Intervention for sleep problems in nursing home residents with dementia: a cluster-randomized study.

OBJECTIVE: To reduce sleep problems in people living with dementia using a multi-component intervention. DESIGN: Cluster-randomized controlled study with two parallel groups and a follow-up of 16 weeks. SETTING: Using external concealed randomization, 24 nursing homes (NH) were allocated either to the intervention group (IG, 12 clusters, 126 participants) or the control group (12 clusters, 116 participants). PARTICIPANTS: Participants were eligible if they had dementia or severe cognitive impairment, at least two sleep problems, and residence of at least two weeks in a NH. INTERVENTION: The 16-week intervention consists of six components: (1) assessment of sleep-promoting activities and environmental factors in NHs, (2) implementation of two "sleep nurses," (3) basic education, (4) advanced education for staff, (5) workshops to develop sleep-promoting concepts, and (6) written information and education materials. The control group (CG) received standard care. MEASUREMENTS: Primary outcome was ≥ two sleep problems after 16 weeks assessed with the Sleep Disorders Inventory (SDI). RESULTS: Twenty-two clusters (IG = 10, CG = 12) with 191 participants completed the study. At baseline, 90% of people living with dementia in the IG and 93% in the CG had at least two sleep problems. After 16 weeks, rates were 59.3% (IG) vs 83.8% (CG), respectively, a difference of -24.5% (95% CI, -46.3% - -2.7%; cluster-adjusted odds ratio 0.281; 95% CI 0.087-0.909). Secondary outcomes showed a significant difference only for SDI scores after eight and 16 weeks. CONCLUSIONS: The MoNoPol-Sleep intervention reduced sleep problems of people living with dementia in NH compared to standard care.

Item distribution, internal consistency and structural validity of the German language person-centred climate questionnaire - staff version (PCQ-G-S): a cross-sectional study.

BACKGROUND: Person-centredness is considered as best practice for people living with dementia. A frequently used instrument to assess person-centredness of a care environment is the Person-centred Climate Questionnaire (PCQ). The questionnaire comprises of 14 items with the three subscales a climate of safety, a climate of everydayness and a climate of community. AIM: The aim of the study is to describe the translation process of the English language Person-centred Climate Questionnaire (Staff version, Patient version, Family version) into German language (PCQ-G) and to evaluate the first psychometric properties of the German language Person-centred Climate Questionnaire- Staff version (PCQ-G-S). METHODS: We conducted a cross-sectional study. The three versions of the 14-item English PCQ were translated into German language (PCQ-G) based on the recommendations for cross-cultural adaption of measures. Item distribution, internal consistency and structural validity of the questionnaire were assessed among nursing home staff (PCQ-G-S). Item distribution was calculated using descriptive statistics. Structural validity was tested using principal component analysis (PCA), and internal consistency was assessed for the resulting subscales using Cronbach's alpha. Data collection took place from May to September 2021. RESULTS: A total sample of 120 nurses was included in the data analysis. Nine out of 14 items of the PCQ-G-S demonstrated acceptable item difficulty, while five times showed a ceiling effect. The PCA analysis demonstrated a strong structural validity for a three-factor solution explaining 68.6% of the total variance. The three subscales demonstrated a good internal consistency with Cronbach's alpha scores of 0.8 for each of the subscales. CONCLUSION: The analysis of the 14-item German version (PCQ-G-S) showed first evidence for a strong internal consistency and structural validity for evaluating staff perceptions of the person-centredness in German nursing homes. Based on this, further investigations for scale validity of the PCQ-G versions should be carried out.

Comparing different scoping and mapping review methodologies: A practical example using the nursing mobile workstation.

AIMS: To provide (1) an overview of core characteristics of scoping and mapping review methodologies and (2) to illustrate the differences and similarities of these methodologies using literature on nursing mobile workstations. DESIGN: Systematic review. METHODS: Systematic searches were conducted to identify (1) scoping and mapping review methodologies used in the field of nursing and (2) literature on nursing mobile workstations. For each systematic search, two reviewers independently screened all titles, abstracts, and full texts. We conducted narrative syntheses for both review questions. Publications on scoping and mapping review methodologies in the field of nursing were searched in MEDLINE (PubMed), Web of Science, Scopus, and CINAHL (September 2022). Publications on nursing mobile workstations were searched in MEDLINE (PubMed), CINAHL, and Web of Science (April 2022). RESULTS: We identified six scoping and mapping review methodologies (aim 1): bibliometric analysis, evidence mapping, focused mapping review and synthesis, and scoping review. The methodologies aim to provide a graphical, tabular, or narrative overview without a formal critical assessment of the literature. We provide an overview of key variables that reflect the different focus of these methodologies. We also included 26 publications on nursing mobile workstations (aim 2). Nineteen different terms were used to describe the workstations. An overall definition of the nursing mobile workstation was not found. CONCLUSION: Scoping and mapping methodologies are regularly applied in nursing research. Although there is overlap between the different methodologies, we found some unique characteristics. Despite the regular use of nursing mobile workstations, little is known about their impact in care processes and important features. Future studies on nursing mobile workstations could explore the impact of the workstations in the care process and the current functions of the workstations. A universal definition of the workstations is warranted. CLINICAL RELEVANCE: Most publications address aspects of practicability of nursing mobile workstations, but we found no universal definition. Little knowledge is available on the impact of the workstations in clinical practice.

Navigating the Future of Organisational Health Services Research in Germany and beyond: a Position Paper. / Die Zukunft der organisationsbezogenen Versorgungsforschung in Deutschland und darüber hinaus ­ ein Positionspapier.

BACKGROUND: Recent analyses have shown that in health services research in Germany, healthcare organisations are often considered primarily as a study setting, without fully taking their complex organisational nature into account, neither theoretically nor methodologically. Therefore, an initiative was launched to analyse the state of Organisational Health Services Research (OHSR) in Germany and to develop a strategic framework and road map to guide future efforts in the field. This paper summarizes positions that have been jointly developed by consulting experts from the interdisciplinary and international scientific community. METHODS: In July 2023, a scoping workshop over the course of three days was held with 32 (inter)national experts from different research fields centred around OHSR topics using interactive workshop methods. Participants discussed their perspectives on OHSR, analysed current challenges in OHSR in Germany and developed key positions for the field's development. RESULTS: The seven agreed-upon key positions addressed conceptual and strategic aspects. There was consensus that the field required the development of a research agenda that can guide future efforts. On a conceptual level, the need to address challenges in terms of interdisciplinarity, terminology, organisation(s) as research subjects, international comparative research and utilisation of organisational theory was recognized. On a strategic level, requirements with regard to teaching, promotion of interdisciplinary and international collaboration, suitable funding opportunities and participatory research were identified. CONCLUSIONS: This position paper seeks to serve as a framework to support further development of OHSR in Germany and as a guide for researchers and funding organisations on how to move OHSR forward. Some of the challenges discussed for German OHSR are equally present in other countries. Thus, this position paper can be used to initiate fruitful discussions in other countries.

Interventions for preventing and reducing the use of physical restraints for older people in all long-term care settings.

BACKGROUND: Physical restraints (PR), such as bedrails and belts in chairs or beds, are commonly used for older people receiving long-term care, despite clear evidence for the lack of effectiveness and safety, and widespread recommendations that their use should be avoided. This systematic review of the efficacy and safety of interventions to prevent and reduce the use of physical restraints outside hospital settings, i.e. in care homes and the community, updates our previous review published in 2011. OBJECTIVES: To evaluate the effects of interventions to prevent and reduce the use of physical restraints for older people who require long-term care (either at home or in residential care facilities) SEARCH METHODS: We searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group's register, MEDLINE (Ovid Sp), Embase (Ovid SP), PsycINFO (Ovid SP), CINAHL (EBSCOhost), Web of Science Core Collection (ISI Web of Science), LILACS (BIREME), ClinicalTrials.gov and the World Health Organization's meta-register, the International Clinical Trials Registry Portal, on 3 August 2022. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and controlled clinical trials (CCTs) that investigated the effects of interventions intended to prevent or reduce the use of physical restraints in older people who require long-term care. Studies conducted in residential care institutions or in the community, including patients' homes, were eligible for inclusion. We assigned all included interventions to categories based on their mechanisms and components. DATA COLLECTION AND ANALYSIS: Two review authors independently selected the publications for inclusion, extracted study data, and assessed the risk of bias of all included studies. Primary outcomes were the number or proportion of people with at least one physical restraint, and serious adverse events related to PR use, such as death or serious injuries. We performed meta-analyses if necessary data were available. If meta-analyses were not feasible, we reported results narratively. We used GRADE methods to describe the certainty of the evidence. MAIN RESULTS: We identified six new studies and included 11 studies with 19,003 participants in this review update. All studies were conducted in long-term residential care facilities. Ten studies were RCTs and one study a CCT. All studies included people with dementia. The mean age of the participants was approximately 85 years. Four studies investigated organisational interventions aiming to implement a least-restraint policy; six studies investigated simple educational interventions; and one study tested an intervention that provided staff with information about residents' fall risk. The control groups received usual care only in most studies although, in two studies, additional information materials about physical restraint reduction were provided. We judged the risk of selection bias to be high or unclear in eight studies. Risk of reporting bias was high in one study and unclear in eight studies. The organisational interventions intended to promote a least-restraint policy included a variety of components, such as education of staff, training of 'champions' of low-restraint practice, and components which aimed to facilitate a change in institutional policies and culture of care. We found moderate-certainty evidence that organisational interventions aimed at implementation of a least-restraint policy probably lead to a reduction in the number of residents with at least one use of PR (RR 0.86, 95% CI 0.78 to 0.94; 3849 participants, 4 studies) and a large reduction in the number of residents with at least one use of a belt for restraint (RR 0.54, 95% CI 0.40 to 0.73; 2711 participants, 3 studies). No adverse events occurred in the one study which reported this outcome. There was evidence from one study that organisational interventions probably reduce the duration of physical restraint use. We found that the interventions may have little or no effect on the number of falls or fall-related injuries (low-certainty evidence) and probably have little or no effect on the number of prescribed psychotropic medications (moderate-certainty evidence). One study found that organisational interventions result in little or no difference in quality of life (high-certainty evidence) and another study found that they may make little or no difference to agitation (low-certainty evidence). The simple educational interventions were intended to increase knowledge and change staff attitudes towards PR. As well as providing education, some interventions included further components to support change, such as ward-based guidance. We found pronounced between-group baseline imbalances in PR prevalence in some of the studies, which might have occurred because of the small number of clusters in the intervention and control groups. One study did not assess bedrails, which is the most commonly used method of restraint in nursing homes. Regarding the number of residents with at least one restraint, the results were inconsistent. We found very-low certainty evidence and we are uncertain about the effects of simple educational interventions on the number of residents with PR. None of the studies assessed or reported any serious adverse events. We found moderate-certainty evidence that simple educational interventions probably result in little or no difference in restraint intensity and may have little or no effect on falls, fall-related injuries, or agitation (low-certainty evidence each). Based on very low-certainty evidence we are uncertain about the effects of simple educational interventions on the number of participants with a prescription of at least one psychotropic medication. One study investigated an intervention that provided information about residents' fall risk to the nursing staff. We found low-certainty evidence that providing information about residents' fall risk may result in little or no difference in the mean number of PR or the number of falls. The study did not assess overall adverse events. AUTHORS' CONCLUSIONS: Organisational interventions aimed to implement a least-restraint policy probably reduce the number of residents with at least one PR and probably largely reduce the number of residents with at least one belt. We are uncertain whether simple educational interventions reduce the use of physical restraints, and interventions providing information about residents' fall risk may result in little to no difference in the use of physical restraints. These results apply to long-term care institutions; we found no studies from community settings.

Non-pharmacological interventions for sleep disturbances in people with dementia.

BACKGROUND: Sleep disturbances occur frequently in people with dementia with a reported prevalence of up to 40%. Common problems are increased number and duration of awakenings and increased percentage of light sleep. Sleep disturbances are associated with a number of problems for people with dementia, their relatives, and carers. In people with dementia, they may lead to worsening of cognitive symptoms, challenging behaviours such as restlessness or wandering, and further harms, such as accidental falls. Sleep disturbances are also associated with significant carer distress and have been reported as a factor contributing to institutionalisation of people with dementia. As pharmacological approaches have shown unsatisfactory results, there is a need to synthesise the research evidence on non-pharmacological strategies to improve sleep in people with dementia. As interventions are often complex, consisting of more than one active component, and implemented in complex contexts, it may not be easy to identify effective intervention components. OBJECTIVES: To evaluate the benefits and harms of non-pharmacological interventions on sleep disturbances in people with dementia compared to usual care, no treatment, any other non-pharmacological intervention, or any drug treatment intended to improve sleep, and to describe the components and processes of any complex intervention included. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search was 13 January 2022. SELECTION CRITERIA: We included individually or cluster-randomised controlled trials in people with dementia comparing non-pharmacological interventions to improve sleep compared to usual care or to other interventions of any type. Eligible studies had to have a sleep-related primary outcome. We included people with a diagnosis of dementia and sleep problems at baseline irrespective of age, type of dementia, severity of cognitive impairment, or setting. Studies reporting results on a mixed sample (e.g. in a nursing home) were only considered for inclusion if at least 80% of participants had dementia. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were 1. objective sleep-related outcomes (e.g. total nocturnal sleep time, consolidated sleep time at night, sleep efficiency, total wake time at night (or time spent awake after sleep onset), number of nocturnal awakenings, sleep onset latency, daytime/night-time sleep ratio, night-time/total sleep ratio over 24 hours) and 2. ADVERSE EVENTS: Our secondary outcomes were 3. subjective sleep-related outcomes, 4. behavioural and psychological symptoms of dementia, 5. quality of life, 6. functional status, 7. institutionalisation, 8. compliance with the intervention, and 9. attrition rates. We used GRADE to assess the certainty of evidence and chose key outcomes to be included in summary of findings tables. MAIN RESULTS: We included 19 randomised controlled trials with 1335 participants allocated to treatment or control groups. Fourteen studies were conducted in nursing homes, three included community residents, one included 'inpatients', one included people from a mental health centre, and one included people from district community centres for older people. Fourteen studies were conducted in the US. We also identified nine ongoing studies. All studies applied one or more non-pharmacological intervention aiming to improve physiological sleep in people with dementia and sleep problems. The most frequently examined single intervention was some form of light therapy (six studies), five studies included physical or social activities, three carer interventions, one daytime sleep restriction, one slow-stroke back massage, and one transcranial electrostimulation. Seven studies examined multimodal complex interventions. Risk of bias of included studies was frequently unclear due to incomplete reporting. Therefore, we rated no study at low risk of bias. We are uncertain whether light therapy has any effect on sleep-related outcomes (very low-certainty evidence). Physical activities may slightly increase the total nocturnal sleep time and sleep efficiency, and may reduce the total time awake at night and slightly reduce the number of awakenings at night (low-certainty evidence). Social activities may slightly increase total nocturnal sleep time and sleep efficiency (low-certainty evidence). Carer interventions may modestly increase total nocturnal sleep time, may slightly increase sleep efficiency, and may modestly decrease the total awake time during the night (low-certainty evidence from one study). Multimodal interventions may modestly increase total nocturnal sleep time and may modestly reduce the total wake time at night, but may result in little to no difference in number of awakenings (low-certainty evidence). We are uncertain about the effects of multimodal interventions on sleep efficiency (very low-certainty evidence). We found low-certainty evidence that daytime sleep restrictions, slow-stroke back massage, and transcranial electrostimulation may result in little to no difference in sleep-related outcomes. Only two studies reported information about adverse events, detecting only few such events in the intervention groups. AUTHORS' CONCLUSIONS: Despite the inclusion of 19 randomised controlled trials, there is a lack of conclusive evidence concerning non-pharmacological interventions for sleep problems in people with dementia. Although neither single nor multimodal interventions consistently improved sleep with sufficient certainty, we found some positive effects on physical and social activities as well as carer interventions. Future studies should use rigorous methods to develop and evaluate the effectiveness of multimodal interventions using current guidelines on the development and evaluation of complex interventions. At present, no single or multimodal intervention can be clearly identified as suitable for widespread implementation.

Personally tailored activities for improving psychosocial outcomes for people with dementia in long-term care.

BACKGROUND: People with dementia who are being cared for in long-term care settings are often not engaged in meaningful activities. We wanted to know whether offering them activities which are tailored to their individual interests and preferences could improve their quality of life and reduce agitation. This review updates our earlier review published in 2018. OBJECTIVES: ∙ To assess the effects of personally tailored activities on psychosocial outcomes for people with dementia living in long-term care facilities. ∙ To describe the components of the interventions. ∙ To describe conditions which enhance the effectiveness of personally tailored activities in this setting. SEARCH METHODS: We searched the Cochrane Dementia and Cognitive Improvement Group's Specialized Register, on 15 June 2022. We also performed additional searches in MEDLINE, Embase, PsycINFO, CINAHL, Web of Science, ClinicalTrials.gov, and the World Health Organization (WHO) ICTRP, to ensure that the search for the review was as up-to-date and as comprehensive as possible. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and controlled clinical trials offering personally tailored activities. All interventions included an assessment of the participants' present or past preferences for, or interest in, particular activities as a basis for an individual activity plan. Control groups received either usual care or an active control intervention. DATA COLLECTION AND ANALYSIS: Two authors independently selected studies for inclusion, extracted data and assessed the risk of bias of included studies. Our primary efficacy outcomes were agitation and participant quality of life. Where possible, we pooled data across studies using a random effects model. MAIN RESULTS: We identified three new studies, and therefore included 11 studies with 1071 participants in this review update. The mean age of participants was 78 to 88 years and most had moderate or severe dementia. Ten studies were RCTs (three studies randomised clusters to the study groups, six studies randomised individual participants, and one study randomised matched pairs of participants) and one study was a non-randomised clinical trial. Five studies included a control group receiving usual care, five studies an active control group (activities which were not personally tailored) and one study included both types of control group. The duration of follow-up ranged from 10 days to nine months. In nine studies personally tailored activities were delivered directly to the participants. In one study nursing staff, and in another study family members, were trained to deliver the activities. The selection of activities was based on different theoretical models, but the activities delivered did not vary substantially. We judged the risk of selection bias to be high in five studies, the risk of performance bias to be high in five studies and the risk of detection bias to be high in four studies. We found low-certainty evidence that personally tailored activities may slightly reduce agitation (standardised mean difference -0.26, 95% CI -0.53 to 0.01; I² = 50%; 7 studies, 485 participants). We also found low-certainty evidence from one study that was not included in the meta-analysis, indicating that personally tailored activities may make little or no difference to general restlessness, aggression, uncooperative behaviour, very negative and negative verbal behaviour (180 participants). Two studies investigated quality of life by proxy-rating. We found low-certainty evidence that personally tailored activities may result in little to no difference in quality of life in comparison with usual care or an active control group (MD -0.83, 95% CI -3.97 to 2.30; I² = 51%; 2 studies, 177 participants). Self-rated quality of life was only available for a small number of participants from one study, and there was little or no difference between personally tailored activities and usual care on this outcome (MD 0.26, 95% CI -3.04 to 3.56; 42 participants; low-certainty evidence). Two studies assessed adverse effects, but no adverse effects were observed. We are very uncertain about the effects of personally tailored activities on mood and positive affect. For negative affect we found moderate-certainty evidence that there is probably little to no effect of personally tailored activities compared to usual care or activities which are not personalised (standardised mean difference -0.02, 95% CI -0.19 to 0.14; 6 studies, 632 participants). We were not able to undertake meta-analyses for engagement and sleep-related outcomes, and we are very uncertain whether personally tailored activities have any effect on these outcomes. Two studies that investigated the duration of the effects of personally tailored activities indicated that the intervention effects they found persisted only during the period of delivery of the activities. AUTHORS' CONCLUSIONS: Offering personally tailored activities to people with dementia in long-term care may slightly reduce agitation. Personally tailored activities may result in little to no difference in quality of life rated by proxies, but we acknowledge concerns about the validity of proxy ratings of quality of life in severe dementia. Personally tailored activities probably have little or no effect on negative affect, and we are uncertain whether they have any effect on positive affect or mood. There was no evidence that interventions were more likely to be effective if based on one theoretical model rather than another. We included three new studies in this updated review, but two studies were pilot trials and included only a small number of participants. Certainty of evidence was predominately very low or low due to several methodological limitations of and inconsistencies between the included studies. Evidence is still limited, and we remain unable to describe optimal activity programmes. Further research should focus on methods for selecting appropriate and meaningful activities for people in different stages of dementia.

Psychosocial interventions for reducing antipsychotic medication in care home residents.

BACKGROUND: Antipsychotic medications are regularly prescribed in care home residents for the management of behavioural and psychological symptoms of dementia (BPSD) despite questionable efficacy, important adverse effects, and available non-pharmacological interventions. Prescription rates are related to organisational factors, staff training and job satisfaction, patient characteristics, and specific interventions. Psychosocial intervention programmes aimed at reducing the prescription of antipsychotic drugs are available. These programmes may target care home residents (e.g. improving communication and interpersonal relationships) or target staff (e.g. by providing skills for caring for people with BPSD). Therefore, this review aimed to assess the effectiveness of these interventions, updating our earlier review published in 2012. OBJECTIVES: To evaluate the benefits and harms of psychosocial interventions to reduce antipsychotic medication use in care home residents compared to regular care, optimised regular care, or a different psychosocial intervention. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was 14 July 2022. SELECTION CRITERIA: We included individual or cluster-randomised controlled trials comparing a psychosocial intervention aimed primarily at reducing the use of antipsychotic medication with regular care, optimised regular care, or a different psychosocial intervention. Psychosocial interventions were defined as non-pharmacological intervention with psychosocial components. We excluded medication withdrawal or substitution interventions, interventions without direct interpersonal contact and communication, and interventions solely addressing policy changes or structural interventions. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Critical appraisal of studies addressed risks of selection, performance, attrition and detection bias, as well as criteria related to cluster randomisation. We retrieved data on the complex interventions on the basis of the TIDieR (Template for Intervention Description and Replication) checklist. Our primary outcomes were 1. use of regularly prescribed antipsychotic medication and 2. ADVERSE EVENTS: Our secondary outcomes were 3. mortality; 4. BPSD; 5. quality of life; 6. prescribing of regularly psychotropic medication; 7. regimen of regularly prescribed antipsychotic medication; 8. antipsychotic medication administered 'as needed'; 9. physical restraints; 10. cognitive status; 11. depression; 12. activities of daily living; and 13. COSTS: We used GRADE to assess certainty of evidence. MAIN RESULTS: We included five cluster-randomised controlled studies (120 clusters, 8342 participants). We found pronounced clinical heterogeneity and therefore decided to present study results narratively. All studies investigated complex interventions comprising, among other components, educational approaches. Because of the heterogeneity of the results, including the direction of effects, we are uncertain about the effects of psychosocial interventions on the prescription of antipsychotic medication. One study investigating an educational intervention for care home staff assessed the use of antipsychotic medication in days of use per 100 resident-days, and found this to be lower in the intervention group (mean difference 6.30 days, 95% confidence interval (CI) 6.05 to 6.66; 1152 participants). The other four studies reported the proportion of participants with a regular antipsychotic prescription. Of two studies implementing an intervention to promote person-centred care, one found a difference in favour of the intervention group (between-group difference 19.1%, 95% CI 0.5% to 37.7%; 338 participants), while the other found a difference in favour of the control group (between-group difference 11.4%, 95% CI 0.9% to 21.9%; 862 participants). One study investigating an educational programme described as "academic detailing" found no difference between groups (odds ratio 1.06, 95% CI 0.93 to 1.20; 5363 participants). The fifth study used a factorial design to compare different combinations of interventions to supplement person-centred care. Results showed a positive effect of medication review, and no clear effect of social interaction or exercise. We considered that, overall, the evidence about this outcome was of low certainty. We found high-certainty evidence that psychosocial interventions intended primarily to reduce antipsychotic use resulted in little to no difference in the number of falls, non-elective hospitalisations, or unplanned emergency department visits. Psychosocial interventions intended primarily to reduce antipsychotic use also resulted in little to no difference in quality of life (moderate-certainty evidence), and BPSD, regular prescribing of psychotropic medication, use of physical restraints, depression, or activities of daily living (all low-certainty evidence). We also found low-certainty evidence that, in the context of these interventions, social interaction and medication review may reduce mortality, but exercise does not. AUTHORS' CONCLUSIONS: All included interventions were complex and the components of the interventions differed considerably between studies. Interventions and intervention components were mostly not described in sufficient detail. Two studies found evidence that the complex psychosocial interventions may reduce antipsychotic medication use. In addition, one study showed that medication review might have some impact on antipsychotic prescribing rates. There were no important adverse events. Overall, the available evidence does not allow for clear generalisable recommendations.

Attitudes and knowledge of nurses working at night and sleep promotion in nursing home residents: multicenter cross-sectional survey.

BACKGROUND: Sleep disturbances are common in nursing home residents and challenging for their nurses. Knowledge about sleep and sleep promoting factors is essential to provide adequate sleep management, where nurses play a key role. Therefore, nurses' knowledge and attitudes towards sleep and sleep promoting interventions is important as enabling or inhibiting factor for successful sleep management. METHODS: A multicenter cross-sectional study was conducted among nurses working wholly or partially at night in nursing homes in Germany. Data were collected between February and April 2021 via online or paper and pencil questionnaires, comprising 56 items. Nursing homes were recruited through existing cooperation with the study centers as well as via nursing home registers. RESULTS: Finally, 138 nursing homes participated and 271 nurses completed the survey. Nurses agreed that sleep disturbances are an important topic with important impact on resident' health. Although, the assessment of sleep was seen as nurses' responsibility, only 40 nurses (14.7%) stated that residents' sleep was always documented. Only 21.7% reported the availability of policy documents providing guidance regarding the management of sleep disturbances. The vast majority (93.2%) reported never having received training about sleep and management of sleep disturbances after their basic nursing training. CONCLUSIONS: Our results indicate that nurses working at night can play an important role in residents' sleep promotion. The findings indicate nurses' educational needs regarding sleep and sleep promotion. Nursing homes should implement institutional guidelines in order to promote residents' sleep based on adequate evidence-based non-pharmacological interventions.

Challenges, strategies and consequences from the perspective of German nursing home managers during the first wave of the COVID-19 pandemic - a qualitative interview study.

BACKGROUND: The first wave of the COVID-19 pandemic reached Germany between March and May 2020. In order to contain the spread of the virus and particularly protect vulnerable people, the government imposed a lockdown in March 2020. In addition to infection control measures, such as hygiene and social distancing requirements, a general ban on access to nursing homes for relatives and external service providers was issued. METHODS: To investigate the challenges and consequences of the enacted infection prevention measures and specific strategies for nursing homes in Germany, a multicentre cross-sectional qualitative interview study with nursing home managers and ward managers was conducted. Recorded audio data were transcribed, analysed using thematic framework analysis and reflected in peer debriefings. RESULTS: Seventy-eight interviews with 40 nursing home managers and 38 ward managers from 43 German nursing homes were conducted. At organisational level, the following six themes were identified: Appointing a multi-professional crisis task force, reorganizing the use of building and spatial structures, continuous adaption and implementation of hygiene plans, adapting staff deployment to dynamically changing demands, managing additional communicative demands and relying on and resorting to informal networks. To deal with the pandemic challenges also six themes can be described for the direct care level: Changed routines, taking over non-nursing tasks, increased medical responsibility, increased documentation demands, promoting social participation and increased communication demands. Also various negative consequences were identified (four themes): Psychological stress, negative emotional consequences, permanent feeling of responsibility and increased potential for conflicts. Positive emotional consequences were also reported (two themes): resources for the challenges and positive emotional consequences for home managers and staff. CONCLUSIONS: The results of the described challenges, strategies and consequences allow recommendations as basis for possible approaches and successful adaptation processes in nursing home care in the future. In particular, there is a need for local networks to act in a coordinated way and a need for quantitative and qualitative support for nurses, such as staff support as well as advanced nursing practice, to cope with the challenges of the pandemic.

[Development and evaluation of complex interventions in nursing : Application of the medical research council's framework using the example of interventions to prevent physical restraints]. / Entwicklung und Evaluation komplexer Interventionen in der Pflege : Anwendung des Rahmenmodells des Medical Research Council am Beispiel von Interventionen zur Vermeidung freiheitsentziehender Maßnahmen.

Many nursing interventions are complex. They comprise different intervention elements (components) and aim to change processes or behaviours of individuals or groups. A framework of the British Medical Research Council comprises methodological recommendations for the development and evaluation of complex interventions. This narrative review describes the framework's methodological recommendations using an example of interventions to reduce physical restraints in hospital and long-term care settings, such as bedrails or belts in chairs and beds. In addition to the characteristics of the complex interventions, the development and theoretical foundation of the interventions as well as the feasibility test and evaluation is described.

Interventions for preventing and reducing the use of physical restraints of older people in general hospital settings.

BACKGROUND: Physical restraints, such as bedrails, belts in chairs or beds, and fixed tables, are commonly used for older people in general hospital settings. Reasons given for using physical restraints are to prevent falls and fall-related injuries, to control challenging behavior (such as agitation or wandering), and to ensure the delivery of medical treatments. Clear evidence of their effectiveness is lacking, and potential harms are recognised, including injuries associated with the use of physical restraints and a negative impact on people's well-being. There are widespread recommendations that their use should be reduced or eliminated. OBJECTIVES: To assess the best evidence for the effects and safety of interventions aimed at preventing and reducing the use of physical restraint of older people in general hospital settings. To describe the content, components and processes of these interventions. SEARCH METHODS: We searched the Cochrane Dementia and Cognitive Improvement Group's register, MEDLINE (Ovid SP), Embase (Ovid SP), PsycINFO (Ovid SP), CINAHL (EBSCOhost), Web of Science Core Collection (Clarivate), LILACS (BIREME), ClinicalTrials.gov and the World Health Organization's meta-register the International Clinical Trials Registry Portal on 20 April 2022. SELECTION CRITERIA: We included randomised controlled trials and controlled clinical trials that investigated the effects of interventions that aimed to prevent or reduce the use of physical restraints in general hospital settings. Eligible settings were acute care and rehabilitation wards. We excluded emergency departments, intensive care and psychiatric units, as well as the use of restrictive measures for penal reasons (e.g. prisoners in general medical wards). We included studies with a mean age of study participants of at least 65 years. Control groups received usual care or active control interventions that were ineligible for inclusion as experimental interventions. DATA COLLECTION AND ANALYSIS: Two review authors independently selected the articles for inclusion, extracted data, and assessed the risk of bias of all included studies. Data were unsuitable for meta-analysis, and we reported results narratively. We used GRADE methods to describe our certainty in the results. MAIN RESULTS: We included four studies: two randomised controlled trials (one individually-randomised, parallel-group trial and one clustered, stepped-wedge trial) and two controlled clinical trials (both with a clustered design). One study was conducted in general medical wards in Canada and three studies were conducted in rehabilitation hospitals in Hong Kong. A total of 1709 participants were included in three studies; in the fourth study the number of participants was not reported. The mean age ranged from 67 years to 84 years. The duration of follow-up covered the period of patients' hospitalisation in one study (21 days average length of stay) and ranged from 4 to 11 months in the other studies. The definition of physical restraints differed slightly, and one study did not include bedrails. Three studies investigated organisational interventions aimed at implementing a least-restraint policy to reduce physical restraints. The theoretical approach of the interventions and the content of the educational components was comparable across studies. The fourth study investigated the use of pressure sensors for participants with an increased falls risk, which gave an alarm if the participant left the bed or chair. Control groups in all studies received usual care. Three studies were at high risk of selection bias and risk of detection bias was unclear in all studies. Because of very low-certainty evidence, we are uncertain about the effect of organisational interventions aimed at implementing a least-restraint policy on our primary efficacy outcome: the use of physical restraints in general hospital settings. One study found an increase in the number of participants with at least one physical restraint in the intervention and control groups, one study found a small reduction in both groups, and in the third study (the stepped-wedge study), the number of participants with at least one physical restraint decreased in all clusters after implementation of the intervention but no detailed information was reported. For the use of bed or chair pressure sensor alarms for people with an increased fall risk, we found moderate-certainty evidence of little to no effect of the intervention on the number of participants with at least one physical restraint compared with usual care. None of the studies systematically assessed adverse events related to use of physical restraint use, e.g. direct injuries, or reported such events. We are uncertain about the effect of organisational interventions aimed at implementing a least-restraint policy on the number of participants with at least one fall (very low-certainty evidence), and there was no evidence that organisational interventions or the use of bed or chair pressure sensor alarms for people with an increased fall risk reduce the number of falls (low-certainty evidence from one study each). None of the studies reported fall-related injuries. We found low-certainty evidence that organisational interventions may result in little to no difference in functioning (including mobility), and moderate-certainty evidence that the use of bed or chair pressure sensor alarms has little to no effect on mobility. We are uncertain about the effect of organisational interventions on the use of psychotropic medication; one study found no difference in the prescription of psychotropic medication. We are uncertain about the effect of organisational interventions on nurses' attitudes and knowledge about the use of physical restraints (very low-certainty evidence). AUTHORS' CONCLUSIONS: We are uncertain whether organisational interventions aimed at implementing a least-restraint policy can reduce physical restraints in general hospital settings. The use of pressure sensor alarms in beds or chairs for people with an increased fall risk has probably little to no effect on the use of physical restraints. Because of the small number of studies and the study limitations, the results should be interpreted with caution. Further research on effective strategies to implement a least-restraint policy and to overcome barriers to physical restraint reduction in general hospital settings is needed.

Algorithm-based pain management for people with dementia in nursing homes.

BACKGROUND: People with dementia in nursing homes often experience pain, but often do not receive adequate pain therapy. The experience of pain has a significant impact on quality of life in people with dementia, and is associated with negative health outcomes. Untreated pain is also considered to be one of the causes of challenging behaviour, such as agitation or aggression, in this population. One approach to reducing pain in people with dementia in nursing homes is an algorithm-based pain management strategy, i.e. the use of a structured protocol that involves pain assessment and a series of predefined treatment steps consisting of various non-pharmacological and pharmacological pain management interventions. OBJECTIVES: To assess the effects of algorithm-based pain management interventions to reduce pain and challenging behaviour in people with dementia living in nursing homes. To describe the components of the interventions and the content of the algorithms. SEARCH METHODS: We searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group's register, MEDLINE, Embase, PsycINFO, CINAHL (Cumulative Index to Nursing and Allied Health Literature), Web of Science Core Collection (ISI Web of Science), LILACS (Latin American and Caribbean Health Science Information database), ClinicalTrials.gov and the World Health Organization's meta-register the International Clinical Trials Registry Portal on 30 June 2021. SELECTION CRITERIA: We included randomised controlled trials investigating the effects of algorithm-based pain management interventions for people with dementia living in nursing homes. All interventions had to include an initial pain assessment, a treatment algorithm (a treatment plan consisting of at least two different non-pharmacological or pharmacological treatment steps to reduce pain), and criteria to assess the success of each treatment step. The control groups could receive usual care or an active control intervention. Primary outcomes for this review were pain-related outcomes, e.g. the number of participants with pain (self- or proxy-rated), challenging behaviour (we used a broad definition that could also include agitation or behavioural and psychological symptoms assessed with any validated instrument), and serious adverse events. DATA COLLECTION AND ANALYSIS: Two authors independently selected the articles for inclusion, extracted data and assessed the risk of bias of all included studies. We reported results narratively as there were too few studies for a meta-analysis. We used GRADE methods to rate the certainty of the results. MAIN RESULTS: We included three cluster-randomised controlled trials with a total of 808 participants (mean age 82 to 89 years). In two studies, participants had severe cognitive impairment and in one study mild to moderate impairment. The algorithms used in the studies varied in the number of treatment steps. The comparator was pain education for nursing staff in two studies and usual care in one study. We judged the risk of detection bias to be high in one study. The risk of selection bias and performance bias was unclear in all studies. Self-rated pain (i.e. pain rated by participants themselves) was reported in two studies. In one study, all residents in the nursing homes were included, but fewer than half of the participants experienced pain at baseline, and the mean values of self-rated and proxy-rated pain at baseline and follow-up in both study groups were below the threshold of pain that may require treatment. We considered the evidence from this study to be very low-certainty and therefore are uncertain whether the algorithm-based pain management intervention had an effect on self-rated pain intensity compared with pain education (MD -0.27, 95% CI -0.49 to -0.05, 170 participants; Verbal Descriptor Scale, range 0 to 3). In the other study, all participants had mild to moderate pain at baseline. Here, we found low-certainty evidence that an algorithm-based pain management intervention may have little to no effect on self-rated pain intensity compared with pain education (MD 0.4, 95% CI -0.58 to 1.38, 246 participants; Iowa Pain Thermometer, range 0 to 12). Pain was rated by proxy in all three studies. Again, we considered the evidence from the study in which mean pain scores indicated no pain, or almost no pain, at baseline to be very low-certainty and were uncertain whether the algorithm-based pain management intervention had an effect on proxy-rated pain intensity compared with pain education. For participants with mild to moderate pain at baseline, we found low-certainty evidence that an algorithm-based pain management intervention may reduce proxy-rated pain intensity in comparison with usual care (MD -1.49, 95% CI -2.11 to -0.87, 1 study, 128 participants; Pain Assessment in Advanced Dementia Scale-Chinese version, range 0 to 10), but may not be more effective than pain education (MD -0.2, 95% CI -0.79 to 0.39, 1 study, 383 participants; Iowa Pain Thermometer, range 0 to 12). For challenging behaviour, we found very low-certainty evidence from one study in which mean pain scores indicated no pain, or almost no pain, at baseline. We were uncertain whether the algorithm-based pain management intervention had any more effect than education for nursing staff on challenging behaviour of participants (MD -0.21, 95% CI -1.88 to 1.46, 1 study, 170 participants; Cohen-Mansfield Agitation Inventory-Chinese version, range 7 to 203). None of the studies systematically assessed adverse effects or serious adverse effects and no study reported information about the occurrence of any adverse effect. None of the studies assessed any of the other outcomes of this review. AUTHORS' CONCLUSIONS: There is no clear evidence for a benefit of an algorithm-based pain management intervention in comparison with pain education for reducing pain intensity or challenging behaviour in people with dementia in nursing homes. We found that the intervention may reduce proxy-rated pain compared with usual care. However, the certainty of evidence is low because of the small number of studies, small sample sizes, methodological limitations, and the clinical heterogeneity of the study populations (e.g. pain level and cognitive status). The results should be interpreted with caution. Future studies should also focus on the implementation of algorithms and their impact in clinical practice.

[Development and feasibility of an intervention to reduce physical restraints in hospitals: A mixed methods study]. / Entwicklung und Machbarkeit einer Intervention zur Vermeidung freiheitsentziehender Maßnahmen im Krankenhaus.

Development and feasibility of an intervention to reduce physical restraints in hospitals: A mixed methods study Abstract. Background: Physical restraints (PR) are regularly used in people with dementia or delirium in general hospital settings. There is no clear evidence for the effectiveness of PR, but their use is associated with an increased risk for harm. Therefore, a restraint-free care is recommended. Aim: Development and feasibility test of an intervention to reduce PR in general hospital settings. Methods: Systematic literature reviews and theory-guided modelling of an intervention involving relevant clinical stakeholders and mixed methods study in two wards of a university hospital (geriatric traumatology and neurology). Results: The complex intervention comprises the following components: qualification of multipliers, interprofessional education about PR reduction, regular audit and feedback meetings, and the support regarding the aim of the intervention from nursing and medical leaders. The results of the feasibility test indicate that the intervention is feasible and helpful, but the interprofessional approach was not implemented as planned. An important barrier hampering PR reduction was the high workload. The results on the prevalence of PR could not be interpreted due to a very low number of measures applied. Conclusion: The complex intervention with a multiplier approach for preventing PR use was judged as feasible, but there is a need for further development to strengthen interprofessional cooperation. The feasibility of the intervention should also be tested in other departments.

Antipsychotics for agitation and psychosis in people with Alzheimer's disease and vascular dementia.

BACKGROUND: Typical and atypical antipsychotics are widely used to treat agitation and psychosis in dementia. However, whether or not they are beneficial is uncertain. Some trials have yielded negative results and effectiveness may be outweighed by harms. OBJECTIVES: To assess the efficacy and safety of antipsychotics for the treatment of agitation and psychosis in people with Alzheimer's disease and vascular dementia. SEARCH METHODS: We searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group's register, MEDLINE (Ovid Sp), Embase (Ovid SP), PsycINFO (Ovid SP), CINAHL (EBSCOhost), Web of Science Core Collection (ISI Web of Science), LILACS (BIREME), ClinicalTrials.gov and the World Health Organization's meta-register, and the International Clinical Trials Registry Portal on 7 January 2021. Two review authors independently screened the title and abstract of the hits, and two review authors assessed the full text of studies that got through this screening. SELECTION CRITERIA: We included randomised, placebo-controlled, parallel-arm trials comparing the effects of antipsychotics and placebo for the treatment of agitation or psychosis in people with dementia due to Alzheimer's disease or vascular dementia, or both, irrespective of age, severity of cognitive impairment, and setting. (The majority of) participants had to have clinically significant agitation (including aggression) or psychosis or both at baseline. We excluded studies about antipsychotics that are no longer available in the USA or EU, or that are used for emergency short-term sedation. We also excluded head-to-head trials and antipsychotic withdrawal trials. DATA COLLECTION AND ANALYSIS: The primary outcomes were (1) reduction in agitation or psychosis in participants with agitation or psychosis, respectively at baseline, and (2) the number of participants with adverse events: somnolence, extrapyramidal symptoms, any adverse event, any serious adverse event (SAE), and death. Two review authors independently extracted the necessary data and assessed risk of bias with the Cochrane risk of bias tool. We calculated the pooled effect on agitation and psychosis for typical and atypical antipsychotics separately, and the pooled risk of adverse effects independent of the target symptom (agitation or psychosis). We used RevMan Web for the analyses. MAIN RESULTS: The search yielded 8233 separate hits. After assessing the full-text of 35 studies, we included 24 trials that met the eligibility criteria. Six trials tested a typical antipsychotic, four for agitation and two for psychosis. Twenty trials tested an atypical antipsychotic, eight for agitation and 12 for psychosis. Two trials tested both drug types. Seventeen of 26 comparisons were performed in patients with Alzheimer's disease specifically. The other nine comparisons also included patients with vascular dementia or mixed dementia. Together, the studies included 6090 participants (12 to 652 per study). The trials were performed in institutionalised, hospitalised and community-dwelling patients, or a combination of those. For typical antipsychotics (e.g. haloperidol, thiothixene), we are uncertain whether these drugs improve agitation compared with placebo (standardised mean difference (SMD) -0.36, 95% confidence interval (CI) -0.57 to -0.15, 4 studies, n = 361); very low-certainty evidence, but typical antipsychotics may improve psychosis slightly (SMD -0.29, 95% CI -0.55 to -0.03, 2studies, n= 240; low-certainty evidence) compared with placebo. These drugs probably increase the risk of somnolence (risk ratio (RR) 2.62, 95% CI 1.51 to 4.56, 3 studies, n = 466; moderate-certainty evidence) and increase extrapyramidal symptoms (RR 2.26, 95% CI 1.58 to 3.23, 3 studies, n = 467; high-certainty) evidence. There was no evidence regarding the risk of any adverse event. The risks of SAEs (RR 1.32, 95% CI 0.65 to 2.66, 1 study, n = 193) and death (RR 1.46, 95% CI 0.54 to 4.00, 6 studies, n = 578) may be increased slightly, but these estimates were very imprecise, and the certainty was low. The effect estimates for haloperidol from five trials were in line with those of the drug class. Atypical antipsychotics (e.g. risperidone, olanzapine, aripiprazole, quetiapine) probably reduce agitation slightly (SMD -0.21, 95% CI -0.30 to -0.12, 7 studies, n = 1971; moderate-certainty evidence), but probably have a negligible effect on psychosis (SMD -0.11, 95% CI -0.18 to -0.03, 12 studies, n = 3364; moderate-certainty evidence). These drugs increase the risk of somnolence (RR 1.93, 95% CI 1.57 to 2.39, 13 studies, n - 3878; high-certainty evidence) and are probably also associated with slightly increased risk of extrapyramidal symptoms (RR 1.39, 95% CI 1.14 to 1.68, 15 studies, n = 4180; moderate-certainty evidence), serious adverse events (RR 1.32, 95% CI 1.09 to 1.61, 15 studies, n= 4316; moderate-certainty evidence) and death (RR 1.36, 95% CI 0.90 to 2.05, 17 studies, n= 5032; moderate-certainty evidence), although the latter estimate was imprecise. The drugs probably have a negligible effect on the risk of any adverse event (RR 1.05, 95% CI 1.02 to 1.09, 11 studies, n = 2785; moderate-certainty evidence). The findings from seven trials for risperidone were in line with those for the drug class. AUTHORS' CONCLUSIONS: There is some evidence that typical antipsychotics might decrease agitation and psychosis slightly in patients with dementia. Atypical antipsychotics reduce agitation in dementia slightly, but their effect on psychosis in dementia is negligible. The apparent effectiveness of the drugs seen in daily practice may be explained by a favourable natural course of the symptoms, as observed in the placebo groups. Both drug classes increase the risk of somnolence and other adverse events. If antipsychotics are considered for sedation in patients with severe and dangerous symptoms, this should be discussed openly with the patient and legal representative.

Characteristics of multicomponent, nonpharmacological interventions to reduce or avoid sleep disturbances in nursing home residents: a systematic review.

BACKGROUND: Dementia guidelines propose the use of nonpharmacological interventions for sleep disturbances for older people. Based on available reviews, it seems most likely that multicomponent interventions have the strongest potential to be effective in improving sleep. However, a detailed description of multicomponent interventions is missing. This systematic review aims to identify, describe, and summarize multicomponent, nonpharmacological interventions to reduce or avoid sleep disturbances in nursing home residents. METHODS: This review followed established methodological frameworks for systematic evidence syntheses. A computerized search was conducted in December 2018, using the databases PubMed, CINAHL, Scopus, and Cochrane Library. Two independent reviewers assessed all search results to identify eligible studies and assessed studies' methodological quality following the Cochrane Risk of Bias methodology for randomized controlled trials and the CASP Appraisal Checklist for controlled trials.Evaluation studies of any design investigating multicomponent interventions were included, except case studies. Components of included intervention programs were analyzed applying the TIDieR and CReDECI 2 criteria. RESULTS: A total of 2056 studies were identified through the database search; ten publications about nine interventions met the inclusion criteria and were included in the review. The identified interventions can be summarized assigned to the categories "daytime activities," "nighttime activities," "staff training," and "light exposure." The approaches showed similarities and differences in procedures, materials, modes of delivery, intervention provider, and intervention period. None of the studies described any intended interactions between components or considered context characteristics in intervention modeling as well as internal and external facilitators or barriers influencing delivery of intervention. We identified positive or mixed positive effects for sleep-related outcomes for the mentioned categories. CONCLUSIONS: The analysis of included interventions demonstrates somehow promising results, although findings are difficult to interpret as interventions were not well described, and the challenges of developing and evaluating complex interventions were not sufficiently acknowledged.

Evaluation of a multi-component, non-pharmacological intervention to prevent and reduce sleep disturbances in people with dementia living in nursing homes (MoNoPol-sleep): study protocol for a cluster-randomized exploratory trial.

BACKGROUND: Sleep problems are highly prevalent in people with dementia. Nevertheless, there is no "gold standard" intervention to prevent or reduce sleep problems in people with dementia. Existing interventions are characterized by a pronounced heterogeneity as well as insufficient knowledge about the possibilities and challenges of implementation. The aim of this study is to pilot and evaluate the effectiveness of a newly developed complex intervention to prevent and reduce sleep problems in people with dementia living in nursing homes. METHODS: This study is a parallel group cluster-randomized controlled trial. The intervention consists of six components: (1) the assessment of established sleep-promoting interventions and an appropriate environment in the participating nursing homes, (2) the implementation of two "sleep nurses" as change agents per nursing home, (3) a basic education course for nursing staff: "Sleep problems in dementia", (4) an advanced education course for nursing staff: "Tailored problem-solving" (two workshops), (5) workshops: "Development of an institutional sleep-promoting concept" (two workshops with nursing management and sleep nurses) and (6) written information and education material (e.g. brochure and "One Minute Wonder" poster). The intervention will be performed over a period of 16 weeks and compared with usual care in the control group. Overall, 24 nursing homes in North, East and West Germany will be included and randomized in a 1:1 ratio. The primary outcome is the prevalence of sleep problems in people with dementia living in nursing homes. Secondary outcomes are quality of life, quality of sleep, daytime sleepiness and agitated behavior of people with dementia, as well as safety parameters like psychotropic medication, falls and physical restraints. The outcomes will be assessed using a mix of instruments based on self- and proxy-rating. A cost analysis and a process evaluation will be performed in conjunction with the study. CONCLUSIONS: It is expected that the intervention will reduce the prevalence of sleep problems in people with dementia, thus not only improving the quality of life for people with dementia, but also relieving the burden on nursing staff caused by sleep problems. TRIAL REGISTRATION: Current controlled trials: ISRCTN36015309 . Date of registration: 06/11/2020.

Process evaluation of a multicomponent intervention to prevent physical restraints in nursing homes (IMPRINT): A mixed methods study.

AIMS: To describe the implementation process and fidelity of two versions of a guideline-based, multicomponent intervention to reduce physical restraints in nursing homes and to identify factors that might explain the heterogeneity of effects between different clusters. DESIGN: Mixed methods evaluation of the implementation process (dose delivered, dose received, response, and adaption) alongside a pragmatic three-arm cluster randomized controlled trial. METHODS: Quantitative and qualitative process data were collected during the study period (February 2015-February 2017). Quantitative data from questionnaires and short surveys were analysed by descriptive statistics. Qualitative data from focus groups and semi-structured interviews were analysed using content analysis. An in-depth analysis was conducted by contrasting responding and non-responding clusters regarding the intervention goal and primary outcome. RESULTS: Both interventions were implemented as planned in all clusters: we found no deviations from the protocol regarding the dose delivered to and received by the clusters. Satisfaction of staff targeted by the interventions was high. The in-depth analysis did not reveal any pronounced variation in the degree of implementation or adoption in clusters with a good or nearly no response to the interventions or factors explaining different study effects. CONCLUSION: Although both versions of a guideline-based multicomponent intervention to prevent physical restraints in nursing homes were implemented as planned and the response was generally acceptable, the interventions' goal to change nursing practice towards a least-restraint policy was not achieved by the entire nursing staff in all of the clusters. No factors could be identified that might explain the different effects of the interventions. IMPACT: For some nursing homes, different approaches than addressing nurses' attitudes and institutional policies might be needed to sustainably reduce the use of physical restraints; however, the process evaluation did not reveal characteristics that might have hampered or facilitated the effectiveness of the intervention.

A behavioural approach to specifying interventions: what insights can be gained for the reporting and implementation of interventions to reduce antibiotic use in hospitals?

BACKGROUND: Reducing unnecessary antibiotic exposure is a key strategy in reducing the development and selection of antibiotic-resistant bacteria. Hospital antimicrobial stewardship (AMS) interventions are inherently complex, often requiring multiple healthcare professionals to change multiple behaviours at multiple timepoints along the care pathway. Inaction can arise when roles and responsibilities are unclear. A behavioural perspective can offer insights to maximize the chances of successful implementation. OBJECTIVES: To apply a behavioural framework [the Target Action Context Timing Actors (TACTA) framework] to existing evidence about hospital AMS interventions to specify which key behavioural aspects of interventions are detailed. METHODS: Randomized controlled trials (RCTs) and interrupted time series (ITS) studies with a focus on reducing unnecessary exposure to antibiotics were identified from the most recent Cochrane review of interventions to improve hospital AMS. The TACTA framework was applied to published intervention reports to assess the extent to which key details were reported about what behaviour should be performed, who is responsible for doing it and when, where, how often and with whom it should be performed. RESULTS: The included studies (n = 45; 31 RCTs and 14 ITS studies with 49 outcome measures) reported what should be done, where and to whom. However, key details were missing about who should act (45%) and when (22%). Specification of who should act was missing in 79% of 15 interventions to reduce duration of treatment in continuing-care wards. CONCLUSIONS: The lack of precise specification within AMS interventions limits the generalizability and reproducibility of evidence, hampering efforts to implement AMS interventions in practice.

Personally tailored activities for improving psychosocial outcomes for people with dementia in community settings.

BACKGROUND: People with dementia living in the community, that is in their own homes, are often not engaged in meaningful activities. Activities tailored to their individual interests and preferences might be one approach to improve quality of life and reduce challenging behaviour. OBJECTIVES: To assess the effects of personally tailored activities on psychosocial outcomes for people with dementia living in the community and their caregivers. To describe the components of the interventions. To describe conditions which enhance the effectiveness of personally tailored activities in this setting. SEARCH METHODS: We searched ALOIS: the Cochrane Dementia and Cognitive Improvement Group's Specialized Register on 11 September 2019 using the terms: activity OR activities OR occupation* OR "psychosocial intervention" OR "non-pharmacological intervention" OR "personally-tailored" OR "individually-tailored" OR individual OR meaning OR involvement OR engagement OR occupational OR personhood OR "person-centred" OR identity OR Montessori OR community OR ambulatory OR "home care" OR "geriatric day hospital" OR "day care" OR "behavioural and psychological symptoms of dementia" OR "BPSD" OR "neuropsychiatric symptoms" OR "challenging behaviour" OR "quality of life" OR depression. ALOIS contains records of clinical trials identified from monthly searches of a number of major healthcare databases, numerous trial registries and grey literature sources. SELECTION CRITERIA: We included randomised controlled trials and quasi-experimental trials including a control group offering personally tailored activities. All interventions comprised an assessment of the participant's present or past interests in, or preferences for, particular activities for all participants as a basis for an individual activity plan. We did not include interventions offering a single activity (e.g. music or reminiscence) or activities that were not tailored to the individual's interests or preferences. Control groups received usual care or an active control intervention. DATA COLLECTION AND ANALYSIS: Two review authors independently checked the articles for inclusion, extracted data, and assessed the methodological quality of all included studies. We assessed the risk of selection bias, performance bias, attrition bias, and detection bias. In case of missing information, we contacted the study authors. MAIN RESULTS: We included five randomised controlled trials (four parallel-group studies and one cross-over study), in which a total of 262 participants completed the studies. The number of participants ranged from 30 to 160. The mean age of the participants ranged from 71 to 83 years, and mean Mini-Mental State Examination (MMSE) scores ranged from 11 to 24. One study enrolled predominantly male veterans; in the other studies the proportion of female participants ranged from 40% to 60%. Informal caregivers were mainly spouses. In four studies family caregivers were trained to deliver personally tailored activities based on an individual assessment of interests and preferences of the people with dementia, and in one study such activities were offered directly to the participants. The selection of activities was performed with different methods. Two studies compared personally tailored activities with an attention control group, and three studies with usual care. Duration of follow-up ranged from two weeks to four months. We found low-certainty evidence indicating that personally tailored activities may reduce challenging behaviour (standardised mean difference (SMD) -0.44, 95% confidence interval (CI) -0.77 to -0.10; I2 = 44%; 4 studies; 305 participants) and may slightly improve quality of life (based on the rating of family caregivers). For the secondary outcomes depression (two studies), affect (one study), passivity (one study), and engagement (two studies), we found low-certainty evidence that personally tailored activities may have little or no effect. We found low-certainty evidence that personally tailored activities may slightly improve caregiver distress (two studies) and may have little or no effect on caregiver burden (MD -0.62, 95% CI -3.08 to 1.83; I2 = 0%; 3 studies; 246 participants), caregivers' quality of life, and caregiver depression. None of the studies assessed adverse effects, and no information about adverse effects was reported in any study. AUTHORS' CONCLUSIONS: Offering personally tailored activities to people with dementia living in the community may be one approach for reducing challenging behaviour and may also slightly improve the quality of life of people with dementia. Given the low certainty of the evidence, these results should be interpreted with caution. For depression and affect of people with dementia, as well as caregivers' quality of life and burden, we found no clear benefits of personally tailored activities.