to use the well-being and health for people with dementia (WHELD) psychosocial approach in their care home and investigate whether there was sustained activity 9 to 12 months after the study ended. METHODS: This qualitative study is part of a wider clinical trial, which demonstrated effectiveness of a psychosocial intervention on quality of life outcomes and neuropsychiatric symptoms for residents. Forty-seven care home staff within nine care homes in the United Kingdom participated in focus groups, between 9 and 12 months after the intervention had finished. Inductive thematic analysis was used to identify themes and interpret the data. RESULTS: The findings highlighted that staff continued to use a range of activities and processes acquired through the research intervention, after the study had ended. Three overarching themes were identified as influential: "recognising the value" of the approach for residents and staff, "being well practiced" with sufficient support and opportunity to consolidate skills prior to the withdrawal of the researchers, and "taking ownership of the approach" to incorporate it as usual care. CONCLUSIONS: The WHELD approach can be sustained where the value of the approach is recognised, and sufficient support is provided during initial implementation for staff to build skills and confidence for it to become routine care. Further follow-up is required to understand longer term use and the impact for residents.
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Actitud del Personal de Salud , Demencia/terapia , Casas de Salud , Psicoterapia/métodos , Adulto , Terapia Combinada , Atención a la Salud/métodos , Demencia/psicología , Femenino , Grupos Focales , Estudios de Seguimiento , Servicios de Salud para Ancianos , Humanos , Masculino , Persona de Mediana Edad , Investigación Cualitativa , Calidad de Vida , Autoeficacia , Reino UnidoRESUMEN
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 REGISTRATION: Current Controlled Trials ISRCTN82288852 , registered 16/01/2014.
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Demencia/terapia , Personal de Salud/normas , Casas de Salud/normas , Evaluación de Procesos, Atención de Salud/métodos , Evaluación de Procesos, Atención de Salud/normas , Instituciones Residenciales/normas , Demencia/psicología , Femenino , Estudios de Seguimiento , Personal de Salud/psicología , Humanos , Masculino , Atención Dirigida al Paciente/métodos , Atención Dirigida al Paciente/normas , Calidad de Vida/psicología , Autocuidado/métodos , Autocuidado/psicología , Autocuidado/normasRESUMEN
BACKGROUND: Agitation is a common, challenging symptom affecting large numbers of people with dementia and impacting on quality of life (QoL). There is an urgent need for evidence-based, cost-effective psychosocial interventions to improve these outcomes, particularly in the absence of safe, effective pharmacological therapies. This study aimed to evaluate the efficacy of a person-centred care and psychosocial intervention incorporating an antipsychotic review, WHELD, on QoL, agitation, and antipsychotic use in people with dementia living in nursing homes, and to determine its cost. METHODS AND FINDINGS: This was a randomised controlled cluster trial conducted between 1 January 2013 and 30 September 2015 that compared the WHELD intervention with treatment as usual (TAU) in people with dementia living in 69 UK nursing homes, using an intention to treat analysis. All nursing homes allocated to the intervention received staff training in person-centred care and social interaction and education regarding antipsychotic medications (antipsychotic review), followed by ongoing delivery through a care staff champion model. The primary outcome measure was QoL (DEMQOL-Proxy). Secondary outcomes were agitation (Cohen-Mansfield Agitation Inventory [CMAI]), neuropsychiatric symptoms (Neuropsychiatric Inventory-Nursing Home Version [NPI-NH]), antipsychotic use, global deterioration (Clinical Dementia Rating), mood (Cornell Scale for Depression in Dementia), unmet needs (Camberwell Assessment of Need for the Elderly), mortality, quality of interactions (Quality of Interactions Scale [QUIS]), pain (Abbey Pain Scale), and cost. Costs were calculated using cost function figures compared with usual costs. In all, 847 people were randomised to WHELD or TAU, of whom 553 completed the 9-month randomised controlled trial. The intervention conferred a statistically significant improvement in QoL (DEMQOL-Proxy Z score 2.82, p = 0.0042; mean difference 2.54, SEM 0.88; 95% CI 0.81, 4.28; Cohen's D effect size 0.24). There were also statistically significant benefits in agitation (CMAI Z score 2.68, p = 0.0076; mean difference 4.27, SEM 1.59; 95% CI -7.39, -1.15; Cohen's D 0.23) and overall neuropsychiatric symptoms (NPI-NH Z score 3.52, p < 0.001; mean difference 4.55, SEM 1.28; 95% CI -7.07,-2.02; Cohen's D 0.30). Benefits were greatest in people with moderately severe dementia. There was a statistically significant benefit in positive care interactions as measured by QUIS (19.7% increase, SEM 8.94; 95% CI 2.12, 37.16, p = 0.03; Cohen's D 0.55). There were no statistically significant differences between WHELD and TAU for the other outcomes. A sensitivity analysis using a pre-specified imputation model confirmed statistically significant benefits in DEMQOL-Proxy, CMAI, and NPI-NH outcomes with the WHELD intervention. Antipsychotic drug use was at a low stable level in both treatment groups, and the intervention did not reduce use. The WHELD intervention reduced cost compared to TAU, and the benefits achieved were therefore associated with a cost saving. The main limitation was that antipsychotic review was based on augmenting processes within care homes to trigger medical review and did not in this study involve proactive primary care education. An additional limitation was the inherent challenge of assessing QoL in this patient group. CONCLUSIONS: These findings suggest that the WHELD intervention confers benefits in terms of QoL, agitation, and neuropsychiatric symptoms, albeit with relatively small effect sizes, as well as cost saving in a model that can readily be implemented in nursing homes. Future work should consider how to facilitate sustainability of the intervention in this setting. TRIAL REGISTRATION: ISRCTN Registry ISRCTN62237498.
Asunto(s)
Antipsicóticos/uso terapéutico , Demencia/enfermería , Educación Continua en Enfermería , Relaciones Enfermero-Paciente , Casas de Salud , Atención Dirigida al Paciente/métodos , Agitación Psicomotora/enfermería , Anciano de 80 o más Años , Antipsicóticos/economía , Análisis Costo-Beneficio , Demencia/tratamiento farmacológico , Demencia/economía , Demencia/psicología , Educación Continua en Enfermería/economía , Educación Continua en Enfermería/métodos , Educación Continua en Enfermería/normas , Femenino , Hogares para Ancianos/economía , Humanos , Análisis de Intención de Tratar , Relaciones Interpersonales , Masculino , Casas de Salud/economía , Atención Dirigida al Paciente/economía , Agitación Psicomotora/tratamiento farmacológico , Agitación Psicomotora/epidemiología , Calidad de Vida , Reino Unido/epidemiologíaRESUMEN
BACKGROUND: Very few interventional studies have directly examined the impact of treatment approaches on health-related quality of life (HRQL) in people with dementia. This is of particular importance in therapies to address behavioural symptoms, where HRQL is often severely affected. METHODS: Analysis within the WHELD cluster randomised factorial study in 16 UK care homes examining the impact of person-centred care in combination with antipsychotic review, social interaction and exercise interventions. This study analysed impact on HRQL through the DEMQOL-Proxy. RESULTS: Data on HRQL were available for 187 participants. People receiving antipsychotic review showed a significant worsening in two DEMQOL-Proxy domains (negative emotion: p = 0.02; appearance: p = 0.04). A best-case scenario analysis showed significant worsening for total DEMQOL-Proxy score. Social interaction intervention resulted in a significant benefit to HRQL (p = 0.04). There was no deterioration in HRQL in groups receiving both antipsychotic review and social interaction (p = 0.62). CONCLUSIONS: This demonstrates an important detrimental impact of discontinuation of antipsychotics in dementia on HRQL, highlighting the need for careful review of best practice guidelines regarding antipsychotic use and emphasising the importance of providing evidence-based non-pharmacological interventions in conjunction with antipsychotic review. Copyright © 2016 John Wiley & Sons, Ltd.
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Antipsicóticos/uso terapéutico , Demencia/terapia , Relaciones Interpersonales , Casas de Salud/estadística & datos numéricos , Calidad de Vida , Terapia Socioambiental/métodos , Anciano , Anciano de 80 o más Años , Análisis por Conglomerados , Demencia/diagnóstico , Terapia por Ejercicio/métodos , Femenino , Estado de Salud , Humanos , Masculino , Psicoterapia Centrada en la Persona/métodosRESUMEN
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.
Agitation is common in care home residents and may result from care that does not meet individual needs. Dementia Care Mapping™ (DCM) is a tool used within care homes to improve the delivery of person-centred care, which may help reduce agitation. This randomised controlled trial aimed to understand whether or not DCM is better than usual care at reducing resident agitation, behaviours that staff may find difficult to support and the use of antipsychotic medicines, as well as at improving residents' quality of life and staff communication. It also assessed its value for money. We recruited 726 residents with dementia from 50 care homes. After initial data collection, care homes were randomly assigned to DCM (31/50) or told to continue with usual care (19/50) and data were collected again after 6 and 16 months. A further 261 residents were recruited after 16 months. We also interviewed staff, relatives and residents about the use of DCM after the final data collection had taken place. Two staff members in each DCM home were trained to use DCM and were helped by an expert to use it for the first time. They were asked to use it again a further two times without support. Results showed that DCM was no better than usual care in relation to any of the outcomes. It was also not shown to be value for money. Only one-quarter of care homes used DCM more than once. The care staff who were interviewed said that the benefits of using DCM included reduced resident boredom and increased staff confidence. There were also many challenges, including the time needed to complete DCM, a lack of managerial support and problems with staffing levels. Putting DCM into practice in care homes was difficult, even with expert support, and most care homes did not complete three DCM cycles. Future research should explore models of implementing DCM that do not rely on care home staff to lead them.
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Ansiedad , Demencia/terapia , Calidad de la Atención de Salud , Calidad de Vida/psicología , Instituciones Residenciales , Anciano , Ansiedad/prevención & control , Ansiedad/psicología , Análisis Costo-Beneficio , Femenino , Humanos , Masculino , Reino UnidoRESUMEN
OBJECTIVE: This study evaluated the impact of antipsychotic review, social interaction, and exercise, in conjunction with person-centered care, on antipsychotic use, agitation, and depression in people with dementia living in nursing homes. METHOD: A cluster-randomized factorial controlled trial with two replications was conducted in people with dementia in 16 U.K. nursing homes. All homes received training in person-centered care. Eight homes were randomly assigned to antipsychotic review, to a social interaction intervention, and to an exercise intervention for 9 months, with most homes assigned to more than one intervention. The primary outcome measures were antipsychotic use, agitation, and depression. Secondary outcome measures were overall neuropsychiatric symptoms and mortality. RESULTS: Antipsychotic review significantly reduced antipsychotic use by 50% (odds ratio 0.17, 95% confidence interval [CI] 0.05 to 0.60). Antipsychotic review plus the social interaction intervention significantly reduced mortality (odds ratio 0.26, 95% CI 0.13 to 0.51) compared with the group receiving neither. The group receiving antipsychotic review but not the social intervention showed significantly worse outcome in neuropsychiatric symptoms compared with the group receiving neither (score difference +7.37, 95% CI 1.53 to 13.22). This detrimental impact was mitigated by concurrent delivery of the social intervention (-0.44, CI -4.39 to 3.52). The exercise intervention significantly improved neuropsychiatric symptoms (-3.59, 95% CI -7.08 to -0.09) but not depression (-1.21, CI -4.35 to 1.93). None of the interventions had a significant impact specifically on agitation. CONCLUSIONS: While reductions in antipsychotic use can be achieved by using a "real world" intervention, this may not be of benefit to people with dementia in the current climate of more judicious prescribing unless nonpharmacological interventions such as social interaction or exercise are provided in parallel.
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Antipsicóticos/uso terapéutico , Demencia , Terapia por Ejercicio/métodos , Relaciones Interpersonales , Calidad de Vida , Terapia Socioambiental/métodos , Anciano , Análisis por Conglomerados , Demencia/diagnóstico , Demencia/psicología , Demencia/terapia , Depresión/terapia , Femenino , Hogares para Ancianos/estadística & datos numéricos , Humanos , Masculino , Casas de Salud/estadística & datos numéricos , Evaluación de Resultado en la Atención de Salud , Escalas de Valoración Psiquiátrica , Agitación Psicomotora/terapiaRESUMEN
BACKGROUND: Up to 90 % of people living with dementia in care homes experience one or more behaviours that staff may describe as challenging to support (BSC). Of these agitation is the most common and difficult to manage. The presence of agitation is associated with fewer visits from relatives, poorer quality of life and social isolation. It is recommended that agitation is treated through psychosocial interventions. Dementia Care Mapping™ (DCM™) is an established, widely used observational tool and practice development cycle, for ensuring a systematic approach to providing person-centred care. There is a body of practice-based literature and experience to suggests that DCM™ is potentially effective but limited robust evidence for its effectiveness, and no examination of its cost-effectiveness, as a UK health care intervention. Therefore, a definitive randomised controlled trial (RCT) of DCM™ in the UK is urgently needed. METHODS/DESIGN: A pragmatic, multi-centre, cluster-randomised controlled trial of Dementia Care Mapping (DCM™) plus Usual Care (UC) versus UC alone, where UC is the normal care delivered within the care home following a minimum level of dementia awareness training. The trial will take place in residential, nursing and dementia-specialist care homes across West Yorkshire, Oxfordshire and London, with residents with dementia. A random sample of 50 care homes will be selected within which a minimum of 750 residents will be registered. Care homes will be randomised in an allocation ratio of 3:2 to receive either intervention or control. Outcome measures will be obtained at 6 and 16 months following randomisation. The primary outcome is agitation as measured by the Cohen-Mansfield Agitation Inventory, at 16 months post randomisation. Key secondary outcomes are other BSC and quality of life. There will be an integral cost-effectiveness analysis and a process evaluation. DISCUSSION: The protocol was refined following a pilot of trial procedures. Changes include replacement of a questionnaire, whose wording caused some residents distress, to an adapted version specifically designed for use in care homes, a change to the randomisation stratification factors, adaption in how the staff measures are collected to encourage greater compliance, and additional reminders to intervention homes of when mapping cycles are due, via text message. TRIAL REGISTRATION: Current Controlled Trials ISRCTN82288852 . Registered on 16 January 2014. Full protocol version and date: v7.1: 18 December 2015.