Patient empowerment in risk management: a mixed-method study to explore mental health professionals’ perspective

Ethical approval for the present study was obtained by the Ethical Committee of the Verona University Hospital (Protocol n.16160; 31/03/2016).

The study was conducted within the Verona Mental Health Department (MHD) in the Northeast of Italy (459,536 inhabitants). Specifically, four mental health services and one “specialized penitentiary mental healthcare unit” (i.e., a small-scale facility for prisoners with mental health problems that, according to Italian law, has recently replaced forensic hospitals) were included. The MHD includes: 1) four 15-bed acute inpatient wards (i.e., open wards with dedicated staff where patients can be admitted on a voluntary or compulsory basis) located in three general hospitals; 2) four community mental health centers providing day care and rehabilitation; 3) 13 outpatient clinics, providing emergency care and continuity of care as well as scheduled domiciliary visits; 4) one liaison service offering psychiatric and psychological consultations for other departments of the general hospital, 5) one 24-h emergency department, and 5) 36 sheltered accommodations. We recruited participants from various MHD settings to encourage different perceptions and points of view and to thus increase representativeness and generalizability of our findings. All the HPs of the MHD having attended a continuing educational course on risk management in 2016 were invited to participate in the study. Indeed, we considered such a common background in risk management as a useful prerequisite for guiding participants more easily during the focus group discussions. All recruited participants signed the informed consent form and were then divided into 12 focus groups of six to 10 participants.

Experienced focus group facilitators introduced the rules highlighting the importance of confidentiality. Participants were then encouraged to provide their opinions derived from their professional experiences and knowledge in the field of mental health and patient safety. According to the aims of this study, the following questions were proposed one by one to stimulate the discussion:

1. What do you think about patients’ involvement in risk management in psychiatry?

2. Which are the potential limits/risks of involving psychiatric patients in risk management?

3. Which are the potential benefits/strengths of involving psychiatric patients in risk management?

4. Which strategies do you usually apply in your daily practice in order to engage patients in their safety?

In the subsequent one-hour discussion, participants exchanged their opinions but were asked to adhere as much as possible to the themes proposed by the facilitators and to respect turn-taking. Facilitators had also to promote the debate and ensure the active involvement of each participant without interfering with the content of the discussion.

We applied a mixed-method approach, since it is one of the most effective methodologies able to “capture the complexity of healthcare processes and to gather advanced insight into healthcare communication phenomena” (p.281) [29]. By combining quantitative and qualitative techniques, a large amount of information, collected in flexible and iterative ways, can be synthetized and analyzed.

The rationale for using multiple forms of research is based on the understanding that all methods have strengths and limitations and that the advantages of quantitative research can outweigh the disadvantages of qualitative research and vice versa.

All focus group discussions, including facilitators’ questions and comments, were audiotaped and fully transcribed. In order to synthesize the transcriptions, two researchers (MR and FM) independently analyzed the discussion of one randomly selected focus group following the guidelines for qualitative content analysis [30]. Each researcher preliminary labeled all verbal contributions (i.e., phrases, comments, opinions, suggestions of each participating HP) according to the above-mentioned questions and then sub-grouped them in areas conveying similar concepts. After this first round of individual text analysis, the researchers discussed and merged their preliminary labels into a unique coding system, organized in a hierarchical structure of four levels (see Fig. 1).

In order to verify if all topics raised by the participants could be captured by the coding system, two researchers separately coded the transcripts of two additional focus group discussions. Since no additional topics emerged, the coding system was considered exhaustive (i.e., saturation criterion) and the four levels were confirmed as follows:

Level 1 aims to distinguish between HPs’ contributions describing or referring to a strategy (i.e., a statement underlying a way patient empowerment may improve risk management) and HPs’ contributions pointing out a critical issue (i.e., a statement underlying critical aspects that may hinder patient empowerment in risk management). Level 2 (thematic areas) refers to different aspects of the process of care (i.e., Treatment and cure, Diagnosis and assessment, Emergency management, Comorbidity, Other). Level 3 (Categories) consists of specific issues related to certain thematic areas (e.g., the thematic area Comorbidity was divided into the two categories Drug abuse and Organic Conditions). Finally, level 4 lists specific strategies or critical issues applicable to each category at level 3 (e.g., the strategy Handling HPs emotions might be referred to several categories, such as Therapeutic compliance, Diagnostic error, or Compulsory treatment).

In order to ensure that facilitators’ interventions did not influence the course of participants’ discussion, one researcher (MR) verified facilitators’ neutrality by analyzing all their verbal turns in the transcripts. To provide definitions and rules for coding each transcript of each focus group, a manual was developed (MR and FM) (see additional file 1 for the definitions of thematic areas and categories).

Two independent raters (VD and EB) then coded all the contributions of all focus groups according to the established four-level hierarchical coding system and by using the above-mentioned manual.

Aiming to evaluate the reliability of the coding system, the inter-rater agreement was evaluated for one randomly selected focus group transcript. The inter-rater agreement turned out to be good at Level 1 (87%, κ = 0.73, 95% CI [0.607, 0.862]), moderate at level 2 (72%, κ = 0.55, 95% CI [0.420, 0.686]) and at level 3 (64%, κ = 0.55, 95% CI [0.425, 0.673]). The fourth and last level was characterized by skewed data and empty cells, inter-rater reliability analysis could therefore not be performed. The overall inter-rater agreement was considered satisfying. In order to further improve the quality of the coding process, in particular for level 4, it was established that unsure codings had to be discussed and resolved in consensus.

Interrater reliability of the coding system has been performed with Cohen’s Kappa by using STATA module Kappaetc [31].

Following a mixed-method approach [30], a frequency distribution of each thematic area, category, and subcategory is provided together with fragments of text extracted from the focus group transcripts. In order to check if all participants contributed to the focus groups discussions, we ensured to maintain the link between each contributing statement and its author in a sub-sample of four focus-groups. Rates of occurrence of all the expressions by participant were calculated.

In most of the medical fields, patients’ willingness to adhere to safety protocols can be presumed. In psychiatry, this aspect is more controversial, as highlighted also in our study by the high percentage of critical issues discussed in the categories Therapeutic compliance, Self-harm/suicide, and Acute/psychotic symptoms. Indeed, some psychopathological conditions [20, 22, 32, 33], such as severe depression, may undermine patients’ willingness to take care of their own health and safety and, in the worst cases, even existence (i.e., suicide). Furthermore, psychotic symptoms (e.g., hallucinations) may alter patients’ perceptions of reality and consequently affect the perception of potential sources of risk. Lastly, even personality traits can compromise patients’ compliance to risk management as demonstrated, for instance, by self-harming behaviors occurring in patients with borderline disorder.

Even if the three most frequently cited strategies to promote patients’ involvement turned out to be Building therapeutic trust/alliance, Providing information/educate, and Relying on the experience/knowledge of patients, HPs considered Patients’ low awareness, reliability, accessibility as one of the most significant limitations to the process. These results underline that HPs value patients’ perspective and collaboration considering it as a mean to ensure higher level of safety but, at the same time, feel that this collaboration may be easily questioned and compromised.

This topic has been already widely discussed in the literature [34]. For instance, Tambuyzer and colleagues [35] demonstrated that the process of patient involvement might be affected by both “the person’s ability to be involved and his motivation or desire to be involved” (p.142). Even if several authors consider patient involvement as a continuum rather than an “all-or nothing” process [36, 37], it seems that HPs still present difficulties in moving along this continuum when they have to decide how and to what extent to involve psychiatric patients with low insight. Thus, this patients’ vulnerability may lead HPs to avoid their involvement instead of trying to tailor the level of empowerment to each patient in each specific phase of the disease.

Some of the psychopathological conditions described above determine also another peculiar challenge, which HPs working in psychiatric and emergency departments have to face: the risk of personal aggressions [38, 39]. Therapeutic relationships usually rely on the implicit assumption that patients are in a fragile position and look for HPs’ care and support. Therefore, interpersonal conflicts, even aggressive reactions, may happen but are generally rare and in most of the cases expressed just at a verbal level. In the focus group discussions, critical issues, referring to the category Aggressive Behavior, were mentioned twice as much as strategies, suggesting that HPs’ consider this aspect particularly challenging. The element that, according to their suggestion, represents the main strategy in handling patients’ aggressive behavior was hosting patients during the acute phases of their disease, in an in-patient psychiatric ward characterized by a comfortable environment, where their privacy, freedom and safety are protected and guaranteed (see the subcategories of additional file 1: Appropriate/Inappropriate setting and Environment). In a recent systematic review on the role of the psychiatric ward as a therapeutic space [40], it has been suggested that psychiatric facilities should be aligned to the current policy on patient-centered healthcare and should therefore be designed following a more holistic approach taking into account structural, organizational, symbolic, and social dimensions. In particular, van der Schaaf et al. [41] found that the availability of private spaces and a high level of comfort were associated with a lower risk of violence.

Nevertheless, it has to be considered that the strategic value attributed by the HPs to the environment might have been determined by the fact that they considered their wards particularly inappropriate. The subcategory Inappropriate setting and environment (critical issue) was indeed the most frequently discussed, mentioned also as relevant in referral to other specific categories like Relapse prevention/symptom management or Self-harm/suicide.

The subcategory Subjective risk assessment or unpredictable behaviours (critical issue) is seen as another peculiar challenge that HPs have to face in dealing with mental illness. Risk assessment of a surgery procedure can be mostly standardized, as it relies on the analysis of objective parameters like cardiac status, type of operation, and level of urgency [42, 43]. Further, the risk of errors in the administration of drugs has been widely reduced in the last few decades with the introduction of some standardized strategies (e.g., double check, guidelines to deal with Look Alike, Sound Alike drugs, the implementation of strategies to reduce interruptions) that have been also mentioned by our participants when commenting the category Therapeutic error. Unfortunately, this approach cannot be fully transferred to the psychiatric setting, especially when decision-making affects the risk assessment of patients’ behaviors. For instance, deciding if a patient can leave the in-patient ward for a walk alone or if she/he can receive visits from friends or parents are therapeutic decisions strictly related to the process of care and in some cases also very relevant for patient safety. Obviously, some objective parameters and clinical protocols guide clinicians’ decisions in these circumstances [44] but, considering that part of these measures are based on HPs’ observation, it is implicitly accepted that they are partially affected by the subjective perspective of the observer. Blumenthal and colleagues [45] investigated the relative impact of actuarial and emotive information on mental health professionals’ rating of the risk of violence. In this paper, actuarial risk assessment was based on records, measures, and historical information (e.g., criminal history, family history), while the emotion-based assessment was considered as driven by emotionally laden information (e.g., empathy, insight). The Authors showed that emotive information had a greater impact on risk assessment compared to actuarial information. Thus, these findings call into question the reliability and applicability of safety protocols and guidelines, one of the core tools in safety culture. The issue of subjectivity in risk evaluation has significant implications for the implementation of the so-called “Just Culture” [46‐48] in patient safety. This approach aims to find a balance between the strictly non-punitive safety culture, that followed and mitigated the previous tendency to blame individuals involved in medical error, and HPs’ accountability and responsibility [48]. According to our results, “drawing the line between blameless and blameworthy actions”, thus defining HPs’ objective responsibility in adverse events [12], seems to be more problematic and challenging than in other settings.

“… They would like to go out at all hours; they would like to have coffee every time they want and they would like to do all the other things they can’t, due to the limitations. It is difficult to create a collaborative relationship. How can you tell them: You can’t go out. They don’t understand why.” Many verbal contributions in the subcategory Impact of risk-management on the process of care/empowerment/autonomy (critical issue) similarly addressed HPs’ dilemma in finding the right balance between protecting and empowering the patient. Promoting autonomy and at the same time protecting from risk, is another challenge of the therapeutic relationship in psychiatry, which strongly affects the effectiveness of the intervention. Ethical issues may derive from the necessity to balance patients’ autonomy and safety by limiting patients’ choices. Taking care of mentally ill patients, especially in the acute phases of their disease, implies taking decisions that interfere and limit their freedom and autonomy, contravening the core principle of empowerment, as also admitted by HPs during the focus groups (categories Compulsory Treatment and Physical/Chemical restraints).

This balancing act is acknowledged by the theory of Protective Empowerment [21], which states that the therapeutic relationship, relying on HP’s sensitivity and openness to the interplay between protective and empowering actions, is the basis for fulfilling the simultaneous responsibility for ensuring patient safety and autonomy. Protection is therefore defined as a set of actions, such as reassurance, valuing patients’ needs and expectations or providing information aimed to help the subject to better meet her/his individual needs, including the need to be protected from risk.

Following this theory [21] and based on our results, therapeutic interventions in risk management can be defined on two axes (see Fig. 2): Restriction vs. Freedom and Safety vs. Risk.

A “defensive” approach where HPs’ priority is to control and reduce all sources of potential risk for patients - and consequently for themselves (e.g., adverse events, lawsuit) - may lead to the development of an overprotective attitude towards patients (Overprotective Disempowerment). In this approach, active involvement and personal freedom are sacrificable, independently from the real level of risk patients might be exposed to. As shown on the opposite quadrant of Fig. 2, excessive freedom in conditions of high risk leads to a misinterpretation of the concept of empowerment and exposes patients to potentially harmful or dangerous conditions (Unprotective Disempowerment). What determines the inappropriateness of HPs’ interventions in these two attitudes is, as indicated in the figure, a low or absent connection with the patient. This is another meaningful result that emerged from the analysis of our focus groups: the connection, which refers to the doctor-patient relationship, is the principal assessment and therapeutic tool of clinicians. Therapeutic compliance is the category with the highest number of comments and Building a therapeutic trust/alliance is, in the subcategory strategies, the one most frequently discussed. Connecting with patients provides the clinicians a better estimation of the emotional and cognitive internal world of the patient and consequently reduces the subjectivity in the assessment of risk. An Empowering connection and a Protective connection are the expression of a real encounter between two persons. Thus, even though they determine very different set of actions, both can be considered appropriate according to the given context.

The other strategies, following Building therapeutic trust/alliance in terms of frequency, similarly highlight the importance of tuning with patients, by acknowledging their contribution (Relying on the experience knowledge of patients), promoting their medical literacy (providing information/educate), and the centrality of their personal world (promoting collaboration with family and individualized healthcare plane). Most of these strategies are indicated by the above-mentioned theory of Protective Empowerment [21] as key elements in the process of balancing patient safety with patients’ freedom of choice in mental health.

Despite our promising results, there are some limitations that need to be considered in the interpretation of our findings.

The high number of facilitators’ interventions might represent another potential limitation, which may lead to questioning their neutrality. However, from the text analysis of their contributions, many of their interventions aimed to refocus participants to the topics of the discussion. Indeed, in several cases, HPs tended to shift from the concept of patients’ involvement in their own safety to more general considerations about patients’ empowerment in the process of care. This was probably due to the fact that, as above stated, in psychiatry, these two aspects are strongly related and therefore jointly represented in the opinions of participants.

It has also to be taken into account that our results might be seen as unspecific and simply intuitive but up to now, to the best of our knowledge, no previous studies addressed psychiatric patient empowerment in their own safety. Therefore, our results represent a primary summary of the current evidence, which could then be used as background for future quantitative projects assessing, for instance, the extent of psychiatric patients’ involvement in risk management.

Further, we have to consider the impact of translating our findings from Italian to English. Thus, to reduce the potential loss of meaning and to avoid limitations in the analysis of data, we stayed in Italian (i.e., the original language) as long as possible, as suggested by Van Nes et al. [49]. Since all participants, facilitators, and researchers spoke Italian, no language differences hindered the collection of data, the transcription of the focus group discussions, and the development of the coding system. Only in the last phase, preparing the manuscript, one of the authors, fluent in both languages, translated participants’ quotes and the labels of the coding system from Italian to English.

The results of our study have several implications for the quality of mental health services and for the direction of future research in risk management.

The most meaningful implication for direct clinical practice and policy makers is the acknowledgement of the key role played by single HPs in the process of risk assessment, adverse event prevention and, more generally, in promoting patient safety in the empowering relationship with the patient. Safety protocols and guidelines can be correctly applied in a therapeutic relationship only if HPs are sufficiently supported in their daily practice. To reach this goal, several actions have been suggested by the participants of the study, such as improving the quality of mental health services’ environment or increasing HPs’ training and supervision. Regarding this last aspect, our results may be considered as reference point in the implementation of educational programs aiming to 1) raise HPs’ awareness of the synergic but also potentially controversial interconnection between empowerment and safety in mental health, and 2) increase the application of patient-centered skills enabling the development of a protective/empowering connection with patients during the process of care and risk management.

Finally, considering that patients’ empowerment is an action requiring the joint collaboration of the two involved parties, patients and HPs, our results have also implications for future research. In particular, the application of our coding system in studies in which psychiatric patients will be engaged in focus groups discussions on this topic, will permit to evaluate if the strategies and critical issues outlined by HPs are similarly perceived by patients.