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Abstract Background Mental disorders are prevalent and cause considerable burden of disease. Exercise has been shown to be efficacious to treat major depressive disorders, insomnia, panic disorder with and without agoraphobia and post traumatic stress disorder (PTSD). Methods This pragmatic, two arm, multi-site randomised controlled trial will evaluate the efficacy and cost-effectiveness of the manualized, group-based six-months exercise intervention “ImPuls”, among physically inactive patients with major depressive disorders, insomnia, panic disorder, agoraphobia and PTSD within a naturalistic outpatient context in Germany. A minimum of 375 eligible outpatients from 10 different study sites will be block-randomized to either ImPuls in addition to treatment as usual (TAU) or TAU only. ImPuls will be conducted by trained exercise therapists and delivered in groups of six patients. The program will combine (a) moderate to vigorous aerobic exercise carried out two-three times a week for at least 30 min with (b) behavior change techniques for sustained exercise behavior change. All outcomes will be assessed pre-treatment, post-treatment (six months after randomization) and at follow-up (12 months after randomization). Primary outcome will be self-reported global symptom severity assessed with the Brief Symptom Inventory (BSI-18). Secondary outcomes will be accelerometry-based moderate to vigorous physical activity, self-reported exercise, disorder-specific symptoms, quality-adjusted life years (QALY) and healthcare costs. Intention-to-treat analyses will be conducted using mixed models. Cost-effectiveness and cost-utility analysis will be conducted using incremental cost-effectiveness and cost-utility ratios. Discussion Despite its promising therapeutic effects, exercise programs are currently not provided within the outpatient mental health care system in Germany. This trial will inform service providers and policy makers about the efficacy and cost-effectiveness of the group-based exercise intervention ImPuls within a naturalistic outpatient health care setting. Group-based exercise interventions might provide an option to close the treatment gap within outpatient mental health care settings. Trial registration The study was registered in the German Clinical Trials Register (ID: DRKS00024152 , 05/02/2021).

Introduction: In the context of a GP-based care programme, we implemented an admission, discharge and follow-up programme. Description: The VESPEERA programme consists of three sets of components: pre-admission interventions, in-hospital interventions and post-discharge interventions. It was aimed at all patients with a hospital stay participating in the GP-based care programme and was implemented in 7 hospitals and 72 general practices in southwest Germany using a range of strategies. Its’ effectiveness was evaluated using readmissions within 90 days after discharge as primary outcome. Questionnaires with staff were used to explore the implementation process. Discussion: A statistically significant effect was not found, but the effect size was similar to other interventions. Intervention fidelity was low and contextual factors affecting the implementation, amongst others, were available resources, external requirements such as legal regulations and networking between care providers. Lessons learned were derived that can aid to inform future political or scientific initiatives. Conclusion: Structured information transfer at hospital admission and discharge makes sense but the added value in the context of a GP-based programme seems modest. Primary care teams should be involved in pre- and post-hospital care. Abstrakt Einleitung: Im Rahmen der hausarztzentrierten Versorgung wurde ein Programm zur Verbesserung von Krankenhausaufnahmen und -entlassungen sowie der Nachsorge implementiert. Beschreibung: Das VESPEERA-Programm bestand aus verschiedenen Komponenten, die vor der Aufnahme, während des Krankenhausaufenthalts sowie nach der Entlassung durchgeführt wurden. Das Programm richtete sich an alle Patienten mit einem Krankenhausaufenthalt, die an der hausarztzentrierten Versorgung teilnahmen und wurde in 7 Krankenhäusern und 72 Hausarztpraxen in Südwestdeutschland unter Anwendung einer Reihe von Strategien implementiert. Seine Wirksamkeit wurde anhand des primären Endpunkts “Rehospitalisierungen innerhalb von 90 Tagen nach der Entlassung” bewertet. Anhand einer Fragebogenbefragung beim Personal wurde der Implementierungsprozess untersucht. Diskussion: Ein statistisch signifikanter Effekt konnte nicht gefunden werden, die Effektgröße war jedoch ähnlich wie bei anderen Interventionen. Die Interventionstreue war gering. Kontextfaktoren, die die Implementierung beeinflussten, waren unter anderem verfügbare Ressourcen, externe Anforderungen wie gesetzliche Vorschriften und die Vernetzung von Leistungserbringern. Es wurden Schlussfolgerungen gezogen, die für künftige politische oder wissenschaftliche Initiativen hilfreich sein können. Schlussfolgerung: Eine strukturierte Informationsweitergabe bei der Aufnahme und Entlassung aus dem Krankenhaus ist sinnvoll, doch scheint der zusätzliche Nutzen im Rahmen der hausarztzentrierten Versorgung begrenzt. Teams der Primärversorgung sollten in die prä- und poststationäre Versorgung einbezogen werden. Schlagwörter: Übergänge in der Versorgung; Einweisungsmanagement; Nachsorge nach Entlassung; Krankenhauswiederaufnahmen; Versorgungskontinuität; starke Primärversorgung; integrierte Versorgung

Abstract Background Hospitalisations are a critical event in the care process. Insufficient communication and uncoordinated follow-up care often impede the recovery process of the patient resulting in a high number of rehospitalisations and increased health care costs. The overall aim of this study is the development, implementation and evaluation of a structured programme (VESPEERA) to improve the admission and discharge process. Methods We will conduct an open quasi-experimental multi-centre study with four intervention arms. A cohort selected from insurance claims data will serve as a control group reflecting usual care. The intervention will be implemented in 25 hospital departments and 115 general practices in 9 districts in Baden-Wurttemberg. Eligibility criteria for patients are: age > 18 years, hospital admission or hospitalisation, insurance at the sickness fund “AOK Baden-Wurttemberg”, enrolment in general practice-centred care contract. Each study arm will receive different intervention components based on the point of study enrolment and the patient’s medical need. The interventions comprise a) a structured assessment in the general practice prior to admission resulting in an admission letter b) a discharge conversation by phone between hospital and general practice, c) a structured assessment and care plan post-discharge and d) telephone monitoring for patients with a high risk of rehospitalisation. The assessments are supported by a software tool (“CareCockpit”), originally developed for structured case management programmes. The primary outcome (rehospitalisation due to the same indication within 90 days) and a range of secondary outcomes (rehospitalisation due to the same indication within 30 days; hospitalisations due to ambulatory care-sensitive conditions; delayed prescription of medication and medical products/ devices and referral to other health practitioner/s after discharge; utilisation of emergency or rescue services within 3 months; average care cost per year and patient participating in the VESPEERA programme) and quality indicators will be determined based on insurance claims data and CareCockpit data. Additionally, a patient survey on satisfaction with cross-sectoral care and health related quality of life will be conducted. Discussion Based on the results, area-wide implementation in usual care is well sought. This study will contribute to an improvement of cross-sectoral care during the admission and discharge process. Trial registration DRKS00014294 on DRKS / Universal Trial Number (UTN): U1111–1210-9657, Date of registration 12/06/2018.