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.

Measuring patients' medical treatment preferences in advance care planning: development and validation of the Treat-Me-ACP instrument - a secondary analysis of a cluster-randomized controlled trial.

BACKGROUND: Advance Care Planning interventions should be evaluated as broadly as possible to gain a holistic understanding of the Advance Care Planning process. However, validated early stage outcome instruments are lacking. Therefore, the Treatment-Preference-Measure-Advance Care Planning (Treat-Me-ACP) instrument was developed and validated as part of the cluster-randomized controlled trial STADPLAN (Study on Advance Care Planning in care-dependent community-dwelling older persons) to assess the effects of Advance Care Planning interventions on patients' medical treatment preferences. METHODS: The design of Treat-Me-ACP is based on the Emanuel Medical Directive and the Life Support Preferences Questionnaires. Using a multi-stage team approach a preliminary version of the Treat-Me-ACP was developed and pre-tested. The pre-tested instrument consists of one global medical care goal-item, five hypothetical scenarios with five hypothetical treatments, and one how would you feel-item within each scenario. A total of five scenario preference scores and five treatment preference scores can be formed. This version was subsequently applied to a subsample of the STADPLAN project (n = 80) to assess patient's preferences at baseline (T0) and at 12-month follow-up (T2). The further validation steps were based on this subsample and included: (1) acceptance by using completion rate and frequencies of missing data, (2) internal consistency by using Cronbach's α to test whether it was possible to create preference scores by scenario and treatment, (3) concurrent validation examining the association between the global medical care goal-item and the preference scores and the association between the how would you feel-items and the scenario preference scores, and (4) responsiveness of the instrument to changes in preferences for life-sustaining treatments by comparing preference scores from T0 to T2 between study groups. RESULTS: Acceptance of the instrument was high. Results of concurrent validation indicate that the five scenarios represent the global medical care goal well. The preference scores showed an average tendency for decreasing preferences for life-sustaining treatments across all scales for the intervention group during study follow-up. CONCLUSIONS: The Treat-Me-ACP can be used to evaluate the dynamics of patients' medical treatment preferences in Advance Care Planning. It has been validated for care-dependent community-dwelling older persons and can be used as an additional outcome measure in evaluating the effectiveness of ACP interventions. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00016886 on 04/06/2019.

[Critical care nurses' decision-making regarding verification of blindly inserted gastric tubes: A cross-sectional questionnaire study]. / Entscheidungsfindung von Intensivpflegefachpersonen zur Verifikation blind applizierter Magensonden.

Critical care nurses' decision-making regarding verification of blindly inserted gastric tubes: A cross-sectional questionnaire study Abstract: Background: The placement and verification of the correct position of blindly applied gastric tubes is regularly performed by nurses in clinical practice. International guidelines recommend a radiological verification as a "first-line" method or if pH measurement is not possible. For Germany, neither evidence-based recommendations nor current data are available. Question: Which methods are used by nurses in German intensive care units for verification of the correct position of blindly applied gastric tubes and how do they assess the reliability of different methods? Methods: Multicenter questionnaire survey. Intensive care units in a non-probability, citeria-based sampling of hospitals in and around Cologne, Germany were included. One nurse was included per participating ward. Analyses were mostly descriptive. Results: In 22 hospitals, 38 wards agreed to participate and 32 (84%) responded to the survey. Auscultation of the upper abdomen with simultaneous air insufflation and aspiration of gastric secretions are frequently used methods for determining the position of gastric tubes. Participants consider auscultation, aspiration of gastric secretions, and radiological control as reliable methods. Conclusions: The findings are in contrast to international recommendations and support the need for evidence-based best practice recommendations and training. Likewise, there is a need for research on feasible bedside methods.

Postpartum relapse risk in multiple sclerosis: a systematic review and meta-analysis.

The influence of pregnancy on the course of multiple sclerosis (MS) has long been controversial. While historical evidence suggests a substantial decline in relapse rates during pregnancy followed by a rebound in the postpartum period, more recent work yielded equivocal results. We performed a systematic review and meta-analysis on data from cohort studies to determine whether women with MS experience increased relapse rates after delivery. A systematic literature search was conducted in the databases MEDLINE and Epistemonikos on the topic 'motherhood choice in MS' in March 2022. We included cohort studies assessing the association between pregnancy and MS relapse activity defined by the annualised relapse rate after 3, 6, 9 and 12 months post partum. Furthermore, information about disease-modifying therapies (DMT) and breast feeding was considered, if available. 5369 publications were identified. Of these, 93 full-text articles on MS relapse activity during the postpartum period were screened. 11 studies including 2739 pregnancies were eligible. Women with MS showed a significantly increased relapse rate in the first 6 months post partum, compared with preconception with the incidence rate ratio (IRR) almost doubled in the first 3 months post partum (1.87, 95% CI 1.40 to 2.50). However, at 10-12 months post partum, the IRR decreased significantly (0.81, 95% CI 0.67 to 0.98). Subanalysis on influencing parameters suggested that preconceptional DMTs (IRR for highly-effective DMTs 2.76, 95% CI 1.34 to 5.69) and exclusive breast feeding (risk ratio 0.39, 95% CI 0.18 to 0.86) significantly influenced postpartum relapse risk. Increased postpartum annualised relapse rate and possible modifiers should be considered in counselling women with MS who are considering pregnancy.

Cluster randomised trial of a complex interprofessional intervention (interprof ACT) to reduce hospital admission of nursing home residents.

BACKGROUND: Some hospital admissions of nursing home residents (NHRs) might be attributed to inadequate interprofessional collaboration. To improve general practitioner-nurse collaboration in nursing homes (NHs), we developed an intervention package (interprof ACT) in a previous study. OBJECTIVE: To assess the impact of interprof ACT on the proportion of hospitalisation and other clinical parameters within 12 months from randomisation among NHRs. METHODS: Multicentre, cluster randomised controlled trial in 34 German NHs. NHRs of the control group received usual care, whereas NHRs in the intervention group received interprof ACT. Eligible NHs had at least 40 long-term care residents. NHs were randomised 1:1 pairwise. Blinded assessors collected primary outcome data. RESULTS: Seventeen NHs (320 NHRs) were assigned to interprof ACT and 17 NHs (323 NHRs) to usual care. In the intervention group, 136 (42.5%) NHRs were hospitalised at least once within 12 months from randomisation and 151 (46.7%) in the control group (odds ratio (OR): 0.82, 95% confidence interval (CI): [0.55; 1.22], P = 0.33). No differences were found for the average number of hospitalisations: 0.8 hospitalisations per NHR (rate ratio (RR) 0.90, 95% CI: [0.66, 1.25], P = 0.54). Average length of stay was 5.7 days for NHRs in the intervention group and 6.5 days in the control group (RR: 0.70, 95% CI: [0.45, 1.11], P = 0.13). Falls were the most common adverse event, but none was related to the study intervention. CONCLUSIONS: The implementation of interprof ACT did not show a statistically significant and clinically relevant effect on hospital admission of NHRs.

Effects of advance care planning in care dependent community-dwelling older persons (STADPLAN): A cluster-randomised controlled trial.

BACKGROUND: Most randomised controlled trials on advance care planning were conducted in people with advanced, life-limiting illnesses or in institutional settings. There are few studies on its effect in older people living in the community. AIM: To determine the effects of advance care planning in older community dwelling people. DESIGN: The STADPLAN study was a cluster-randomised trial with 12 months follow-up. The complex intervention comprised a 2-days training for nurse facilitators that delivered a formal advance care planning counselling and a written information brochure. Patients in the control group received optimised usual care, that is, provision of a short information brochure. SETTING/PARTICIPANTS: Home care services in three regions of Germany were randomised using concealed allocation. Care dependent clients of participating home care services, aged 60 years or older, and rated to have a life-expectancy of at least 4 weeks were included. Primary outcome was active participation in care at 12 months, assessed by blinded investigators using the Patient Activation Measure (PAM-13). RESULTS: Twenty-seven home care services and 380 patients took part. Three hundred seventy-three patients were included in the primary analysis (n = 206 in the intervention and n = 167 in the control group). There was no statistically significant difference between the intervention and control group with regard to the PAM-13 after 12 months (75.7 vs 78.4; p = 0.13). No differences in quality of life, anxiety and depression, advance care planning engagement, and in proportion of participants with advance directives were found between groups. CONCLUSIONS: The intervention showed no relevant effects on patient activation or quality of life in community dwelling older persons, possibly indicating the need for more tailored interventions. However, results are limited by a lack of statistical power. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00016886.

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.

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.

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.

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.

Expanded nursing roles to promote person-centred care for people with cognitive impairment in acute care (ENROLE-acute): study protocol for a controlled clinical trial, process and economic evaluation.

BACKGROUND: For people with cognitive impairment, hospitalisation is challenging and associated with adverse events as well as negative outcomes resulting in a prolonged hospital stay. Person-centred care can improve the quality of care and the experience of people with cognitive impairment during hospitalisation. However, current care processes in German hospitals are rarely person-centred. To enable successful implementation of person-centred care on hospital wards, change agents within the interprofessional team are key. The aim of this study is to test the feasibility and initial effects of a newly developed complex person-centred care intervention for people with cognitive impairment provided by expanded practice nurses in acute care. METHODS: We will conduct an exploratory non-randomised controlled clinical trial with accompanying process and cost evaluation with three intervention and three control wards at one university hospital. The person-centred care intervention consists of 14 components reflecting the activities of expanded practice nurses within the interprofessional team on the intervention wards. The intervention will be implemented over a six-month period and compared with optimised care on the control wards. We will include people aged 65 years and older with existing cognitive impairment and/or at risk of delirium. The estimated sample size is 720 participants. The primary outcome is length of hospital stay. Secondary outcomes include prevalence of delirium, prevalence of agitation, sleep quality, and person-centred care. We will collect patient level data at six time points (t1 admission, t2 day 3, t3 day 7, t4 day 14, t5 discharge, t6 30 days after discharge). For secondary outcomes at staff level, we will collect data before and after the intervention period. The process evaluation will examine degree and quality of implementation, mechanisms of change, and the context of the complex intervention. The economic evaluation will focus on costs from the hospital's perspective. DISCUSSION: The ENROLE-acute study will provide insights into the effectiveness and underlying processes of a person-centred care intervention for people with cognitive impairment provided by expanded practice nurses on acute hospitals wards. Results may contribute to intervention refinement and evidence-based decision making. TRIAL REGISTRATION: Current controlled trials: ISRCTN81391868. Date of registration: 12/06/2023. URL: https://doi.org/10.1186/ISRCTN81391868.

Exploring stakeholders' perspectives on the adaptation of the Living Lab approach to dementia care: A qualitative study.

Collaborative research can promote knowledge translation and help to link care practice and research. Academic-practice partnerships enable joint research projects in collaboration between care professionals, researchers, patients, and other stakeholders. This qualitative study was conducted during the adaptation phase of the Living Lab Dementia, an academic-practice partnership for collaborative research on long-term dementia care. The aim was to explore stakeholders' perspectives on linking care practice and research in a sustainable, research-focused partnership. Data were collected in fifteen qualitative interviews with representatives from three stakeholder groups: nursing care professionals, people with dementia, and nursing researchers. Thematic Framework Analysis resulted in five themes: (1) Access, (2) Expectations, (3) Shaping the collaboration, (4) Linking Pins, and (5) Participation. The findings suggest that care professionals expect support in implementing research results into practice. Researchers should take the lead in shaping the collaboration and create opportunities for stakeholders to get involved.

[Health promotion and prevention in nursing homes in the context of the German Prevention Act]. / Gesundheitsförderung und Prävention in der stationären Langzeitpflege im Kontext des Präventionsgesetzes.

The German Prevention Act obliges the nursing care insurance funds to provide health-promoting interventions and preventive offers in nursing homes. These interventions should clearly differ from activating nursing care and be of proven effectiveness and cost-effectiveness.The present opinion article critically appraises the evidence base of the interventions belonging to the pre-defined preventive areas "nutrition," "physical activity," "cognitive resources," "psychosocial health," and "prevention of elder abuse." The interventions' underlying evidence is weak or even missing. It is unclear whether the interventions contribute to the intended strengthening of the health-promoting potential of care facilities and meet the goal of improving the health situation and resources of the care-dependent people. On the other hand, there are areas of prevention, which are not covered, but have great potential for improving the life situation of those in need of care, for example, in the context of person-centered care and a caring nursing culture.

Evolution of advanced practice nursing in acute care in Germany: A cross-sectional study of nurses' scope of practice.

AIM: To describe activities and professional characteristics of nurses in expanded roles in acute care in Germany and achieve a greater understanding of the current situation of advanced practice nursing. BACKGROUND: Advanced practice nursing plays an important role in meeting increased demands in healthcare and promoting high-quality care. INTRODUCTION: In Germany, advanced practice nursing is still at an early stage with a lack of studies describing the scope of practice of nurses in expanded roles. METHODS: We conducted a cross-sectional-study using a paper-and-pencil questionnaire. In a nationwide convenience sample, we surveyed nurses with an academic degree, who work in an acute care hospital and take over expanded roles in direct patient care. Reporting followed the STROBE checklist. RESULTS: Of 108 eligible nurses, 84 (77%) completed the survey. The majority had a Master's degree (63.1%) and the average work experience was 18.2 years. Participants carried out activities in all the domains that were queried (direct clinical practice, guidance and coaching, consultation, leadership and research) with differences within and between domains. Foci were on direct clinical practice and coaching and guidance. DISCUSSION: In Germany, qualifications are nearing the international standard of advanced practice nursing. Results suggest that participants partly undertake activities within the scope of registered nurses' practice that do not correspond fully to their formal qualifications. CONCLUSION AND IMPLICATIONS FOR NURSING AND/OR HEALTH POLICY: In order to foster the role development of expanded practice nurses in Germany, political efforts are needed in terms of training (e.g. specific Master's programmes), funding of corresponding positions in practice and control mechanisms (e.g. professional registration).

[Role understanding of expert nurses in primary and acute care in Germany: A descriptive cross-sectional study]. / Rollenverständnis von Pflegeexpert_innen in der Primär- und Akutversorgung in Deutschland.

Role understanding of expert nurses in primary and acute care in Germany: A descriptive cross-sectional study Abstract. Background: Innovative care concepts are necessary to cope with the increase in complex care situations due to a rising number of older people with chronic diseases and a simultaneous shortage of nursing and medical staff. In the context of the implementation and development of new, innovative nursing roles, an unclear role understanding is considered a barrier. Aim: Description of expert nurses' (EN) role understanding in primary and acute care in Germany. Method: Using questionnaires, EN are asked cross-sectionally about role clarity, competencies and performance as well as perceived autonomy and interprofessional collaboration. Results are analysed descriptively. Results: A total of eight (primary care) and 14 (acute care) EN completed the questionnaires. The majority of EN often/very often perform both the clinical (77.5% and 85.7%, respectively) and the expert role (75% and 78.6%, respectively) and indicate that they can explain their role to patients (75% and 92.9%, respectively) and physicians (87.5% and 90.9%, respectively). Having a high degree of autonomy is more likely to be perceived by EN working in acute care. Conclusion: Although there are similarities in terms of role understanding, EN working in acute care can apparently benefit from already established structures, which is reflected, among other things, in their perceived autonomy.

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.

Contextual factors influencing advance care planning in home care: process evaluation of the cluster-randomised controlled trial STADPLAN.

BACKGROUND: The STADPLAN study is a cluster-randomised controlled trial including 27 home care services in Germany. It assesses the effect of an advance care planning (ACP) intervention delivered by trained nurses to older care-dependent patients. Patients received two ACP conversations and an information brochure. Nurses were educated through a two-day programme and topic guides structuring the conversations. Objectives of the process evaluation were to determine: [1] whether the intervention was implemented as planned, [2] which change mechanisms were observed, [3] whether targeted process outcomes were achieved and [4] in which way contextual factors influenced the implementation process. METHODS: The process evaluation is based on a mixed methods approach following the recommendations of the UK-MRC framework for the development and evaluation of complex interventions. Qualitative and quantitative assessments were developed and analysed guided by a logic model comprising intervention, participants, mechanisms of change and context factors. The results of the main trial will be published elsewhere. RESULTS: Educational programme and topic guides were mostly implemented as planned and resulted in motivation, knowledge, and perceived competencies to facilitate ACP conversations in nurses. Deviances in the performance of ACP conversations indicated patients' varied individual needs, but also obstacles like reluctance of patients and caregivers to participate actively and time constraints of nurse facilitators. Patients and caregivers reported increased awareness of ACP, planning and other activities indicating that targeted process outcomes could be achieved. The relevance of multifaceted contextual factors acting as barriers or facilitators for the engagement in ACP interventions on the individual, organisational and macro level was evident. CONCLUSIONS: The process evaluation elicits obstacles and achievements of the ACP intervention. The logic model organised a plethora of mixed methods data into a holistic picture of multifaceted results. Nurses as ACP facilitators in home care can fulfil a crucial initiating role based on a trusting relationship with their patients. To support older care-dependent people's ACP engagement, access should be simplified. Furthermore, education for nurse facilitators and sufficient resources for service provision are needed. Independent of monetary reimbursement, healthcare providers must respect patients' choice for or against any ACP intervention. ETHICS AND TRIAL REGISTRATION: Approved by the Ethics Committees of Martin Luther University Halle-Wittenberg (Ref.-No. 2019-045), Carl von Ossietzky University Oldenburg (Ref.-No. 2019-024), and University of Lübeck (Ref.-No. 19-080). GERMAN CLINICAL TRIALS REGISTER: DRKS00016886. Registered retrospectively 04/06/2019, first participant included 29/05/2019.

[Educational Programmes in Health Services Research in Germany: Current State and Future Perspectives]. / Studiengänge zur Versorgungsforschung in Deutschland: aktueller Stand und zukünftige Perspektiven.

OBJECTIVE: The aim of this study was to analyse accredited study programmes of health services research in Germany at Master's degree level regarding their structural data and content. METHODS: Using a descriptive qualitative design, all included plans of study courses, module handbooks and descriptions of the Master's degree programmes were analysed. RESULTS: The Master's degree programmes were similar in their structural elements as well as in their content of education. They aim at enhancing competences related to the areas of health services research to identify health care needs and to develop, initiate, evaluate and critically assess innovative care strategies across disciplines. DISCUSSION: Although the content is similar, the study programmes focus on specific aspects that allow students to choose a certain programme depending on their preferences. A next step can be the development of a core curriculum that takes into consideration further findings and the discourse of different stakeholders.