Non-pharmacological interventions to reduce thirst in patients with heart failure or hemodialysis: A systematic review and meta-analysis.

BACKGROUND: Thirst is a frequent and burdening symptom in many patients, especially in patients with chronic heart failure (CHF) and/or receiving hemodialysis (HD). As drug therapies are not feasible, non-pharmacological strategies are needed to reduce thirst and thirst-related burden. OBJECTIVES: To identify non-pharmacological interventions aiming to reduce thirst in patients with CHF and/ or HD, to describe intervention components, and to evaluate the effectiveness of these interventions. METHODS: In February 2024, we completed a systematic search in MEDLINE via PubMed, Livivo, CINAHL, Cochrane Library and Web of Science. Two reviewers independently screened titles, abstracts, and full texts, performed critical appraisal and data extraction. We checked risk of bias with the checklists of the Joanna Briggs Institute and the Cochrane Risk of Bias tool and calculated meta-analyses for sufficiently homogeneous studies using fixed-effects models. RESULTS: We included 15 intervention studies applying non-pharmacological interventions including chewing gum (n = 8), low-sodium diet (n = 2), acupressure (n = 1), frozen strawberries (n = 1), fluid timetables (n = 1), ice cubes and mouthwash (n = 1), and a psychological intervention (n = 1). Sample sizes varied between 11 and 88 participants. Eleven intervention studies showed a reduction of thirst as intervention effect. Meta-analyses for chewing gum showed no significant effect on thirst using a visual analogue scale (IV: -2,32 [-10.37,5.73]; p = 0.57) or the dialysis thirst inventory (IV: -0.26 [- 1.83, 1.30]; p = 0.74). Quality of studies was moderate to low. CONCLUSION: Results indicate that various non-pharmacological interventions could be helpful to reduce thirst in patients with CHF or HD, but important uncertainty remains.

Interprofessional collaboration in the home care setting: perspectives of people receiving home care, relatives, nurses, general practitioners, and therapists-results of a qualitative analysis.

BACKGROUND: About one million people in need of home care in Germany are assisted by 15,400 home care services. Home healthcare is mostly a complex endeavour because interprofessional collaboration is often challenging. This might negatively impact patient safety. The project interprof HOME aims to develop an interprofessional person-centred care concept for people receiving home care in a multistep approach. In one of the work packages we explored how people receiving home care, relatives, nurses, general practitioners, and therapists (physiotherapists, occupational therapists, and speech therapists) perceive collaboration in this setting. METHODS: Semi-structured interviews were conducted with 20 people receiving home care and with 21 relatives. Additionally, we worked with nine monoprofessional focus groups involving nurses of home care services (n = 17), general practitioners (n = 14), and therapists (n = 21). The data were analysed by content analysis. RESULTS: Three main categories evolved: "perception of interprofessional collaboration", "means of communication", and "barriers and facilitators". People receiving home care and relatives often perceive little to no interprofessional collaboration and take over a significant part of the organisational coordination and information exchange. Interprofessional collaboration in steady care situations does exist at times and mostly occurs in coordination tasks. Contact and information exchange are rare, however, interprofessional personal encounters are sporadic, and fixed agreements and permanent contact persons are not standard. These trends increase with the complexity of the healthcare situation. Joint collaborations are often perceived as highly beneficial. Means of communications such as telephone, fax, or e-mail are used differently and are often considered tedious and time-consuming. No interprofessional formal written or electronic documentation system exists. Personal acquaintance and mutual trust are perceived as being beneficial, while a lack of mutual availability, limited time, and inadequate compensation hinder interprofessional collaboration. CONCLUSIONS: Interprofessional collaboration in home care occurs irregularly, and coordination often remains with people receiving home care or relatives. While this individual care set-up may work sufficiently well in low complex care situations, it becomes vulnerable to disruptions with increasing complexity. Close interactions, joint collaboration, and fixed means of communication might improve healthcare at home. The findings were integrated into the development of the person-centred interprofessional care concept interprof HOME. TRIAL REGISTRATION: This study is registered on the International Clinical Trails registry platform ClinicalTrials.gov as NCT05149937 on 03/11/2021.

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.

Evaluating Relapse Knowledge in People with Multiple Sclerosis: A Cross-Sectional Study on the Development and Validation of the Relapse Knowledge Questionnaire.

BACKGROUND: Multiple sclerosis (MS) knowledge is a prerequisite for active patient engagement in medical decision-making. Treatment of relapses in MS is a clinical field with many uncertainties and each acute relapse requires decisions regarding possible options for action, indicating the need for patient involvement. However, there is no validated instrument assessing relapse knowledge in people with MS. Our study aims to develop a valid MS relapse questionnaire for use as an outcome instrument for educational interventions. METHODS: A multidisciplinary panel developed the relapse knowledge questionnaire (RKQ) based on a previously developed questionnaire. We tested the RKQ on MS patients for comprehensibility, usability and acceptance in qualitative think-aloud interviews and conducted a cross-sectional quantitative online survey to validate the questionnaire. People with suspected or confirmed relapsing-remitting MS and a recent relapse experience were eligible for inclusion. We checked normal distribution of the RKQ score and determined the item difficulty. Construct validity was analysed using correlational analysis. RESULTS: The final RKQ consists of 10 items. After minor changes of the RKQ during pre-testing (n = 2), pilot testing (n = 10) confirmed the usability and acceptance of the instrument. The subsequent validation study (n = 203) resulted in a mean item difficulty of 0.44, ranging from 0.18 to 0.83. Seven items were particularly difficult and answered incorrectly by more than 50 % of participants. Construct validity of the RKQ was satisfactory. The RKQ score correlated only weakly with participants' degree of education (|rp|>0.1), years since diagnosis (|rp|>0.1), and the intention to receive corticosteroids (|rp|>0.1). CONCLUSION: This study indicates the validity of the RKQ and proposes that the RKQ is a suitable instrument to assess relapse knowledge in people with MS participating in educational interventions.

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.

Nurse-based counselling on thirst in patients with advanced chronic heart failure : Study protocol for a pilot before-after study and process evaluation.

BACKGROUND: Many patients with chronic heart failure (CHF) are critically ill and experience increased thirst. Study aims are to develop and evaluate a nurse-based counselling intervention to promote self-care competencies related to thirst in hospitalised patients with advanced CHF eligible or listed for heart transplantation. METHODS: A mixed-methods approach will be adapted with three study phases: (1) development of the nurse-based counselling intervention, (2) feasibility testing and training of nurses, and (3) implementation of the intervention and, evaluation of initial effects and process measures. In phase (1), interviews with hospitalised patients with advanced CHF listed for heart transplantation (n = 10), focus groups (n = 2) and a Germany-wide survey with nurses will be performed. In phase (2), experts experienced with caring for patients with advanced CHF and patients with advanced CHF will be consulted for content validation and pretest of the counselling intervention. The training concept for nurses will be evaluated using questionnaires. In phase (3), a pilot before-after study will be conducted (n = 60). Primary patient-related outcome for the pilot study is thirst intensity using a numeric rating scale. Furthermore, a process evaluation (interviews with patients [n = 10], survey with nurses and physicians) will be performed. Quantitative data will be analysed descriptively, and qualitative data will be analysed using content analysis. Mean values of thirst intensity of the individual measurement points will be evaluated as interrupted time-series analysis using regression analyses. CONCLUSION: The development and implementation of a counselling intervention is influenced by various factors. Therefore, it is important to consider all factors throughout the process from development to evaluation.

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.

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).

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.

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.

Development of an interprofessional person-centred care concept for persons with care needs living in their own homes (interprof HOME): study protocol for a mixed-methods study.

INTRODUCTION: People receiving home care usually have complex healthcare needs requiring the involvement of informal caregivers and various health professionals. In this context, successful collaboration is an important element of person-centred care, which is often insufficiently implemented. Consequences might be found in avoidable hospitalisations. The aim of the study is to develop a care concept to improve person-centred interprofessional collaboration for people receiving home care considering the perspectives of all person groups involved. METHODS AND ANALYSIS: This study uses a mixed-methods design consisting of a literature review, several qualitative inquiries, a cross-sectional quantitative study and a final structured workshop. After a literature review (work package (WP) 1), we will explore the perspectives of people receiving home care (n=20), their relatives (n=20) and representatives of statutory health insurances (n=5) in semistructured interviews (WP2). Moreover, 100 individuals of each group (people receiving home care, relatives, registered nurses, general practitioners and therapists) involved in home care will answer a survey on collaboration that will be analysed descriptively (WP3). Additionally, monoprofessional focus groups (n=9) of registered nurses, general practitioners and therapists, respectively, will discuss current practices. Data will be analysed by qualitative content analysis. Best practice cases (n=8) will be analysed by a case-based qualitative content analysis based on data of observations of home visits and interviews (WP4). The findings of WP2 will be discussed in mixed focus groups (n=4) with 10 participants each (WP5). Considering the results of joint displays of WP3, WP4 and WP5, the interprofessional care concept and its implementation will be elaborated in an expert workshop (WP6). ETHICS AND DISSEMINATION: Ethical approval was obtained from all ethics committees of the project partners. Study results will be disseminated through publications, conference presentations, student education and advanced training of health professionals. TRIAL REGISTRATION NUMBER: NCT05149937.

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.

Knowledge and worries on motherhood choice in multiple sclerosis - a cross-sectional study on patient-reported outcome measures.

BACKGROUND: Since multiple sclerosis (MS) is often diagnosed in young women, pregnancy is a common topic for women with MS (wwMS). The study aimed to assess the measurement properties of two patient-reported outcome measures on motherhood choice in MS, and to explore the information and support needs of wwMS concerning motherhood. METHODS: We conducted an anonymous web-based survey to validate the motherhood/pregnancy choice and worries questionnaire (MPWQ, 31 items plus up to 3 additional items) and the motherhood choice knowledge questionnaire (MCKQ, 16 items). We used mailing lists and social media for nationwide recruitment in Germany, and included women of childbearing age with relapsing-remitting MS, clinically isolated syndrome or suspected MS who were considering pregnancy or were pregnant. For the MPWQ, we assessed item difficulty, discriminatory power, and internal consistency (Cronbach's alpha; CA). We analysed construct validity using the Leipzig Questionnaire of Motives to have a Child, the Decisional Conflict Scale, the Hospital Anxiety and Depression Scale, and the Pregnancy-Related Anxiety Questionnaire-revised 2. We studied the structural validity using exploratory factor analysis (EFA). The MCKQ was evaluated descriptively. We explored the information and support needs of wwMS on motherhood descriptively. We examined correlations between MCKQ, MPWQ and clinical characteristics and performed exploratory group comparisons considering the following binary variables: having children and being pregnant. RESULTS: 325 wwMS started the survey; 232 wwMS met our inclusion criteria and were analysed. Their mean age was 30 years (SD 5). Most women had relapsing-remitting MS (n = 218; 94%), 186 (80%) had no children, and 38 (16%) were pregnant. Internal consistency was good for the worries subscale (CA>0.8), while it was unsatisfactory for the attitude and coping subscales (CA<0.7). The EFA did not support the three-scale structure (coping, attitude, and worries). Due to these findings, we decided to keep the worries scale without any subscale. The items from the coping scale and attitude scale could be assessed as additional descriptive items. Convergent and divergent construct validity of the MPWQ was satisfactory. 206 wwMS (89%) completed the MCKQ. On average, 9 of 16 (56%) items were answered correctly (range 2-15), and the questionnaire showed a good balance between easy and difficult items. Questions on immunotherapy, disease activity, and breastfeeding were the most challenging. WwMS were confident in getting pregnant and raising a child (n = 222; 96%). Most wwMS were worried about postpartum relapses (n = 200; 86%) and the long-term effects of pregnancy on disease evolution (n = 149; 64%). About half of the wwMS (n = 124; 54%) did not know where to find professional help and 127 (55%) had no strategies to cope with future impairments so that they could take care of a child. CONCLUSION: Our results support the suitability and acceptability of both questionnaires as potential patient-reported measures for assessment of knowledge and worries around motherhood/pregnancy in MS. The survey results highlight the need for evidence-based information on motherhood in MS to increase knowledge, reduce worries and support wwMS in making informed decisions.

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.

[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.

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.

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.

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.