Anticoagulant treatment in German family practices - screening results from a cluster randomized controlled trial.

BACKGROUND: Oral anticoagulation (OAC) with coumarins and new anticoagulants are highly effective in preventing thromboembolic complications. However, some studies indicate that over- and under-treatment with anticoagulants are fairly common. The aim of this paper is to assess the appropriateness of treatment in patients with a long-term indication for OAC, and to describe the corresponding characteristics of such patients on the basis of screening results from the cluster randomized PICANT trial. METHODS: Randomly selected family practices in the federal state of Hesse, Germany, were visited by study team members. Eligible patients were screened using an anonymous patient list that was generated by the general practitioners' software according to predefined instructions. A documentation sheet was filled in for all screened patients. Eligible patients were classified into 3 categories (1: patients with a long-term indication for OAC and taking anticoagulants, 2: patients with a long-term indication for OAC but not taking anticoagulants, 3: patients without a long-term indication for OAC but taking an anticoagulant on a permanent basis). IBM SPSS Statistics 20 was used for descriptive statistical analysis. RESULTS: We screened 2,036 randomly selected, potentially eligible patients from 52 family practices. 275 patients could not be assigned to one of the 3 categories and were therefore not considered for analysis. The final study sample comprised 1,761 screened patients, 1,641 of whom belonged to category 1, 78 to category 2, and 42 to category 3. INR values were available for 1,504 patients of whom 1,013 presented INR values within their therapeutic ranges. The majority of screened patients had very good compliance, as assessed by the general practitioner. New antithrombotic drugs were prescribed in 6.1% of cases. CONCLUSIONS: The screening results showed that a high proportion of patients were receiving appropriate anticoagulation therapy. The numbers of patients with a long-term indication for OAC therapy that were not receiving oral anticoagulants, and without a long-term indication that were receiving OAC, were considerably lower than expected. Most patients take coumarins, and the quality of OAC control is reasonably high. TRIAL REGISTRATION: Current Controlled Trials ISRCTN41847489.

[Guideline compliance in the treatment of patients with chronic heart failure through family doctor-centred health care: results of an evaluation study]. / Leitliniengerechte Behandlung bei chronischer Herzinsuffizienz im Rahmen der Hausarztzentrierten Versorgung. Ergebnisse einer Evaluationsstudie.

PROBLEM: Family doctor centred health care (German abbreviation: HzV) agreements in Baden-Wuerttemberg provides that every year the strategies and results of at least two high-quality guidelines shall be discussed and worked on in quality circles. In this regard, the 'heart failure' guideline by the German Society of General Practice and Family Medicine (DEGAM) is especially important due to the high treatment costs and the continuously increasing prevalence of this medical condition. Another specified objective of the HzV agreements is to increase the DMP participation rate. The study addressed two questions: Is the medical care provided to patients with chronic heart failure who are being treated under HzV more compliant with guidelines than routine care? Does further improvement result from working on the guidelines in quality circles? METHODS: Routine data were provided by the AOK Baden-Wuerttemberg statutory health insurance company. Patients with heart failure receiving treatment under an HzV agreement (HzV group) were compared with patients receiving routine care (control group) with regard to quality of care eight months before and eight months after working on the guideline on heart failure in quality circles. Primary endpoints were the prescription of ACE inhibitors, AT1 antagonists and beta blockers in accordance with guidelines. Adjustment for various covariates was done by means of multivariate multilevel regression. RESULTS: Data were available for 3,667 practices [1,295 HzV practices; 2,158 non-HzV practices]. After applying validated diagnosis criteria, 16,584 patients were included in the intervention group and 28,992 in the control group. The HzV group received significantly better care in terms of the primary endpoint "prescription of ACE inhibitors or AT1 antagonists" (73.1 % vs. 69.3 % of the patients received ACE inhibitors or AT1 antagonists at T0 (OR 1.40; 95% CI [1,25; 1,57]; p < .001). 54.2 % vs. 52.3 % of the patients received beta blockers at T0 (not significant after adjustment, p = .260). No further improvement could be demonstrated to result from working on guidelines in quality circles. DISCUSSION AND CONCLUSION: The treatment of HzV patients with chronic heart failure is more compliant with guidelines than that of patients receiving routine care. Quality of care was already high at the beginning, and working on guidelines in quality circles had no noticeable effect. The increased DMP participation rate, which is one of the specified objectives of the HzV agreements, appears to have a mediation effect.

Primary care management for optimized antithrombotic treatment [PICANT]: study protocol for a cluster-randomized controlled trial.

BACKGROUND: Antithrombotic treatment is a continuous therapy that is often performed in general practice and requires careful safety management. The aim of this study is to investigate whether a best-practice model that applies major elements of case management and patient education, can improve antithrombotic management in primary healthcare in terms of reducing major thromboembolic and bleeding events. METHODS: This 24-month cluster-randomized trial will be performed with 690 adult patients from 46 practices. The trial intervention will be a complex intervention involving general practitioners, healthcare assistants, and patients with an indication for oral anticoagulation. To assess adherence to medication and symptoms in patients, as well as to detect complications early, healthcare assistants will be trained in case management and will use the Coagulation-Monitoring List (Co-MoL) to regularly monitor patients. Patients will receive information (leaflets and a video), treatment monitoring via the Co-MoL and be motivated to perform self-management. Patients in the control group will continue to receive treatment as usual from their general practitioners. The primary endpoint is the combined endpoint of all thromboembolic events requiring hospitalization and all major bleeding complications. Secondary endpoints are mortality, hospitalization, strokes, major bleeding and thromboembolic complications, severe treatment interactions, the number of adverse events, quality of anticoagulation, health-related quality of life, and costs. Further secondary objectives will be investigated to explain the mechanism by which the intervention is effective: patients' assessment of chronic illness care, self-reported adherence to medication, general practitioners' and healthcare assistants' knowledge, and patients' knowledge and satisfaction with shared decision making. Practice recruitment is expected to take place between July and December 2012. Recruitment of eligible patients will start in July 2012. Assessment will occur at three time points: baseline and follow-up after 12 months and after 24 months. DISCUSSION: The efficacy and effectiveness of individual elements of the intervention, such as antithrombotic interventions, self-management concepts in orally anticoagulated patients, and the methodological tool of case management, have already been extensively demonstrated. This project foresees the combination of several proven instruments, as a result of which we expect to profit from a reduction in the major complications associated with antithrombotic treatment.