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Abstract Background People with dementia are often inapproachable due to symptoms of their illness. Therefore nurses should establish relationships with dementia patients via their remaining resources and facilitate communication. In order to achieve this, different targeted non-pharmacological interventions are recommended and practiced. However there is no sufficient evidence about the efficacy of most of these interventions. A number of publications highlight the urgent need for methodological sound studies so that more robust conclusions may be drawn. Methods/Design The trial is designed as a cluster randomized controlled trial with 20 nursing homes in Saxony and Saxony-Anhalt (Germany) as the units of randomization. Nursing homes will be randomly allocated into 4 study groups consisting of 5 clusters and 90 residents: snoezelen, structured reminiscence therapy, 10-minutes activation or unstructured verbal communication (control group). The purpose is to determine whether the interventions are effective to reduce apathy in long-term care residents with dementia (N = 360) as the main outcome measure. Assessments will be done at baseline, 3, 6 and 12 months after beginning of the interventions. Discussion This trial will particularly contribute to the evidence on efficacy of non-pharmacological interventions in dementia care. Trial Registration ClinicalTrials.gov NCT00653731

Abstract Background ICU stay is often associated with negative experiences for the individual patient. Many patients are disabled and their communication is restricted during the ICU stay. Specific information on procedures, sensations and coping behavior are thought to reduce anxiety on the ICU. Until now information programs to reduce anxiety were mainly delivered preoperatively, completely neglecting informational needs of non-elective ICU patients. Methods The trial is designed as a prospective multicenter randomized controlled trial in the cities of Marburg, Halle and Stuttgart. Elective and non-elective ICU patients will be included. The trial includes an intervention and a control group on the ICU. The control group receives a trivial conversation without any ICU-specific information. The intervention group receives an information program with specific procedural, sensory and coping information about their ICU stay. Both conversations take place in the ICU and are planned to take about 10 minutes. Discussion In contrast to former trials on information programs on the ICU-stay our intervention will take place in the ICU itself. This approach will ensure to compensate for memory effects due to anesthesia or preoperative stress. Further the results will be applicable to non-elective ICU-patients. Trial Registration ClinicalTrials NCT00764933

Abstract Background According to current evidence and psychological theorizing proper information giving seems to be a promising way to reduce patient anxiety. In the case of surgical patients, admission to the intensive care unit (ICU) is strongly associated with uncertainty, unpredictability and anxiety for the patient. Thus, ICU specific information could have a high clinical impact. This study investigates the potential benefits of a specifically designed ICU-related information program for patients who undergo elective cardiac, abdominal or thoracic surgery and are scheduled for ICU stay. Methods/Design The trial is designed as a prospective randomized controlled trial including an intervention and a control group. The control group receives the standard preparation currently conducted by surgeons and anesthetists. The intervention group additionally receives a standardized information program with specific procedural, sensory and coping information about the ICU. A measurable clinical relevant difference regarding anxiety will be expected after discharge from ICU. Power calculation (α = 0.05; β = 0.20; Δ = 8.50 score points) resulted in a required sample size of N = 120 cardiac surgical patients (n = 60 vs. n = 60). Furthermore, N = 20 abdominal or thoracic surgical patients will be recruited (n = 10 vs. n = 10) to gain insight to a possible generalization to other patient groups. Additionally the moderating effect of specific patient attributes (need for cognition, high trait anxiety) will be investigated to identify certain patient groups which benefit most. Discussion The proposed study promises to strengthen evidence on effects of a specific, concise information program that addresses the information needs of patients scheduled for ICU stay.

Background: People with dementia are often inapproachable due to symptoms of their illness. Therefore nurses should establish relationships with dementia patients via their remaining resources and facilitate communication. In order to achieve this, different targeted non-pharmacological interventions are recommended and practiced. However there is no sufficient evidence about the efficacy of most of these interventions. A number of publications highlight the urgent need for methodological sound studies so that more robust conclusions may be drawn. Methods/Design: The trial is designed as a cluster randomized controlled trial with 20 nursing homes in Saxony and Saxony-Anhalt (Germany) as the units of randomization. Nursing homes will be randomly allocated into 4 study groups consisting of 5 clusters and 90 residents: snoezelen, structured reminiscence therapy, 10-minutes activation or unstructured verbal communication (control group). The purpose is to determine whether the interventions are effective to reduce apathy in long-term care residents with dementia (N = 360) as the main outcome measure. Assessments will be done at baseline, 3, 6 and 12 months after beginning of the interventions. Discussion: This trial will particularly contribute to the evidence on efficacy of non-pharmacological interventions in dementia care. Trial Registration: ClinicalTrials.gov NCT00653731 [ABSTRACT FROM AUTHOR]

Background Indwelling urinary catheters go along with high risk of urinary tract infections. Clinical guidelines therefore recommend restrictive catheter use in hospitals. However, interventions to reduce indwelling urinary catheters in hospitals are challenging. Several systematic reviews identified promising approaches mostly as part of intervention bundles. It remains unclear how intervention components should actually be implemented. Therefore, we performed a comprehensive synthesis of existing evidence and aimed to identify and describe appropriate intervention components to reduce the use of indwelling urinary catheters in acute care hospitals, and to identify and describe implementation strategies associated with these intervention components. Methods We performed a scoping review with the following concepts of interest: interventions to reduce indwelling urinary catheters in hospitals, their theoretical foundation and drivers enabling implementation. The systematic search was conducted in five consecutive steps from July 2015 to February 2016 and covered the Cochrane Library, Med-line, Cinahl, and guideline databases. Primary research articles (published since 2008), systematic reviews, and clinical guidelines (updated at the latest in 2010) in German or English language were included (n = 70 publications). To systemize implementation strategies for intervention components we used implementation drivers related to organization and staff competency according to the Active Implementation Framework. Results Identified core intervention components were defined indications for indwelling urinary catheters, reminder systems, and stop orders. On the organizational level they are flanked by institutionalized guidelines addressing responsibilities and processes, integrating the program's components in electronic medical records, and performance assessment and feedback. On the staff competency level the interventions are accompanied by various training modalities as well as deployment of staff with special responsibilities and authorization. Consideration of multiprofessional stakeholders' view and circumstances by assessment of knowledge, barriers and needs was used to model an intervention and to support the implementation process. The intervention components can be justified in a satisfactory manner by a range of guideline recommendations and systematically assessed evidence of mainly observational trials. Conclusions The identified intervention components and implementation strategies are suitable to model a complex intervention to reduce catheters in hospitals. Many of the components involve multiprofessional aspects. In particular, collaboration of physicians and nurses seems to be mandatory. Limitations exist in the underlying evidence for some components due to used study designs in primary research. [ABSTRACT FROM AUTHOR]

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.

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.

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.

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.

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.

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., (Copyright © 2020. Published by Elsevier GmbH.)

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., (Copyright © 2019. Published by Elsevier GmbH.)

Chronic leg ulcers influence the daily lives of patients. Besides the burden of therapy, research results in the field of quality of life indicate constraints in the psychological, physiological, occupational and social parts of life. In order to take an active role in coping with the chronic disease, patients need knowledge and information that account for individual needs. Therefore our study had the objective to describe the lived experience of patients with leg ulcer and their corresponding needs for patient education. We used a qualitative study design. In a first step we made five narrative interviews. In a second step we made seven interviews using an interview guide that was based on results of the narrative interviews. Participants were recruited in two regions in Germany via two specialist practices and a hospital. We used a purposeful sampling strategy in order to account for the heterogenity of the patient group. Data was analysed using the content analysis approach by Mayring. Our analysis identified 4 interconnected main categories: living with the illness, experiences of wound care, being an expert, and educational needs. Patients are trying to integrate their illness into daily life and maximize their independence. They prefer individual counselling during regulartreatment to group counselling or meetings with other leg ulcer patients. Overall the described problems and solutions illustrate the complexities of the disease and its care.

An appropriate postoperative wound management helps to prevent surgical site infections. However, ideal timing of dressing removal is an unresolved issue in current practice. The objective of this systematic review therefore was to provide a comprehensive synthesis of existing evidence concerning the efficacy of different periods of postoperative dressing removal in surgical wounds which are healing by primary intention. We searched MEDLINE, EMBASE, CINAHL, The Cochrane Library (all in August 2011), and hand-searched additional sources. All randomised controlled trials that were comparing different periods of leaving dressings in place, including not dressing the surgical site at all, and covering wounds until suture removal were included. We conducted our systematic review and meta-analysis in accordance with the recommendations of the Cochrane Collaboration. Eight trials with a total of 2097 participants were included in our meta-analysis. All studies were at high or unclear risk of bias. This meta-analysis did not show a higher rate of wound infections or other wound complications associated with an early dressing removal in wounds that are healing by primary intention: risk difference (RD) -0.01; 95%-confidence interval (CI) -0.03, 0.01. However, conclusions are limited due to bad study quality of included studies. Finally more sound research is needed.

Caring for residents in long-term care who suffer from dementia is a special challenge. In the context of a research project a questionnaire for a mail survey in nursing homes was developed in order to describe specific nursing interventions for dementia in daily practice. The Questionnaire development was done according to acknowledged standards for questionnaire development, using means of operationalisation and external expert rating. Then the questionnaire was tested in a two-phase-pretest. Seven nursing homes were involved in a cognitive pretest. The standard-pretest was sent to 200 nursing homes (response rate 17.5 percent). Evaluation of the questionnaire drafts by means of two-phase-pretesting proved to be an effective measure for continuous improvement. The resulting questionnaire should be used to collect data about specific interventions for people suffering from dementia in residential long-term care.

Background: This systematic review will investigate the question of how non-physician health care providers may be involved in the care and treatment of patients with chronic disease and which role they could play within the scope of the German Disease Management Programmes (DMP)., Methods: This article is limited to the German DMP diagnoses asthma, COPD, coronary heart disease, and type-1 and -2 diabetes mellitus. Several databases were systematically searched to find national and international studies with interventions carried out by non-physician health care providers such as nurses, dieticians, physiotherapists or occupational therapists., Results: More than 300 studies and reviews were included in this systematic review. Nurses and dieticians were by far the prevailing professional groups performing the largest number of the interventions identified. Transferring. the results of the literature review to the German setting, non-physician health care providers could both undertake certain tasks on their own responsibility and provide other services in support of the medical treatment of the chronically ill. Some interventions are given as examples.