Improving patient self-reporting of antihypertensive adverse drug events in primary care: a stepped wedge cluster randomised trial.

BACKGROUND: About 25% of patients experience adverse drug events (ADE) in primary care, but few events are reported by the patients themselves. One solution to improve the detection and management of ADEs in primary care is for patients to report them to their general practitioner. The study aimed to assess the effect of a booklet designed to improve communication and interaction between patients treated with anti-hypertensive drugs and general practitioners on the reporting of ADEs. METHODS: A cluster randomized controlled cross-sectional stepped wedge open trial (five periods of 3 months) was conducted. A cluster was a group of general practitioners working in ambulatory offices in France. Adults consulting their general practitioner to initiate, modify, or renew an antihypertensive prescription were included. A booklet including information on cardiovascular risks, antihypertensive treatments, and ADE report forms was delivered by the general practitioner to the patient in the intervention group. The primary outcome was the reporting of at least one ADE by the patient to his general practitioner during the three-month period after enrolment. Two clusters were randomised by sequence for a total of 8 to receive the intervention. An intention-to-treat analysis was conducted. A logistic mixed model with random intercept was used. RESULTS: Sixty general practitioners included 1095 patients (median: 14 per general practitioner; range: 1-103). More patients reported at least one ADE to their general practitioner in the intervention condition compared to the control condition (aOR = 3.5, IC95 [1.2-10.1], p = 0.02). The modification and initiation of an antihypertensive treatment were also significantly associated with the reporting of ADEs (aOR = 4.4, CI95 [1.9-10.0], p <  0.001 and aOR = 11.0, CI95 [4.6-26.4], p <  0.001, respectively). The booklet delivery also improved patient satisfaction on general practitioner communication and high blood pressure management. CONCLUSION: A booklet can improve patient self-reporting of ADEs to their general practitioners. Future research should assess whether it can improve general practitioner management of ADEs and patient's health status. TRIAL REGISTRATION: Trial registry identifier NCT01610817 (2012/05/30).

[Information and active patient participation using an interactive booklet in the prescription of antihypertensive drugs in primary care]. / Information et participation active des patients à l'aide d'une brochure interactive lors de la prescription d'antihypertenseurs en soins primaires.

AIM: Antihypertensive drugs are thought to be responsible for adverse drug events in 25% of patients, with severe consequences in 13% of cases. The purpose of this study was to develop an interactive booklet designed to inform and involve patients with a view to preventing adverse drug events. METHODS: The development of the booklet involved several stages, including a literature review, a Delphi survey, a readability assessment, a qualitative study in primary care, a revision process, and graphic design work. 27 experts (patients, general practitioners, public health practitioners, cardiologists, geriatricians, psychologists, economists, pharmacists, nurses and ethicists) participated in the Delphi survey, while the qualitative study was based on a sample that included 7 doctors, 13 patients and 2 healthcare assistants. RESULTS: We developed an interactive booklet containing information items on the benefits and risks of antihypertensive drugs, a care plan to be completed by the patient, and a form for reporting adverse drug events. Ambiguous sentences and incomprehensible medical terms were rephrased. The time required to present the booklet and ease of use were key acceptability criteria for caregivers. Among the patients, the study found that interest in the booklet required clear evidence of an expected benefit. CONCLUSION: An understandable and acceptable interactive booklet was developed using a systematic process to prevent severe adverse drug events in primary care.

[The "doctor" effect in primary care]. / Efficacité thérapeutique de "l'effet médecin" en soins primaires.

AIM: To characterize the factors associated with the 'doctor' effect in primary care, as reported in randomized controlled trials (RCTs). METHOD: A systematic search of Medline (1964-2004) sought to identify all original reports of RCTs, as well as those reported in reviews and metaanalyses. We used the following key words: RCT, doctor-patient relationship, doctor-patient communication, knowledge, skill, attitude, non-pharmacologic effectiveness, primary care. RESULTS: Ten RCTs and one metaanalysis provided evidence that a combination of emotional and cognitive care has a consistently positive effect on health outcomes. This effect relies on specific attitudes and skills: empathy, reassurance, explanation, counseling, influencing patients' 'health beliefs and expectations, promoting change in behavior, thoughts or emotions. These can be integrated into a specific patient-centered approach to general practice. Medical education must provide training in the relational skills needed for effective treatment. CONCLUSION: Qualitative and quantitative research, including RCTs, are necessary; they should be designed to deal with the heterogenous situations and specific characteristics of general practice.

Evaluation of an interactive program for preventing adverse drug events in primary care: study protocol of the InPAct cluster randomised stepped wedge trial.

BACKGROUND: Adverse drug events could often be prevented. One of their main causes is that patients rarely know how to detect them. Another cause is inadequate communication between patients and physicians. If patients were to be effectively trained in detecting and reporting adverse drug events, this should help to prevent their occurrence and subsequent complications. Our purpose is to present the protocol of the InPAct trial, which aims to evaluate an interactive program that encourages patients to report adverse drug events in primary care. METHODS/DESIGN: We will conduct a cluster randomised controlled stepped wedge trial, with eight clusters of 10 general practitioners each. The physicians will suggest to all of their antihypertensive-treated patients that they take part in this study. The InPAct program will be implemented in the clusters in random order along five successive three-month periods. Two new clusters will be trained in implementing the program at each step. The program features: an interactive patient booklet including informative paragraphs, several care plans and adverse drug event report forms; and standardised training of physicians in how to present the booklet to the patient. The primary outcome will be the reporting of adverse drug events by patients to their physician within three months. We assume that the number of patients reporting at least one adverse drug event will increase from 3% before program implementation to 7.5% afterward (coefficient of variation = 0.5, α = 0.05, ß = 0.2), which means that 1,200 patients must be included. The effect of the intervention on the main outcome will be quantified and tested using a mixed logistic model to integrate cluster and time effects. DISCUSSION: Our choice of a stepped wedge design is particularly appropriate for evaluating the implementation of a patient safety program within the constraints of general practice. We describe the InPAct intervention, which is an original program that is intended to improve communication between patients and physicians. Indeed, none of the previously published intervention studies has combined a patient education program and a patient reporting system for adverse drug events with the aim of improving patient safety in primary care. TRIAL REGISTRATION: This study is registered in ClinicalTrials.gov NCT01610817.

[Classifications and definitions of adverse events in primary care: a systematic review]. / Classifications et définitions des événements indésirables associés aux soins primaires: une synthèse de la littérature.

UNLABELLED: In an aim to standardize the terminology used in patient safety research, the World Health Organization (WHO) has recommended the use of internationally acceptable patient safety concepts for the collection and classification of adverse events and near misses in health care settings worldwide. OBJECTIVE: The principal aims of this study were to clarify patient safety terminology and concepts, to suggest a comprehensible definition of medical error, and to propose patient safety classifications for use in primary health care. DESIGN: Systematic review and synthesis of the international medical literature. METHODS: In order to define "medical error" as a health care term and to identify various published or unpublished classifications of medical errors, we searched the Medline, Web of Science, Cochrane Library, Pascal, and French Data Bank of Public Health bibliographical medical databases for the years 2000 through 2011. A grey literature search was carried out using the Google and Google Scholar search engines. We used the recommendations of WHO to analyze these classifications. The principal key words used were: primary care, family practice, patient safety event, adverse event and taxonomy. RESULTS: The online search identified 191 documents; among these, 51 articles, eight reports and two books were deemed appropriate. Twelve classifications were analyzed and compared using WHO recommendations. Eight definitions of medical error were identified during this analysis. CONCLUSION: The WHO Alliance for Patient Safety has clarified the definition of several terms - medical error, adverse event, patient safety event, and near miss - through the development of the International Patient Safety Event Classification. This conceptual framework and classification for patient safety should be applicable across the full spectrum of health care, including primary health care.

Patient versus general practitioner perception of problems with treatment adherence in type 2 diabetes: from adherence to concordance.

OBJECTIVES: To determine the prevalence of problems with treatment adherence among type-2 diabetic patients with regards to medication, dietary advice, and physical activity; to identify the associated clinical and psychosocial factors; and to investigate the degree of agreement between patient-perceived and GP-perceived adherence. METHODS: Consecutive patients were solicited during visits to 39 GPs. In total, 521 patients self-reported on treatment adherence, anxiety and depression, and disease perception. The GPs reported clinical and laboratory data and patients' adherence. A multivariate analysis identified the factors associated with adherence problems. RESULTS: Problems of adherence to medication, dietary advice, and physical activity recommendations were reported by 17%, 62%, and 47% of the patients, respectively. Six independent factors were found associated with adherence problems: young age, body-mass index (BMI) > 30 kg/m(2), glycosylated haemoglobin (HbA(1c)) > 8%, single life, depression, and perception of medication as a constraint. Agreement between patients' and GPs' assessments of treatment problems reached 70%. CONCLUSION: In type 2 diabetes, problems with dietary advice or physical activity are far more frequent than problems with medication, and not all physicians are fully aware of patients' problems. More active listening and shared decision-making should enhance adherence and improve outcomes.

[Impact of adverse events on the practices of 15 general practitioners]. / Impact des événements indésirables sur la pratique de 15 médecins généralistes maîtres de stage.

INTRODUCTION: General practitioners are sometimes faced with adverse events, which we define here as "all untoward or unfortunate events occurring unintentionally during the provision of health care services, but also all such events related to any kind of intervention during care." While their social, economic, and health repercussions are often studied, little is known about their effects on general practitioners, except perhaps for their legal consequences. Our principal objectives here were to study the impact of adverse events (including medical errors) on the practices of general practitioners and to study their representations of the concepts of adverse events and medical errors. METHOD: This qualitative work is based on interviews with 15 general practitioners in the Rhone-Alpes region. RESULTS: This study collected 66 real situations experienced and identified as adverse events by the subjects. Analysis shows that these events had a major impact on these practitioners: they caused changes in their procedures for diagnosis and treatment, had sometimes important psychological consequences, induced them to participate in targeted continuing education, and increased their awareness of the legal aspects of some practices, including, for example, record-keeping. Most expressed a need to discuss these situations, especially in peer groups. CONCLUSION: It appears essential to study adverse events and professional practices in primary care and to facilitate their ongoing study, especially in the area of family care.