With a prevalence of around 7.6%, developmental language disorders (DLDs) without comorbidities are among the most common and most frequently treated childhood disorders. Standard DLD therapy in Germany consists of individual therapy sessions once per week within speech–language therapy practices. In reality, these sessions only take place every 10–14 days on average. Online therapy may be beneficial but is not yet standard practice in Germany. Although DLD group therapy has been proven to be effective, it is rarely undertaken in Germany. The aim of this study is to compare the effectiveness of online DLD therapy for small groups of children with standard one-to-one therapy.
The effectiveness of two treatment settings is evaluated in 212 children with moderate-to-severe DLD (ages 3 years to 6 years 11 months) in the multicentre, block randomised controlled trial (RCT) THErapy ONline. Five centres in Germany participate. Children are randomly assigned to the intervention group (online interval-intensive therapy, IG1, n=106) or the control group (extensive standard in-person therapy, IG2, n=106). A speech and language assessment is conducted at baseline (study entry, T0), 12 months (T1) and 18 months (T2) after therapy start. The co-primary outcome parameters are the speech and language test scores of phonological speech sound production, expressive vocabulary, grammar production and language comprehension at T1. The secondary outcome parameters comprise two composite speech and language test scores at T1 and T2, including phonological working memory scores and the individual scores of the aforementioned tests at T2, as well as process evaluation parameters (time expenditure, resource utilisation, such as salary costs of speech–language therapists, additional costs of the online therapy, adherence to appointments and therapy acceptance).
This study has been approved by the Institutional Ethics Review Board of Westphalia-Lippe (2022-282 f-S). Parents provide written informed consent. Findings will be disseminated through presentations, peer-reviewed journals and conferences.
DRKS00030068
Discharge planning (DP) is essential to ensure continuity of care during patient transitions between inpatient and outpatient settings. Although DP has been legally required for all hospitals in Germany since 2017, several studies show considerable variation in its implementation, likely due to differences in structural characteristics and organisational processes. Both quality and efficiency-enhancing DP processes are particularly important in the context of cardiovascular disease, which is the leading cause of mortality and a major contributor to healthcare costs in Germany. The ‘Ready to Discharge’ (R2D) project investigates the implementation status, influencing factors and outcomes of DP in cardiac units of German hospitals. By integrating quantitative and qualitative data, we aim to identify best practices and provide actionable recommendations for improving DP processes.
A mixed-methods study design will be used. Quantitative analyses will be based on primary data from hospital and patient surveys combined with secondary data from health insurance claims and hospital quality reports. Key outcome measures will include healthcare utilisation outcomes (eg, readmissions, emergency department visits), patient health status outcomes (eg, patient satisfaction, self-rated health) and medication-related outcomes (eg, medication adherence). Qualitative interviews with healthcare professionals will enrich the findings by providing insights into barriers and facilitators to DP.
This study was approved by the Ethics Committee of Bergische University of Wuppertal and the German Federal Office for Social Security. Informed consent will be obtained for all primary data collections. Hospital managing directors will be informed prior to the hospital survey and will be able to withdraw consent. Patients can withdraw their consent at any time. Secondary data will be analysed in pseudonymised form to ensure patient confidentiality. Results will be disseminated through workshops, regional and international conferences and peer-reviewed publications.