Background

Quality in health care: patient safety

One of the definition of the quality is that doing something excellence or degree of excellence in specific field [1]. Inappropriateness of the Quality Control and Quality Assurance model which focus on inspection created need for more comprehensive model which called Total Quality Management (TQM) in Manufacturing Industry. As a comparison to the previous approaches, TQM is more comprehensive, participative and preventive. Changes and improvements in manufacturing, aviation and nuclear industries have led health organizations to provide safer care for their patients. Several institutions and studies identified six dimensions of quality in healthcare [2, 3]. They are safety, efficiency, access (timeliness), efficacy, equity (appropriateness) and patient centeredness (consumer participation). One of the high quality of healthcare indicators relies on safety. World Health Organization (WHO) defined patient safety as “the absence of preventable harm to a patient during the process of healthcare” [4].

Unsafe events and their categorizations

Previously, medical incidents were called errors and medical errors can refer to 'wrong action or failures in planned care' or 'implementing wrong care plan to the patient'. Furthermore, medical error was defined as “an unintended health care outcome caused by a defect in the delivery of care to a patient” by National Patient Safety Foundation in Australia [5]. More recently, errors have started to be called as “unsafe events”. Broader understanding of unsafe event’s etiology and better classification of the unsafe event were done by psychologist James Reason (Fig. 1). Recent International Forums on Quality and Patient Safety in Healthcare and Institute for Healthcare Improvement (IHI) have taken up those understanding and classification of unsafe event that help providers for better understanding of unsafe events.

Fig. 1
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Categorization of unsafe events [9]

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Safety issues are more likely to occur in intensive care units, operating rooms and emergency services [5, 6]. In addition to these safety problems there are non-clinical issues which considered as operational risk factors such as: manpower, medical supplies- product quality, patient transfer, occupational safety and health (OSH), facilities defects, data security & confidentiality, equipment failure, hospital security, fire safety and financial issues [5].

After IOM report released in 1999, most of health care organizations focused to prevention of medical errors however experts from most recent safety forums have suggested understanding of why these unsafe event occurs in health industry. In order to prevent errors and harm, professionals should understand error causation to prevent these unsafe events and address complex issues in system. Psychologist James Reason, to facilitate learning and identifying, he defined unsafe acts via dividing them to four groups: slips, lapses, mistakes, and violations (Fig. 1).

Unsafe act can be error or a violation that committed in the existence of a potential risk [7]. According to WHO, violation is defined as “a deliberate deviation from an operating procedure, standard, or rules” however such violations may occur and the intentions may not be causing harm [8]. Errors are whether mistakes (rule based, knowledge based), lapses or slips. Human failures are an actions that may “not go as intended” or “go as intended, but it is wrong”. For the action that doesn’t go as intended, it might be observable slip or unobservable lapse. On the other hand, action which goes as intended but it is wrong, so called as a mistake that involves failure in planning process. Mistakes are either rule based which provider has knowledge but applies it wrong or knowledge based that provider doesn’t have required knowledge for responding.

The shift in approaching and understanding of patient safety issues

The previous perspective for underlying factors of unsafe event focused to complexity of the health system and blamed individual (providers) for causing errors. After several researches and evaluations were conducted, professionals saw that blaming, naming and shaming approaches do not help to improve patient safety outcomes. After 15 years of IMO report, when providers were being understood that they do not intend to cause harm on patients, then the perspective has started to shift from individual level to system failures. They realize that most errors cannot be linked to the individual performance and these issues are mostly results of a series of preventable system errors. Redesigning systems to prevent errors and violations may help healthcare organization to improve the system and have better human condition and the conditions under which humans work.

Human factors and changing behaviors of providers

“Human factors” are discipline of engineering that deals with the interface of people, equipment, and the environment in which professional perform their duties. There are internal and external factors that affect human performance. These several circumstances influence human performance and increase risk of occurrence of unsafe events. Mental and physiological states, such as: fatigue, stress, dehydration, hunger, and boredom are playing role before the unsafe event occur. On the other hand, perception, attention, memory, reasoning, and judgment directly influence decision making process. Lastly, communication and being able to carry out the intended action are factors that directly increase possibility of decision execution.

Behaviors of provider may play essential role to improve safety for patients. Absence of safe behaviors in healthcare can lead to patient harm. The way to prevent errors is not to tell people to be more careful and work harder, it is changing the systems in which they work. As James Reason’s teaching of latent errors: those “accidents waiting to happen” because of defects in the design of the systems in which people work. So that, WHO suggests using human factors principles to understand relationships between humans-humans, humans-medical equipment and humans-environment [9]. Well designed processes may make it easy for people to do the right things, and hard to do the wrong things. Multiple factors, which affect ‘brain processes and responds’ and influence ‘personal performance’ negatively, need to be prevented and mitigated for intended safety outcomes.

Critical behaviors of healthcare staff: speaking up!

There are four critical behaviors which are under our control that help to improve patient safety. They were classified by IHI as [10]:

  • Following safety protocols

  • Speak up when you have concerns

  • Communicate effectively

  • Take care of yourself

Joint Commission predicted that 80 % of the serious safety events occur due to miscommunications among professionals. ‘Speaking up’ is one of the critical behaviors of patient safety that both provider and patient have ability to improve it. It is defined as raising of concerns by professionals or patients in existence of recognized deficient or risky actions that affect patient safety and quality of care [11]. It may display essential role in preventing and mitigating unsafe event which is causing harm on patient.

Public health significance

According to the IOM report in 1999, medical errors cost $29 billion and least 44, 000 people; however more than 98,000 deaths occur as results of medical errors every year and burden of the medical errors exceed the sum of the burden of vehicle accidents, breast cancer and AIDS in the United States [6, 12]. Some studies present that 1 in 3 Americans have experienced medical incidents while seeking care for their selves or their relatives [13].

Apart from US, WHO highlighted that [14]:

  • Almost, 1 in 10 hospital patients is harmed while receiving care in developed countries.

  • Hospital infections influence 14 of every 100 hospital admissions. As a result, 1.4 million people suffer from hospital-acquired infections in the world.

  • Unsafe injections can cause 1.3 million deaths every year.

  • In some countries, as many as 70 % of injections are done with unsterilized syringes or needles.

  • Poor quality in healthcare could result with 20 % - 40 % waste. So that, studies demonstrate that improving patient safety could save some countries between $6 and $29 billion annually.

Safety events may occur between 3.7-16 % and avoidable harm expected to be 10 % of events [15]. In one of the survey (n: 192,462), results showed that 53 % of professionals afraid to raise a question when something did not seems right during procedure [16]. Unsafe events are not just causing lost income, household productivity, physical and psychological discomfort on patient but also resulting with such impacts on caregivers, providers and patient families. Healthcare organizations should seek solutions to mitigate these unsafe acts for better safety outcomes and ensure that their patients are safe during admission, diagnosis, treatment and discharge processes.

Objective

The objective of the literature review is to determine the evidence of the role of “speaking up” as a safety behavior in healthcare.

Methods

Search strategy

A literature search was conducted mainly using PubMed to find articles which were relevant to patient safety and speaking up behaviors of both patient and provider and published up to January 2016. A systematic search of articles and reports was performed by using key words of “Speak Up”, “Speaking up”, “Speaking up Behaviors”, “Safety Behaviors”, “Patient Safety”, “Unsafe Event”, “Safety Event”, “Inter-professional Relations”, “Human Factors in Patient Safety” and “Safety Culture”. Several institutions’ websites such as: World Health Organization (WHO), The Institute for Safe Medication Practices, The Joint Commission, Canadian Patient Safety Institute, Australian Patient Safety Foundation, Institute for Innovation and Improvement (UK), Patient Safety Resource Centre (UK), Institute for Healthcare Improvement (IHI), Agency for Healthcare Research and Quality, The International Society for Quality in Health Care and Safety Division, HA, HKSAR.

Inclusion criteria

  • Articles were selected if their subjects were physicians, nurses, medical residents, fellows, experts in field, interns (medical field) and patients. Articles were included if they studied speaking up behaviors relevant to patient safety.

  • Studies were included if they are meta-analysis, systematic review and observational studies.

  • Relevant articles were included if they studied “Speak Up”, “Speaking up”, “Speaking up Behaviors” and “Safety Behaviors” in healthcare field.

  • Not only the selected studies but also their references were scanned. Their relevant parts were included for the project.

  • Regardless of types of study (observational and experimental), relevant articles were included.

Exclusion criteria

Articles not involving same objectives of this literature review and unrelated to the objectives of the review were excluded. Studies with outcomes of interest other than “Speak Up”, “Speaking up”, “Speaking up Behaviors” and “Safety Behaviors” were also excluded. When there were studies that cannot be discarded due to their initial screening of the title and abstract, their full texts were reviewed. After reviewing, their potential contributions (regarding to associations with purpose of the research) were assessed.

Data collection method

Studies were extracted through list of keywords mentioned in the beginning of the project. Articles which were not relevant to inclusion and exclusion criteria were discarded.

Quality assessment criteria

Checklist of Standards for Quality Improvement Reporting Excellence was used for the assessment of studies [17]. The SQUIRE guidelines are beneficial for authors to make sense about writing excellent and usable articles related to quality improvement in healthcare field.

Results

Findings

53 relevant articles were identified in 83 articles. 4 literature reviews, 3 RCTs, 8 cohorts, 1 case control, 34 Cross Sectional studies and 3 reports were identified. More than half of the studies (32) came from United States while others from UK (7), Switzerland (4), New Zealand (2), Canada (2), Hong Kong (1), S. Korea (1), Ireland (1), Japan (1) and Iran (1). Most of the selected studies based on interviews and surveys results. Most of the studies mentioned speaking up behaviors of healthcare staff while four of them mentioned patient speaking up behaviors (Fig. 2) (Table 1).

Fig. 2
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Study selection process

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Table 1 Summary of studies
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Factors that influencing speaking up

Factors that influencing speaking up among professional

There were bunch of studies that they illustrated influencing factors of speaking up in healthcare organization. The one which was introduced by Marrison EW had better classification of the factors that influencing healthcare staff's speaking up behaviors (Fig. 3). Perceived efficacy of speaking up, motivation and clinical factors, individual factors, general contextual factors and perceived safety of speaking up were found as categorized influencing factors of speaking up [18].

Fig. 3
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Framework of Marrison’s model of employee speaking up

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Perceived efficacy of speaking up

Studies illustrated that healthcare staff expect to be informed about safety issues that happen in their unit. They should feel that management is not sweeping the issues under the rug (nothing will be done) [19–21]. Impact of work and perception of autonomy are considered under the personal control which influence speaking up behaviors [20].

Motivation and clinical factors

Predictors of the decision to speaking up have multiple influential factors such as: limited time, cumbersome documentation systems, clinical frame, lack of managerial support or follow up for an event, the level of perceived potential harm (varied perception in harm rating) and clinical situation (clarity, ambiguity, contrast) [19, 20, 22, 23].

Individual factors

Individual factors that influencing speaking up are illustrated on Fig. 4 (Fig. 4). Speaking up is varied towards well-known coworker and unknown person [23, 24]. Lover expressed likelihood of speaking up is linked to younger age, male gender, being nurse and working on ward [22]. Compared to males, females are more likely to have negative perceptions of speaking up [25]. Persons who express their concerns positively are associated with better satisfaction and promote safer environment [20].

Fig. 4
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Individual factors that influencing speaking up among Professional

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General contextual factors

There are several organizational and managerial factors that affect speaking up behaviors in healthcare organization and they are illustrated on Fig. 5 (Fig. 5). If culture of safety is negative which means that it involves punitive actions and blames then nurses are less likely to speak up in the team [26]. Visible and strong administrative support has been enhancing voicing behaviors of professionals. It has been found that professionals tend to speak up when hospital policies openly support and encourage them to raise their concerns [20].

Fig. 5
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General contextual factors that influencing speaking up among Professional

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Perceived safety of speaking up

Presence of an audience (such as fear of causing lose in trust of the patient), perceived response of addressed actor (colleague) (fear of appearing incompetent, concerns and reprisal), seniority of the actor and his/her role, existence of senior encouragement towards speaking up behaviors, existence of common understanding of patient and patient needs, uncertainty about the issue, actual or perceived punishment towards the employee reporting an event and the fear, cost and results of raising concerns are found influencing factors about remaining silent or speaking up [11, 19, 22–24, 27–29]. Likelihood of speaking up is strongly influenced by seniority of the actor. Speaking up is significantly higher among managerial staff. Compared to senior staff, junior staff have two times discomfort about speaking up [22].

Factors that influencing speaking up among patients

Four studies were identified that they studied patient voicing up behaviors and patient safety. Proactive patients are associated with better safety outcomes. Patient involvement, participating to decision making process are ways to reduce occurrence of medical events [30]. Sometimes, if patient speaks up, it might result with unintended consequences. Speaking up might appear rude or disrespectful, makes staff upset and endanger patient care. Healthcare staff are welcoming patient’s questions. Providers thought that if patients ask many questions and wrote something, they probably will complain about them. Patient-mediated approaches which prompt patients to speak up are criticized by professionals due to rarely considering the needs of healthcare staff [31]. In another study, half of the patients in maternity care indicated that there were insistent and vehement communication with staff while experiencing failures. Interviewees also highlighted receiving lack of listening and responds from professionals. 14 women thought that they experienced urgent safety issues. The patients think that the presence of their partners or relatives encourage them to speak up when they have concerns. Distress and harm are described by patients when the professionals failed to listen them [32].

Raising concerns from patients and their relatives are depend on their ability to recognize changes in ‘self-monitoring’, ‘culture and system of health care’, ‘clinical condition’ and ‘confidence and trust’. Healthcare staff display a role of mediator when there are concerns from patients and their relatives [33].

Effectiveness of speaking up for patient safety

There are several studies that clearly demonstrate relationship between speaking up behaviors and patient safety. A randomized control study (RCT) aimed to identify how surgeon’s behaviors can encourage or discourage medical students to speak up when there is a safety event. The results indicated that encouraged group were more likely to speak up than discouraged group (82 % vs 30 % and p < 0.001). The senior surgeons play an essential role to improve and enhance 'patient safety' and 'intraoperative communication' at Operating Theatre [28]. In another RCT, Non- technical skills coaching improved in the intervention group compared to those in control group (p: 0.04). Intervention group was faster to respond unstoppable bleeding (p: 0.03) [34].

Speaking up is strongly linked to safety problems. Being silence is associated with issues such as hygiene, isolation and invasive procedures [35].

Effectiveness of speaking up training

It has been found that nursing students don’t feel comfortable to speak up when safety events occur [36, 37]. Providing prior formal training about patient safety is linked with more positive perceptions of speaking up climates for safety [25]. In a case control study, nurses were trained regarding to speaking up behaviors. Results showed that their perceptions of ability to improve safety and speak up behaviors increased. Intervention arm had a significant difference in ‘mean speaking up scores’ from baseline to posttest (p < 0.0001) while control group was having no significant change (p = 0.68) [38]. In a cohort study, knowledge of the interns increased significantly due to training program. There was an evidence to support a shift in attitudes towards intended direction related to need for speaking up to seniors however, there was not an effect of training on behaviors of interns [39]. In another cohort study, after Crew Resource Management (CRM) training applied to employees, results showed that healthcare staff were more likely to speak up when they have concern about safety (p < 0.002) [40]. In another cohort study, after senior practicum course applied to student, their confidence increased significantly however students’ confidences in questioning someone of authority was not found statistically significant [41]. After successful implementation of TeamSTEPPS tools in one of the cohort study, participants rated lower for “In this clinical area, it is difficult to speak up if I perceive a problem with patient care” (before implementation 69.4 % of agreement, after implementation 25.5 % agreement, p < 0.001) [42].

In some studies, medical students indicated desire to increase additional training regarding to patient safety [37]. They (medical students) may be good opportunity to prevent safety events and ensure safety in health care organizations. Cultural changes in patient safety are needed to increase proactive contribution of medical student when they experience safety events [43]. Studies have been showing that there is a continued need for communication, additional education, medication safety and prioritization in practice [19, 37]. So that, providing training in regular intervals may improve speaking up behaviors of both medical students and residents of hospital.

Discussion

Speaking up is responsibility of everyone in the team. It is not essential just for operating theatre but also applicable to any other relevant situations in health setting. It is obviously needed when staff and patient are at risk or vulnerable, and when the team members have lack of awareness. Speaking up is an essential action considered belong professional accountability [44]. Some enabler of speaking up could be as follows:

  • In a result of a RCT, having a second opinion or getting help, realizing the speaking up problem, certainty about the consequences of the speaking up and having a speaking up rubric were found as the five most frequent enablers for speaking up [24].

  • Recommendation of Institute for Healthcare Improvement (IHI): In order to speak up in healthcare organization [21]: Psychologically safe environment is needed for speaking up openly. Active leadership and management support are important to talk about concerns confidently. Transparency that where healthcare team and management are handling safety issues seriously rather that sweeping them under the rug. Fairness that where people are not receiving punishment or blame due to system based errors.

  • As an individual level, ‘identifying and reporting problems with procedures and policies’, ‘reporting unsafe working conditions, adverse events and close calls’ and speaking up when having concerns [45].

  • Using structured techniques to communicate effectively (for instance: using SBAR, critical language) [45].

  • Having knowledge of human factors [46, 47].

  • Studies have been showing that there is a continued need for communication, additional education, medication safety and prioritization in practice [19, 37]. So that, providing training regarding to critical behaviors in regular intervals may improve speaking up behaviors of both medical students and residents of hospital.

  • Ensuring ‘Safety Culture’ and ‘Horizontal Communication’ in a dynamic clinical setting [27, 46, 48].

  • Creating ‘shared workmates norms’, ‘common understanding of patient and patient’s needs’ and ‘values about speaking up’ may promote willingness to speak up in an organization [29, 48, 49].

  • Strong leadership and supervisory [50].

  • Listening and valuing of provider concerns [51].

  • Patient involvement and participating to decision making process [30].

In the relevant literature, theoretical framework on speaking up (illustrated for better understanding by Jennifer Rainer) and relationship between employees’ voice concerns and organizational outcomes (illustrated for better understanding by Aled Jones and Daniel Kelly) are illustrated in (Fig. 6 and Fig. 7). In this literature review, various influencing factors of speaking up are listed via using Marrison’s model of employee voice (Fig. 3). The decision to speak up in a clinical setting is dynamic, highly context-dependent, embedded in the interaction rituals that suffuse everyday work and constrained by organizational dynamics in healthcare [27, 46]. Voicing is affected by multiple things such as person, group, organization, human factors and leadership [46].

Fig. 6
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Theoretical framework on speaking up. Reprinted and copyright by permission of Jennifer Rainer, January 11, 2016

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Fig. 7
figure 7

Relationship between employees’ voice concerns and organizational outcomes. Reprinted and copyright by permission of Aled Jones and Daniel Kelly, January 11, 2016

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Settlement of positive safety culture in healthcare organization is an important action that promote mutual trust among professionals. Culture of safety encourage healthcare staff to talk freely about unsafe events and their management without fear of stigmatization, blame or punishment. For improvement in speaking up behaviors among health care organization, leaders may require to take varied action plans regarding to need and level of ‘speaking up behaviors’ and ‘safety culture’. The need for critical behaviors of safety may vary in healthcare organizations. In order to have desired level of behavioral results for enhancing patient safety, varied tools can be used by leaders to assess current level of ‘speaking up behaviors’ and ‘culture of safety’. Those tools are:

  • Hospital Survey on Patient Safety Culture, The Agency for Healthcare Research and Quality (AHRQ) [52].

  • Two scales that they are “speaking up climates patient safety concerns (SUC-Safe)” and “speaking up climates unprofessional behavior (SUC-Prof). Scales help to measure safety and teamwork climate, assess degree of culture that encourages speaking up about safety and professionalism concerns, identify educational needs and track the progress in relevant interventions [25].

  • The Safety Attitudes questionnaire (SAQ), The Agency for Healthcare Research and Quality (AHRQ) [53].

  • The High-Performance Work Systems survey (HPWSs) was found as a strongest predictor of extent to which healthcare practitioners felt confident to speak up about safety events [54].

  • Social science and Organization behavior research (OBR) help health care organization to create safer environment in their units/services. They are helping health organizations to shift from slow improvement to faster and more effective progressivity in safety culture [55].

This study was first study about not just identifying factors that influencing speaking up behaviors among providers but also including factors of patients’ voicing up behaviors for safety. This study is also providing some ‘enablers of speaking up behaviors’ which may help leaders and professionals’ decision making process for quality and safety improvements in their organizations.

Limitation

Most of the studies were cross sectional and studied influencing factors of speaking up behaviors. Further experimental studies are needed for identifying enabling factors of speaking up behavior for enhancing and improving patient safety. On the other hand, most of the relevant studies were conducted in western countries, so that influencing factors may vary for eastern countries. Before taking any decision or having implementations about safety, relevant tools which mentioned in introduction part of this study are suggested for identifying local influencing factors of speaking up behaviors.

Conclusion

Speaking up is one of the critical behaviors of patient safety [10]. Awareness of factors that ‘influencing’ and ‘enabling’ speaking up behaviors may help leaders and decision makers to improve quality and safety of healthcare in their organization. This study is providing complex process of speaking up behavior and their impacts on patient safety outcomes.