Interaction of Systemic Morbidity and Oral Health in Ambulatory Patients in Need of Home Care (InSEMaP): an observational study at the sector boundary between dental and general practice care in Germany.

INTRODUCTION: Older people in need of home care are at risk of declining oral health as their visits to dentists are becoming less frequent due to restricted mobility. There is increasing evidence that poor oral health and systemic diseases are closely associated, for example, in cardiological, metabolic or neurodegenerative conditions. Thus, Interaction of Systemic Morbidity and Oral Health in Ambulatory Patients in Need of Home Care (InSEMaP) is investigating the need, provision and utilisation of oral healthcare, systemic morbidity and clinical status of the oral cavity in older people. METHODS AND ANALYSIS: InSEMaP consists of four subprojects (SP), all involving the target population of older people in need of home care. In SP1 part a, a sample is surveyed using a self-report questionnaire. In SP1 part b, stakeholders (general practitioners, dentists, medical assistants, family and professional caregivers) are interviewed regarding barriers and facilitators using focus groups and personal interviews. In SP2, a retrospective cohort study, health insurance claims data are examined to investigate the utilisation of oral healthcare, its association with systemic morbidity and healthcare costs. In SP3, a clinical observational study will assess the oral health of participants by a dentist's visit at home. SP4 synthesises the results of SP1, SP2 and SP3 to develop integrated clinical pathways, identifying strategies to uphold oral healthcare in older people. In assessing and evaluating the process of oral healthcare, and its associated systemic morbidity, InSEMaP aims to improve general healthcare across the sector boundary of dental and general practitioner care. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Institutional Review Board of the Hamburg Medical Chamber (approval number: 2021-100715-BO-ff). The results of this study will be disseminated through conference presentations and publications in peer-reviewed journals. An expert advisory board to support the InSEMaP study group will be established. TRIAL REGISTRATION NUMBER: German Clinical Trials Register: DRKS00027020.

Regional and patient-related factors influencing the willingness to use general practitioners as coordinators of the treatment in northern Germany - results of a cross-sectional observational study.

BACKGROUND: In most countries, the general practitioner (GP) is the first point of contact in the healthcare system and coordinator of healthcare. However, in Germany it is possible to consult an outpatient specialist even without referral. Coordination by a GP might thus reduce health expenditures and inequalities in the healthcare system. The study describes the patients' willingness/commitment to use the GP as coordinator of healthcare and identifies regional and patient-related factors associated with the aforementioned commitment to the GP. METHODS: Cross-sectional observational study using a standardised telephone patient survey in northern Germany. All counties and independent cities within a radius of 120 km around Hamburg were divided into three regional categories (urban areas, environs, rural areas) and stratified proportionally to the population size. Patients who had consulted the GP within the previous three months, and had been patients of the practice for at least three years were randomly selected from medical records of primary care practices in these districts and recruited for the study. Multivariate linear regression models adjusted for random effects at the level of federal states, administrative districts and practices were used as statistical analysis methods. RESULTS: Eight hundred eleven patients (25.1%) from 186 practices and 34 administrative districts were interviewed. The patient commitment to a GP attained an average of 20 out of 24 possible points. Significant differences were found by sex (male vs. female: + 1.14 points, p < 0.001), morbidity (+ 0.10 per disease, p = 0.043), education (high vs. low: - 1.74, p < 0.001), logarithmised household net adjusted disposable income (- 0.93 per step on the logarithmic scale, p = 0.004), regional category (urban areas: - 0.85, p = 0.022; environs: - 0.80, p = 0.045) and healthcare utilisation (each GP contact: + 0.30, p < 0.001; each contact to a medical specialist: - 0.75, p = 0.018). Professional situation and age were not significantly associated with the GP commitment. CONCLUSION: On average, the patients' commitment to their GP was relatively strong, but there were large differences between patient groups. An increase in the patient commitment to the GP could be achieved through better patient information and targeted interventions, e.g. to women or patients from regions of higher urban density. TRIAL REGISTRATION: The study was registered in ClinicalTrials.gov (NCT02558322).

Study protocol for the COMET study: a cluster-randomised, prospective, parallel-group, superiority trial to compare the effectiveness of a collaborative and stepped care model versus treatment as usual in patients with mental disorders in primary care.

INTRODUCTION: Mental healthcare is one of the biggest challenges for healthcare systems. Comorbidities between different mental disorders are common, and patients suffer from a high burden of disease. While the effectiveness of collaborative and stepped care models has been shown for single disorders, comorbid mental disorders have rarely been addressed in such care models. The aim of the present study is to evaluate the effectiveness of a collaborative and stepped care model for depressive, anxiety, somatoform and alcohol use disorders within a multiprofessional network compared with treatment as usual. METHODS AND ANALYSIS: In a cluster-randomised, prospective, parallel-group superiority trial, n=570 patients will be recruited from primary care practices (n=19 practices per group). The intervention is a newly developed collaborative and stepped care model in which patients will be treated using treatment options of various intensities within an integrated network of outpatient general practitioners, psychiatrists, psychotherapists and inpatient institutions. It will be compared with treatment as usual with regard to effectiveness, cost-effectiveness and feasibility, with the primary outcome being a change in mental health-related quality of life from baseline to 6 months. Patients in both groups will undergo an assessment at baseline, 3, 6 and 12 months after study inclusion. ETHICS AND DISSEMINATION: The study has been approved by the ethics committee of the Hamburg Medical Association (No. PV5595) and will be carried out in accordance with the principles of the Declaration of Helsinki. For dissemination, the results will be published in peer-reviewed journals and presented at conferences. Within the superordinate research project Hamburg Network for Health Services Research, the results will be communicated to relevant stakeholders in mental healthcare. TRIAL REGISTRATION NUMBER: NCT03226743.

[Clinical trial of a stepped and collaborative care model for mental illnesses and comorbidities in the Hamburg Network for Health Services Research]. / Erprobung eines integrierten und gestuften Behandlungsmodells für psychische Störungen und Komorbiditäten im Hamburger Netzwerk für Versorgungsforschung.

Healthcare for mental disorders is a big challenge for the German healthcare system. In cases of comorbid mental diseases, patients suffer from an especially high burden of disease. So far, innovative care models for collaborative and stepped care have only been investigated with respect to their effectiveness for single mental disorders.The project "Collaborative and Stepped Care in Mental Health by Overcoming Treatment Sector Barriers" (COMET), which is being carried out by the Hamburg Network for Health Services Research (HAM-NET) from 2017 until 2020, examines an innovative, guideline-based healthcare model for the improvement of healthcare for patients with mental illnesses and their potential comorbidities. In this article this new stepped and collaborative care model for patients in primary care that integrates general practitioners, psychiatrists, psychotherapists, and hospitals is presented. For the implementation and facilitation of the model, guideline-based treatment pathways, a tablet-based computer program for screening, diagnostic and guideline-based treatment recommendations, as well as a web-based transferal platform were developed.The results of this project on the effectiveness and efficacy of the model can help determine if the model can be implemented in routine healthcare. This could represent a major step towards more integrated and cross-sectoral healthcare for patients with mental illnesses.

Cost-utility of collaborative nurse-led self-management support for primary care patients with anxiety, depressive or somatic symptoms: A cluster-randomized controlled trial (the SMADS trial).

BACKGROUND: Anxiety, depressive and somatoform disorders are highly prevalent and cause a huge economic burden. A nurse-led collaborative care intervention has been set up in order to improve self-management of patients with these mental disorders in primary care in Hamburg, Germany. The aim of this study was to determine the cost-utility of this nurse-led intervention from the health care payer perspective. METHODS: This analysis was part of a 12-month cluster-randomized controlled trial aiming to increase perceived self-efficacy of primary care patients with anxiety, depressive or somatic symptoms by collaborative nurse-led self-management support compared with routine care. A cost-effectiveness analysis using quality-adjusted life years was performed. Net-monetary benefit regressions adjusted for baseline differences for different willingness-to-pay thresholds were conducted and cost-effectiveness acceptability curves were constructed. RESULTS: In total, n = 325 patients (intervention group: n = 134; control group: n = 191) with a mean age of 40 from 20 primary care practices were included in the analysis. The adjusted differences in quality-adjusted life years and mean total costs between intervention group and control group were +0.02 and +€1145, respectively. Neither of the two differences was statistically significant. The probability for cost-effectiveness of the complex nurse-led intervention was 49% for a willingness-to-pay of €50,000 per additional quality-adjusted life year. The probability for cost-effectiveness did not exceed 65%, independent of the willingness-to-pay. CONCLUSION: The complex nurse-led intervention promoting self-management for primary care patients with anxiety, depressive or somatic symptoms did not prove to be cost-effective relative to routine care from a health care payer perspective.

Collaborative nurse-led self-management support for primary care patients with anxiety, depressive or somatic symptoms: Cluster-randomised controlled trial (findings of the SMADS study).

BACKGROUND: Collaborative, nurse-led care is a well-established model of ambulatory care in many healthcare systems. Nurses play a key role in managing patients' conditions as well as in enhancing symptom- and self-management skills. OBJECTIVE: The SMADS trial evaluated the effectiveness of a primary care-based, nurse-led, complex intervention to promote self-management in patients with anxiety, depressive or somatic symptoms. Change in self-efficacy 12 months post baseline was used as the primary outcome. DESIGN: The SMADS trial set up a two-arm, cluster randomised controlled trial in the city of Hamburg, a large metropolitan area in the North West of Germany. SETTING: We randomly allocated participating primary care practices to either the intervention group (IG), implementing a nurse-led collaborative care model, or to the control group (CG), where patients with the above psychosomatic symptoms received routine treatment. PARTICIPANTS: Patients from 18 to 65 years of age, regularly consulting a participating primary care practice, scoring≥5 on the anxiety, depressive or somatic symptom scales of the Patient Health Questionnaire (PHQ-D), German version. METHODS: A mixed model regression approach was used to analyse the outcome data. Analyses were based on the intention-to-treat population: All enrolled patients were analysed at their follow-up. Additionally, we reported results as effect sizes. The robustness of the results was investigated by performing an observed cases analysis. RESULTS: 325 participants (IG N=134, CG N=191) from ten practices in each study arm consented to take part and completed a baseline assessment. The mean group difference (ITT-LOCF, IG vs. CG) in self-efficacy at the post baseline follow-up (median 406days) was 1.65 points (95% CI 0.50-2.8) in favour of IG (p=0.004). This amounts to a small Cohen's d effect size of 0.33. An observed cases analysis (168 participants, IG=56, CG=105) resulted in a mean difference of 3.13 (95% CI 1.07-5.18, p=0.003) between the groups, amounting to a moderate effect size of d=0.51. CONCLUSION: A complex, nurse-led intervention, implemented as a collaborative care model, increased perceived self-efficacy in patients with symptoms of anxiety, depression or somatisation compare to control patients. For the first time in the German healthcare system, the SMADS trial validated the belief that a nurse can successfully complement the work of a general practitioner - particularly in supporting self-management of patients with psychosomatic symptoms and their psychosocial needs.

[Promoting Self-Management in Primary Care - the Association of Motivation for Change, Self-Efficacy and Psychological Distress Prior to the Onset of Intervention]. / Selbstmanagementförderung in der hausärztlichen Versorgung - der Zusammenhang zwischen Veränderungsmotivation, Selbstwirksamkeit und psychischer Belastung vor Beginn der Intervention.

Anxiety, depressive and somatoform disorders are highly prevalent in primary care. Managing these disorders is time-consuming and requires strong commitment on behalf of the general practitioners (GPs). Furthermore, the resources for the management of these patients are limited by the increasing workload in primary care practices, especially in the German health care system. In order to address the SMADS-study within psychenet - the Hamburg Network for Mental Health (NCT01726387) implements and evaluates a complex, low-threshold, nurse-led intervention using a goal-oriented set of case management and counseling techniques to promote self-management in these patients. This paper investigates the association of the patients' motivation for change and their perceived self-efficacy, the primary outcome - to get to know whether the intervention will target the appropriate population.