Efficacy of nurse-led and general practitioner-led comprehensive geriatric assessment in primary care: protocol of a pragmatic three-arm cluster randomised controlled trial (CEpiA study).

INTRODUCTION: Older patients raise therapeutic challenges, because they constitute a heterogeneous population with multimorbidity. To appraise this complexity, geriatricians have developed a multidimensional comprehensive geriatric assessment (CGA), which may be difficult to apply in primary care settings. Our primary objective was to compare the effect on morbimortality of usual care compared with two complex interventions combining educational seminars about CGA: a dedicated geriatric hotline for general practitioners (GPs) and CGA by trained nurses or GPs. METHODS AND ANALYSIS: The Clinical Epidemiology and Ageing study is an open-label, pragmatic, multicentre, three-arm, cluster randomised controlled trial comparing two intervention groups and one control group. Patients must be 70 years or older with a long-term illness or with unscheduled hospitalisation in the past 3 months (750 patients planned). This study involves volunteering GPs practising in French primary care centres, with randomisation at the practice level. The multifaceted interventions for interventional arms comprise an educational interactive multiprofessional seminar for GPs and nurses, a geriatric hotline dedicated to GPs in case of difficulties and the performance of a CGA updated to primary care. The CGA is systematically performed by a nurse in arm 1 but is GP-led on a case-by-case basis in arm 2. The primary endpoint is a composite criterion comprising overall death, unscheduled hospitalisations, emergency admissions and institutionalisation within 12 months after inclusion. Intention-to-treat analysis will be performed using mixed-effects logistic regression models, with adjustment for potential confounders. ETHICS AND DISSEMINATION: The protocol was approved by an appropriate ethics committee (CPP Ile-de-France IV, Paris, France, approval April 2015;15 664). This study is conducted according to principles of good clinical practice in the context of current care and will provide useful knowledge on the clinical benefits achievable by CGA in primary care. TRIAL REGISTRATION NUMBER: NCT02664454; Pre-results.

Reasons for non-intensification of treatment in people with type 2 diabetes receiving oral monotherapy: Outcomes from the prospective DIAttitude study.

OBJECTIVES: To describe the management of glucose-lowering agents in people with type 2 diabetes initially on oral monotherapy, cared for by French general practitioners, and to identify reasons underlying treatment non-intensification. METHODS: People with type 2 diabetes on oral monotherapy were recruited by general practitioners and followed-up over 12 months. Patient characteristics, HbA1c, and glucose-lowering treatments were recorded electronically. Management objectives and reasons for treatment non-intensification were solicited from the general practitioners. RESULTS: A total of 1212 patients were enrolled by 198 general practitioners; 937 patients (mean age 68 years) were treated with oral monotherapy, and 916 patients had at least two successive HbA1c values recorded. Of these, 390 patients (43%) had HbA1c≥6.5% on both occasions, and 164/390 (42%) had their treatment intensified. The 226 patients whose treatment was not intensified were older (69±11 years vs. 66±12 years, P=0.02) and had better glycaemic control at study inclusion (6.9%±0.6 vs. 7.3%±0.8, P<0.0001) than treatment intensified patients. Among uncontrolled patients, there were no differences in general practitioner treatment objectives at inclusion for treatment intensified and non-intensified patients; the main reason given by general practitioners for non-intensification was that the patient had an adequate HbA1c (66%). HbA1c did exceed the 6.5% target, but was less than 7.0% in 69% of cases. CONCLUSIONS: General practitioners showed a patient-centred approach to treatment, but clinical inertia was apparent for 31% of the uncontrolled patients.

Effect of reminders mailed to general practitioners on colorectal cancer screening adherence: a cluster-randomized trial.

Reminders have been used in various settings, but failed to produce convincing evidence of benefits on patient adherence to colorectal cancer (CRC) screening. The aim of this study was to assess the effectiveness of sending general practitioners (GPs) printed reminders about CRC screening. We conducted a cluster-randomized controlled trial involving 144 GPs in the Val-de-Marne district (France), who provided care for any reason to 20 778 patients eligible for CRC screening between June 2010 and November 2011. Data were collected from the main statutory health-insurance programme and local cancer screening agency. GPs were randomly assigned in a 1 : 1 proportion to the intervention or the control group. Every 4 months, intervention-group GPs received a computer-generated printed list of patients who had not performed scheduled faecal occult blood test (FOBT) screening. The primary outcome was patient adherence to FOBT screening or exclusion from CRC screening for medical reasons. The screening adherence rate was 31.2% [95% confidence interval (CI) 30.3-32.1] in the control group and 32.9% (95% CI 32.0-33.8) in the intervention group [crude relative risk, 1.05 (95% CI 1.01-1.09), P<0.01]. This rate was not significantly different between groups by multilevel modelling accounting for clustering and confounding variables [adjusted relative risk, 1.07 (95% CI 0.95-1.20), P=0.27]. Computer-generated printed reminders sent to GPs did not significantly improve patient adherence to organized CRC screening by the FOBT.

[Determinants of the cost of initiation of insulin therapy type 2 diabetic patients in France: possible approaches to optimization]. / Déterminants des coûts du passage à l’insuline en France chez le patient diabétique de type 2 : quelles pistes d’optimisation ?

Increased costs cannot be exclusively attributed to the consequences of insulin prescription. Any initiative designed to accelerate acquisition of patient autonomy would be likely to reduce the costs observed after switching to insulin, provided this initiative is adapted to the patient’s health profile, diabetes history and available medical resources..

[COPD patient care pathways: points of view of hospital personnel]. / Trajectoires de soins des patients ayant une bronchopneumopathie chronique obstructive: points de vue des acteurs hospitaliers.

INTRODUCTION: The aim of this study was to identify, from an hospital point of view, the care pathways of patients with chronic obstructive pulmonary disease (COPD) between the ambulatory and in-hospital settings in two regions to the East of Paris (Val-de-Marne and Seine-et-Marne). METHODS: A qualitative multisite case study was conducted from January to October 2012 with hospital doctors managing patients with COPD. Semi-structured individual interviews were carried out with 46 hospital practitioners from the 25 main hospitals of this area. RESULTS: A marked variability in care pathways was observed between the 25sites studied, but no typology could be established. The care pathways depended on the configuration of the available local medical facilities. The main finding of this study was the global lack of coordination between ambulatory care and in-hospital care of patients before and after hospitalization. DISCUSSION: The care pathways identified concerned the probably most severely ill patients who frequently attend hospital emergency rooms. The lack of pre-hospital coordination for the management of acute exacerbations resulted in a very high hospitalization rate. However, international studies have showed that a better management in an ambulatory care setting reduced significantly the hospitalization rates. The problem ofcoordination between ambulatory and in-hospital carefor optimizing of the care pathways remains unsolved in the territories studied here. This example of COPD care shows that a better management of patients with chronic diseases requires a restructuring of the local health care systems in France.

Use of Vildagliptin in Management of Type 2 Diabetes: Effectiveness, Treatment Persistence and Safety from the 2-Year Real-Life VILDA Study.

INTRODUCTION: There is an increasing interest for real-life data on drug use in many countries. Reimbursement authorities more and more request observational studies to assess the conditions of use of the products but also to improve knowledge about efficacy and safety in the real world and on a longer term than in clinical trials. AIM: To evaluate the effectiveness, treatment persistence and tolerability of vildagliptin in clinical practice. METHODS: This observational, 2-year prospective cohort study was conducted in France on request of the Health Authorities [Haute Autorite de Sante (HAS)]. Type 2 diabetic mellitus (T2DM) patients initiating vildagliptin (including the fixed combination vildagliptin-metformin) or treated for <6 months were recruited through a national representative sample of general practitioners (GPs) (n = 482) and diabetologists (n = 84) between March 2010 and December 2011. At inclusion and each follow-up visit at ~ 6, 12, 18 and 24 months, a questionnaire was completed by the physician collecting information on socio-demographic, clinical and biological data, treatments and adverse events. RESULTS: 1,700 patients were included: 60% were males, aged 63 ± 11 years, with diabetes duration 7 ± 6 years and body mass index (BMI) 30 ± 6 kg/m(2). 45% were obese, 70% treated for hypertension and 66% for dyslipidemia. 64% of the patients received vildagliptin in dual therapy with metformin. 82% of patients completed the 2-year follow-up. Glycosylated hemoglobin (HbA1c) decreased from a mean baseline of 7.8 ± 1.2% when vildagliptin was started, to 7.0 ± 1.1% at 6 months and remained stable thereafter over 2 years. Mean weight, glomerular filtration rate, liver enzymes, and lipid parameters were unchanged over the study period. Eight patients (0.5%), all concomitantly treated with insulin and/or sulphonylureas, reported one severe hypoglycemia and 47 (2.9%) patients reported 64 non-severe symptomatic hypoglycemia (59% occurred when patients were treated with insulin and/or sulphonylureas). At 6 months, 44.9% of vildagliptin-treated patients reached an HbA1c <7% without hypoglycemia and no weight gain, and this percentage increased to 49.7% at 24 months. Vildagliptin treatment maintenance at 2 years was 88.8% [95% CI (87.2%; 90.4%)], with 4% of patients discontinuing for adverse events. CONCLUSIONS: In everyday conditions of care, vildagliptin efficacy was in line with existing data from randomized clinical trials, sustained over 2 years, with low discontinuation rate and low hypoglycemia risk.

Long-term effects of an educational seminar on antibiotic prescribing by GPs: a randomised controlled trial.

BACKGROUND: High levels of outpatient antibiotic use remain observed in many European countries. Several studies have shown a strong relationship between antibiotic use and bacterial resistance. AIM: To assess the long-term effect of a standardised educational seminar on antibiotic prescriptions by GPs. DESIGN AND SETTING: Randomised controlled trial of 171 GPs (of 203 initially randomised) in France. METHOD: GPs in the control group (n = 99) received no antibiotic prescription recommendation. Intervention group GPs (n = 72) attended an interactive seminar presenting evidence-based guidelines on antibiotic prescription for respiratory infections. The proportion of prescriptions containing an antibiotic in each group and related costs were compared to the baseline up to 30 months following the intervention. Data were obtained from the National Health Insurance System database. RESULTS: In the intervention group, 4-6 months after the intervention, there was a significant decrease in the proportion of prescriptions containing an antibiotic from 15.2 ± 5.4% to 12.3 ± 5.8% (-2.8% [95% CI = -3.8 to -1.9], P<0.001). By contrast, an increase was observed in controls from 15.3 ± 6.0 to 16.4 ± 6.7% (+1.1% [95% CI = +0.4 to +1.8], P<0.01), resulting in a between-group difference of 3.93% ([95% CI = 2.75 to 5.11], P<0.001). The between-group difference was maintained 30 months after intervention (1.99% [95% CI = 0.56 to 3.42], P<0.01). Persistence of the intervention effect over the entire study period was confirmed in a hierarchical multivariate analysis. CONCLUSION: This randomised trial shows that a standardised and interactive educational seminar results in a long-term reduction in antibiotic prescribing and could justify a large-scale implementation of this intervention.

[Type 2 diabetes in France: epidemiology, trends of medical care, social and economic burden]. / Le diabète de type 2 en France : épidémiologie, évolution de la qualité de la prise en charge, poids social et économique. Entred 2007.

Between 2001 and 2007, treatments for type 2 diabetes have increased and therapeutic choices have improved. However glycemic control remains insufficient. Cardiovascular risk control has widely increased. Statins, hypertensive and antithrombotic treatments are more often prescribed. Blood pressure and LDL cholesterol levels have decreased whatever age. However, progress remains possible, especially regarding blood pressure control. Obesity has increased between 2001 and 2007 to reach 41% whereas the frequency of dietetic visits has decreased. Insulin therapy (more than obesity) determines the frequency of dietetic visits: dietetic care happens too late. Important improvements of the quality of follow-up are observed. However, fundus exams and more specifically albuminuria measurement remain insufficiently performed and their progression is too slow, as well as the podiatric examination. Only 10% of people with type 2 diabetes have an endocrinology visit, which has been stable between 2001 and 2007. Information expectations of people with type 2 diabetes are strong, especially for diet. Education demand is lower but more important for people who have already benefited. This improvement of medical care leads to an increase in the cost of reimbursements. The consequences of diabetes, more than the disease itself, alter the quality of life.

Understanding barriers to organized breast cancer screening in France: women's perceptions, attitudes, and knowledge.

BACKGROUND: The participation rate in organized breast cancer screening in France is lower than recommended. Non-participants either use opportunistic screening or do not use either screening modality. OBJECTIVE: To assess any differences in perceptions, attitudes and knowledge related to breast cancer screening between users of opportunistic screening and non-users of any screening mammograms and to identify potential barriers to participation in organized screening. METHODS: Six focus groups were conducted in May 2010 with 34 French non-participants in organized screening, 15 who used opportunistic screening (OpS group) and 19 who used no screening (NoS group). The guide used for both groups explored perceptions and attitudes related to health, cancer and screening; perceptions of femininity; and knowledge about breast cancer screening. Thematic content analysis was performed. RESULTS: Perceptions, attitudes and knowledge differed between the two groups. Women in the OpS group perceived a high susceptibility to breast cancer, visited their gynaecologist regularly, were unfamiliar with organized screening modalities and had doubts about its quality. NoS women had very high- or low-perceived susceptibility to breast cancer, knew about screening modalities, had doubts about its usefulness and expressed negative opinions of mammograms. CONCLUSIONS: Differences in perceptions and attitudes related to breast cancer screening partially explain why some women choose opportunistic screening or no screening. General practitioners and gynaecologists are in a unique position to provide individually tailored preventative messages to improve participation in organized screening.

Improving participation in colorectal cancer screening: targets for action.

OBJECTIVE: Our aim was to determine whether physician-related factors influenced patient participation in colorectal cancer (CRC) screening programs and to identify patient characteristics associated with lower participation in order to facilitate the development of targeted actions to improve participation. METHOD: A retrospective cohort study was conducted in a French department during its first CRC screening campaign from June 2007 to May 2010. Data for 157,766 patients followed by 903 general practitioners (GPs) were analyzed. Patient participation was assessed using multilevel logistic modeling. RESULTS: The overall participation rate was 30% (95% confidence interval [95% CI], 29.8-30.2) and varied across the 903 GPs from 0% to 75.5% (median, 30; interquartile range, 24-35). Inter-GP variance explained only 5.5% of the participation rate variance. Participation was significantly lower in males (odds ratio [OR], 0.79; 95% CI, 0.78-0.91), the youngest age group (55-59 years, OR, 0.61; 95% CI, 0.58-0.63), and patients living in socioeconomically deprived areas (OR, 0.82; 95% CI, 0.77-0.87). CONCLUSION: Targeted actions to improve CRC screening participation should focus on patients younger than 60 years, males, and individuals living in deprived areas. Actions to enhance the influence of GPs on patient participation should be directed to the overall population of GPs.

Physicians' understanding of patients' personal representations of their diabetes: accuracy and association with self-care.

The degree of accuracy with which physicians understand their patients' views may be of central importance for promoting self-care in the majority of chronic illnesses and in type 2 diabetes in particular. The objectives of this study were to measure the accuracy of the general practitioners' understanding of the patients' views and relate it to health behavioural outcomes in patients with non-complicated type 2 diabetes. The participants in this cross-sectional study consisted of 14 clinicians and 78 of their patients from Paris, France. The predictors were levels of accuracy in understanding the patients' views derived from the illness perception questionnaire-revised (IPQ-R). The outcomes were patient-reported self-care measures. In regression models controlling for clinical and personal variables, higher accuracy on chronicity beliefs was associated with an improved diet and increased blood glucose self-testing and higher accuracy in identifying treatment control beliefs was associated with better dietary self-care. Accuracy was higher with regard to beliefs about causes, treatment control and consequences. These results suggest that accuracy may impact self-care in specific domains of illness perception but not others. The results may help identify useful avenues of communication training designed for professionals.