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Background: In Germany, patients receiving oral anticoagulation (OAC) are often treated by general practitioners (GPs), and large proportions of patients receive vitamin K antagonists (VKAs). The quality of OAC in German GP practices, differences between various practices, and improvement potential through implementation of case management, have not yet been investigated satisfactorily. Based on results of a cluster-randomized controlled trial, we aimed to assess whether OAC quality can be improved, any variations between practices exist and determine practice- and patient-level factors., Methods: The PICANT trial (2012-2015) was performed in 52 GP practices in Hesse, Germany. Adult patients with long-term indication for OAC received best practice case management in the intervention group. International normalized ratio (INR) values were recorded from anticoagulation passes. The Rosendaal method was used to calculate Time in Therapeutic Range (TTR) at patient level, and mean pooling to obtain center-specific TTR (cTTR) at practice level. The quality of OAC was assessed by TTR and cTTR. Linear model analyses were used to investigate associations between practice-/ patient-level factors and TTR., Results: Inclusion of 736 patients (49.6% intervention and 50.4% control patients); 690 (93.8%) received phenprocoumon. Within 24 months, the TTR was 75.1% (SD 17.6) in the intervention versus 74.3% (SD 17.8) in the control group (p = 0.670). The cTTR averaged 75.1% (SD 6.5, range: 60.4 to 86.7%) in the intervention versus 74.3% (SD 7.2, range: 52.7 to 85.7%) in the control group (p = 0.668). At practice level, the TTR was significantly lower in practices with a male physician and certification in quality management. At patient level, the TTR was significantly higher in patients with moderate to high compliance, in men, and in patients that performed self-management. The TTR was significantly lower in patients with certain comorbidities, and who were hospitalized., Conclusions: The intervention did not effectively improve OAC quality compared to routine care. Quality of INR control was generally good, but considerable variation existed between GP practices. The variability indicates optimization potential in some practices. The demonstrated association between patient-level factors and TTR highlights the importance of considering patient characteristics that may impede achieving high quality therapeutic outcomes., Trial Registration: ISRCTN registry, ISRCTN41847489 , registered 27 February 2012.

Purpose: To examine whether applying case management in general practices reduces thromboembolic events requiring hospitalization and major bleeding events (combined primary outcome). Secondary endpoints were mortality, frequency and duration of hospitalization, severe treatment interactions, adverse events, quality of anticoagulation, health-related quality of life and intervention costs, patients' assessment of chronic illness care, self-reported adherence to medication, GP and HCA knowledge, patient knowledge and satisfaction with shared decision-making., Methods: Cluster-randomized controlled trial undertaken at 52 general practices in Germany with adult patients with a long-term indication for oral anticoagulation. The complex intervention included training for healthcare assistants, information and quality circles for general practitioners and 24 months of case management for patients. Assessment was after 12 and 24 months. The intention-to-treat population included all randomized practices and patients, while the per-protocol analysis included only those that received treatment without major protocol violations., Results: The mean (SD) age of the 736 patients was 73.5 (9.4) years and 597 (81.1%) had atrial fibrillation. After 24 months, the primary endpoint had occurred in 40 (11.0%) intervention and 48 (12.9%) control patients (hazard ratio 0.83, 95% CI 0.55 to 1.25; P = .37). Patients' perceived quality of care, their knowledge, and HCAs' knowledge, had improved significantly at 24 months. The other secondary endpoints did not differ between groups. In the intervention group, hospital admissions were significantly reduced in patients that received treatment without major protocol deviations., Conclusions: Even though the main outcomes did not differ significantly, the intervention appears to have positively influenced several process parameters under 'real-world conditions'., Competing Interests: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Juliana J. Petersen has been a co-investigator in the PANORA study (‘Prevalence of anti-cyclic citrullinated peptide (CCP) positivity in patients with new non-specific onset of musculoskeletal symptoms, possibly related to early rheumatoid arthritis in general practices in Germany’), which is being conducted by the Fraunhofer Institute and financed by Bristol‐Meyer Squibb. She is employed by the Institute of General Practice of Goethe-University Frankfurt and has never personally received financial remuneration from a pharmaceutical company. Karola Mergenthal is employed as project manager in the PANORA study. She has also never personally received financial remuneration from a pharmaceutical company. Andrea Siebenhofer received funding from the Federation of Austrian Social Insurance Institutions (HVB) for the preparation of a systematic review on self-management of oral anticoagulation in 2014 and was financed by ROCHE Diagnostics to carry out a study on self-management of oral anticoagulation from 2002-2005. Sebastian Harder has received honoraria for scientific lectures from Boehringer Ingelheim GmbH, Pfizer GmbH, Daiichi Sankyo GmbH, and Bayer AG. The other authors declare no competing interests. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Purpose: Collaborative care is effective in improving symptoms of patients with depression. The aims of this study were to characterize symptom trajectories in patients with major depression during one year of collaborative care and to explore associations between baseline characteristics and symptom trajectories., Methods: We conducted a cluster-randomized controlled trial in primary care. The collaborative care intervention comprised case management and behavioral activation. We used the Patient Health Questionnaire-9 (PHQ-9) to assess symptom severity as the primary outcome. Statistical analyses comprised latent growth mixture modeling and a hierarchical binary logistic regression model., Results: We included 74 practices and 626 patients (310 intervention and 316 control recipients) at baseline. Based on a minimum of 12 measurement points for each intervention recipient, we identified two latent trajectories, which we labeled 'fast improvers' (60.5%) and 'slow improvers' (39.5%). At all measurements after baseline, 'fast improvers' presented higher PHQ mean values than 'slow improvers'. At baseline, 'fast improvers' presented fewer physical conditions, higher health-related quality of life, and had made fewer suicide attempts in their history., Conclusions: A notable proportion of 39.5% of patients improved only 'slowly' and probably needed more intense treatment. The third follow-up in month two could well be a sensible time to adjust treatment to support 'slow improvers'., Competing Interests: Juliana J. Petersen has been a co-investigator in the PANORA study (‘Prevalence of anti-cyclic citrullinated peptide (CCP) positivity in patients with new non-specific onset of musculoskeletal symptoms, possibly related to early rheumatoid arthritis in general practices in Germany’), which is being conducted by the Fraunhofer Institute and financed by Bristol‐Meyer Squibb. She is employed by the Institute of General Practice of Goethe-University Frankfurt and has never personally received financial remuneration from a pharmaceutical company. Andreas Reif has received research grants from Medice, Speaker’s fees from Medice, Shire, Servier, Janssen and neuraxpharm. This does not alter our adherence to PLOS ONE policies on sharing data and materials. All other authors declare no competing interests exist.

Background: Oral anticoagulation therapy (OAT) is a challenge in general practice, especially for high-risk groups such as the elderly. Insufficient patient knowledge about safety-relevant aspects of OAT is considered to be one of the main reasons for complications. The research question addressed in this manuscript is whether a complex intervention that includes practice-based case management, self-management of OAT and additional patient and practice team education improves patient knowledge about anticoagulation therapy compared to a control group of patients receiving usual care (as a secondary objective of the Primary Care Management for Optimised Antithrombotic Treatment (PICANT) trial)., Methods: The cluster-randomised controlled PICANT trial was conducted in 52 general practices in Germany, between 2012 and 2015. Trial participants were patients with a long-term indication for oral anticoagulation. A questionnaire was used to assess knowledge at baseline, after 12, and after 24 months. The questionnaire consists of 13 items (with a range of 0 to 13 sum-score points) covering topics related to intervention. Differences in the development of patient knowledge between intervention and control groups compared to baseline were assessed for each follow-up by means of linear mixed-effects models., Results: Seven hundred thirty-six patients were included at baseline, of whom 95.4% continued to participate after 12 months, and 89.3% after 24 months. The average age of patients was 73.5 years (SD 9.4), and they mainly suffered from atrial fibrillation (81.1%). Patients in the intervention and control groups had similar knowledge about oral anticoagulation at baseline (5.6 (SD 2.3) in both groups). After 12 months, the improvement in the level of knowledge (compared to baseline) was significantly larger in the intervention group than in the control group (0.78 (SD 2.5) vs. 0.04 (SD 2.3); p = 0.0009). After 24 months, the difference between both groups was still statistically significant (0.6 (SD 2.6) vs. -0.3 (SD 2.3); p = 0.0001)., Conclusion: Since this intervention was effective, it should be established in general practice as a means of improving patient knowledge about oral anticoagulation., Trial Registration: Current controlled trials ISRCTN41847489 ; Date of registration: 13/04/2012.

Background: Although the risk of developing colorectal cancer (CRC) is 2-4 times higher in case of a positive family history, risk-adapted screening programs for family members related to CRC- patients do not exist in the German health care system. CRC screening recommendations for persons under 55 years of age that have a family predisposition have been published in several guidelines. The primary aim of this study is to determine the frequency of positive family history of CRC (1st degree relatives with CRC) among 40-54 year old persons in a general practitioner (GP) setting in Germany. Secondary aims are to detect the frequency of occurrence of colorectal neoplasms (CRC and advanced adenomas) in 1st degree relatives of CRC patients and to identify the variables (e.g. demographic, genetic, epigenetic and proteomic characteristics) that are associated with it. This study also explores whether evidence-based information contributes to informed decisions and how screening participation correlates with anxiety and (anticipated) regret., Methods/design: Prior to the beginning of the study, the GP team (GP and one health care assistant) in around 50 practices will be trained, and about 8,750 persons that are registered with them will be asked to complete the "Network against colorectal cancer" questionnaire. The 10% who are expected to have a positive family history will then be invited to give their informed consent to participate in the study. All individuals with positive family history will be provided with evidence-based information and prevention strategies. We plan to examine each participant's family history of CRC in detail and to collect information on further variables (e.g. demographics) associated with increased risk. Additional stool and blood samples will be collected from study-participants who decide to undergo a colonoscopy (n ~ 350) and then analyzed at the German Cancer Research Center (DKFZ) Heidelberg to see whether further relevant variables are associated with an increased risk of CRC. One screening list and four questionnaires will be used to collect the data, and a detailed statistical analysis plan will be provided before the database is closed (expected to be June 30, 2015)., Discussion: It is anticipated that when persons with a family history of colorectal cancer have been provided with professional advice by the practice team, there will be an increase in the availability of valid information on the frequency of affected individuals and an increase in the number of persons making informed decisions. We also expect to identify further variables that are associated with colorectal cancer. This study therefore has translational relevance from lab to practice., Trial Registration: German Clinical Trials Register DRKS00006277.

Objective: The aims of this study were (1) to assess the long-term effects of a collaborative care intervention for patients with depression on process of care outcomes, and (2) to describe whether case management was continued after the end of the original one-year intervention., Methods: This 24-month follow-up of a randomized controlled trial took place 12 months after the end of the 1-year intervention. Data collection occurred by means of self-rating questionnaires and from medical records. We calculated linear mixed and logistic generalized estimating equation models., Results: Of the 626 patients included at baseline, 439 (70.1%) participated in this follow-up. Intervention recipients gave higher ratings than control recipients in terms of mean overall Patient Assessment of Chronic Illness Care (PACIC) scores (3.12 vs. 2.86; P = .019), but no difference was found in medication adherence (mean Morisky score 2.59 vs. 2.65, P = .56), prescribed antidepressant medications (60.2% vs. 55.1%; P = .25), visits to the family physician (15.96 vs. 14.46, P = .58) or mental health specialist (3.01 vs. 2.94, P = .94) over the 12 month follow-up period. Case management was continued for 47 (22.5%) selected intervention patients after the original intervention had ended., Conclusion: At 24 months, intervention and control recipients had different PACIC ratings, but other process of care outcomes did not differ., Practice Implications: The main effects of the intervention are apparent at 12 months., (Copyright © 2014 Elsevier Inc. All rights reserved.)

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.

Aim: Oral anticoagulation (OAC) has been shown to be highly effective in preventing thromboembolic complications. Self-management can enable patients with a long-term indication for OAC to be actively involved in the therapy, but in Germany the implementation of self-management is linked to mandatory training. To illustrate significant structural disparities between education centres in Hesse, all such centres were identified and a list generated, specifying the differences., Method: Using our own questionnaire, we interviewed all known patient education centres in Hesse between January and July 2012, and conducted a descriptive analysis of their structural features., Results: There were 44 datasets for statistical interpretation. We distinguished between centres with ASA certification (n=19) and centres without (n=25). On average, certified centres provide 6 h of training (range 2-9) compared to 5.5 h (range 1-12) in uncertified centers. Certified centres hold more group sessions per year (on average 17 vs. 8) and more individual training sessions (on average 10 vs. 5). Certified centres train 10-365 patients per year and uncertified centers between 5 and 77. Certified centres offer retraining more frequently (84% vs. 40%) and more often conclude the training with a written test (74% vs. 44%). Only 9 centres provide materials for patients with a migration background., Conclusion: The results show that in Hesse, severe structural discrepancies exist in training programmes for self-management of OAC, and it can be assumed that patients participating in trainings in different Hessian education centres face very differing conditions. To improve the quality of the trainings and to ensure patients have similar levels of knowledge, it is imperative that centres be regularly inspected with the help of proven quality indicators., (© Georg Thieme Verlag KG Stuttgart · New York.)

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.

Objective: Family practice-based depression case management improves depression symptoms and adherence to medication. The aim of this study was to explore the long-term effects of practice-based depression case management on patient depression-related self-management knowledge and activities., Methods: This long-term follow-up of a randomized controlled trial study took place 12 months after the end of the 1-year case management intervention. We used a modified version of the depression-specific self-management questionnaire described in Ludman et al. [Psychol Med, 33 (2003) 1061-1070]. Analyses of self-management knowledge and activities used a linear mixed model accounting for practice cluster effects and treatment group., Results: Of the 626 patients included at baseline, 439 (70.1%) participated 24 months later in this follow-up study, i.e., 12 months after the end of the intervention. Compared to control recipients, intervention recipients presented statistically significant increased knowledge of medication side-effects and felt more able to avoid situations that may trigger depression. They also tried more often to undertake enjoyable activities and set more time aside for these activities., Conclusion: This study suggests that case management improves depression-related self-management knowledge and activities in depressed primary care patients 12 months after the end of the intervention., Practice Implications: Clinicians may consider introducing practice-based case management for improving patients' self-management activities and knowledge., (Copyright © 2011 Elsevier Inc. All rights reserved.)