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Background: Clinical practice guidelines are crucial for enhancing healthcare quality and patient outcomes. Yet, their implementation remains inconsistent across various professions and disciplines. Previous findings on the implementation of the German guideline for schizophrenia (2019) revealed low adherence rates among healthcare professionals. Barriers to guideline adherence are multifaceted, influenced by individual, contextual, and guideline-related factors. This study aims to investigate the effectiveness of a digital guideline version compared to print/PDF formats in enhancing guideline adherence. Methods: A multicenter, cluster-randomized controlled trial was conducted in South Bavaria, Germany, involving psychologists and physicians. Participants were divided into two groups: implementation of the guideline using a digital online version via the MAGICapp platform and the other using the traditional print/PDF version. The study included a baseline assessment and a post-intervention assessment following a 6-month intervention phase. The primary outcome was guideline knowledge, which was assessed using a guideline knowledge questionnaire. Results: The study included 217 participants at baseline and 120 at post-intervention. Both groups showed significant improvements in guideline knowledge; however, no notable difference was found between both study groups regarding guideline knowledge at either time points. At baseline, 43.6% in the control group (CG) and 52.5% of the interventional group (IG) met the criterion. There was no significant difference in the primary outcome between the two groups at either time point (T0: Chi2(1) = 1.65, p = 0.199, T1: Chi2(1) = 0.34, p = 0.561). At post-intervention, both groups improved, with 58.2% in the CG and 63.5% in the IG meeting this criterion. Conclusions: While the study did not include a control group without any implementation strategy, the overall improvement in guideline knowledge following an implementation strategy, independent of the format, was confirmed. The digital guideline version, while not superior in enhancing knowledge, showed potential benefits in shared decision-making skills. However, familiarity with traditional formats and various barriers to digital application may have influenced these results. The study highlights the importance of tailored implementation strategies, especially for younger healthcare providers. Trial registration: https://drks.de/search/de/trial/DRKS00028895 [ABSTRACT FROM AUTHOR]

Background: According to recent legislation, facilitated advance care planning (ACP) for nursing home (NH) residents is covered by German sickness funds. However, the effects of ACP on patient-relevant outcomes have not been studied in Germany yet. This study investigates whether implementing a complex regional ACP intervention improves care consistency with care preferences in NH residents.Methods: This is a parallel-group cluster-randomized controlled trial (cRCT) with 48 NHs (≈ 3840 resident beds) between 09/2019 and 02/2023. The intervention group will receive a complex, regional ACP intervention aiming at sustainable systems redesign at all levels (individual, institutional, regional). The intervention comprises comprehensive training of ACP facilitators, implementation of reliable ACP processes, organizational development in the NH and other relevant institutions of the regional healthcare system, and education of health professionals caring for the residents. Control group NHs will deliver care as usual. Primary outcome is the hospitalization rate during the 12-months observation period. Secondary outcomes include the rate of residents whose preferences were known and honored in potentially life-threatening events, hospital days, index treatments like resuscitation and artificial ventilation, advance directives, quality of life, psychological burden on bereaved families, and costs of care. The NHs will provide anonymous, aggregated data of all their residents on the primary outcome and several secondary outcomes (data collection 1). For residents who have given informed consent, we will evaluate care consistency with care preferences and further secondary outcomes, based on chart reviews and short interviews with residents, surrogates, and carers (data collection 2). Process evaluation will aim to explain barriers and facilitators, economic evaluation the cost implications.Discussion: This study has the potential for high-quality evidence on the effects of a complex regional ACP intervention on NH residents, their families and surrogates, NH staff, and health care utilization in Germany. It is the first cRCT investigating a comprehensive regional ACP intervention that aims at improving patient-relevant clinical outcomes, addressing and educating multiple institutions and health care providers, besides qualification of ACP facilitators. Thereby, it can generate evidence on the potential of ACP to effectively promote patient-centered care in the vulnerable population of frail and often chronically ill elderly.Trial Registration: ClinicalTrials.gov ID NCT04333303 . Registered 30 March 2020. [ABSTRACT FROM AUTHOR]

Background: Substance-related and addictive disorders are among the most common mental disorders in adolescence and young adulthood. Vocational school students are a risk group for problematic substance use and addictive behavior. However, the availability of evidence-based prevention concepts and programs is underdeveloped in the vocational school setting.Methods/design: A two-arm cluster randomized waitlist-controlled trial will be conducted to evaluate the effectiveness of an app-based intervention to decrease substance use, gambling, and digital media use in vocational school students in Germany. Vocational students will participate in an app-based intervention that is designed to support voluntary commitment to abstain from or reduce substance or digital media use over a period of 2 weeks. The "education-as-usual" control arm will have access to the intervention after data collection is completed. One of the primary outcome measures will be the use of alcohol, nicotine, and digital media 30 days after the intervention. Several secondary outcome measures will also be included, such as cannabis consumption, gambling, symptoms of stress, physical activity, mindfulness, well-being, impulsivity and sensation seeking, and readiness to change. A total of 4500 vocational students from 225 classes will be recruited and randomized across three German federal states.Discussion: This study protocol describes the design of an RCT testing the effectiveness of an app-based intervention to reduce addictive behaviors in vocational school students. It is expected that this approach will be feasible for and effective in the vocational school setting and that the study provides comprehensive information on the key factors involved in temporary abstaining or reducing substance or digital media use.Trial Registration: German Clinical Trials Register DRKS00023788 . Registered on 20 January 2021. [ABSTRACT FROM AUTHOR]

Vocational students are a risk group for problematic substance use and addictive behaviors. The study aim was to evaluate the effects of an app-based intervention on tobacco, e-cigarettes, alcohol, and cannabis use as well as gambling and digital media-related behaviors in the vocational school setting. A total of 277 classes with 4591 students (mean age 19.2 years) were consecutively recruited and randomized into an intervention (IG) or waitlist control group (CG). Students from IG classes received access to an app, which encouraged a voluntary commitment to reduce or completely abstain from the use of a specific substance, gambling, or media-related habit for 2 weeks. Substance use, gambling, and digital media use were assessed before and after the intervention in both groups with a mean of 7.7 weeks between assessments. Multi-level logistic regression models were used to test group differences. Intention-to-treat-results indicated that students from IG classes had a significantly larger improvement on a general adverse health behavior measure compared to CG (OR = 1.24, p = 0.010). This difference was mainly due to a significantly higher reduction of students' social media use in the IG (OR = 1.31, p < 0.001). Results indicate that the app "Meine Zeit ohne" is feasible for the target group and seems to have a small but measurable impact on students' health behavior.

Targeting dementia prevention, first trials addressing multiple modifiable risk factors showed promising results in at-risk populations. In Germany, AgeWell.de is the first large-scale initiative investigating the effectiveness of a multi-component lifestyle intervention against cognitive decline. We aimed to investigate the recruitment process and baseline characteristics of the AgeWell.de participants to gain an understanding of the at-risk population and who engages in the intervention. General practitioners across five study sites recruited participants (aged 60-77 years, Cardiovascular Risk Factors, Aging, and Incidence of Dementia/CAIDE dementia risk score ≥ 9). Structured face-to-face interviews were conducted with eligible participants, including neuropsychological assessments. We analyzed group differences between (1) eligible vs. non-eligible participants, (2) participants vs. non-participants, and (3) between intervention groups. Of 1176 eligible participants, 146 (12.5%) dropped out before baseline; the study population was thus 1030 individuals. Non-participants did not differ from participants in key sociodemographic factors and dementia risk. Study participants were M = 69.0 (SD = 4.9) years old, and 52.1% were women. The average Montreal Cognitive Assessment/MoCA score was 24.5 (SD = 3.1), indicating a rather mildly cognitively impaired study population; however, 39.4% scored ≥ 26, thus being cognitively unimpaired. The bandwidth of cognitive states bears the interesting potential for differential trial outcome analyses. However, trial conduction is impacted by the COVID-19 pandemic, requiring adjustments to the study protocol with yet unclear methodological consequences.

Background : In the absence of treatment options, the WHO emphasizes the identification of effective prevention strategies as a key element to counteract the dementia epidemic. Regarding the complex nature of dementia, trials simultaneously targeting multiple risk factors should be particularly effective for prevention. So far, however, only few such multi-component trials have been launched, but yielding promising results. In Germany, comparable initiatives are lacking, and translation of these complex interventions into routine care was not yet done. Therefore, AgeWell.de will be conducted as the first multicomponent prevention trial in Germany which is closely linked to the primary care setting. Methods : AgeWell.de will be designed as a multi-centric, cluster-randomized controlled multicomponent prevention trial. Participants will be older community-dwelling general practitioner (GP) patients (60-77 years; n = 1,152) with increased dementia risk according to CAIDE (Cardiovascular Risk Factors, Aging, and Incidence of Dementia) Dementia Risk Score. Recruitment will take place at 5 study sites across Germany. GP practices will be randomized to either intervention A (advanced) or B (basic). GPs will be blinded to their respective group assignment, as will be the statistician conducting the randomization. The multi-component intervention (A) includes nutritional counseling, physical activity, cognitive training, optimization of medication, management of vascular risk factors, social activity, and, if necessary, further specific interventions targeting grief and depression. Intervention B includes general health advice on the intervention components and GP treatment as usual. We hypothesize that over the 2-year follow-up period the intervention group A will benefit significantly from the intervention program in terms of preserved cognitive function/delayed cognitive decline (primary outcome), and other relevant (secondary) outcomes (e.g. quality of life, social activities, depressive symptomatology, costeffectiveness). Discussion: AgeWell.de will be the first multi-component trial targeting risk of cognitive decline in older adults in Germany. Compared to previous trials, AgeWell.de covers an even broader set of interventions suggested to be beneficial for the intended outcomes. The findings will add substantial knowledge on modifiable lifestyle factors to prevent or delay cognitive decline. [ABSTRACT FROM AUTHOR]

Background: In the absence of treatment options, the WHO emphasizes the identification of effective prevention strategies as a key element to counteract the dementia epidemic. Regarding the complex nature of dementia, trials simultaneously targeting multiple risk factors should be particularly effective for prevention. So far, however, only few such multi-component trials have been launched, but yielding promising results. In Germany, comparable initiatives are lacking, and translation of these complex interventions into routine care was not yet done. Therefore, AgeWell.de will be conducted as the first multi-component prevention trial in Germany which is closely linked to the primary care setting.Methods: AgeWell.de will be designed as a multi-centric, cluster-randomized controlled multi-component prevention trial. Participants will be older community-dwelling general practitioner (GP) patients (60-77 years; n = 1,152) with increased dementia risk according to CAIDE (Cardiovascular Risk Factors, Aging, and Incidence of Dementia) Dementia Risk Score. Recruitment will take place at 5 study sites across Germany. GP practices will be randomized to either intervention A (advanced) or B (basic). GPs will be blinded to their respective group assignment, as will be the statistician conducting the randomization. The multi-component intervention (A) includes nutritional counseling, physical activity, cognitive training, optimization of medication, management of vascular risk factors, social activity, and, if necessary, further specific interventions targeting grief and depression. Intervention B includes general health advice on the intervention components and GP treatment as usual. We hypothesize that over the 2-year follow-up period the intervention group A will benefit significantly from the intervention program in terms of preserved cognitive function/delayed cognitive decline (primary outcome), and other relevant (secondary) outcomes (e.g. quality of life, social activities, depressive symptomatology, cost-effectiveness).Discussion: AgeWell.de will be the first multi-component trial targeting risk of cognitive decline in older adults in Germany. Compared to previous trials, AgeWell.de covers an even broader set of interventions suggested to be beneficial for the intended outcomes. The findings will add substantial knowledge on modifiable lifestyle factors to prevent or delay cognitive decline.Trial Registration: German Clinical Trials Register (reference number: DRKS00013555 ). [ABSTRACT FROM AUTHOR]

We tested the feasibility of a nursing intervention (DEMIAN) in routine care and its effects on care providers' job satisfaction, motivation, and work strain. This cluster-randomized trial was conducted in 20 German long-term care facilities. We randomly assigned 20 facilities to an intervention group (84 care providers, 42 residents with dementia) or a control group (96 care providers, 42 residents with dementia). Intervention group providers received two training days on the intervention; 68 providers attended both training days. Sixty two providers completed both baseline and follow-up questionnaires. Trained providers created individualized mini-intervention plans for participating residents. Control group residents received 'usual care'. Intervention group providers stated that the intervention was feasible and helped them improve emotional well-being of residents with dementia. We found significantly decreased time pressure and decreased job dissatisfaction for intervention group providers. DEMIAN is an effective and pragmatic contribution to implementing person-centred care in long-term care, with positive effects on providers' working conditions.

Objectives: Current research suggests that dementia care management (DCM) can decrease burden and associated health impairments of caregivers. The objective of this secondary analysis is to investigate the impact of DCM on multifaceted caregivers' burden dimensions by differentiating between objective and subjective burden., Methods: A sample of n = 317 dyads of caregivers and community-dwelling people with dementia (PwD) participated in a general practitioner-based, cluster-randomized intervention trial (Identifier:NCT01401582) with two arms and comprehensive data assessment at baseline and 12-month follow-up. Data provided by the caregiver included an inventory with 88 items in 20 different dimensions., Results: Caregivers in the intervention 'DCM' group showed decreased caregiver burden, especially in caregivers' objective burden due to caring (i.e. emotional support), caregivers' subjective burden due to behavior change (i.e. cognition, aggression and resistance, depression, late symptoms) and caregivers' subjective burden due to perceived conflicts between needs and responsibilities to care (i.e. financial losses) compared to caregivers in the control 'care as usual' group, which showed significant increased caregiver burden after 12 months., Conclusion: Our findings support evidence for the effectiveness of DCM to lower family dementia caregivers' burden in multifaceted dimensions.

Introduction: There is a noticeable increase in hazardous alcohol use during adolescence, which is significantly associated with adverse consequences. In Germany, up to 30% of adolescents report regular heavy episodic drinking. However, only a few German prevention programmes target adolescents of legal drinking age (16 years and above); thus, this trial aims to develop, implement and evaluate 'Klar bleiben' ('Stay clearheaded'), a school-based prevention programme for grade 10 students., Methods and Analysis: 'Klar bleiben' consists of a class commitment to drink responsibly and refrain from hazardous consumption patterns for 9 weeks. The commitment is accompanied by educational lessons on alcohol-related cognitions and consequences. It will be evaluated in a sample of approximately 3000 students (150 classes) from two German federal states (Schleswig-Holstein and Lower Saxony) via a two-armed cluster randomised controlled trial with baseline and postassessment 6 months apart. The intervention group (75 classes) will participate in 'Klar bleiben', whereas the control group (75 classes) will receive education as usual. 'Klar bleiben' addresses classes, individuals, teachers and parents. It is based on a social norms approach and aims to reduce hazardous drinking and drinking-related consequences in adolescents. Secondary outcomes include general drinking behaviour, use of other substances, alcohol-related cognitions and social factors. Covariates include sociodemographic characteristics, environmental and individual (vulnerability) factors., Ethics and Dissemination: 'Klar bleiben' provides a multicomponent school-based programme that bridges a gap in alcohol prevention. Similar class-level and social norms-based prevention programmes have already been proven to be successful for other substances among adolescents. Thus, dissemination to other federal states as well as longer term follow-up testing of the robustness of effects is to be anticipated. The study was approved by the Ethics Committee of the German Psychological Society (RH&#95;0620152), and study findings will be disseminated through peer-reviewed publications and conference contributions., Trial Registration Number: German Clinical Trials Register: DRKS00009424., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)