A multimodal aftercare intervention improves the outcome after kidney transplantation - results of the KTx360° aftercare program using claims data.

Background: The after-care treatment project KTx360° aimed to reduce graft failure and mortality after kidney transplantation (KTx). Methods: The study was conducted in the study centers Hannover, Erlangen and Hannoversch Muenden from May 2017 to October 2020 under the trial registration ISRCTN29416382. The program provided a multimodal aftercare program including specialized case management, telemedicine support, psychological and exercise assessments, and interventions. For the analysis of graft failure, which was defined as death, re-transplantation or start of long-term dialysis, we used longitudinal claims data from participating statutory health insurances (SHI) which enabled us to compare participants with controls. To balance covariate distributions between these nonrandomized groups we used propensity score methodology, in particular the inverse probability of treatment weighting (IPTW) approach. Findings: In total, 930 adult participants were recruited at three different transplant centres in Germany, of whom 320 were incident (enrolled within the first year after KTx) and 610 prevalent (enrolled >1 year after KTx) patients. Due to differences in the availability of the claims data, the claims data of 411 participants and 418 controls could be used for the analyses. In the prevalent group we detected a significantly lower risk for graft failure in the study participants compared to the matched controls (HR = 0.13, 95% CI = 0.04-0.39, p = 0.005, n = 389 observations), whereas this difference could not be detected in the incident group (HR = 0.92, 95% CI = 0.54-1.56, p = 0.837, n = 440 observations). Interpretation: Our findings suggest that a multimodal and multidisciplinary aftercare intervention can significantly improve outcome after KTx, specifically in patients later after KTx. For evaluation of effects on these outcome parameters in patients enrolled within the first year after transplantation longer observation times are necessary. Funding: The study was funded by the Global Innovation fund of the Joint Federal Committee of the Federal Republic of Germany, grant number 01NVF16009.

A Stepped Health Services Intervention to Improve Care for Mental and Neurological Diseases: Protocol for a Prospective Cohort Trial.

BACKGROUND: Mental and neurological disorders cause a large proportion of morbidity burden and require adequate health care structures. However, deficits in the German health care system like long waiting times for access to specialized care and a lack of coordination between health care providers lead to suboptimal quality of care and elevated health care costs. OBJECTIVE: To overcome these deficits, we implement and evaluate a unique stepped and coordinated model of care (the Neurologisch-psychiatrische und psychotherapeutische Versorgung [NPPV] program) for patients with mental and neurological diseases. METHODS: Patients included in the program receive an appropriate treatment according to medical needs in a multiprofessional network of ambulatory health care providers. The therapy is coordinated by a managing physician and complemented by additional therapy modules, such as group therapy, internet-based cognitive behavioral therapy, and a case management. Statutory health insurance (SHI) routine data and data from a longitudinal patient survey will be used to compare the program with regular care and evaluate SHI expenditures and patient-related outcomes. A health care provider survey will evaluate the quality of structure and processes and provider satisfaction. Finally, an analysis of ambulatory claims data and drug prescription data will be used to evaluate if health care providers follow a needs-led approach in therapy. Ethics approval for this trial was obtained from the ethics committee of the chamber of physicians in North Rhine (September 13, 2017, reference No. 2017287). RESULTS: Patient enrollment of NPPV ended in September 2021. Data analysis has been completed in 2022. The results of this study will be disseminated through scientific publications, academic conferences, and a publicly available report to the German Federal Joint Committee, which is expected to be available in the first half of 2023. CONCLUSIONS: The NPPV program is the first intervention to implement a stepped model of care for both mental and neurological diseases in Germany. The analysis of several data sources and a large sample size (more than 14,000 patients) enable a comprehensive evaluation of the NPPV program. TRIAL REGISTRATION: German Clinical Trials Register DRKS00022754; https://tinyurl.com/3mx9pz5z. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/37569.

CCSchool: a multicentre, prospective study on improving continuum of care in children and adolescents with mental health problems associated with school problems in Germany.

BACKGROUND: Most psychiatric disorders in childhood and adolescence cause impairment in academic performance. Early interventions in school are thought to reduce the burden of disorder and prevent chronicity of disorder, while a delay in reachable help may result in more severe symptoms upon first time presentation, often then causing upon first-time presentation immediate need of inpatient care. METHODS: The study aims at reducing hospitalization rates and increasing social participation and quality of life among children and adolescents by establishing collaborations between schools, mental health care services and youth welfare services. CCSchool offers children and adolescents, aged six to 18 years, who present with psychiatric problems associated to school problems, a standardized screening and diagnostic procedure as well as treatment in school if necessary. Students can participate in CCSchool in three federal states of Germany if they a) show symptoms vindicating a mental health diagnosis, b) present with confirmed school problems and c) have a level of general functioning below 70 on the children global assessment of Functioning (C-GAF). Intervention takes place in three steps: module A (expected n = 901, according to power calculation) with standardized diagnostic procedures; module B (expected n = 428) implies a school-based assessment followed by a first intervention; module C (expected n = 103) offering school-based interventions with either four to six sessions (basic, 80% of patients) or eight to 12 sessions (intensive, 20% of patients). Primary aim is to evaluate the effectiveness of CCSchool, in reducing the need of hospitalization in children with mental health problems. The analyses will be conducted by an independent institute using mainly data collected from patients and their caregivers during study participation. Additionally, claims data from statutory health insurances will be analysed. Relevant confounders will be controlled in all analyses. DISCUSSION: Evaluation may show if CCSchool can prevent hospitalizations, enhance social participation and improve quality of life of children and adolescents with mental health problems by providing early accessible interventions in the school setting. TRIAL REGISTRATION: Deutsches Register Klinischer Studien, Trial registration number: DRKS00014838 , registered on 6th of June 2018.

Examining patient preferences in the treatment of rheumatoid arthritis using a discrete-choice approach.

BACKGROUND: Biological disease-modifying antirheumatic drugs (bDMARDs) used in second-line treatment of rheumatoid arthritis (RA) are administered parenterally. However, so-called targeted synthetic DMARDs (tsDMARDs) - developed more recently - offer alternative (ie, oral) administration forms in second-line treatment. Since bDMARDs and tsDMARDs can be regarded as equal in terms of efficacy, the present study examines whether such characteristics as route of administration drive RA patients' treatment choice. This may ultimately suggest superiority of some second-line DMARDs over equally effective options, at least according to RA-patient preferences. OBJECTIVE: The current study assessed the importance of oral administration among other treatment characteristics differing between available second-line DMARDs for RA patients' preferences using a discrete-choice experiment (DCE). MATERIALS AND METHODS: The DCE involved scenarios of three hypothetical treatment options in a d-efficient design with varying levels of key attributes (route and frequency of administration, time till onset of drug effect, combination therapy, possible side effects), as defined by focus groups. Further patient characteristics were recorded by an accompanying questionnaire. In the DCE, patients were asked to choose best and worst options (best-worst scaling). Results were analyzed by count analysis and adjusted regression analysis. RESULTS: A total of 1,588 subjects completed the DCE and were eligible for final analyses. Across all characteristics included in the DCE, "oral administration" was most desired and "intravenous infusion" was most strongly rejected. This was followed by "no combination with methotrexate" being strongly preferred and "intake every 1-2 weeks" being strongly rejected. On average, levels of route of administration showed strongest influences on patients' decisions in post hoc bootstrapping analysis. CONCLUSION: According to the results, an oral DMARD that does not have to be combined with methotrexate and is not administered (only) every 1-2 weeks appears a highly favorable treatment option for patients with RA. DMARDs meeting these preferences may increase compliance and adherence in RA treatment.

[Nurse turnover: A differential analysis of the predictors for intent to change the job and intent to leave the profession]. / Beschäftigtenfluktuation bei Pflegenden: Ein Vergleich der Bedeutung von arbeitsbedingtem Stress, organisationalen und individuellen Faktoren für die Absicht zum Berufswechsel und zum inner- beruflichen Arbeitsplatzwechsel.

In a cross-sectional questionnaire study predictors for the intent to leave the nursing profession on the one hand and predictors for the intent to change the job within the nursing profession on the other hand are examined. Data were collected by a national survey of nursing personnel in Germany. The sample of the study consists of 454 nurses working in acute care hospitals. As possible predictors work-related psychological stress, the strain due to illness and behaviour of the patients, psychosomatic pains, organisational, structural as well as sociodemographic variables are taken into account. The relevant predictors are identified by two multiple, linear regression analyses. Psychosomatic pains, low decision latitude, high psychological job demands, short job tenure, the strain due to aggressive and nagging patients, bad cooperation between doctors and nurses, low support by the supervisor and professional status (supervising position) turn out to be predictive for the intent to leave the nursing profession (R2 = 30%). For the intent to change the job within the profession significant predictors are low social support by colleagues, low support by the supervisor, psychosomatic pains, age, short job tenure, and the number of beds in the unit (R2 = 44%). The results indicate, that for the prevention of professional exit early individual measures should be taken where-as the improvement of communication and cooperation among colleagues could keep nurses from job rotation within the profession.