Evaluating a rehabilitative intervention for substance-dependent patients with and without their accompanying children in Germany (KontextSucht): study protocol for a non-randomised trial.

INTRODUCTION: People suffering from substance use disorders often live in social contexts with children or are parents themselves. Addicted parents show specific substance-related problems while raising their children, which often leads to various lifelong consequences for the children. The German rehabilitative treatment system allows bringing children to inpatient treatment centres. This mixed-methods study evaluates a newly developed intervention, called 'KontextSucht' or 'AddictionContext', for parents in rehabilitation treatment centres concerning the effectiveness of the intervention in parenting and abstinence outcome. METHODS AND ANALYSIS: The study uses a two-stage parallel mixed-methods design. A feasibility study (stage 1) and a benefit assessment (stage 2) will be conducted to evaluate the intervention. Both parts of the study will be carried out with qualitative and quantitative work packages. German-speaking parents of children 0-14 years will be included in this study. Qualitative data will be analysed using qualitative content analyses, whereas quantitative data will be analysed descriptively using regression analysis as well as linear mixed models. ETHICS AND DISSEMINATION: All participants will receive detailed information on the study and sign informed consent before data collection. The research team has obtained the approval of the Ethical Review Committee at the Technical University of Munich in Germany and will follow all legislation rules regarding data protection. The study results will be published in peer-reviewed national and international journals. Furthermore, the study results will be included in an intervention manual distributed to treatment centres. TRIAL REGISTRATION NUMBER: DRKS00030950.

Development, piloting and evaluation of an app-supported psychosocial prevention intervention to strengthen participation in working life: a study protocol of a mixed-methods approach.

INTRODUCTION: Rates of incapacity to work due to mental disorders have increased in many European countries. The consequences of persistent stress can impact individuals' physical and psychological well-being and gradually develop into chronic stress. Mental disorders or symptoms of burn-out syndrome can have severe consequences. Mental disorders leading to work incapacity significantly burden the health system. Prevention interventions can protect against burn-out, depression, anxiety and other mental health disorders. Digital health is a promising approach to increase the utilisation of effective prevention interventions. This mixed-methods study evaluates a newly developed app-supported psychosocial prevention intervention called 'RV Fit Mental Health' to strengthen participation in working life. METHODS AND ANALYSIS: The study uses a three-stage parallel mixed-methods design. This study accompanies the development (stage 1), piloting (stage 2) and evaluation (stage 3) of the new intervention. Within the stages, there is a quantitative as well as a qualitative research strand. Employed persons with an incipient mental disorder will be included. Additionally, experts within the project or connected areas will be included. Quantitative data will be analysed using multifactorial variance analyses in a pre-post design. Qualitative data will be analysed using qualitative content analysis. The study is a comprehensive research approach to investigate the development, piloting and evaluation of an app-supported psychosocial app-based prevention intervention. The rigour of the study will be achieved through data triangulation. ETHICS AND DISSEMINATION: All participants will receive detailed study information and give written informed consent before data collection. Ethical approval was obtained from the Technical University of Munich Ethics Committee. All data collection will follow all legislative rules regarding data protection, also following the Declaration of Helsinki. The study results will be disseminated in peer-reviewed journals and presented at international conferences. TRIAL REGISTRATION NUMBERS: DRKS00030818 and DRKS00033080.

[Participation in primary care research - From the idea to the constitution of a citizens advisory board]. / Partizipation in der allgemeinmedizinischen Forschung ­ Von der Idee bis zur Gründung eines Bürger*innenbeirats.

INTRODUCTION: Public participation in research processes is becoming increasingly important and is justified with positive effects for research. The first successful initiatives can also be found in general practice and health services research. The transparent presentation of these projects is essential to the discussion about participation. The aim of this article is to present and discuss the conception and implementation of the initiative at the Institute of General Practice and Health Services Research at the Technical University of Munich and the kick-off event for the participation of patients, citizens and patient representatives. METHODS: This article reports the planning, recruitment, implementation, and evaluation of the kick-off event. Frameworks for future events are described. RESULTS: In total, twelve persons were recruited through various recruitment channels to participate in the kick-off event. The participants showed a diverse structure of motives with regard to participation in research. All participants shared the essential goal of improving research and care by adding their perspectives to research processes. However, the specific opportunities for participation and the role of patients and citizens in research processes were unclear. During the event, future workshops were planned to address these challenges. The focus was on strengthening relationships and communicating the basics of primary care research in order to enable sustainable participation. DISCUSSION: The participants' different motivations resulted in the need to explore the concrete possibilities of participation. One of the specific requirements was to focus on role identification and the structure of the initiative. The question of self-description and -identification as a patient and/or citizen seemed crucial. Furthermore, a concise introduction to the topic of participation in research processes, as well as patient and citizen qualifications, is considered necessary. CONCLUSION: Establishing an advisory board for patients and citizens in primary care research is associated with specific requirements. In addition to fundamental necessities such as the joint clarification of the possibilities of participation, defining the role and establishing the identity of the initiative should be promoted.

"It's pretty much flying blind in the home care setting": A qualitative study on the influence of home care specific circumstances on sedation in specialist palliative home care.

BACKGROUND: Existing data on sedation at the end of life indicate challenges in the home care setting, leading to deviations from guidelines or non-provision of sedation. AIM: As part of the "SedPall" study, we aimed to explore circumstances in specialist palliative home care, which influence the practice of sedation. DESIGN: Semi-structured qualitative interviews (n = 59) and two focus groups (n = 4, n = 5). Recruitment took place via contact persons. We thematically analyzed the transcripts with the Framework Approach, using MAXQDA 2018.2. SETTING/PARTICIPANTS: Physicians, nurses, and other members of the multiprofessional team from 10 palliative care units and seven home care teams. RESULTS: Participants reported home care specific circumstances that can be categorized into three interrelated topics. (1) Lack of 24/7 on-site availability, (2) active involvement of the family, (3) challenges regarding teamwork and multidisciplinarity. Participants drew different conclusions from the reported circumstances regarding the feasibility of different types of sedation at home: While some reported to generally use all types of sedation, others stated that some types of sedation are not feasible in home care, for example deep sedation until death. Most participants questioned the applicability of existing sedation guidelines in the home care setting. CONCLUSION: Our data indicate that sedation practices might currently follow the healthcare professional's attitude or service policy rather than the patient's need. To avoid hospital admission in manageable cases and ensure that home care specific best practice standards are met, existing guideline recommendations have to be adapted and supplemented by additional supporting measures specific for the home care setting.