Frequency and estimated costs of ten low-value practices in the Spanish primary care: a retrospective study.

BACKGROUND: The frequency of low-value practices (LVPs) in the healthcare system is a worldwide challenge. This study aimed to evaluate the LVPs trend in Spanish primary care (PC), its frequency in both sexes, and estimate its related extra cost. METHODS: A multicentric, retrospective, and national research project was conducted. Ten LVPs highly frequent and potentially harmful for patients were analyzed (majority of them related to prescription). Algorithms were applied to collect the data from 28,872,851 episodes registered into national databases (2015-2017). RESULTS: LVPs registered a total of 7,160,952 (26.5%) episodes plus a total of 259,326 avoidable PSA screening tests. In adults, a high frequency was found for inadequate prescription of paracetamol antibiotics, and benzodiazepines . Women received more jeopardizing practices (p ≤ 0.001). Pediatrics presented a downward of antibiotic and paracetamol-ibuprofen prescription combination. The estimated extra cost was close to €292 million (2.8% of the total cost in PC). CONCLUSION: LVPs reduction during the analyzed period was moderate compared to studies following 'Choosing Wisely list' of LVPs and must improve to reduce patient risk and the extra related costs.

Avoidable Adverse Events Related to Ignoring the Do-Not-Do Recommendations: A Retrospective Cohort Study Conducted in the Spanish Primary Care Setting.

OBJECTIVE: This study aimed to measure the frequency and severity of avoidable adverse events (AAEs) related to ignoring do-not-do recommendations (DNDs) in primary care. METHODS: A retrospective cohort study analyzing the frequency and severity of AAEs related to ignoring DNDs (7 from family medicine and 3 from pediatrics) was conducted in Spain. Data were randomly extracted from computerized electronic medical records by a total of 20 general practitioners and 5 pediatricians acting as reviewers; data between February 2018 and September 2019 were analyzed. RESULTS: A total of 2557 records of adult and pediatric patients were reviewed. There were 1859 (72.7%) of 2557 (95% confidence interval [CI], 71.0%-74.4%) DNDs actions in 1307 patients (1507 were performed by general practitioners and 352 by pediatricians). Do-not-do recommendations were ignored more often in female patients (P < 0.0001). Sixty-nine AAEs were linked to ignoring DNDs (69/1307 [5.3%]; 95% CI, 4.1%-6.5%). Of those, 54 (5.1%) of 1062 were in adult patients (95% CI, 3.8%-6.4%) and 15 (6.1%) of 245 in pediatric patients (95% CI, 3.1%-9.1%). In adult patients, the majority of AAEs (51/901 [5.7%]; 95% CI, 4.2%-7.2%) occurred in patients 65 years or older. Most AAEs were characterized by temporary minor harm both in adult patients (28/54 [51.9%]; 95% CI, 38.5%-65.2%) and pediatric patients (15/15 [100%]). CONCLUSIONS: These findings provide a new perspective about the consequences of low-value practices for the patients and the health care systems. Ignoring DNDs could place patients at risk, and their safety might be unnecessarily compromised. TRIAL REGISTRATION NUMBER: NCT03482232.

Qualitative Study About the Experiences of Colleagues of Health Professionals Involved in an Adverse Event.

OBJECTIVES: Identify what occurs among health-care providers (HCPs) after an adverse event (AE) and what colleagues could do to help them. METHOD: A qualitative study with participation by physicians and nurses from hospitals and primary care facilities. RESULTS: Fifteen HCPs and 12 health professionals with quality management responsibilities with between 8 and 30 years of experience participated; 15 (56%) were physicians (9 general practitioners, 3 surgeons, 2 intensivists, and 1 from an emergency unit), and 12 (44%) were nurses (5 worked in primary care and 7 in hospitals). There was consensus that second victims require support from colleagues and management; however, instead, many times they perceive rejection. They experience repetitive thoughts, fear, and loneliness. Formal channels of information favor the implementation of improvements. Health-care providers reported that information about measures for preventing a new adverse event is inaccessible, whereas management said that a change in behavior was necessary to promote a culture of safety. Common informal channels were the hallways and cafeteria. Reactions by colleagues of second victims were of surprise and to avoid involvement. CONCLUSIONS: Organized plans and protocols about what to do to help HCPs after an AE are uncommon. Formal channels of information mitigate rumors and misinformation. Informal channels hinder learning from the experience and strengthening the culture of safety, and they encourage incidents to be hidden. Approaches that permit HCPs involved in an AE to speak about what has happened offer a positive response to their emotional needs.

Nursing Home Survey on Patient Safety Culture: Cross-cultural Validation Data From Spanish Nursing Homes.

OBJECTIVES: Developing an adequate patient safety culture is a relevant objective for all health care levels. The Nursing Home Survey on Patient Safety Culture (NHSOPS) is a 12-dimension tool assessing safety culture in nursing homes (NH) for elder people. The psychometric properties of its Spanish adaptation are evaluated in this study. METHODS: Nursing homes with 15 beds or more, located in the Basque Country (North Spain), were invited in the study. All staff types were allowed to participate. Internal consistency was tested with Cronbach's α. Convergent and divergent validity with Spearman's correlations. Two-sample t test was used for known-groups validity. The NHSOPS dimensionality was tested with confirmatory factor analysis (CFA), and its stability in consecutive administrations (test-retest) was explored. RESULTS: Five hundred fifty-three valid baseline and 83 retest replies were received. The data suggest that the NHSOPS can be represented by a 10-factor model. Two items (A6 and A10) had loadings of less than 0.12. The rest survey items obtained loadings of greater than 0.40. Estimated correlations supported the convergent and divergent validity of the survey. Managers and administrators, as well as staff considering their NH to be a safe place for residents, obtained higher NHSOPS scores, suggesting acceptable known-groups validity. On the other hand, test-retest variation was considerable. CONCLUSIONS: The current data support a simpler model, similar to that of the Norwegian NHSOPS validation. The stability of the scale should be further assessed in a bigger sample. Test-retest reliability and developing an adequate scoring scheme are issues worth of further study.

Dejar de hacer lo que no aporta valor en la Era COVID-19 / No disponible

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Eventos adversos evitables en atención primaria. Estudio retrospectivo de cohortes para determinar su frecuencia y gravedad / Avoidable adverse events in primary care. Retrospective cohort study to determine their frequency and severity

OBJETIVO: Determinar la frecuencia de eventos adversos evitables (EAE) en atención primaria (AP). DISEÑO: Estudio retrospectivo de cohortes. Emplazamiento: consultas de medicina de familia y pediatría de Andalucía, Aragón, Castilla La Mancha, Cataluña, Madrid, Navarra y Comunidad Valenciana. PARTICIPANTES: Se determinó revisar un mínimo de 2.397 historias clínicas (nivel de confianza del 95% y una precisión del 2%). La muestra se estratificó por grupos de edad de forma proporcional a su frecuentación y con revisión paritaria de historias de hombres y mujeres. Mediciones principales: Número y gravedad de los EAE identificados entre febrero de 2018 y septiembre de 2019. RESULTADOS: Se revisaron un total de 2.557 historias clínicas (1.928, 75.4% de pacientes adultos y 629, 24.6% pediátricos). Se identificaron 182 EAE que afectaron a 168 pacientes (7,1%, IC 95% 6,1-8,1%); en adultos 7,6% (IC 95% 6,4-8,8%) y 5,7% (IC 95% 3,9-7,5%) en pacientes pediátricos. Las mujeres sufrieron más EAE que los hombres (p = 0,004). La incidencia de EAE en niños y niñas fue similar (p = 0,3). 6 (4.1%) de los EAE supusieron un daño permanente en pacientes adultos. CONCLUSIONES: Buscar fórmulas para incrementar la seguridad en AP, particularmente en pacientes mujeres, debe seguir siendo un objetivo prioritario incluso en pediatría. Uno de cada 24 EAE supone un daño grave y permanente en el adulto

OBJECTIVE: To determine the frequency of avoidable adverse events (AAEs) in Primary Care (PC). DESIGN: Retrospective cohort study. LOCATION: Family medicine and paediatric clinics in Andalusia, Aragon, Castilla-La Mancha, Catalonia, Madrid, Navarre, and Valencia. PARTICIPANTS: A review was performed on a designated sample of 2,397 medical records (95% confidence level and 2% accuracy). The sample was stratified by age group as regards the frequency of physician consultations and considering equal distribution of male and female patients. MAIN MEASUREMENTS: Number and severity of identified AAEs from February 2018 to September 2019. RESULTS: A total of 2,557 medical records were reviewed (1,928, 75.4% of adult patients, and 629, 24.6% paediatrics). A total of 182 (7.1%, 95% CI 6.1-8.1%) AAEs that affected 168 patients were identified, which included 7.6% (95% CI 6.4-8.8%) in adults and 5.7% (95% CI 3.9-7.5%) in paediatric patients. The number of AAEs in women was higher than in men (P = 0.006). The incidence of AAEs in boys and girls was similar (P = 0.3). Permanent damage was caused by AAEs in 6 (4.1%) adult patients. CONCLUSIONS: Seeking formulas to increase patient safety in PC should remain a priority objective, particularly in female patients and in paediatrics. One in 24 AAEs causes serious and permanent damage in adults

[Avoidable adverse events in primary care. Retrospective cohort study to determine their frequency and severity]. / Eventos adversos evitables en atención primaria. Estudio retrospectivo de cohortes para determinar su frecuencia y gravedad.

OBJECTIVE: To determine the frequency of avoidable adverse events (AAEs) in Primary Care (PC). DESIGN: Retrospective cohort study. LOCATION: Family medicine and paediatric clinics in Andalusia, Aragon, Castilla-La Mancha, Catalonia, Madrid, Navarre, and Valencia. PARTICIPANTS: A review was performed on a designated sample of 2,397 medical records (95% confidence level and 2% accuracy). The sample was stratified by age group as regards the frequency of physician consultations and considering equal distribution of male and female patients. MAIN MEASUREMENTS: Number and severity of identified AAEs from February 2018 to September 2019. RESULTS: A total of 2,557 medical records were reviewed (1,928, 75.4% of adult patients, and 629, 24.6% paediatrics). A total of 182 (7.1%, 95% CI 6.1-8.1%) AAEs that affected 168 patients were identified, which included 7.6% (95% CI 6.4-8.8%) in adults and 5.7% (95% CI 3.9-7.5%) in paediatric patients. The number of AAEs in women was higher than in men (P = 0.006). The incidence of AAEs in boys and girls was similar (P = 0.3). Permanent damage was caused by AAEs in 6 (4.1%) adult patients. CONCLUSIONS: Seeking formulas to increase patient safety in PC should remain a priority objective, particularly in female patients and in paediatrics. One in 24 AAEs causes serious and permanent damage in adults.

SOBRINA Spanish study-analysing the frequency, cost and adverse events associated with overuse in primary care: protocol for a retrospective cohort study.

INTRODUCTION: Several institutions and quality national agencies have fostered the creation of recommendations on what not to do to reduce overuse in clinical practice. In primary care, their impact has hardly been studied. The frequency of adverse events (AEs) associated with doing what must not be done has not been analysed, either. The aim of this study is to measure the frequency of overuse and AEs associated with doing what must not be done (commission errors) in primary care and their cost. METHODS AND ANALYSIS: A coordinated, multicentric, national project. A retrospective cohort study using computerised databases of primary care medical records from national agencies and regional health services will be conducted to analyse the frequency of the overuse due to ignore the do-not-do recommendations, and immediately afterwards, depending on their frequency, a representative random sample of medical records will be reviewed with algorithms (triggers) that determine the frequency of AEs associated with these recommendations. Cost will determine by summation of the direct costs due to the consultation, pharmacy, laboratory and imaging activities according to the cases. ETHICS AND DISSEMINATION: The study protocol has been approved by the Ethics Committee of Primary Care Research of the Valencian Community. We aim to disseminate the findings through international peer-reviewed journals and on the website (http://www.nohacer.es/). Outcomes will be used to incorporate algorithms into the electronic history to assist in making clinical decisions. TRIAL REGISTRATION NUMBER: NCT03482232; Pre-results.

Low-value clinical practices and harm caused by non-adherence to 'do not do' recommendations in primary care in Spain: a Delphi study.

OBJECTIVE: To determine the non-adherence to the primary care 'do not do' recommendations (DNDs) and their likelihood to cause harm. DESIGN: Delphi study. SETTING: Spanish National Health System. PARTICIPANTS: A total of 128 professionals were recruited (50 general practitioners [GPs], 28 pediatricians [PEDs], 31 nurses who care for adult patients [RNs] and 19 pediatric nurses [PNs]). INTERVENTIONS: A selection of 27 DNDs directed at GPs, 8 at PEDs, 9 at RNs and 4 at PNs were included in the Delphi technique. A 10-point scale was used to assess whether a given practice was still present and the likelihood of it causing of an adverse event. MAIN OUTCOME MEASURE: Impact calculated by multiplying an event's frequency and likelihood to cause harm. RESULTS: A total of 100 professionals responded to wave 1 (78% response rate) and 97 of them to wave 2 (97% response rate). In all, 22% (6/27) of the practices for GPs, 12% (1/8) for PEDs, 33% (3/9) for RNs and none for PNs were cataloged as frequent. A total of 37% (10/27) of these practices for GPs, 25% (2/8) for PEDs, 33% (3/9) for RNs and 25% (1/4) for PNs were considered as potential causes of harm. Only 26% (7/27) of the DNDs for GPs showed scores equal to or higher than 36 points. The impact measure was higher for ordering benzodiazepines to treat insomnia, agitation or delirium in elderly patients (mean = 57.8, SD = 25.3). CONCLUSIONS: Low-value and potentially dangerous practices were identified; avoiding these could improve care quality.

Drivers and strategies for avoiding overuse. A cross-sectional study to explore the experience of Spanish primary care providers handling uncertainty and patients' requests.

OBJECTIVES: Identify the sources of overuse from the point of view of the Spanish primary care professionals, and analyse the frequency of overuse due to pressure from patients in addition to the responses when professionals face these demands. DESIGN: A cross-sectional study. SETTING: Primary care in Spain. PARTICIPANTS: A non-randomised sample of 2201 providers (general practitioners, paediatricians and nurses) was recruited during the survey. PRIMARY AND SECONDARY OUTCOME MEASURES: The frequency, causes and responsibility for overuse, the frequency that patients demand unnecessary tests or procedures, the profile of the most demanding patients, and arguments for dissuading the patient. RESULTS: In all, 936 general practitioners, 682 paediatricians and 286 nurses replied (response rate 18.6%). Patient requests (67%) and defensive medicine (40%) were the most cited causes of overuse. Five hundred and twenty-two (27%) received requests from their patients almost every day for unnecessary tests or procedures, and 132 (7%) recognised granting the requests. The lack of time in consultation, and information about new medical advances and treatments that patients could find on printed and digital media, contributed to the professional's inability to adequately counter this pressure by patients. Clinical safety (49.9%) and evidence (39.4%) were the arguments that dissuaded patients from their requests the most. Cost savings was not a convincing argument (6.8%), above all for paediatricians (4.3%). General practitioners resisted more pressure from their patients (x2=88.8, P<0.001, percentage difference (PD)=17.0), while nurses admitted to carrying out more unnecessary procedures (x2=175.7, P<0.001, PD=12.3). CONCLUSION: Satisfying the patient and patient uncertainty about what should be done and defensive medicine practices explains some of the frequent causes of overuse. Safety arguments are useful to dissuade patients from their requests.

Effective translation of a type-2 diabetes primary prevention programme into routine primary care: The PreDE cluster randomised clinical trial.

AIMS: We assessed the effectiveness of a Type 2 diabetes mellitus (T2D) prevention programme in routine primary health care (PHC) in high-risk patients. METHODS: Phase IV cluster clinical trial involving 14 PHC centres in the Basque Health Service were randomised to the DE-PLAN educational healthy lifestyle promotion programme or standard care. All non-diabetic 45- to 70-year-old PHC attendees considered at high risk of T2D (FINDRISC ≥ 14 points) were eligible. The primary outcome was the 24-month cumulative incidence of T2D confirmed by oral glucose tolerance testing. Secondary outcomes were self-reported physical activity and dietary changes at 12 months in a subsample. RESULTS: Of the 4170 patients screened, 2128 (51%) were considered high risk, but 355 (33%) and 459 (43.6%) refused to participate in the control and intervention groups, respectively. Of all eligible non-diabetic patients, 634 and 454 were included in the control and intervention arms, 545 (85.9%) and 411 (90.5%) completed the follow-up. Intention-to-treat cumulative incidences of T2D were 12.1% (77/634) in the control group and 8.4% (38/454) in intervention group, with an absolute difference of 3.8% (95% CI: 0.18%-7.4%, p = 0.045) and a relative risk reduction of 32% (0.68; 95% CI: 0.47-0.99, p = 0.048) in favour of the intervention. Intervention patients were 1.83-fold more likely to meet recommended physical activity levels at 12 months (95% CI: 1.06-3.17, p = 0.03). CONCLUSIONS: The DE-PLAN programme was effective in reducing T2D incidence in PHC high-risk patients. Research on implementation strategies to improve its feasible and sustainable adoption, reach and public health impact is warranted.

Lessons learned for reducing the negative impact of adverse events on patients, health professionals and healthcare organizations.

PURPOSE: To summarize the knowledge about the aftermath of adverse events (AEs) and develop a recommendation set to reduce their negative impact in patients, health professionals and organizations in contexts where there is no previous experiences and apology laws are not present. DATA SOURCES: Review studies published between 2000 and 2015, institutional websites and experts' opinions on patient safety. STUDY SELECTION: Studies published and websites on open disclosure, and the second and third victims' phenomenon. Four Focus Groups participating 27 healthcare professionals. DATA EXTRACTION: Study characteristic and outcome data were abstracted by two authors and reviewed by the research team. RESULTS OF DATA SYNTHESIS: Fourteen publications and 16 websites were reviewed. The recommendations were structured around eight areas: (i) safety and organizational policies, (ii) patient care, (iii) proactive approach to preventing reoccurrence, (iv) supporting the clinician and healthcare team, (v) activation of resources to provide an appropriate response, (vi) informing patients and/or family members, (vii) incidents' analysis and (viii) protecting the reputation of health professionals and the organization. CONCLUSION: Recommendations preventing aftermath of AEs have been identified. These have been designed for the hospital and the primary care settings; to cope with patient's emotions and for tacking the impact of AE in the second victim's colleagues. Its systematic use should help for the establishment of organizational action plans after an AE.

The Second Victim Phenomenon After a Clinical Error: The Design and Evaluation of a Website to Reduce Caregivers' Emotional Responses After a Clinical Error.

BACKGROUND: Adverse events (incidents that harm a patient) can also produce emotional hardship for the professionals involved (second victims). Although a few international pioneering programs exist that aim to facilitate the recovery of the second victim, there are no known initiatives that aim to raise awareness in the professional community about this issue and prevent the situation from worsening. OBJECTIVE: The aim of this study was to design and evaluate an online program directed at frontline hospital and primary care health professionals that raises awareness and provides information about the second victim phenomenon. METHODS: The design of the Mitigating Impact in Second Victims (MISE) online program was based on a literature review, and its contents were selected by a group of 15 experts on patient safety with experience in both clinical and academic settings. The website hosting MISE was subjected to an accreditation process by an external quality agency that specializes in evaluating health websites. The MISE structure and content were evaluated by 26 patient safety managers at hospitals and within primary care in addition to 266 frontline health care professionals who followed the program, taking into account its comprehension, usefulness of the information, and general adequacy. Finally, the amount of knowledge gained from the program was assessed with three objective measures (pre- and posttest design). RESULTS: The website earned Advanced Accreditation for health websites after fulfilling required standards. The comprehension and practical value of the MISE content were positively assessed by 88% (23/26) and 92% (24/26) of patient safety managers, respectively. MISE was positively evaluated by health care professionals, who awarded it 8.8 points out of a maximum 10. Users who finished MISE improved their knowledge on patient safety terminology, prevalence and impact of adverse events and clinical errors, second victim support models, and recommended actions following a severe adverse event (P<.001). CONCLUSIONS: The MISE program differs from existing intervention initiatives by its preventive nature in relation to the second victim phenomenon. Its online nature makes it an easily accessible tool for the professional community. This program has shown to increase user's knowledge on this issue and it helps them correct their approach. Furthermore, it is one of the first initiatives to attempt to bring the second victim phenomenon closer to primary care.

Qué, quién, cuándo, dónde y cómo informar a los pacientes tras un evento adverso: un estudio cualitativo / What, who, when, where and how to inform patients after an adverse event: a qualitative study

OBJETIVOS: Explorar experiencias y recomendaciones para informar adecuadamente al paciente que ha sufrido un evento adverso (EA) en un contexto donde no se cuenta con leyes de disculpa. MÉTODO: Estudio cualitativo basado en las técnicas de grupo focal y Metaplan. Este estudio se realizó con médicos y enfermeros de atención primaria y hospitales del sistema público de salud en España. RESULTADOS: Participaron 27 profesionales con entre 8 y 30 años de experiencia, 15 (56%) médicos y 12 (44%) enfermeros; 13 (48%) trabajaban en hospitales. Existió consenso en cuanto a cómo (lenguaje claro, honestidad), dónde (evitar pasillos, en espacio acondicionado, con intimidad) y cuándo informar (con agilidad pero sin precipitación, al disponer de suficiente información y tras reflexionar sobre la forma más adecuada según la naturaleza del EA). Existió controversia en cuanto a qué decirle al paciente tras EA con consecuencias graves, dudas sobre en qué casos se debía informar de lo sucedido; quién debía informar (si el profesional más directamente implicado en el EA u otro profesional, el papel del equipo directivo o de los mandos intermedios); y sobre en qué casos una disculpa podía suponer un problema. CONCLUSIONES: La naturaleza del EA determina quién debe conversar con el paciente en hospitales y atención primaria. Debe meditarse, según los casos, la forma más apropiada para trasladarle una disculpa al paciente. Una actuación temprana, directa, empática, proactiva y acompañada de información sobre una compensación por el daño sufrido contribuiría a reducir el número de reclamaciones

OBJECTIVE: To explore suggestions and recommendations for conducting open disclosure with a patient after an adverse event in a setting without professionals' legal privileges. METHOD: Qualitative study conducting focus groups/Metaplan. This study was conducted with physicians and nurses from Primary Care and Hospitals working in the public health system in Spain. RESULTS: Twenty-seven professionals were involved 8-30 years of experience, 15 (56%) medical and 12 (44%) nurses, 13 (48%) worked in hospitals. Consensus was obtained on: how (honesty and open and direct language), where (avoid corridors, with privacy), and when to disclose (with agility but without precipitation, once information is obtained, and after reflecting on the most suitable according to the nature of the AE). There was controversy as to what to say to the patient when the AE had serious consequences and doubts about what type of incidents must be reported; who should be required to disclose (the professional involved in the AE or other professional related to the patient, the role of the staff and the management team); and in which cases an apology can be a problem. CONCLUSIONS: The severity of the AE determines who should talk with the patient in both hospital and primary care. The most appropriate way to convey an apology to the patient depends of the AE. An early, direct, empathetic and proactive action accompanied by information about compensation for the harm suffered could reduce the litigation intention

What, who, when, where and how to inform patients after an adverse event: a qualitative study. / Qué, quién, cuándo, dónde y cómo informar a los pacientes tras un evento adverso: un estudio cualitativo.

OBJECTIVE: To explore suggestions and recommendations for conducting open disclosure with a patient after an adverse event in a setting without professionals' legal privileges. METHOD: Qualitative study conducting focus groups/Metaplan. This study was conducted with physicians and nurses from Primary Care and Hospitals working in the public health system in Spain. RESULTS: Twenty-seven professionals were involved 8-30 years of experience, 15 (56%) medical and 12 (44%) nurses, 13 (48%) worked in hospitals. Consensus was obtained on: how (honesty and open and direct language), where (avoid corridors, with privacy), and when to disclose (with agility but without precipitation, once information is obtained, and after reflecting on the most suitable according to the nature of the AE). There was controversy as to what to say to the patient when the AE had serious consequences and doubts about what type of incidents must be reported; who should be required to disclose (the professional involved in the AE or other professional related to the patient, the role of the staff and the management team); and in which cases an apology can be a problem. CONCLUSIONS: The severity of the AE determines who should talk with the patient in both hospital and primary care. The most appropriate way to convey an apology to the patient depends of the AE. An early, direct, empathetic and proactive action accompanied by information about compensation for the harm suffered could reduce the litigation intention.

Design and Testing of BACRA, a Web-Based Tool for Middle Managers at Health Care Facilities to Lead the Search for Solutions to Patient Safety Incidents.

BACKGROUND: Lack of time, lack of familiarity with root cause analysis, or suspicion that the reporting may result in negative consequences hinder involvement in the analysis of safety incidents and the search for preventive actions that can improve patient safety. OBJECTIVE: The aim was develop a tool that enables hospitals and primary care professionals to immediately analyze the causes of incidents and to propose and implement measures intended to prevent their recurrence. METHODS: The design of the Web-based tool (BACRA) considered research on the barriers for reporting, review of incident analysis tools, and the experience of eight managers from the field of patient safety. BACRA's design was improved in successive versions (BACRA v1.1 and BACRA v1.2) based on feedback from 86 middle managers. BACRA v1.1 was used by 13 frontline professionals to analyze incidents of safety; 59 professionals used BACRA v1.2 and assessed the respective usefulness and ease of use of both versions. RESULTS: BACRA contains seven tabs that guide the user through the process of analyzing a safety incident and proposing preventive actions for similar future incidents. BACRA does not identify the person completing each analysis since the password introduced to hide said analysis only is linked to the information concerning the incident and not to any personal data. The tool was used by 72 professionals from hospitals and primary care centers. BACRA v1.2 was assessed more favorably than BACRA v1.1, both in terms of its usefulness (z=2.2, P=.03) and its ease of use (z=3.0, P=.003). CONCLUSIONS: BACRA helps to analyze incidents of safety and to propose preventive actions. BACRA guarantees anonymity of the analysis and reduces the reluctance of professionals to carry out this task. BACRA is useful and easy to use.

Type-2 diabetes primary prevention program implemented in routine primary care: a process evaluation study.

BACKGROUND: Process evaluation studies are recommended to improve our understanding of underlying mechanisms related to clinicians, patients, context and intervention delivery that may impact on trial or program results and on their potential transferability to practice. This paper aims to document the translation of a type-2 diabetes (T2D) prevention program into the routine context of several primary care centers, assessing process indicators related to clinician adoption, patient recruitment, exposure to the intervention components and baseline characteristics. METHODS: An observational descriptive process evaluation study was conducted of the 2.5-year implementation of the Prevention of Diabetes in Euskadi cluster randomized trial in 14 primary care centers of the Basque Health Service (Osakidetza). The clinical intervention consisted of three components: (1) risk screening, (2) an educational intervention promoting healthy lifestyles, and (3) remote support (follow-up). A passive dissemination strategy of providing training and materials was used to translate the intervention into practice. All non-diabetic patients aged 45 to 70 years who were identified as being at high risk of developing T2D were eligible for study inclusion. The RE-AIM framework guided the process evaluation. RESULTS: Overall, 31.4 % of family physicians and 57.6 % of nurses participated in the study, while 4170 out of 67,293 (6.2 %) targeted patients who attended the centers during the implementation period were reached through the screening. Around half of the screened patients were identified as being at high risk of developing T2D (FINDRISC score ≥14). The rate of refusal to participate and the proportion of women were higher in the intervention group. Finally, 634 and 454 non-diabetic 45- to 70-year-old patients who were at high risk of T2D were included in the control and intervention group centers (intervention reach = 48 %). Significant variability in most process indicators was observed at center level. CONCLUSION: The passive dissemination strategy has produced modest process indicators related to the adoption, reach and implementation of the intervention program, and reduced the possibility of its standardized application in heterogeneous contexts. The resulting different procedures and strategies used by the centers were associated with process outcomes. Context-specific variability and possible confounding will require rigorous procedures for analysis of the intervention effects. TRIAL REGISTRATION: The trial was registered in ClinicalTrials.gov (identifier: NCT01365013 ). Registered on June 2011.

Qualitative Evaluation of the Implementation of an Integrated Care Delivery Model for Chronic Patients with Multi-Morbidity in the Basque Country.

INTRODUCTION: The objective of this study was to assess a model for improving healthcare integration for patients with multiple chronic diseases in an integrated healthcare organisation in the Basque Country and to propose areas for improvement. METHODS: We organised four nominal groups composed of representatives from different categories of clinicians involved in the development of an integrated healthcare organisation and in the integrated care of patients with multiple diseases, namely, internists, general practitioners, and primary care and hospital nurses. RESULTS: The aspect rated most positively was the concept itself of an integrated care model, which is able to improve communication between levels of care, increase the quality of the care provided and enhance patient safety. Additionally, it was agreed that the role of assigned clinicians is a key element. The problems identified mostly concern its implementation in daily practice. CONCLUSIONS: The results of this study made it possible to suggest at least 8 areas of improvement to be implemented. These are related to: nurses' roles; care and monitoring of stable patients; team work; communication with patients; coordination with social workers and between internists and family doctors; as well as the development of an office of medical services to lead the integration process.

Interventions in health organisations to reduce the impact of adverse events in second and third victims.

BACKGROUND: Adverse events (AE) are also the cause of suffering in health professionals involved. This study was designed to identify and analyse organization-level strategies adopted in both primary care and hospitals in Spain to address the impact of serious AE on second and third victims. METHODS: A cross-sectional study was conducted in healthcare organizations assessing: safety culture; health organization crisis management plans for serious AE; actions planned to ensure transparency in communication with patients (and relatives) who experience an AE; support for second victims; and protective measures to safeguard the institution's reputation (the third victim). RESULTS: A total of 406 managers and patient safety coordinators replied to the survey. Deficient provision of support for second victims was acknowledged by 71 and 61% of the participants from hospitals and primary care respectively; these respondents reported there was no support protocol for second victims in place in their organizations. Regarding third victim initiatives, 35% of hospital and 43% of primary care professionals indicated no crisis management plan for serious AE existed in their organization, and in the case of primary care, there was no crisis committee in 34% of cases. The degree of implementation of second and third victim support interventions was perceived to be greater in hospitals (mean 14.1, SD 3.5) than in primary care (mean 11.8, SD 3.1) (p < 0.001). CONCLUSIONS: Many Spanish health organizations do not have a second and third victim support or a crisis management plan in place to respond to serious AEs.

The aftermath of adverse events in Spanish primary care and hospital health professionals.

BACKGROUND: Adverse events (AEs) cause harm in patients and disturbance for the professionals involved in the event (second victims). This study assessed the impact of AEs in primary care (PC) and hospitals in Spain on second victims. METHODS: A cross-sectional study was conducted. We carried out a survey based on a random sample of doctors and nurses from PC and hospital settings in Spain. A total of 1087 health professionals responded, 610 from PC and 477 from hospitals. RESULTS: A total of 430 health professionals (39.6%) had informed a patient of an error. Reporting to patients was carried out by those with the strongest safety culture (Odds Ratio -OR- 1.1, 95% Confidence Interval -CI- 1.0-1.2), nurses (OR 1.9, 95% CI 1.5-2.3), those under 50 years of age (OR 0.7, 95% CI 0.6-0.9) and primary care staff (OR 0.6, 95% CI 0.5-0.9). A total of 381 (62.5%, 95% CI 59-66%) and 346 (72.5%, IC95% 69-77%) primary care and hospital health professionals, respectively, reported having gone through the second-victim experience, either directly or through a colleague, in the previous 5 years. The emotional responses were: feelings of guilt (521, 58.8%), anxiety (426, 49.6%), re-living the event (360, 42.2%), tiredness (341, 39.4%), insomnia (317, 38.0%) and persistent feelings of insecurity (284, 32.8%). In doctors, the most common responses were: feelings of guilt (OR 0.7 IC95% 0.6-0.8), re-living the event (OR 0.7, IC95% o.6-0.8), and anxiety (OR 0.8, IC95% 0.6-0.9), while nurses showed greater solidarity in terms of supporting the second victim, in both PC (p = 0.019) and hospital (p = 0.019) settings. CONCLUSIONS: Adverse events cause guilt, anxiety, and loss of confidence in health professionals. Most are involved in such events as second victims at least once in their careers. They rarely receive any training or education on coping strategies for this phenomenon.