Maintenance Notice

Due to necessary scheduled maintenance, the JMIR Publications website will be unavailable from Monday, March 11, 2019 at 4:00 PM to 4:30 PM EST. We apologize in advance for any inconvenience this may cause you.

Who will be affected?

Advertisement

Citing this Article

Right click to copy or hit: ctrl+c (cmd+c on mac)

Published on 08.06.17 in Vol 19, No 6 (2017): June

Preprints (earlier versions) of this paper are available at http://preprints.jmir.org/preprint/7840, first published Apr 11, 2017.

This paper is in the following e-collection/theme issue:

    Original Paper

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

    1Alicante-Sant Joan Health District, Universidad Miguel Hernández, Elche (Alicante), Spain

    2Universidad Miguel Hernández, Elche (Alicante), Spain

    3Hospital Universitario Fundación Alcorcón, Madrid, Spain

    4Patient Safety Observatory, Andalusian Agency for Health Care Quality, Sevilla, Spain

    5Servicio Navarro de Salud - Osasunbidea, Pamplona, Spain

    6Consorci Sanitari Integral, L’Hospitalet de Llobregat, Barcelona, Spain

    7Spanish Health System, Spain

    Corresponding Author:

    José Joaquín Mira, PhD

    Alicante-Sant Joan Health District, Universidad Miguel Hernández

    Avenue Universidad s/n

    Elche (Alicante), 03202

    Spain

    Phone: 34 606433599

    Email: jose.mira@umh.es


    ABSTRACT

    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.

    J Med Internet Res 2017;19(6):e203

    doi:10.2196/jmir.7840

    KEYWORDS



    Introduction

    Patient safety incidents include both near misses (incidents that do not cause harm) and adverse events (incidents that do). Although the frequency of near misses in clinical practice is difficult to specify, the frequency of adverse events at hospitals in developed countries has been established at approximately 9% [1]; in developing countries, it increases to approximately 10.5% [2]. In ambulatory care, the prevalence of adverse events has been confirmed to be approximately 2% [3-4] and 5%, respectively [5]. One-half of these adverse events are usually considered to be preventable [1]. Most are related to clinical errors, which are defined as the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim [6]. These include system failures and human errors.

    Safety incidents associated with clinical errors have a negative emotional impact on patients, but also on the health professionals thought to be involved in them. The term second victim is used to describe the experience of the health professional who becomes emotionally overwhelmed as a result of being involved in an incident affecting patient safety [7,8]. The view of health care organizations as third victims was introduced because safety incidents may damage the reputation of and reduce trust in health care organizations [9].

    Mitigating the impact from these incidents in patients, the health organization, and its professionals is a responsibility of managers and middle managers in the health organizations [10]. One reason is to prevent the same incident from reoccurring [11] and another is to create a proactive culture of safety that creates conditions to alleviate their impact [12].

    Impact of Incidents for the Safety of Professionals

    Among second victims, fear from legal consequences deriving from the harm done to the patient, fear of damage to their professional reputation, feelings of guilt, doubts about their own abilities for making clinical decisions, anxiety, and mood swings are frequent [7,13-15]. In some cases, these situations can progress toward posttraumatic stress disorder [16].

    Among professionals, suspicion—if not fear—persists in disclosing what happened to patients due to the consequences that may result from such conversations [17,18]. Most professionals do not know what to do after an adverse event occurs, nor do they feel prepared for informing the patient [19,20]. They also question the support they would receive from their institution and colleagues [21-23].

    Frequency of the Second Victim Phenomenon

    Incident severity, its consequences, and individual variability influence the impact of the adverse event in professionals and make the number of second victims vary.

    In the United States and Canada, it has been estimated that between 30% [24] and 43% [25] of professionals have experienced a negative emotional response following an incident. In one recent study carried out in Australia, 76% of the professionals involved in either a near miss or an adverse event were seen to be emotionally affected by the incident [26]. As for Spanish hospitals, as much as 69% of nurses and 77% of physicians had, either firsthand or through close colleagues, experienced being the second victim within the preceding five years [27]. In primary care, these figures varied between 55% for nurses and 67% for physicians [27]. In Belgium, Van Gerven et al [28] analyzed the magnitude of the impact among professionals, its evolution over time, and the factors that contribute to minimizing such impact, arriving at the conclusion that health organizations might anticipate this impact and plan for dealing with the second victim phenomenon.

    The Help Second Victims Count On

    Assistance for second victims is not part of the actions planned to be carried out when an incident affecting patient safety occurs in hospitals [9,29,30], and there are no interventions designed for primary care [29]. Professionals feel unprotected by their institutions [31-33]. Only a few hospitals have developed their own intervention programs so, thus far, the extent of intervention programs in health systems is limited.

    Intervention Programs in the Literature

    Two approaches in interventions have been described. On the one hand, interventions are centered on the incident [11]. On the other, they focus on dealing with the emotional consequences of the incident [24,34]. These interventions require a positive attitude, empathy toward the second victim, and awareness about the issue of clinical errors that may occur at any moment.

    Scott [24], who leads the forYOU program at the University of Missouri Health System, has described the stages that a health professional goes through subsequent to an adverse event. According to this research, only 10% of second victims require specialized mental health services. Above all, most professionals in the first moments after an incident need to talk to a colleague, be relieved of care obligations for the time being, feel respect and empathy from others, and feel supported by their institution [24].

    The work group of Wu [34] at Johns Hopkins Hospital has also developed an intervention program to help second victims in adverse events. Theirs is called RISE (Resilience in Stressful Events) and it is based on the fact that most professionals involved in an adverse event need to talk to a colleague, which is usually sufficient for coping with the emotional impact in most cases.

    These interventions are meant to be activated after an adverse event occurs. Actions preventive in nature have not been designed for direct care professionals or for middle managers to become aware of the problem and learn how to address it.

    The literature has emphasized that professionals do not know how to act after an adverse event and that most health centers do not have protocols in place or provide instructions on how to support second victims [9,27-30]. The second victim phenomenon is unknown to a large number of health professionals and managers, and interventions designed to raise awareness in professionals about the problems presented by near errors and adverse events are nonexistent. There are also not any for providing that first support that second victims need either. A need exists for intervention programs to reinforce the proactive culture of safety at health centers and to promote natural support structures among professionals that would be activated if needed after a patient safety incident.

    Study Objective

    This study’s purpose was to develop and assess an online awareness and information program on the second victim phenomenon directed at health professionals in direct contact with patients at both hospitals and primary care. Such a program should provide demonstrations on how to act with colleagues and patients during the first moments after a severe incident for patient safety. This intervention was initially designed for Spanish frontline health care professionals.

    Specific Intervention Objectives

    The specific objectives included:

    1. Facilitate information and training for a large number of health professionals about the issue of second victims at a reduced cost.
    2. Describe emotional reactions and common behavior after being involved in an adverse event and that characterize the second victim phenomenon.
    3. Describe correct and incorrect actions of how to act after an adverse effect in order to respect the rights of patients and support the second victim.
    4. Act in the area of primary care, expanding the extent of studies that up to now have only taken place at hospitals.

    Methods

    This is a design and evaluation study of a website devised to mitigate the impact from severe adverse events in hospitals and primary care professionals. This intervention was named Mitigating Impact in Second Victims (MISE).

    The phases in the design and evaluation of the website and the preventive intervention program to mitigate the initial impact from an error in health professionals (MISE) are described in Figure 1.

    Website Design and Mitigating Impact in Second Victims

    A website was designed that hosted an awareness and preventive intervention program (MISE) to mitigate the impact from errors in frontline professionals [35]. The website was structured around two menus: the main menu contained general information on the second victim phenomenon regarding the different actors involved (with sections entitled “Professionals,” “Patients and Family,” “Health Managers,” “Safety Coordinators,” and “Insurers”), and a secondary menu with information related to the project and its outcomes, in addition to international studies (sections entitled “Presentation,” “Who we Are,” “Project Timetable,” “Definitions,” “News,” “Publications of Interest,” “Reviews and Comments,” and “Project Outcomes”). Access to MISE was gained by clicking on the upper right-hand corner on all website pages [36]

    Based on patient safety literature, and that specifically on second victims, a preventive intervention program was designed with informative and demonstrative contents.

    A review of review studies relating to open disclosure and second and third victims published in English or Spanish between 2000 and 2015 was conducted. This search was carried out using MEDLINE and Web of Knowledge. Keywords used for the review included a combination of the terms “patient safety” and “adverse event” with the following terms: emotional response, impact, professionals, second victim, third victim, and open disclosure. This yielded 22 possible documents on second victims and 83 on open disclosure. A review of health care organization websites was also conducted. This review included proposals of applied programs, checklists, and algorithms about interventions in the aftermath of an adverse event to support patient and second victims. This was carried out with the Google meta-search engine using the same descriptors. Only websites in English or Spanish were considered. A total of 16 websites were reviewed, two from Europe and the rest from the United States.

    A group of 15 health professionals with at least 10 years’ experience in quality and safety participated as a promoting group, and they were responsible for identifying content and elements of relevant information and example situations to be included in MISE. Chosen first to be disseminated were elements of patient safety information, specifically on second victims. Then, an index for MISE was created. Third, problem situations were selected for the demonstrative program that were then ultimately acted out by professional actors and recorded on video.

    MISE was structured in two packages, one informative and the other demonstrative. The informative package offered information on basic patient safety concepts (incidents for patient safety, incidents without harm, near errors, adverse events), along with the frequency, causality, consequences, avoidability, and other characteristics of adverse events at hospitals and within primary care. Furthermore, it introduced the concepts of second and third victims and the results from research on the impact of adverse events.

    The demonstrative intervention package provided a description of the emotional consequences from adverse events in professionals (affective and emotional, in clinical decision making, loss of self-esteem and professional reputation, in relationships with other professionals, with the family, legal implications) and recommendations for action following an adverse event, specifically about how to interact with the patient and their family (open disclosure), how to support a colleague who becomes a second victim, and how to personally cope with the second victim experience. This package included 15 demonstrative videos that showed what and what not to do in different clinical situations linked to errors (Table 1).

    Figure 1. Study phases.
    View this figure
    Table 1. Situations represented in the videos included in the demonstrative intervention packet.
    View this table

    Textbox 1. Index of the contents and their format in the website’s informative and demonstrative packages.
    View this box

    In order to make MISE contents more dynamic, different formats were used to convey information: text, images, Portable Document Formats (PDFs), PowerPoint presentations with voice narration, videos in which a patient safety expert appears and explains a concept, demonstrative videos (simulations of situations with actors), in addition to a mobile app.

    Textbox 1 lists the contents selected by the group of experts for each MISE package and the chosen format in each case for presenting such information.

    First, an independent agency specializing in the evaluation of health websites completed the accreditation of its overall design, structure, organizational, and functional quality according to a certification standard [38]. This external evaluation was led by technical personnel from that agency with experienced auditors.

    Second, MISE was evaluated by academic and professional safety experts who themselves were responsible for the services of patient quality and safety at hospitals and within primary care in Spain.

    Then, MISE was evaluated by a group of professionals who voluntarily followed this program between November 2015 and February 2017. Moreover, they considered the usefulness of MISE for improving information about the second victim phenomenon and what to do after an adverse event. For this purpose, the participants answered a series of knowledge tests.

    Website Certification (External Assessment)

    The research team assessed the website (self-assessment), following the quality standards of the Andalusian Agency for Healthcare Quality [38]. It was then evaluated externally following the accreditation program for health-related websites of this agency.

    This accreditation procedure consisted of 55 standards (31 were required, 10 were recommended, but in order to receive Advanced Accreditation, 8 of these must be met; the remaining 14 are voluntary commitments) that address the following aspects: usability, accessibility, confidentiality-privacy, transparency, credibility, editorial policy, elements related to the Web user, attribution of contents, updating of information, and provision of electronic services.

    This evaluation was based on a double procedure of self-assessment and external evaluation. The self-assessment permitted interactive identification of elements from the webpage in need of improvements. By following this system, changes in the design and browsing conveniences were introduced into the website. The subsequent external evaluation ensured compliance with the criteria based on webpage operation, content, and resources.

    Suitability of Mitigating Impact in Second Victims by Patient Safety Experts

    A group of 26 health professionals who were managers of patient safety services assessed MISE. This professional profile was chosen because their criteria were thought to be the best for assessing the program’s focus and content. To complete their assessment, they were allowed to freely explore the program for several weeks. This group included physicians and nurses from the health services at hospitals and within primary care, and the participants had more than three years’ professional experience in patient safety. They completed an online questionnaire after being called on the telephone to request their participation and to provide an email address in order to send them an online questionnaire link. Their responses were anonymous and voluntary, and these experts assessed the comprehension of the information, practical usefulness of the contents, and overall suitability on a scale from 0 to 10, with 10 representing the highest possible assessment.

    Evaluation of Mitigating Impact in Second Victims

    To assess the acquisition of knowledge by intervention program users, three objective tests with pre-established response options at different points in the program were included. Specifically, two tests with pre- and posttest measures were prepared, and these included a total of 20 questions. The first evaluated the additional knowledge gained after completing the informative package (12 items); the second evaluated additional knowledge gained in the demonstrative package (8 items). These test questions consisted of statements with true/false answers. A third series of questions was used, prepared from the demonstrative videos, in which the user had to choose the correct action between two response options. These additional questions also permitted assessing the program’s effectiveness in terms of the ability to discriminate between how to act in each situation. These consisted of a total of 25 questions and were answered only after the videos were watched.

    Once they finished the program, the participants assessed MISE in terms of comprehending the information, the practical value of its contents, and its overall suitability. Furthermore, the following measures were also considered: the number of connections required to finish the program, total time invested to finish it, average time of each connection, number of program dropouts, and correct answers on the knowledge test (pre- and postmeasures and questions on the situations represented in the demonstrative videos).

    Participants in Mitigating Impact in Second Victims Evaluation

    Safety professionals from nine autonomous health services in Spain participated in this study. As a country, Spain has 17 autonomous communities, and each has its own health system. The nine participating health services account for 75% of all care activity occurring at hospitals and within primary care in the country.

    A sample of 351 professionals from hospitals and primary care within these health services were asked to voluntarily participate. A minimum sampling size of 245 participants was determined, considering a sampling error of 5%, 80% correct answers on the questions, and 70% participation for a 95% confidence level. Quality and safety managers at the centers collaborated in recruiting participants by extending invitations to their hospital and health center staff to participate. To enter the system, the participants had to use a personal password to identify themselves; this way, they could continue participating in the MISE program as time permitted.

    Before entering the system, the participants were informed about the study’s scope, objectives, and method, in addition to the conditions for their participation. They granted their consent as a requirement for access.

    Simple Blind System

    Two databases were employed. The first contained the keys used by each participant, separate from the remaining databases. The second contained the anonymized registries of the participants’ responses. Only the authorized webmaster had access to the participant databases and no personal data in the response database were linked to the pre-post measures.

    Statistics

    A student t test with repeated measures (intrasubject comparisons) was used to assess the intervention’s effectiveness by comparing the pre-post measures. A McNemar test was used to assess the impact of the videos.

    Investigation Ethics

    This study was approved by the Ethics Committee of the San Juan de Alicante Hospital (Alicante, Spain).


    Results

    Accreditation

    The external evaluation recognized the entire research project website (including MISE) as a health website and awarded it the level of Advanced Accreditation on November 25, 2016. To gain this recognition, 100% of the required standards were satisfied (31/31) along with 80% or more of those recommended (8/10), surpassing the thresholds required by the evaluated standards. Overall, the website complied with 73% (40/55) of those standards. Four standards were not applicable because they referred to patients’ rights and the treatment of their health information (the website is directed solely at health professionals and does not allow compiling clinical data of patients), advertising content (absent on the website), virtual health communities (interaction between users is not included among the website’s objectives), and the provision of electronic services (the website is not used as a tool for carrying out commercial activities). If these four standards are discounted, the percentage of compliance with the requirements increases from 73% to 78%.

    Its strengths were related to identifying the recipients, usability, confidentiality-privacy, transparency and honesty, credibility, attribution of contents, and updating of information. Areas for improvement were related to elements related to website users, accessibility, editorial policy, and usability (Table 2).

    Table 2. Results of the website’s external accreditation.
    View this table
    Table 3. Description of the user sample (N=266).
    View this table
    Table 4. MISE evaluation by participating professionals (N=266).
    View this table

    Evaluation by National Patient Safety Experts

    Twenty-six patient safety experts from four autonomous health services assessed MISE (100% response rate). Of these, 92% (24/26) positively assessed the ease of browsing and following the programmed activities, 88% (23/26) positively assessed the comprehension of the contents (mean 8.8, SD 0.9), and 92% (24/26) did likewise for the practical value of the designed intervention (mean 8.7, SD 1.1).

    Participation and Evaluation of the Activity

    In all, 266 of 351 professionals (75.8% response rate) followed the activities proposed in MISE; of them, 183 were women and 83 were men (Table 3).

    Those who completed MISE viewed 99% of its pages (Table 4). On average, two months were required to finish reading its content, watching its videos, and completing the activities. The mean number of connections needed to complete MISE was 11.4 (SD 8.3), and these ranged between 1 and 57. The mean length of each connection was almost 30 minutes. MISE dropouts (those who quit without viewing at least 70% of its pages) were less than 5% (12/266, 4.5%).

    Mitigating Impact in Second Victims was highly rated by the professional users, and they awarded it almost nine points out of a maximum of 10 (Table 4). Only two of 266 participants (0.7%) awarded it less than six points for comprehension and usefulness of the program’s information.

    Postmeasures on the Program’s Effectiveness: Pre-Post Comparisons

    Participants who completed MISE increased their level of knowledge on patient safety terminology (near misses, adverse events, and sentinel events), prevalence and impact of adverse events and errors (first, second, and third victims), support models for the second victim, and the recommended actions following a severe adverse event. There was a significant difference in the pre- and postmeasures of the knowledge test of information about basic patient safety concepts, prevalence and nature of adverse events, and second victims (informative package). Out of a maximum of 12, the premeasure mean was 6.9 (SD 2.0) and the postmeasure mean was 8.8 (SD 1.6; t265=–10.0, P<.001). There was also a significant difference in the pre- and postmeasures of the knowledge test of what to do after an adverse event or error (demonstrative package). Out of a maximum of 8, the premeasure mean was 6.3 (SD 1.5) and the postmeasure mean was 7.2 (SD 1.0; t265=–6.2, P<.001).

    The correct answers on the knowledge tests did not vary between physicians and nurses in all cases (general knowledge test: P=.27; informative test package, MISE: P=.13; and demonstrative test package, MISE: P=.89).

    After watching the problem situations (demonstrative videos), most test questions were answered correctly with the exception of situations representing a system failure. For these, 13.9% (37/266) of the users attributed the event of the hypothetical situation shown in the video to a human error instead of a system failure, and they considered that such failures can always be prevented (Table 5).

    Knowledge Test Error Analysis

    In the pretest, questions in which the answer given was incorrect more than 50% of the time had to do with the number of professionals involved in this type of event, patient safety concepts (definitions of incidents without harm and the second victim), the preventive ability against system failures, and procedures for crisis communication and open disclosure (who and how). In all these cases, the participants answered these questions as being true when in fact the correct answers were false (Table 6).

    Table 5. Number of correct answers after watching demonstrative videos on what and what not to do (N=266; total questions answered=25).
    View this table
    Table 6. Analysis and evolution of the errors (&gt;50%) in the knowledge tests.
    View this table

    Discussion

    Principal Results

    Mitigating Impact in Second Victims includes a set of contents that has been considered appropriate by patient safety experts. It has also shown to contribute to improving knowledge among health professionals about the second victim phenomenon. The methodology employed for disseminating this knowledge and explaining what and what not to do has been considered appropriate by the MISE participants.

    Data from the MISE evaluation confirm that the program increases knowledge about the issue of second victims and how to act with a colleague when either an adverse event or near miss occurs. It also shows how to interact with patients who are victims of an adverse event, providing information on how to act and how to disclose what has occurred.

    Five hours was the mean total time dedicated to complete MISE, distributed generally over 12 sessions lasting approximately 30 minutes each. This time demand is reasonable for this group of professionals and is compatible with other care responsibilities and tasks and their personal lives.

    Comparison With Previous Studies

    Emotional needs immediately following incidents have been analyzed in several studies. The emotional isolation professionals find themselves in, along with the difficulty of talking about what has happened with their colleagues and the lack of protection they feel from their superiors, have been identified as two important gaps that contribute to progressing along the scale of the second victim syndrome [39]. Both aspects have been corroborated by research carried out among participants in benchmark intervention programs (forYOU or RISE) with second victims and that, in turn, pointed out that most of what second victims were searching for and would have liked to receive was support from their colleagues and the management at their centers [24,34].

    We know that colleagues of second victims can do much more than what they currently do to prevent the emotional impact from safety incidents for the patient from progressing until manifesting itself as posttraumatic stress [8,23,40,41]. We also know that most professionals do not require specialized intervention to alleviate their initial emotional symptoms because sensing empathy by their colleagues can be sufficient [34]. The MISE intervention program considers these aspects and seeks to act at the base of Scott’s pyramid, where 60% of the professionals who suffer from the impact of incidents for safety as second victims are found [24].

    The role of managers is crucial in two senses due to their role as a barrier and their role as a facilitator [10,28,42]. Managers should prepare the organization so that if a severe incident does occur, it is prepared to act, and this includes analysis of what happened and the recovery by and support for the patient and for the second victim as well. Furthermore, they should create a just culture [43] that permits analyzing the incident without prejudging the second victim’s role in it. Likewise, managers should facilitate organizational learning from incidents using formal and informal processes as well as reactive and proactive approaches. Incident reporting is a crucial step for improving patient safety, but frontline professionals identify barriers (ie, lack of training, undesirable repercussions, lack of feedback) that lead to underuse of incident reporting systems [44]. However, Sujan [44] found that professionals use informal processes, such as regular staff meetings, discussions with line managers, and discussions with peers, that facilitate sharing concerns and experiences that can actively contribute to improving patient safety. Organization leadership should be aware of these alternative ways of learning and promote them.

    Subsequent to a severe adverse event, the second victim may become helpless and not inform the patient about the incident [45-49]. However, such attention and information on the part of the professionals, when presented in an appropriate manner, usually facilitates resolution of the crisis and prevents litigation [50]. The contents and approach of MISE aim in this direction.

    Relevance of This Study

    Mitigating Impact in Second Victims is easily accessible to a large number of professionals. It is a low-cost program that can be accessed from work or home with ease.

    This program responds to three deficiencies identified in the literature and in daily practice at health centers: (1) the lack of programs raising awareness and providing information about the second victim phenomenon that reaches high numbers of professionals, (2) the issue of second victims in primary care, and (3) the inexistence of structured interventions at most health centers to support professionals and patients following adverse events.

    The MISE program provides information to professionals about the second victim phenomenon in nine weeks of online training in which are presented general issues and problem situations based on experiences after committing a clinical error.

    The need for second victims to change their care functions could be reduced and less absenteeism linked to this phenomenon [27] could result if these professionals gain greater information and a change in attitude toward second victims. This sought-after attitudinal change would also facilitate a distinct attitude when interacting with patients in order to overcome the traditional difficulties resulting after an adverse event [51].

    Limitations

    It is possible that those who followed the MISE program were professionals who are more sensitive to the issue of what severe adverse events mean for professionals. We did not possess information about the type of professionals who declined invitations to follow MISE.

    A minimum sampling size was defined considering a worst case of 80% correct answers to the questions. The correct answers related to system failure did not match this assumption.

    The measure of the resulting impact was based on correct answers to knowledge tests and to self-test questions after watching a set of problem situations on video. Actual adverse events that occur may involve circumstances that are different from what these videos represented.

    This study was not designed to assess its effect on secondary prevention of posttraumatic stress; that is something that future research should evaluate. Thus, the effectiveness of this website in contributing to any kind of change was not assessed, and this will be done in the future. In this sense, realistic evaluation, a form of theory-driven evaluation developed by Pawson and Tilley in 1997 [52], may be a good methodology for testing MISE. Realistic explanation refutes the idea that a program works or does not work in an absolute manner and proposes that it is necessary to identify the mechanism (ie, the process of how subjects interpret and act on the intervention) by which the program works for whom and under what particular circumstances [52]. In this way, a program can be effective for achieving some outcomes or changes but not others, always depending on the context.

    Recommendations for Practice and Research

    The MISE program is designed to assist intervention programs to mitigate the impact of adverse events in professionals. It is not an emotional recovery program for second victims; instead, it responds to the need for the group of professionals to understand what is felt subsequent to an adverse event. MISE also contributes to frontline professionals gaining greater awareness about the emotional needs that are experienced when an error occurs and the importance of speaking about the incident with their colleagues. It also provides ideas about how to act with the patient victim of the adverse event [37]. This way, when an adverse event does occur, MISE contributes by helping the professional affected (second victim) to face the facts and recover his/her clinical capacity and emotional balance early on.

    These types of programs, along with other recommendations about what to do after an adverse event occurs, contribute to safer environments at hospitals and primary care.

    Future research could analyze whether MISE modifies the frequency, which up until now is relatively low, of patients who are victims of adverse events being informed about the incident. This research could also examine the impact of MISE in the initial hours after an incident. One example of this would be whether the colleagues of the second victims gain a greater ability to listen and act appropriately to prevent the emotional escalation that may result.

    Acknowledgments

    This study was financed by the Spanish Research Health Agency (FIS) and the European Regional Development Fund (references PI13/01220 and PI13/0473).

    Authors' Contributions

    JJM and SL conceived of the study. All participated in the design of the study. IC and JJM performed the statistical analysis. SL, PP, CS, and LF coordinated the qualitative and quantitative research, and captured and prepared data to design and improve MISE. IC and MG supervised the website. JJM, IC, and MG prepared a first version of this original. All authors read and approved the final manuscript.

    The Spanish Second Victim Research Team is composed of Roser Anglès (Vall d’Hebron University Hospital), Pilar Astier (Servicio Aragonés de Salud), Angélica Bonilla (Complutense University of Madrid), Ana Jesús Bustinduy (Gipuzkoa Primary Care Health District), Clara Crespillo (Alcorcón Foundation University Hospital), Sara Guila Fidel (Vall d’Hebron University Hospital), Álvaro García (Alcorcón Foundation University Hospital), Ana Jesús González (Gipuzkoa Primary Care Health District), María Jesús Gutiérrez, Emilio Ignacio (University of Cadiz), Fuencisla Iglesias (SESCAM, Toledo), Juan José Jurado (Madrid Primary Care Health Centre), Araceli López (Integrated Health Consortium), José Ángel Maderuelo-Fernández (SACYL), Mª Magdalena Martínez (Alcorcón Foundation University Hospital), Isabel María Navarro (Miguel Hernández University), María Cristina Nebot (Department of Health; Regional Government of Valencia), Roberto Nuño-Solinís (Universidad de Deusto), Guadalupe Olivera (SERMAS, Madrid), Antonio Ochando (Alcorcón Foundation University Hospital), Pedro Orbegozo (Gipuzkoa Primary Care Health District), Elene Oyarzabal (Donostia University Hospital), Jesús María Palacio (Muñoz Fernández-Ruiseñores Health Centre), María Esther Renilla (Alcorcón Foundation University Hospital), Carolina Rodriguez-Pereira (Basque Institute for Healthcare Innovation, O+Berri), Sira Sanz (Alcorcón Foundation University Hospital), María Luisa Torijano (Castilla-La Mancha Health Service, SESCAM), Julián Vitaller (Consellería Sanidad Universal y Salud Pública), Elena Zavala (Osakidetza, Donostia).

    Conflicts of Interest

    None declared.

    References

    1. de Vries EN, Ramrattan MA, Smorenburg SM, Gouma DJ, Boermeester MA. The incidence and nature of in-hospital adverse events: a systematic review. Qual Saf Health Care 2008 Jun;17(3):216-223 [FREE Full text] [CrossRef] [Medline]
    2. Aranaz-Andrés JM, Aibar-Remón C, Limón-Ramírez R, Amarilla A, Restrepo FR, Urroz O, IBEAS team. Prevalence of adverse events in the hospitals of five Latin American countries: results of the 'Iberoamerican Study of Adverse Events' (IBEAS). BMJ Qual Saf 2011 Dec;20(12):1043-1051. [CrossRef] [Medline]
    3. Tsang C, Bottle A, Majeed A, Aylin P. Adverse events recorded in English primary care: observational study using the General Practice Research Database. Br J Gen Pract 2013 Aug;63(613):e534-e542 [FREE Full text] [CrossRef] [Medline]
    4. Aranaz-Andrés JM, Aibar C, Limón R, Mira JJ, Vitaller J, Agra Y, et al. A study of the prevalence of adverse events in primary healthcare in Spain. Eur J Public Health 2012 Dec;22(6):921-925. [CrossRef] [Medline]
    5. Montserrat-Capella D, Suárez M, Ortiz L, Mira JJ, Duarte HG, Reveiz L, AMBEAS Group. Frequency of ambulatory care adverse events in Latin American countries: the AMBEAS/PAHO cohort study. Int J Qual Health Care 2015 Feb;27(1):52-59. [CrossRef] [Medline]
    6. Kohn LT, Corrigan JM, Donaldson MS. To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Press; 2000.
    7. Wu AW. Medical error: the second victim. The doctor who makes the mistake needs help too. BMJ 2000 Mar 18;320(7237):726-727 [FREE Full text] [Medline]
    8. Scott SD, Hirschinger LE, Cox KR, McCoig M, Brandt J, Hall LW. The natural history of recovery for the healthcare provider “second victim” after adverse patient events. Qual Saf Health Care 2009 Oct;18(5):325-330. [CrossRef] [Medline]
    9. Seys D, Wu AW, Van Gerven E, Vleugels A, Euwema M, Panella M, et al. Health care professionals as second victims after adverse events: a systematic review. Eval Health Prof 2013 Jun;36(2):135-162. [CrossRef] [Medline]
    10. Burlison JD, Quillivan RR, Scott SD, Johnson S, Hoffman JM. The effects of the second victim phenomenon on work-related outcomes: connecting self-reported caregiver distress to turnover intentions and absenteeism. J Patient Saf 2016 Nov:1 (forthcoming). [CrossRef] [Medline]
    11. Carrillo I, Mira JJ, Vicente MA, Fernandez C, Guilabert M, Ferrús L, et al. 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. J Med Internet Res 2016 Sep;18(9):e257 [FREE Full text] [CrossRef] [Medline]
    12. Mira JJ, Carrillo I, Fernandez C, Vicente MA, Guilabert M. Design and testing of the safety agenda mobile app for managing health care managers' patient safety responsibilities. JMIR Mhealth Uhealth 2016 Dec;4(4):e131 [FREE Full text] [CrossRef] [Medline]
    13. Mizrahi T. Managing medical mistakes: ideology, insularity and accountability among internists-in-training. Soc Sci Med 1984;19(2):135-146. [Medline]
    14. Edrees HH, Paine LA, Feroli ER, Wu AW. Health care workers as second victims of medical errors. Pol Arch Med Wewn 2011 Apr;121(4):101-108 [FREE Full text] [Medline]
    15. Lander LI, Connor JA, Shah RK, Kentala E, Healy GB, Roberson DW. Otolaryngologists' responses to errors and adverse events. Laryngoscope 2006 Jul;116(7):1114-1120. [CrossRef] [Medline]
    16. Rassin M, Kanti T, Silner D. Chronology of medication errors by nurses: accumulation of stresses and PTSD symptoms. Issues Ment Health Nurs 2005 Oct;26(8):873-886. [CrossRef] [Medline]
    17. Varjavand N, Nair S, Gracely E. A call to address the curricular provision of emotional support in the event of medical errors and adverse events. Med Educ 2012 Dec;46(12):1149-1151. [CrossRef] [Medline]
    18. Mazor KM, Simon SR, Gurwitz JH. Communicating with patients about medical errors: a review of the literature. Arch Intern Med 2004 Aug;164(15):1690-1697. [CrossRef] [Medline]
    19. Manser T, Staender S. Aftermath of an adverse event: supporting health care professionals to meet patient expectations through open disclosure. Acta Anaesthesiol Scand 2005 Jul;49(6):728-734. [CrossRef] [Medline]
    20. Mira JJ, Lorenzo S, en nombre del Grupo de Investigación en Segundas Víctimas. [Something is wrong in the way we inform patients of an adverse event]. Gac Sanit 2015 Sep;29(5):370-374 [FREE Full text] [CrossRef] [Medline]
    21. Waterman AD, Garbutt J, Hazel E, Dunagan WC, Levinson W, Fraser VJ, et al. The emotional impact of medical errors on practicing physicians in the United States and Canada. Jt Comm J Qual Patient Saf 2007 Aug;33(8):467-476. [Medline]
    22. Wu AW, Boyle DJ, Wallace G, Mazor KM. Disclosure of adverse events in the United States and Canada: an update, and a proposed framework for improvement. J Public Health Res 2013 Dec;2(3):e32 [FREE Full text] [CrossRef] [Medline]
    23. Ferrús L, Silvestre C, Olivera G, Mira JJ. Qualitative study about the experiences of colleagues of health professionals involved in an adverse event. J Patient Saf 2016 Nov:1 (forthcoming). [CrossRef] [Medline]
    24. Scott SD, Hirschinger LE, Cox KR, McCoig M, Hahn-Cover K, Epperly KM, et al. Caring for our own: deploying a systemwide second victim rapid response team. Jt Comm J Qual Patient Saf 2010 May;36(5):233-240. [Medline]
    25. Wolf ZR, Serembus JF, Smetzer J, Cohen H, Cohen M. Responses and concerns of healthcare providers to medication errors. Clin Nurse Spec 2000 Nov;14(6):278-287. [Medline]
    26. Harrison R, Lawton R, Stewart K. Doctors' experiences of adverse events in secondary care: the professional and personal impact. Clin Med (Lond) 2014 Dec;14(6):585-590. [CrossRef] [Medline]
    27. Mira JJ, Carrillo I, Lorenzo S, Ferrús L, Silvestre C, Pérez-Pérez P, Research Group on Second and Third Victims. The aftermath of adverse events in Spanish primary care and hospital health professionals. BMC Health Serv Res 2015 Apr;15:151 [FREE Full text] [CrossRef] [Medline]
    28. Van Gerven E, Bruyneel L, Panella M, Euwema M, Sermeus W, Vanhaecht K. Psychological impact and recovery after involvement in a patient safety incident: a repeated measures analysis. BMJ Open 2016 Aug;6(8):e011403 [FREE Full text] [CrossRef] [Medline]
    29. Mira JJ, Lorenzo S, Carrillo I, Ferrús L, Pérez-Pérez P, Iglesias F, Research Group on Second and Third Victims. Interventions in health organisations to reduce the impact of adverse events in second and third victims. BMC Health Serv Res 2015 Aug;15:341 [FREE Full text] [CrossRef] [Medline]
    30. Gerven EV, Seys D, Panella M, Sermeus W, Euwema M, Federico F, et al. Involvement of health-care professionals in an adverse event: the role of management in supporting their workforce. Pol Arch Med Wewn 2014 Apr;124(6):313-320 [FREE Full text] [Medline]
    31. Pratt SD, Jachna BR. Care of the clinician after an adverse event. Int J Obstet Anesth 2015 Feb;24(1):54-63. [CrossRef] [Medline]
    32. Christensen JF, Levinson W, Dunn PM. The heart of darkness: the impact of perceived mistakes on physicians. J Gen Intern Med 1992 Jul;7(4):424-431. [Medline]
    33. Ullström S, Andreen Sachs M, Hansson J, Ovretveit J, Brommels M. Suffering in silence: a qualitative study of second victims of adverse events. BMJ Qual Saf 2014 Apr;23(4):325-331 [FREE Full text] [CrossRef] [Medline]
    34. Edrees H, Connors C, Paine L, Norvell M, Taylor H, Wu AW. Implementing the RISE second victim support programme at the Johns Hopkins Hospital: a case study. BMJ Open 2016 Sep;6(9):e011708 [FREE Full text] [CrossRef] [Medline]
    35. Second and Third Victim Research Group. Second victims research project   URL: http://www.segundasvictimas.es/ [accessed 2017-05-30] [WebCite Cache]
    36. Second and Third Victim Research Group. Access to Mitigating Impact in Second Victims (MISE) online program   URL: http://www.segundasvictimas.es/acceso.php [WebCite Cache]
    37. Mira JJ, Lorenzo S, Carrillo I, Ferrús L, Silvestre C, Astier P. Lessons learned for reducing the negative impact of adverse events on patients, health professionals and healthcare organisations. Int J Qual Health Care 2017:00 (forthcoming).
    38. Andalusian Agency for Health Care Quality. ACSA certification of health websites and blogs   URL: http:/​/www.​juntadeandalucia.es/​agenciadecalidadsanitaria/​en/​acsa-accreditation/​accreditation-of-health-websites-and-blogs/​ [accessed 2017-05-09] [WebCite Cache]
    39. White AA, Waterman AD, McCotter P, Boyle DJ, Gallagher TH. Supporting health care workers after medical error: considerations for health care leaders. J Clin Outcomes Manag 2008 May;15(5):240-247.
    40. Aasland OG, Førde R. Impact of feeling responsible for adverse events on doctors' personal and professional lives: the importance of being open to criticism from colleagues. Qual Saf Health Care 2005 Feb;14(1):13-17 [FREE Full text] [CrossRef] [Medline]
    41. Wu AW, Folkman S, McPhee SJ, Lo B. How house officers cope with their mistakes. West J Med 1993 Nov;159(5):565-569 [FREE Full text] [Medline]
    42. MacLeod L. “Second victim” casualties and how physician leaders can help. Physician Exec 2014 Jan;40(1):8-12. [Medline]
    43. Dekker S. Just Culture: Balancing Safety and Accountability. Aldershot, UK: Ashgate; 2007.
    44. Sujan M. An organisation without a memory: a qualitative study of hospital staff perceptions on reporting and organisational learning for patient safety. Reliab Eng Syst Safe 2015 Dec;144:45-52. [CrossRef]
    45. Vincent JL. Information in the ICU: are we being honest with our patients? The results of a European questionnaire. Intensive Care Med 1998 Dec;24(12):1251-1256. [Medline]
    46. Blendon RJ, DesRoches CM, Brodie M, Benson JM, Rosen AB, Schneider E, et al. Views of practicing physicians and the public on medical errors. N Engl J Med 2002 Dec;347(24):1933-1940. [CrossRef] [Medline]
    47. Gallagher TH, Waterman AD, Ebers AG, Fraser VJ, Levinson W. Patients' and physicians' attitudes regarding the disclosure of medical errors. JAMA 2003 Feb;289(8):1001-1007. [Medline]
    48. Kaldjian LC, Jones EW, Wu BJ, Forman-Hoffman VL, Levi BH, Rosenthal GE. Disclosing medical errors to patients: attitudes and practices of physicians and trainees. J Gen Intern Med 2007 Jul;22(7):988-996 [FREE Full text] [CrossRef] [Medline]
    49. Gallagher TH, Waterman AD, Garbutt JM, Kapp JM, Chan DK, Dunagan WC, et al. US and Canadian physicians' attitudes and experiences regarding disclosing errors to patients. Arch Intern Med 2006 Aug;166(15):1605-1611. [CrossRef] [Medline]
    50. Wu AW, Marks CM. Close calls in patient safety: should we be paying closer attention? CMAJ 2013 Sep;185(13):1119-1120 [FREE Full text] [CrossRef] [Medline]
    51. Garbutt J, Waterman AD, Kapp JM, Dunagan WC, Levinson W, Fraser V, et al. Lost opportunities: how physicians communicate about medical errors. Health Aff (Millwood) 2008 Jan;27(1):246-255 [FREE Full text] [CrossRef] [Medline]
    52. Pawson R, Tilley N. Realistic Evaluation. London: Sage; 1997.


    Abbreviations

    MISE: Mitigating Impact in Second Victims
    PDF: Portable Document Formats
    RISE: Resilience in Stressful Events


    Edited by G Eysenbach; submitted 11.04.17; peer-reviewed by K Vanhaecht, C Fernández, W Sermeus, M Sujan; comments to author 17.05.17; revised version received 23.05.17; accepted 23.05.17; published 08.06.17.

    ©José Joaquín Mira, Irene Carrillo, Mercedes Guilabert, Susana Lorenzo, Pastora Pérez-Pérez, Carmen Silvestre, Lena Ferrús, Spanish Second Victim Research Team. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 08.06.2017.

    This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.