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).

A multifaceted risk management program to improve the reporting rate of patient safety incidents in primary care: a cluster-randomised controlled trial.

BACKGROUND: While patient safety incident reporting is of key importance for patient safety in primary care, the reporting rate by healthcare professionals remains low. This study aimed to assess the effectiveness of a risk management program in increasing the reporting rate within multiprofessional primary care facilities. METHODS: A nation-wide cluster-randomised controlled trial was performed in France, with each cluster defined as a primary care facility. The intervention included professional e-learning training, identification of a risk management advisor, and multidisciplinary meetings to address incident analysis. In the first observational period, a patient safety incident reporting system for professionals was implemented in all facilities. Then, facilities were randomised, and the program was implemented. Incidents were reported over the 15-month study period. Quasi-Poisson models were used to compare reporting rates. RESULTS: Thirty-five facilities (intervention, n = 17; control, n = 18) were included, with 169 and 232 healthcare professionals, respectively, involved. Overall, 7 out of 17 facilities carried out the entire program (41.2%), while 6 did not hold meetings (35.3%); 48.5% of professionals logged on to the e-learning website. The relative rate of incidents reported was 2.7 (95% CI = [0.84-11.0]; p = 0.12). However, a statistically significant decrease in the incident rate between the pre-intervention and post-intervention periods was observed for the control arm (HR = 0.2; 95% CI = [0.05-0.54]; p = 0.02), but not for the intervention arm (HR = 0.54; 95% CI = [0.2-1.54]; p = 0.23). CONCLUSION: This program didn't lead to a significant improvement in the patient safety incident reporting rate by professionals but seemed to sustain reporting over time. Considering that the program was fully implemented in only 41% of facilities, this highlights the difficulty of implementing such multidisciplinary programs in primary care despite its adaptation to the setting. A better understanding of how risk management is currently organized in these multiprofessional facilities is of key importance to improve patient safety in primary care. TRIAL REGISTRATIONS: The study has been registered at clinicaltrials.gov (NCT02403388) on 30 March 2015.

[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.

Patient safety incidents are common in primary care: A national prospective active incident reporting survey.

BACKGROUND: The study objectives were to describe the incidence and the nature of patient safety incidents (PSIs) in primary care general practice settings, and to explore the association between these incidents and practice or organizational characteristics. METHODS: GPs, randomly selected from a national influenza surveillance network (n = 800) across France, prospectively reported any incidents observed each day over a one-week period between May and July 2013. An incident was an event or circumstance that could have resulted, or did result, in harm to a patient, which the GP would not wish to recur. Primary outcome was the incidence of PSIs which was determined by counting reports per total number of patient encounters. Reports were categorized using existing taxonomies. The association with practice and organizational characteristics was calculated using a negative binomial regression model. RESULTS: 127 GPs (participation rate 79%) reported 317 incidents of which 270 were deemed to be a posteriori judged preventable, among 12,348 encounters. 77% had no consequences for the patient. The incidence of reported PSIs was 26 per 1000 patient encounters per week (95% CI [23‰ -28‰]). Incidents were three times more frequently related to the organization of healthcare than to knowledge and skills of health professionals, and especially to the workflow in the GPs' offices and to the communication between providers and with patients. Among GP characteristics, three were related with an increased incidence in the final multivariable model: length of consultation higher than 15 minutes, method of receiving radiological results (by fax compared to paper or email), and being in a multidisciplinary clinic compared with sole practitioners. CONCLUSIONS: Patient safety incidents (PSIs) occurred in mean once every two days in the sampled GPs and 2% of them were associated with a definite possibility for harm. Studying the association between organizational features of general practices and PSIs remains a major challenge and one of the most important issues for safety in primary care.

[Morbidity and mortality conference in general practice: about an experiment in Rhône-Alpes]. / Mise en place d'une revue de morbi-mortalité en médecine générale: à propos d'une expérimentation conduite en Rhône-Alpes.

UNLABELLED: A morbidity and mortality conference (MMC) is a collective analysis, retrospective and systemic cases marked by occurrence of death, complication, or event that could cause harm to patient (adverse event). OBJECTIVES: Its aim is the implementation and monitoring of actions to improve the care of patients and patient safety. A group for analysis of adverse events in general practice was created in 2011 in the Rhone-Alps, in order to test the feasibility of a MMC with general practitioners (GPs). METHOD: A charter setting out the ethical framework and the terminology, methodology and the role of individual players was drafted. Then a group of volunteers was created among the members of an association of continuing medical education. Each session has been the subject of a report. The evaluation was conducted through interviews with participants, and with an electronic survey of satisfaction. RESULTS: Since 2011, 12 physicians participated, analysing 36 cases during seven sessions. Reported events were most frequently interested women with a mean age of patients being 48 years (median 46 years). The situations reported were mixed (error diagnostic, therapeutic, adverse drug). Failures are related to care protocols, decision-making, the care environment (frequent disruptive pop) and human factors (caregiver stress). The participants were satisfied with the initiative. Analyses revealed some redundant causes that can be corrected to secure care. Beyond the non-stigmatising approach it may allow doctors to discuss their feelings without making them feel guilty (concept of second victim). CONCLUSION: If such initiatives are still not widespread in ambulatory, they should be promoted by organizations. Openness to other caregivers in Ambulatory is a fundamental change desired by the GP. The National Programme for Patient Safety recently published in February 2013 mentions these aspects, emphasizing the key role of the DPC for acquisition techniques analysis of the causes by caregivers.

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.