Implementation of integrated care for type 2 diabetes Mellitus and Periodontitis in Germany: study protocol for a practice-based and cluster-randomized trial.

BACKGROUND: Type 2 Diabetes mellitus (T2DM) and periodontitis share common risk factors and influence one another. However, primary care and oral health care continue to operate separate from each other and fail to synchronize care for patients with T2DM and periodontitis. The purpose of this practice-based trial is to evaluate the implementation of a new integrated care pathway for patients with T2DM and periodontitis. The new approach integrates a screening for T2DM risk in dental care settings in patients with periodontitis, a screening for periodontitis risk in primary care settings in patients with T2DM, and mutual referrals between dentists and primary care physicians. METHODS: Two practice-based studies will be carried out in parallel: (i) In dental care settings: a practice-based, multi-centric, cluster-randomized, controlled trial with a control and an intervention group; (ii) in primary care settings: a practice-based, multi-centric, non-randomized, controlled trial with a synthetic control group calculated from claims data. Following a two-step recruitment approach, 166 dentists and 248 general practitioners will be recruited, who themselves will recruit a total of 3808 patients in their practices. Patient data will be collected at baseline, 12 months, and 24 months after study enrollment. The evaluation comprises: (i) impact evaluation, using a hierarchical linear mixed model; (ii) process evaluation, based on surveys alongside the trials; (iii) economic evaluation. In addition, a Discrete-Choice-Experiment will identify provider's payment preferences for the new care approach. DISCUSSION: Upon successful implementation, the intervention will enable health care providers to detect a risk for T2DM and periodontitis in patients at an early stage, thus providing patients an opportunity for timely diagnosis and therapy. Ultimately, this can lead to increased quality of life and reduced health care expenditures. On a methodologic level, the project provides novel insights into a complex intervention on the intersection of general practice and dental care. TRIAL REGISTRATION: The study was prospectively registered at the German Clinical Trials Register ( https://drks.de/search/de/trial/DRKS00030587 ) on 3. July 2023 under ID "DRKS00030587".

Antibiotic prescribing in general practice--the rhythm of the week: a cross-sectional study.

OBJECTIVES: Overprescribing of antibiotics in primary care is a worldwide phenomenon. Prescriptions can be used to reduce the uncertainty inherent in general practice. We assumed a heightened prescribing rate on Fridays because of more uncertainty before the pending weekend. METHODS: Cross-sectional study from a general practice research database with 102 140 patients of 32 practices in Germany. Prescribing rates of antibiotics on different days of the week were analysed. In order to evaluate the influence of the weekday within a multivariate setting, we used SAS PROC GENMOD. This procedure was parameterized accordingly to account for the cluster design of the study. RESULTS: The prescribing rate of antibiotics on Fridays was 23.3% higher than the average of the other days of the working week (6.04% versus 4.90%, P < 0.0001). The significance of this finding was confirmed by the multivariate analysis. CONCLUSIONS: There is periodic fluctuation of antibiotic prescribing rates over the week. This cannot be explained by morbidity itself. Factors beyond biomedical indication are well known to influence prescribing patterns. These factors should not only be further explored, but also acknowledged when trying to reduce overprescribing.

Sustainable reduction of antibiotic-induced antimicrobial resistance (ARena) in German ambulatory care: study protocol of a cluster randomised trial.

BACKGROUND: Despite many initiatives to enhance the rational use of antibiotics, there remains substantial room for improvement. The overall aim of this study is to optimise the appropriate use of antibiotics in German ambulatory care in patients with acute non-complicated infections (respiratory tract infections, such as bronchitis, sinusitis, tonsillitis and otitis media), community-acquired pneumonia and non-complicated cystitis, in order to counter the advancing antimicrobial resistance development. METHODS: A three-armed cluster randomised trial will be conducted in 14 practice networks in two German federal states (Bavaria and North Rhine-Westphalia) and an added cohort that reflects standard care. The trial is accompanied by a process evaluation. Each arm will receive a different set of implementation strategies. Arm A receives a standard set, comprising of e-learning on communication with patients and quality circles with data-based feedback for physicians, information campaigns for the public, patient information material and performance-based additional reimbursement. Arm B receives this standard set plus e-learning on communication with patients and quality circles with data-based feedback tailored for non-physician health professionals of the practice team and information material for tablet computers (culture sensitive). Arm C receives the standard set as well as a computerised decision support system and quality circles in local multidisciplinary groups. The study aims to recruit 193 practices which will provide data on 23,934 patients each year (47,867 patients in total). The outcome evaluation is based on claims data and refers to established indicators of the European Surveillance of Antimicrobial Consumption Network (ESAC-Net). Primary and secondary outcomes relate to prescribing of antibiotics, which will be analysed in multivariate regression models. The process evaluation is based on interviews with surveys among physicians, non-physician health professionals of the practice team and stakeholders. A patient survey is conducted in one of the study arms. Interview data will be qualitatively analysed using thematic framework analysis. Survey data of physicians, non-physician health professionals of the practice team and patients will use descriptive and exploratory statistics for analysis. DISCUSSION: The ARena trial will examine the effectiveness of large scale implementation strategies and explore their delivery in routine practice. TRIAL REGISTRATION: ISRCTN, ISRCTN58150046 . Registered 24 August 2017.

Diuretics for hypertension--an inconsistency in primary care prescribing behaviour.

OBJECTIVE: Internationally there is an ongoing debate on diuretics as first-line therapy for most patients with hypertension. In spite of many arguments against them in antihypertensive monotherapy, the authors of the present study perceived them to be regularly prescribed in combination therapy in Germany. The study objective was to look for this discrepancy in prescribing reality as a contribution from clinical practice to an academic debate. METHODS: A descriptive cross-sectional study in a yearly contact group (YCG; 1.7.2007-31.06.2008) was conducted based on data from a scientific network of 22 general practitioners in Germany. All patients with hypertension as diagnosed by their general practitioner were included. Antihypertensives were grouped according to the ATC classification. To assess for potential design effects by the given two-level setting, 95% confidence intervals (CI) were adjusted for clustering. RESULTS: Hypertension had been diagnosed in 9.3% of the 58 852 patients. Of these, 21.6% received no antihypertensives. Of those who were treated, 30.6% (CI [28.6-32.6]) had monotherapy. In monotherapy, 8.6% (CI [7.1-10.2]) were prescribed some diuretic, 1.5% (CI [0.5-3.0]) received hydrochlorothiazide (HCT). Combination therapy was prescribed to 69.4% (CI [67.2-71.6]). These patients received some diuretic in 79.0% (CI [76.9-81.0]) of the cases, of which 80.8% (CI [78.5-83.1]) had a combination with HCT. HCT was prescribed in 76.2% (CI [73.5-78.9]) in fixed-dose formulations. CONCLUSION: In spite to the many arguments against them, leading to their almost complete disregard in monotherapy, thiazide-diuretics seem to be standard in combination therapy in Germany. This inconsistency can not be explained by the arguments of the current debate. Key limitations of the present study include the lack of ability to tell whether a given monotherapy is the first-line medication, the small sample size and the possible selection bias.

[Antihypertensive pharmacotherapy of patients in primary care with either a statutory or private health insurance]. / Antihypertensive medikamentöse Therapie von gesetzlich und privat versicherten Patienten in der Primärversorgung.

BACKGROUND AND PURPOSE: In Germany, hypertension has a prevalence of about 20%. Cardiovascular morbidity and mortality are closely associated with hypertension. Therefore, antihypertensive medical treatment is of crucial importance. Currently, five groups of drugs for the medical treatment of hypertension are available: diuretics, beta-receptor blockers, calcium antagonists, angiotensin-converting enzyme (ACE) inhibitors, and angiotensin II receptor blockers. Besides medical considerations for the treatment of hypertension costs of treatment and other economic aspects become more and more important. Within this article, the antihypertensive treatment of insurants of the statutory health insurance and the private health insurance is compared with regard to the medical treatment and associated costs. METHODS: The analyzed data derive from the general practice morbidity research network CONTENT (CONTinuous morbidity registration Epidemiologic NeTwork). The implementation of this network is funded by the German Federal Ministry of Research and Education (BMBF) for a continuous registration of health-care utilization, morbidity, course of disease, and outcome parameters within primary care. RESULTS: Altogether 4,842 patients from the participating general practitioners were regularly treated with antihypertensive drugs in 2007 and corresponding episodes were documented within electronic medical records. The proportion of insurants of the private health insurance was 7.6%. The costs of the antihypertensive medical treatment within the total sample in 2007 constituted 1.03 million Euros overall and per patient on average 212.82 Euros. Although the regarded sample of private health insurants was less morbid and the sum of defined daily doses (DDDs) within the observation period was notably lower (582.6 vs. 703.1; p < 0.0001), the annual therapy costs of the private health insurants compared to the statutory health insurants were 35.2% higher (280.29 Euros vs. 207.29 Euros; p < 0.0001). Hence, costs per DDD for antihypertensive medical treatment for private health insurants were 63.2% higher than for statutory health insurants. This refers to the great proportion of angiotensin II receptor blockers as well as the low proportion of generic drugs prescribed for private health insurants. CONCLUSION: Antihypertensive treatment with original drugs and/or angiotensin II receptor blockers is an expensive option. Based on the actual state of knowledge it must be questioned critically whether this constitutes a superior treatment option concerning the potential for lowering high blood pressure levels and organ protection.