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.

[Structured case conference for sleep disturbances in nursing home residents with cognitive impairment]. / Strukturierte Fallbesprechung bei Schlafproblemen von Pflegeheimbewohner_innen mit kognitiven Einschränkungen.

Structured case conference for sleep disturbances in nursing home residents with cognitive impairment Abstract: Background: Nursing home residents living with cognitive impairment often suffer from sleep disturbances. Pharmacological interventions are not recommended to be the first-choice therapy. In general, a wide variance of non-pharmacological interventions is available, but no clearly suitable intervention can currently be specified. Aim: The case report presents the procedure of a structured analysis to support the selection of non-pharmacological interventions to promote sleep. Methods: A structured case conference was held using a developed case management template to draw up an individual intervention plan. Results: Based on the description of the situation and the determination of causes, different interventions from six main topics were planned: "offering appropriate activations during daytime", "creating bedtime routines", "checking the sleep environment", "observation of potential physical and psychological causes", "reflection on night care routines", and "use of drug therapies only in exceptional cases". Conclusions: For a successful management of sleep disturbances in nursing home residents living with cognitive impairment, it is essential that the specific sleep-related symptoms and causes are assessed systematically and interprofessionally to be able to work towards an improvement with appropriate measures. In order to obtain adequate solutions, evidence-based expertise should be taken into consideration.

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.

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.

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.

The partner's experiences of childbirth in countries with a highly developed clinical setting: a scoping review.

BACKGROUND: In Western countries, it is common practice for a woman to be supported by a trusted person during childbirth, usually the other parent. Numerous studies have shown that this has a positive effect both on the woman's satisfaction with the birth process and on physical outcomes. However, there is little research on the birth experience of partners and their wellbeing. The aim of this review is to summarise the existing literature on partner experience, consider its quality and identify the underlying themes. METHODS: Both a systematic literature search in three databases and a manual search were conducted, for qualitative, quantitative, and mixed-methods studies from Western countries examining the experiences of partners present at a birth. RESULTS: A total of 35 studies were included. Only one study included same-sex partners (the other studies addressed fathers' experiences only) and only one validated questionnaire examining partners' birth experiences was identified. Four major themes were found to influence partners' birth experiences: (1) intense feelings, (2) role of support, (3) staff support, and (4) becoming a father. CONCLUSIONS: Partners may feel very vulnerable and stressed in this unfamiliar situation. They need emotional and informal support from staff, want to be actively involved, and play an important role for the birthing woman. To promote good attachment for parents, systematic exploration of the needs of partners is essential for a positive birth experience. Because of the diversity of family constellations, all partners should be included in further studies, especially same-sex partners.

[Nurses' perspectives on their potential role in advance care planning in home care: A qualitative study]. / Die Sichtweise von Pflegefachpersonen auf ihre mögliche Rolle bei Advance Care Planning in der ambulanten Pflege.

Nurses' perspectives on their potential role in advance care planning in home care: A qualitative study Abstract. Background: Advance Care Planning (ACP) in long-term care in Germany has been identified as a potential area of nurses' responsibility. In the StAdPlan study (DRKS0016886), an ACP intervention in outpatient care was implemented and evaluated: Trained nurses conducted ACP conversations with patients. A comprehensive process evaluation was part of the study. Aim: A partial result of the process evaluation was analysing the perspective of nurses on their potential role as ACP facilitators for outpatients. Methods: Semi-structured interviews with nursing professionals and nursing service managers (n = 42) were carried out prior to the implementation of the ACP intervention. A qualitative content analysis of the recorded interviews was performed. Results: Participants described the importance of ACP in outpatient care, their personal motivation and competence as well as necessary contextual conditions. Nursing professionals are motivated to offer ACP to patients to be able to care for them according to their wishes. For effective ACP conversations, nurse professionals considered in-depth knowledge of ACP, conversational skills and sufficient time resources as necessary. ACP consultations can be a suitable field of action for nurses as they have access and an established relationship of trust with patients. Conclusions: Under certain conditions, nurses' role in offering guidance on ACP in outpatient care was seen as feasible and beneficial. Prerequisites for implementation are financial resources and training for nurses for this service.

[Advance care planning conversations in home care: Intervention development with the Behaviour Change Wheel]. / Beratung zu Advance Care Planning in der ambulanten Pflege.

Advance care planning conversations in home care: Intervention development with the Behaviour Change Wheel Abstract. Background: StAdPlan is a multicenter, cluster-randomized controlled trial aimed to develop and evaluate an advance care planning (ACP) intervention for the German home care setting. Aim: This paper reports the intervention development. Available ACP concepts were reviewed and adapted to the German home care context in terms of staffing and available time resources. Skilled nurses are assigned to raise the awareness on ACP among older care-dependent people and their informal caregivers/relatives through structured conversation and facilitating the use of existing counselling services. Methods: The Behavior Change Wheel (BCW) was applied to the development of the intervention components. Results: The complex intervention addresses care-dependent people aged 65 years and above and their informal caregivers. A two-day training session qualifies nursing professionals to offer guideline-based conversations which take place at least twice at the care-dependent person's home, if possible with the involvement of relatives. An additional information brochure is provided. Conclusions: The application of the BCW model proved to be appropriate for the analysis, description and definition of the specific functions of the intervention. The intervention is prepared for the effectiveness study.

Factors influencing the implementation of person-centred care in nursing homes by practice development champions: a qualitative process evaluation of a cluster-randomised controlled trial (EPCentCare) using Normalization Process Theory.

BACKGROUND: Person-centred care (PCC) has been suggested as the preferred model of dementia care in all settings. The EPCentCare study showed that an adapted PCC approach was difficult to implement and had no effect on prescription of antipsychotics in nursing home residents in Germany. This paper reports the qualitative process evaluation to identify facilitators and barriers of the implementation of PCC in German nursing homes from the perspective of participating practice development champions. METHODS: Five individual and 14 group interviews were conducted with 66 participants (staff and managers) from 18 nursing homes. The analysis was based on inductive coding to identify factors influencing the PCC implementation process. Identified factors were systematised and structured by mapping them to the four constructs (coherence, cognitive participation, collective action, reflexive monitoring) of the Normalization Process Theory (NPT) as a framework that explains implementation processes. RESULTS: Facilitating implementation factors included among others broadening of the care perspective (coherence), tolerance development within the care team regarding challenging behaviour (cognitive participation), testing new approaches to solutions as a multi-professional team (collective action), and perception of effects of PCC measures (reflexive monitoring). Among the facilitating factors reported in all the NPT constructs, thus affecting the entire implementation process, were the involvement of relatives, multi-professional teamwork and effective collaboration with physicians. Barriers implied uncertainties about the implementation and expectation of a higher workload (coherence), concerns about the feasibility of PCC implementation in terms of human resources (cognitive participation), lack of a person-centred attitude by colleagues or the institution (collective action), and doubts about the effects of PCC (reflexive monitoring). Barriers influencing the entire implementation process comprised insufficient time resources, lack of support, lack of involvement of the multi-professional team, and difficulties regarding communication with the attending physicians. CONCLUSIONS: The findings provide a comprehensive and detailed overview of facilitators and barriers structured along the implementation process. Thus, our findings may assist both researchers and clinicians to develop and reflect more efficiently on PCC implementation processes in nursing homes. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02295462 ; November 20, 2014.

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.

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

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

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

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

Process evaluation of a complex intervention to promote advance care planning in community-dwelling older persons (the STADPLAN study)-study protocol.

BACKGROUND: Process evaluation addresses the implementation, mechanisms of impact, and context of participants in complex interventions. The STADPLAN study assesses the effects of conversations on advance care planning (ACP) led by trained nurse facilitators. The complex intervention consists of several components that may lead to various changes in attitude and behavior regarding personal ACP activities. With the process evaluation, we aim to assess how changes were achieved in the STADPLAN intervention. METHODS: The planned process evaluation study will be conducted alongside a cluster-randomized controlled trial on ACP in home care services (HCS). Trained nurse facilitators will deliver the ACP intervention consisting of an information brochure and two ACP conversations. A logic model depicts the assumed change processes of the intervention: the educational program enables nurses to conduct ACP conversations with patients and their caregivers. Patients gain knowledge and reflect upon and engage in their own ACP. Caregivers better understand patients' wishes and feel reassured in their role as surrogates. Designation of a surrogate and communication on ACP are facilitated. We will assess the effects of the educational program with questionnaires and a focus group including all participating nurses. We will measure ACP engagement, and prevalence of advance directives in patients, and ask for their experiences with the intervention. We will conduct semi-structured interviews with caregivers about their expectations and experiences regarding ACP in general and the intervention. We will address context factors, e.g., basic characteristics of the HCS (such as ownership, number of clients, staff and qualification). Analysis will be based upon the logic model, integrating qualitative and quantitative data. DISCUSSION: The comprehensive process evaluation will provide essential information on the feasibility of implementation strategies and the clinical relevance of a nurse-led ACP intervention in home care recipients and its generalizability and transferability to other settings. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00016886 . Registered retrospectively on June 4, 2019, first participant included on May 29, 2019.

Agreement between the Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW) interview and a paper-administered adaption.

BACKGROUND: The Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW) is a prevalent face-to-face interview method for measuring quality of life by integrating respondent-generated dimensions. To apply this method in clinical trials, a paper-administered alternative would be of interest. Therefore, our study aimed to analyze the agreement between the SEIQoL-DW and a paper questionnaire version (SEIQoL-PF/G). METHODS: In a crossover design, both measures were completed in a random sequence. 104 patients at a heart surgery hospital in Germany were randomly assigned to receive either the SEIQoL-DW or the SEIQoL-PF/G as the first measurement in the sequence. Patients were approached on their earliest stable day after surgery. The average time between both measurements was 1 day (mean 1.3; SD 0.8). Agreement regarding the indices, ratings, and weightings of nominated life areas (cues) was explored using Bland-Altman plots with 95% limits of agreement (LoA). Agreement of the SEIQoL indices was defined as acceptable if the LoA did not exceed a threshold of 10 scale points. Data from n = 99 patients were included in the agreement analysis. RESULTS: Both measures led to similarly nominated cues. The most frequently nominated cues were "physical health" and "family". In the Bland-Altman plot, the indices showed a mean of differences of 2 points (95% CI, - 1 to 6). The upper LoA showed a difference of 36 points (95% CI, 30 to 42), and the lower LoA showed a difference of - 31 points (95% CI, - 37 to - 26). Thus, the LoAs and confidence intervals exceeded the predefined threshold. The Bland-Altman plots for the cue levels and cue weights showed similar results. The SEIQoL-PF/G version showed a tendency for equal weighting of cues, while the weighting procedure of the SEIQoL-DW led to greater variability. CONCLUSIONS: For cardiac surgery patients, use of the current version of the SEIQoL-PF/G as a substitute for the SEIQoL-DW is not recommended. The current questionnaire weighting method seems to be unable to distinguish weighting for different cues. Therefore, the further design of a weighting method without interviewer support as a paper-administered measure of individual quality of life is desirable.

Study on advance care planning in care dependent community-dwelling older persons in Germany (STADPLAN): protocol of a cluster-randomised controlled trial.

BACKGROUND: In Germany, advance care planning (ACP) was first introduced by law in 2015. However, ACP is still uncommon in Germany and only few people have advance directive forms. This study aims to evaluate an ACP program in care dependent community-dwelling persons, compared to optimised usual care. METHODS: A cluster-randomised controlled trial of 12 months duration will be conducted in 3 German study sites comparing the pretested ACP-counselling offered by trained nurses with a control group receiving optimised usual care. Using external concealed randomisation, 16 home care services each will be included in the intervention and the control group (30 participants per cluster; n = 960). Eligibility criteria for patients are: ≥60 years, somehow care dependent, adequate German language skills, assumed life-expectancy of ≥4 weeks, and cognitive ability for participation. ACP will be delivered by trained nurse facilitators of the respective home care services and communication will include proxy decision-makers. The primary endpoint will be patient activation, assessed by the Patient Activation Measure (PAM-13). Secondary endpoints include ACP-engagement, proportion of prepared advance directives, number and duration of hospitalisations, quality of life as well as depression and anxiety. Further, comprehensive economic and process evaluations will be conducted. DISCUSSION: STADPLAN is the first study in Germany that assesses an adapted ACP intervention with trained nurses in home care services and the first international study focusing on cost effectiveness of ACP in community-dwelling older persons. The results will help to improve the understanding and communicating of patients' preferences regarding medical treatment and care and thereby contribute to patients' autonomy. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00016886 (Date of registration: 04.06.2019).

[Improving psychosocial health of nursing home residents: a systematic review of interventions for prevention and health promotion]. / Stärkung der psychosozialen Gesundheit von Bewohnerinnen und Bewohnern der stationären Langzeitpflege: Systematische Übersicht zu Interventionen der Prävention und Gesundheitsförderung.

BACKGROUND: Long-term care insurance funds have been mandated by the German Prevention Act to support long-term care facilities in the implementation of health-promoting structures. One area of action is the promotion of the nursing home residents' psychosocial health. The objective of this systematic review was to describe and analyze interventions and intervention components related to the psychosocial health of nursing home residents. METHODS: First, we conducted a search for systematic reviews and meta-analyses in Medline via PubMed, the Cochrane Library, CINAHL, Gerolit, Embase, Psyndex, and Livivo, and hand-searched additional sources. Second, references of all relevant randomized controlled trials (n=86) were extracted from the identified systematic reviews (n=27). The original articles of the included primary studies were then analyzed using criteria for the evaluation of complex interventions. The GRADE approach was used to assess the quality of the evidence. RESULTS: Seventeen interventions for promoting the psychosocial health of nursing home residents were identified. The majority of the study participants were nursing home residents with dementia. Since the underlying evidence was predominantly very low, it was not possible to draw clear conclusions concerning the efficacy of the interventions for psychosocial health outcomes. The best indications of positive effects were found for reminiscence, mealtime interventions, music therapy, and special care staff training. CONCLUSION: The diversity and heterogeneity of the interventions made both classification and consistent judgments of the quality of the evidence difficult. From the perspective of promoting the psychosocial health of nursing home residents, the identified interventions should only be considered as suggestions or proposals for prevention and health promotion measures, and future studies should evaluate their implementation.

Effect of person-centred care on antipsychotic drug use in nursing homes (EPCentCare): a cluster-randomised controlled trial.

BACKGROUND: antipsychotic drugs are regularly prescribed as first-line treatment for neuropsychiatric symptoms in persons with dementia although guidelines clearly prioritise non-pharmacological interventions. OBJECTIVE: we investigated a person-centred care approach, which has been successfully evaluated in nursing homes in the UK, and adapted it to German conditions. DESIGN: a 2-armed 12-month cluster-randomised controlled trial. SETTING: nursing homes in East, North and West Germany. METHODS: all prescribing physicians from both study arms received medication reviews for individual patients and were offered access to 2 h of continuing medical education. Nursing homes in the intervention group received educational interventions on person-centred care and a continuous supervision programme. Primary outcome: proportion of residents receiving at least one antipsychotic prescription after 12 months of follow-up. Secondary outcomes: quality of life, agitated behaviour, falls and fall-related medical attention, a health economics evaluation and a process evaluation. RESULTS: the study was conducted in 37 nursing homes with n = 1,153 residents (intervention group: n = 493; control group: n = 660). The proportion of residents with at least one antipsychotic medication changed after 12 months from 44.6% to 44.8% in the intervention group and from 39.8 to 33.3% in the control group. After 12 months, the difference in the prevalence was 11.4% between the intervention and control groups (95% confidence interval: 0.9-21.9; P = 0.033); odds ratio: 1.621 (95% confidence interval: 1.038-2.532). CONCLUSIONS: the implementation of a proven person-centred care approach adapted to national conditions did not reduce antipsychotic prescriptions in German nursing homes. TRIAL REGISTRATION: ClinicalTrials.gov NCT02295462.

[Improving cognitive resources of nursing home residents: a systematic review of prevention and health promotion interventions]. / Stärkung kognitiver Ressourcen von Bewohnerinnen und Bewohnern der stationären Langzeitpflege: Systematische Übersicht zu Interventionen der Prävention und Gesundheitsförderung.

BACKGROUND: The German Prevention Act mandated long-term care insurance funds to support long-term care facilities in designing health-promoting structures. One area of action is the promotion of the cognitive resources of nursing home residents. The objective of this systematic review was to describe and analyze interventions and intervention components that improve cognitive resources of nursing home residents. METHODS: First, we conducted a search for systematic reviews to identify relevant randomised controlled trials in Medline via PubMed, the Cochrane Library, CINAHL, Gerolit, Embase, Psyndex, and Livivo; additional sources were hand-searched. Second, references of all relevant randomized controlled trials (n=43) were extracted from the identified systematic reviews (n=26). The original articles of the primary studies included were then considered and data extracted using criteria for the evaluation of complex interventions. The quality of evidence was assessed using the GRADE approach. RESULTS: Nine interventions to promote cognitive resources were identified: cognitive stimulation, cognitive training, physical training, art and music interventions, bright light, multicomponent stimulation, multisensory stimulation, care staff training and reminiscence. The quality of the underlying evidence in the inpatient long-term care setting was predominantly low, therefore, it was not always possible to draw clear conclusions regarding the efficacy of the interventions. The low quality of evidence was mainly due to the high heterogeneity as well as the low number and limited methodological quality of the primary studies. CONCLUSION: In general, a wide range of nonpharmacological interventions were reported. Due to the limited evidence, however, these may be regarded as ideas only or possible options for promoting the cognitive resources of nursing home residents.