Patient safety-related adverse events : Perspectives of health care professionals

DISSERTATIONS | MARI LIUKKA | PATIENT SAFETY-RELATED ADVERSE EVENTS... | No 629

MARI LIUKKA

Dissertations in Health Sciences

PUBLICATIONS OF

THE UNIVERSITY OF EASTERN FINLAND

This study examined the differences in patient safety culture, how patient safety incident reports are analysed, what kind of

developments have been proposed based on reports and how an adverse event affects

those involved in the event and managers’

role after an adverse event.The results could be used in health care professionals’ and managers’ education and practices when adverse event occur. This information is also

useful in organisations to understand the effects of adverse events.

MARI LIUKKA

P ATIENT SAFETY - RELATED ADVERSE EVENTS

PERSPECTIVES OF HEALTH CARE PROFESSIONALS

Mari Liukka

P ATIENT SAFETY - RELATED ADVERSE EVENTS

PERSPECTIVES OF HEALTH CARE PROFESSIONALS

To be presented by permission of the Faculty of Health Sciences, University of Eastern Finland for public examination in Medistudia MS300

Auditorium, Kuopio

on June 18^th, 2021, at 12 o’clock noon

Publications of the University of Eastern Finland Dissertations in Health Sciences

No 629

Series Editors

Professor Tomi Laitinen, M.D., Ph.D.

Institute of Clinical Medicine, Clinical Physiology and Nuclear Medicine Faculty of Health Sciences

Professor Tarja Kvist, Ph.D.

Department of Nursing Science Faculty of Health Sciences

Professor Ville Leinonen, M.D., Ph.D.

Institute of Clinical Medicine, Neurosurgery Faculty of Health Sciences

Professor Tarja Malm, Ph.D.

A.I. Virtanen Institute for Molecular Sciences Faculty of Health Sciences

Lecturer Veli-Pekka Ranta, Ph.D.

School of Pharmacy Faculty of Health Sciences

Distributor:

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Grano Oy Jyväskylä, 2021

ISBN: 978-952-61-3806-0 (print) ISBN: 978-952-61-3807-7 (PDF)

ISSNL: 1798-5706 ISSN: 1798-5706

Author’s address: Department of Nursing Science University of Eastern Finland KUOPIO

FINLAND

Doctoral programme: Doctoral Programme in Health Sciences

Supervisors: Professor Hannele Turunen, Ph.D.

Department of Nursing Science University of Eastern Finland KUOPIO

FINLAND

Markku Hupli M.D., PhD

South Karelia Social and Health Care District LAPPEENRANTA

FINLAND

Reviewers: Professor Maria Kääriäinen, Ph.D.

Research Unit of Nursing Science and Health Management University of Oulu

OULU FINLAND

Docent Anja Rantanen, Ph.D.

Faculty of Social Sciences University of Tampere TAMPERE

FINLAND

Opponent: Professor Riitta Suhonen, Ph.D.

Department of Nursing Science

Liukka, Mari

Patient safety-related adverse events – Perspectives of health care professionals Kuopio: University of Eastern Finland

Publications of the University of Eastern Finland Dissertations in Health Sciences 629. 2021, 65 p.

ISBN: 978-952-61-3806-0 (print) ISSNL: 1798-5706

ISSN: 1798-5706

ISBN: 978-952-61-3807-7 (PDF) ISSN: 1798-5714 (PDF)

ABSTRACT

This study aimed to describe the level of and differences in the patient safety culture in acute and long-term care and to clarify how patient safety incident reports are

analysed and what kind of developments have been proposed based on reports. A further purpose was to explain how an adverse event affects those involved in the event and the role of managers after an adverse event.

The thesis is based on four sub-studies. In sub-studies I, II and III, data were collected at one integrated Finnish healthcare organisation. In cross-sectional sub-study I, the data were collected in 2016 from healh care professionals in long-term care (n=196, wards and nursing homes) and acute care (n=168) using the Hospital Survey on Patient Safety Culture questionnaire. The data were analysed statistically using the Kruskall- Wallis test and Mann-Whitney U-test. Data (n=3755) from the organisations’ incident reporting system HaiPro were also used to determine the number of reported patient safety incidents. In registered-based sub-study II, data were collected from the HaiPro database (years 2011–2015, n=16019) and trends in patient safety incident repots were analysed statistically. Quantitative statistics are presented as percentages and

frequencies. In qualitative sub-study III, nursing managers (n=11) were interviewed in 2013-2014 using a semi-structured format. The data were analysed using inductive content analyses. Sub-study IV was an integrative literature review (years 2009–2018), looking at 25 articles focusing on action after adverse events in health care

organisations.

patient safety incidents more and more every year, but at the same time, written recommendations for developing action to avoid patient safety incidents happening again has decreased. When an adverse event occurs, four themes emerged in nursing managers’ action: patient-centeredness as a principle for common action; courage to reform operational models to prevent future adverse events; encouragement of nursing staff’s open and blame-free discussion; and the challenge to recognise adverse events.

Three types of victim were identified in literature after an adverse event: first victims (patients and their families); second victims (healthcare professionals); and third victims (healthcare organisation). Communication, support types, coping strategies, learning and apology were linked differently to these victim types. Comprehensive models for action after adverse events are insufficient.

Managers receive a significant number of incident reports and this number increases every year. For more effective recovery, there should be a definition of what kinds of event should be reported, a definition of the severity of the events on which managers have to make a development recommendation, and control to ensure that the

recommendations are implemented. Disclosing processes and comprehensive action after adverse events should be developed and implemented.

Keywords: patient safety; patient safety culture; adverse events; incident reporting;

transformational leadership

Liukka, Mari

Potilasturvallisuuteen liittyvät haittatapahtumat – Terveydenhuollon ammattilaisten näkökulmia

Kuopio: Itä-Suomen yliopisto

Publications of the University of Eastern Finland Dissertations in Health Sciences 629. 2021, 65 s.

ISBN: 978-952-61-3806-0 (print) ISSNL: 1798-5706

ISSN: 1798-5706

ISBN: 978-952-61-3807-7 (PDF) ISSN: 1798-5714 (PDF)

TIIVISTELMÄ

Tämän tutkimuksen tarkoituksena oli kuvailla potilasturvallisuuskulttuurin tasoa ja eroja akuutin- ja pitkäaikaishoidon välillä sekä selventää, miten potilasturvallisuuteen liittyvät vaaratapahtumaraportit analysoidaan ja millaisia kehittämistoimenpiteitä on tehty raporttien perusteella. Tämän tutkimuksen tarkoituksena oli myös selittää keihin ja miten haittatapahtuma vaikuttaa, ja mikä on lähijohtajan rooli haittatapahtuman jälkeen.

Osatutkimuksissa I, II ja III tiedot kerättiin yhdessä integroidussa suomalaisessa sosiaali- ja terveydenhuollon organisaatiossa. Vuonna 2016 tehtiin poikittaistutkimus (I osatutkimus) pitkäaikais- (osastoilla ja hoitokodeissa, n=196) ja akuuttihoidossa (n=168) käyttämällä Hospital Survey on Patient Safety Culture (HSOPSC) –mittaria.

Tiedot analysoitiin tilastollisesti Kruskall-Wallis-testillä ja Mann-Whitney U-testillä.

Tutkimuksessa käytettiin myös organisaation vaaratapahtumien raportointijärjestemän (HaiPro) tietoja ilmoitettujen vaaratapahtumien määrän määrittämiseen.

Rekisteritutkimuksessa (II osatutkimus) tiedot kerättiin HaiPro-järjestelmästä. Aineisto sisälsi tammikuun 2011 ja joulukuun 2015 välisenä aikana laaditut potilasturvallisuutta vaarantaneet ilmoitukset (n = 16 019). Tulokset raportoitiin prosentteina ja

frekvensseinä. Lähijohtajien toimintaa haittatapahtumien jälkeen selvitettiin haastattelututkimuksella (osatutkimus III). Yhden akuutin sairaalan ja yhden

perusterveydenhuollon sairaalan lähijohtajat (n=11, 50%) haastateltiin talvella 2013-

Akuuttihoidossa työntekijöillä oli paremmat näkemykset

potilasturvallisuuskulttuurista kuin pitkäaikaishoidon työntekijöillä. Lähijohtajien näkemykset olivat positiivisimpia monilla potilasturvallisuuskulttuurin osa-alueella, kun taas lähi-/perushoitajien käsitykset olivat negatiivisimmat. Työntekijät olivat tehneet 3755 vaaratapahtumaraporttia vuonna 2016, joista suurin osa (75%) tehtiin

pitkäaikaishoidossa. Vaaratapahtumista raportoidaan joka vuosi enemmän, mutta samaan aikaan kirjallisten suositusten määrä toiminnan kehittämiseksi on vähentynyt.

Neljä teemaa nousi esiin lähijohtajien toiminnassa suhteessa haittatapahtumiin:

potilaskeskeisyys yhteisen toiminnan periaatteena, rohkeus uudistaa toimintamalleja haittatapahtumien estämiseksi, työntekijöiden rohkaiseminen avoimeen ja

syyttämättömään keskusteluun sekä vaaratapahtumien tunnistamisen haasteellisuus.

Kirjallisuuden mukaan haittatapahtuman jälkeen voidaan tunnistaa kolme uhrityyppiä: ensimmäiseen uhriin (potilaat ja heidän perheensä) liittyviä elementtejä olivat haittatapahtumasta kertominen, viestintä tapahtuman jälkeen, henkinen tuki ja anteeksipyyntö. Toisiin uhreihin (terveydenhuollon ammattilaiset) liittyviä asioita olivat tukityypit ja -palvelut, selviytymisstrategiat, ammatilliset muutokset haittatapahtumien jälkeen ja haittatapahtumista oppiminen. Kolmanteen uhriin (terveydenhuollon organisaatio) liittyvät asiat koostuvat organisaation toiminnasta haittatapahtumien jälkeen, strategiasta, infrastruktuurista ja koulutuksesta sekä haittatapahtumiin liittyvästä avoimesta viestinnästä. Tutkimuksen perusteella haittatapahtumien jälkeisestä toiminnasta ei ole kattavia malleja.

Lähijohtajat saavat suuren määrän vaaratapahtumailmoituksia ja määrä kasvaa vuosittain. Ilmoitusten paremman hyödynnettävyyden vuoksi olisi hyvä määrittää, minkä tyyppisistä tapahtumista on raportoitava, määriteltävä ne tapahtumat, joihin on aina mietittävä kehittämistoimenpide sekä valvonta sen varmistamiseksi, että

suositukset pannaan täytäntöön. Ilmoitusprosessia sekä kattavaa toimintaa haittatapahtumien jälkeen tulisi kehittää.

Avainsanat: potilasturvallisuus; potilasturvallisuuskulttuuri; haittatapahtuma;

vaaratapahtumien raportointi; transformationaalinen johtaminen

ACKNOWLEDGEMENTS

This study was conducted at the University of Eastern Finland, Department of Nursing Science, in the Nursing Science doctoral programme. The journey has been very long. It began in 2010 when I had just started work as a patient safety coordinator and I was a real rookie in terms of questions about patient safety. Now it is time to thank all those wonderful people who have been part of this journey.

First and foremost, I would like to thank my principal supervisor, Professor Hannele Turunen. You gave me your guidance and support and challenged me to find solutions independently.

I owe my sincere thanks to my second supervisor, Markku Hupli M.D. I can honestly say that I wouldn’t be here without you. You have supported me with this doctoral thesis and in my working life by giving me the opportunity to educate myself and giving me the responsibility to create better patient safety health and social care in South Karelia.

I would like to thank my official reviewers professor Maria Kääriäinen and dosent Anja Rantanen, and I sincerely thank professor Riitta Suhonen for promising to act as my opponent.

This study was financially supported by the Research Committee of the Helsinki University Hospital Catchment Area for State Research Funding and the Finnish Nurse Association, to whom I am deeply grateful. In addition, I would like to thank my working organisation, South Karelia social and healthcare district Eksote, for enabling me to study full time when it was necessary to do so.

I thank my friend, Susanna Tella. You have supported me during this whole journey.

It has been inspiring and instructive to work with you on research articles and in working life.

Warm thanks to my good friend and fellow student Tuija Ylitörmänen. It has been great to have somebody to share good and bad moments with all through this doctoral thesis and in real life.

I have been lucky to have so much patient safety knowledge in my network. I have had the opportunity to share patient safety experience and knowledge for so many years with the best experts, and with so many pizzas and so many glasses of wine. It is

I thank all my friends who have supported me in one way or another on this journey. The warmest thanks to my ice hockey family, and my friends Hanna and Hannamari. Thank you all for your friendship and thank you that with you I have always been somebody other than the doctoral student. With you I was able to think about something other than study. Cheers!

I would like to thank my parents and my brother for all the support you have always given me. You have helped in so many ways to make this study easier. Thank you.

And last I thank my family. My children, Nenna and Niklas. I love you so much! I have been studying for most of your life, but still you have always come first. I hope I have given you an example that everything is possible if you believe in yourself. As Walt Disney said, if you can dream it, you can do it!

My dear husband, Simo. I am so lucky that I have you, my teenage love and my best friend beside me today. You have supported me all these years no matter what. …I love you more with every breath truly, madly, deeply do…

In Imatra, 18^th June 2021

Mari Liukka

LIST OF ORIGINAL PUBLICATIONS

This dissertation is based on the following original publications:

I Liukka, M., Hupli, M. and Turunen, H. Differences between professionals’ patient safety culture in long-term and acute care. Submitted 2020.

II Liukka, M., Hupli, M. and Turunen, H., 2018. Problems with incident reporting:

reports lead rarely to recommendations. Journal of Clinical Nursing. vol. 28, pp.

1607‒13.

III Liukka, M., Hupli, M. and Turunen, H., 2018. How does transformational leadership appear in action with adverse events? A study for Finnish nurse managers. Journal of Nursing Management. vol. 26, pp. 639‒46.

IV Liukka, M., Steven, A., Vizcaya-Moreno, M. F., Sara-aho, A., Khakurel, J., Pearson, P., Turunen, H. and Tella, S., 2020. Action after adverse events in healthcare: an integrative literature review. International Journal of Environmental Research and Public Health. vol. 17, p. 4717.

The publications were adapted with the permission of the copyright owners.

In addition, this summary includes previously unpublished material.

CONTENTS

ABSTRACT ... 7

TIIVISTELMÄ ... 9

ACKNOWLEDGEMENTS ... 11

1 INTRODUCTION ... 19

2 FROM CREATING PATIENT SAFETY CULTURE TO DISCLOSING ADVERSE EVENTS ... 21

2.1 Literature search ... 21

2.2 Main concepts of the study ... 23

2.3 Transformational leadership ... 25

2.4 Patient safety culture ... 26

2.4.1 Meaning of patient safety culture ... 26

2.4.2 Measuring patient safety culture... 26

2.5 Patient safety incident reporting ... 27

2.5.1 Factors that promote reporting of patient safety incidents ... 28

2.5.2 Barriers to reporting patient safety incidents ... 29

2.6 Analysing incident reports to learn from them ... 29

2.7 Disclosing after an adverse event ... 30

2.7.1 Disclosing adverse events with patients and families is incomplete .. 31

2.7.2 Healthcare professionals’ disclosure needs and skills ... 31

2.7.3 Disclosure impact on organisations’ reputation ... 32

2.8 Summary of literature ... 32

3 PURPOSES OF THE STUDY ... 35

4 SUBJECTS AND METHODS ... 36

4.1 Study design and settings ... 36

4.2 Sample, data collection and analysis ... 37

4.2.1 Cross-sectional and register-based study, Article I ... 37

4.2.2 Register study, Article II ... 38

4.2.3 Qualitative study, Article III ... 38

5.3 Nursing managers’ transformational leadership after adverse events (Article III) 44

5.4 Action after an adverse events in health care organisations (Article IV) ... 44

5.5 Summary of the results ... 45

6 DISCUSSION ... 47

6.1 Ethical considerations ... 47

6.2 Discussion of the results ... 47

6.2.1 Patient safety culture outcomes ... 48

6.2.2 Operational development on the basis of incident reports is minor .. 48

6.2.3 Leadership after adverse event outcomes ... 49

6.2.4 Action after an adverse event ... 50

6.3 Discussion of strengths and limitations of study ... 51

7 CONCLUSIONS ... 53

8 RECOMMENDATIONS ... 54

REFERENCES... 56

ABBREVIATIONS

AE Adverse event

AHRQ The Agency for

Healthcare Research and Quality

HaiPro Finnish safety incident reporting database

HCO Healthcare organisation

HCP Healthcare professional

HSOPC Hospital Survey on Patient Safety Culture

IRS Incident reporting system

NM Nursing manager

PRR Positive response rate

PS Patient safety

PSI Patient safety incident

PSC Patient safety culture

THL The Finnish Institute for Health and Welfare

TFL Transformational leadership

1 INTRODUCTION

In 1983, McIntyre and Popper promoted learning from mistakes in healthcare, reporting mistakes and analysing them so we can understand why they occurred and how they could have been prevented. Kohn et al. (2000) called on organisations to develop a culture of safety where the goal is clear and there is a focus on improvement of patient care. A good patient safety culture (PSC) is based on reporting adverse events (AE); analysing reports without blame and punishment; disclosing events with patients, their families and healthcare professionals (HCP) (Brook et al. 2015;

Slawomirski et al. 2017); and learning from events in the organisation. PSC is

increasingly one of the most important factors influencing healthcare outcomes and it requires leadership at every level of an organisation to work towards a better culture (Slawomirski et al. 2017). A culture has different components such as leadership, teamwork, communication and accountability (Frankel et al. 2017). A big problem has been a lack of measurement of PSC. This led to the creation of the Hospital Survey on Patient Safety Culture (HSOPSC) (Sorra and Battles 2014).

Healthcare organisations (HCO) have a responsibility to deliver safe care to our citizens. A significant component of development in patient safety (PS) is leadership (Frankel et al. 2017) and learning (Department of Health Expert Group 2000). Leaders can influence staff’s safety behaviours and attitudes towards safety with their own actions (Willis et al. 2017). Leaders are responsible for PS and they play a central role in improving safety. Responsibility for safety is something that cannot be delegated to somebody else (Ministry of Social Affairs and Health 2017). Unfortunately, according to Saarikoski et al. (2019), hospital district boards have an inadequate understanding of PS. Information about PS topics is also poorly used in decicion-making. One sad example of poor leadership and culture is the Francis report by the Mid Staffordshire NHS Foundation Trust. Lack of transparency and openness, lack of a culture of listening to patients and staff, and a culture of fear lead to many patients suffering (Mid

Staffordshire NHS Foundation Trust Public Inquiry 2013).

One strong measurement of patient safety is the rate of adverse events (AE) or accidents in an organisation (Itoh et al. 2014). The problem here is that there is not a great deal of evidence that reporting incidents improves patient safety outcomes in the

incident reporting in Finland, including over 800,000 incident reports, showed that only 4.2 per cent had led to some development in action (Rauhala et al. 2018).

Patient safety-related AEs affect patients and their families, professionals and the organisation. These three groups can be categorised as the first victim—the patient and their families; the second victim—healthcare professionals (HCP); and the third victim—HCOs. All of these mentioned ‘victims’ suffer in different ways, and more attention should be given to minimise the effects of AEs. The term ‘second victim’ was first mentioned by Wu in 2000. He also wrote that disclosing with patients and families should be discussed by HCOs, and that physicians have an ethical responsibility to tell a patient if an adverse event has occurred (Wu 2000).

There are a number of baseline studies about PSC, mostly in the hospital

environment. Fewer studies have focused on PSC in elderly care, comparing acute care and long-term care. The purposes of this study were to describe the level and

differences in patient safety cultures in acute and long-term care, to clarify how patient safety incident reports are analysed, and to determine what kind of developments have been proposed based on those reports. Because the effects of AEs differ, this study also sought to explain how adverse event effects those who involved in the event and managers’ role after an adverse event.

2 FROM CREATING PATIENT SAFETY CULTURE TO DISCLOSING ADVERSE EVENTS

2.1 LITERATURE SEARCH

The literature review was carried out using Scopus, CINAHL, PubMed and Cochrane databases. The search was for peer reviewed studies from 2014–2020 in the English language. The keyword “adverse event” was used in combination with different words/terms such as “leadership”, “transformational leadership”, “patient safety”,

“patient safety culture”, “reporting”, “learning”, “management” and “disclosure”. A search was also carried out using shortened words such as report*, organi*, manage*, leader*. Most studies were found on Scopus and PubMed.

Firstly, the titles of retrieved articles were screened for relevance: if they were not relevant, they were removed. If the result was fewer than 15 articles (for example in Cochrane searches), all abstracts were also read at the first stage. In the second step, selected studies’ abstracts were read. Reading the full text was the last stage. Studies considered not relevant were baseline studies about patient safety culture, studies which were about different kinds of AE, and studies which were about creating an incident reporting system. On the basis of full text, 53 research articles were accepted to this literature review. (Figure 1) Studies included were quantitative studies,

qualitative studies and literature reviews. The quality of these articles was not scored.

Study selection was based more on content. Articles are presented in Appendix 1.

This literature review also includes other articles, book chapters, reports and data from websites. Google was used to find that kind of relevant information based on the study topic.

Figure 1. Literature search and selection Literature search

Keywords: adverse event, patient safety, patient safety culture, reporting, learning, leadership, transformational leadership, management, disclosure

Limits: Between 2014 and 2020, English language, peer-reviewed, full text available Databases: Scopus* 536, CINAHL 217, Cochrane 34, PubMed 1,187

Total: n=1,974

*search limited to nursing and medicine

Excluded duplicates and

exclusions based on the titles (n=1,781) occupational hazards, adverse life events, second victim curriculum, diagnosis errors, frequency of adverse events, treatment of disease, drug treatment

Included based on titles (n=193)

PSC, first/second or third victim, action after adverse event, aftermath/disclosing of adverse event, HCP support after adverse event

Exclusions based on the abstracts (n=87)

Not an empirical study or not a literature review, baseline studies of PSC

Included based on the abstracts (n=64)

Exclusions based on the full texts (n=11)

Not related to the scope, not English language, full text not available Included based on the full texts and

manual search (n=53)

2.2 MAIN CONCEPTS OF THE STUDY

Patient safety has been defined as freedom from or avoidance of accidental or preventable injuries in medical care (Agency for Health Care Research and Quality [AHRQ] 2018; Kohn et al. 2000; Vincent 2010). It also includes risk reduction to an acceptable low level (World Health Organisation [WHO] 2009). Patient safety is also the practices and interventions which minimise the likelihood of errors and occurrence of preventable AEs using timely knowledge, available resources and context of care (AHRQ 2018; Kohn et al. 2000; WHO 2009).

The safety culture can be described as “the sum of what an organisation is and does in the pursuit of safety” (The Joint Commission 2017). Related to culture is the term

“climate”. “Climate emerges through a social process, where staff attach meaning to the policy and practice they experience and the behaviours they observe” (Waterson 2014, 2). Why things are done or not done can be explained by an organisation’s culture. Organisational culture is a key element of quality improvement (Slawomirski et al. 2017). In this study it includes staff’s attitudes and values, along with managers’

commitment to safety, leadership style and communication. Important viewpoints in PSC are openness and a blame-free or non-punitive, reporting and learning culture (Fischer et al. 2018; Itoh et al. 2014; Vincent 2010). HCPs, patients, managers and leaders are responsible for making the PSC better (Wami et al. 2016).

Transformational leadership (TFL) style positively effects to PSC (Wang et al. 2014;

Xie et al. 2017; Boamah et al. 2018). Transformational leaders are trusted, respected and visionary role models to staff (Bass 1995, Broome & Marshall 2017). In this study, Bass’ (1995) theory of TFL with four components – idealised influence, inspirational motivation, intellectual stimulation and individualised consideration – has been used.

Patient safety incident (PSI) reporting is important for improving PS. The term

“incident” has three different types: near miss, no harm incident and harmful incident (adverse event) (WHO 2009). In Finland, adverse events and near misses are labelled as patient safety incidents. In the present study, an adverse event is any incident which reached a patient, no matter whether it did or did not cause harm and PSI reporting includes adverse events and near misses. Table 1 offers definitions of incident reporting and related concepts that have been used in this study.

Table 1. Definitions of incident reporting and related concepts

Concept Definition Author

Adverse event “Any injury caused by medical care”

“An injury resulting from a medical intervention”

“Unintended injury caused by medical management rather than by disease process and which is sufficiently serious to lead to prolongation of hospitalization or to temporary or permanent impairment or disability to the patient”

“A harmful incident”

AHRQ 2018

Kohn et al.

2000, p. 210

Vincent 2010, p.53

WHO 2009 Incident/

patient safety incident

“An event or circumstance that could have resulted, or did result, in unnecessary harm to a patient”

WHO 2009

Incident reporting “A process used to document occurrences that are not consistent with routine hospital operation or patient care”

Institute For Healthcare Improvement 2019

Near miss “An event or situation that did not produce patient injury, but only because of chance. This good fortune might reflect robustness of the patient or a fortuitous, timely intervention”

“An incident which did not reach the patient”

AHRQ 2018

WHO 2009

Transformational leadership

Leader who has idealised influence, inspirational motivation, intellectual stimulation and individualised consideration.

Bass 1995

2.3 TRANSFORMATIONAL LEADERSHIP

Based on Bass’s (1995) theory of TFL includes four components: idealised influence, inspirational motivation, intellectual stimulation and individualised consideration. This means that transformational leaders are charismatic role models with a positive view of the future. They are trusted and respected with the ability to empower and motivate staff to work towards the organisation’s goals. They can also express important things in comprehensible ways. Transformational leaders are interested in what problems staff have at work and also empower staff to look at problems in a new way and solve these problems on their own using evidence-based practices (Bass 1990 1995; Broome &

Marshall 2017; Hassan 2019). Based on Fischer’s (2016) study, the skill to translate practice into evidence and evidence into practice is one competence transformational leaders have. They also have the skill to encourage staff to try new ways of working without fear of failure or criticism. The transformational leader is also interested in consulting and seeking information from other fields of science to develop practices.

The transformational leader pays attention to followers and praises them; the individual needs, weaknesses and strengths of staff members are taken into account (Hassan 2019; see figure 2). TFL is related to higher job-satisfaction and lower turnover rates with employees (Boamah et al. 2018).

Transformational leaders encourage staff to report AEs and near misses. Studies have shown that a TFL style is associated with a higher rate of reported PSIs, but a lower rate of AEs (Hillen et al. 2015; Boamah et al. 2018). Fear of being stigmatised by colleagues can lead to low psychological safety, which in turn is a barrier to PSI reporting (Appelbaum et al. 2016), but transformational leaders can even see errors as an opportunity to make things better (Merrill 2015).

Idealied influence

•charisma

•role model

•trusted

•respected

Inspirational motivation

•visionary

•positive attitude

•shared goals

Intellectual stimulation

•engouracement

•empowering

• careful problem solving

Individualised consideration

•equal and individual treatment

•teamwork

2.4 PATIENT SAFETY CULTURE

2.4.1 Meaning of patient safety culture

Patient safety culture (PSC) is part of the organisational culture. A positive

organisational culture is associated, for example, with patient mortality rates, patient satisfaction and mood, pressure ulcers, falls and hospital-acquired infections

(Braithwaite et al. 2017). Important factors to achieve better PSC are a positive attitude towards patient safety, a system of incident reporting, HCP’s openness, good

teamwork, and better communication between the HCP and patients who suffered an AE (Bishop and Cregan 2015; Chang et al. 2016; Wami et al. 2016). A non-punitive environment also helps HCPs’ self-confidence after an AE (Chan et al. 2016).

Stronger PSC in an organisation is associated with a lower rate of AEs, but willingness to report them increases (Naveh and Katz-Navon 2014; Wang et al. 2014;

Lee et al. 2018). PSC can be improved with training (AbuAlRub and Abu Alhijaa 2014;

Xie et al. 2017) or accreditation (Lee 2016) programmes. Increasing patient safety competence positively affects the perceived safety climate (Hwang 2015). Also, leadership style, such as TFL, has been found to be effective in creating better PSC (Wang et al. 2014; Xie et al. 2017; Boamah et al. 2018).

Communication and feedback about patient safety issues, leaders’ commitment to safety, and analysing and learning from patient safety incidents are ways to build strong PSC (Barros et al. 2014; Correia et al. 2017; Fischer et al. 2018). When an organisation has a strong safety culture, everyone, including patients and family members, is encouraged to “stop the line” when something seems to be wrong (Thornton et al. 2017).

2.4.2 Measuring patient safety culture

Organisations use surveys that measure PSC to assess the current PSC status. In the longer term, with surveys, organisations can check the development of PSC. Surveys are also a good way to raise staff awareness of patient safety (Sorra and Battles 2014).

Two of the most commonly used surveys to measure PSC are the Safety Questionnaire (SAQ) and the Hospital Survey on Patient Safety Culture (HSOPSC) (Carthey 2014). In the European Union, HSOPSC is used in 12 states while SAQ is used in four EU member

The first version of HSOPSC was developed in 2004 by the AHRQ for assessment of the safety culture in healthcare organisations (Appendix 2). HSPOSC contains 12 dimensions which all have three or four (altogether, 42) items to measure an area of PSC (table 2). Items are graded on a 5-point Likert-type scale (1 = strongly

disagree/never, 2 = disagree/rarely, 3 = neither/sometimes, 4 = agree/most of the time, or 5 = strongly agree/always). The survey also includes two questions: one asks respondents to give an overall grade to patient safety (excellent/very good/acceptable/

poor/failing); the other asks them to estimate how many event reports have been made in the past 12 months (no event reports/1 or 2 event reports/3 to 5 event reports/6 to 10 event reports/11 to 20 event reports/21 event reports or more) (Sorra et al. 2018;

AHRQ 2020). The survey was updated in 2019. The first version is still available, but using version 2.0 is encouraged (AHRQ 2020). A problem with HSOPSC is that many dimensions give low reliabilities (Waterson et al. 2019).

Table 2. Description of HSOPSC’s dimensions

Dimension Items included*

Teamwork Within Units A1, A3, A4, A11

Supervisor/Manager Expectations & Actions

Promoting Patient Safety B1, B2, B3, B4

Organizational Learning—Continuous Improvement A6, A9, A13

Management Support for Patient Safety F1, F8, F9

Overall Perceptions of Patient Safety A10, A15, A17, A18

Feedback & Communication About Error C1, C3, C5

Communication Openness C2, C4, C6

Frequency of Events Reported D1, D2, D3

Teamwork Across Units F2, F4, F6, F10

Staffing A2, A5, A7, A14

Handoffs & Transitions F3, F5, F7, F11

Nonpunitive Response to Error A8, A12, A16

*) See appendix 2

2.5 PATIENT SAFETY INCIDENT REPORTING

Patient safety incident (PSI) reports give valuable information about patient safety issues and risk areas in the system (Rafter et al. 2015), but should not be used as the only measurement when estimating safe and unsafe hospitals. The primary role of

voluntary and the most used incident report system is called HaiPro (Appendix 2). It is used nationwide, and over 1,000,000 patient safety-related incidents have been reported since it was introduced in 2007. Reporting is voluntary and anonymous for all professionals. HaiPro is a generic system where all types of incident can be reported (;

Rauhala et al. 2018; Awanic 2016. Those who analyse reports (usually ward managers) can choose one or more of the following actions to be taken after an adverse event or near miss: 1) to be informed about the event; 2) to refer to a higher level for a decision;

or 3) to design a development measure. Managers have to write recommendations for development or, alternatively, to explain why recommendations are not needed.

In Finland, one study has been made based on the HaiPro data included all incident categories (Rauhala et al. 2018). More Haipro data are used in studies focused on one incident category, such as Holmström’s 2017 dissertation on medical errors.

2.5.1 Factors that promote reporting of patient safety incidents

There are many reasons for HCPs to report patient safety-related incidents; they see that reports are the main instrument in healthcare management and they want to share problems with higher managers. They also see that incident reporting is part of their job: it supports continuing training and improves the learning culture (da Silva de Paiva, 2014; Hong and Qiujie 2017; Siman et al. 2017; Wami et al. 2016). Although voluntary reporting is not telling the truth about the number of patient safety incidents, reports give important and valuable information about events (Ramírez et al. 2018).

If an organisation is willing to report patient safety incidents, it has to have a reporting system which is easy to use and designed according to professionals’ needs (Hong and Qiujie 2017). Organisations also have to take care that staff get enough education and guidelines on incident reporting. Studies show that education and training programmes increase the number of reported AEs and near misses (Smith et al. 2017; McFarland and Doucette 2018; Ramírez et al. 2018; Turyahabwe et al. 2020).

Education about AE which is led by a staff member from one’s own department or discussion of AEs with a supervisor in clinical practice on a case basis seem to be effective in increasing use of an incident reporting system (Hatoun et al. 2016; Stewart et al. 2016). HCPs need feedback and visible action based on incident reports to maintain their willingness to report incidents (Turyahabwe et al. 2020).

Good leadership has an important role in patient safety and quality of care (Nhongo et al. 2018). Leaders have to be role models by admitting their own mistakes and failures. Their inclusiveness enhances psychological safety. In a supportive environment

2.5.2 Barriers to reporting patient safety incidents

Although professionals attach importance to incident reporting, there are still events that go unreported even though the AE affects a patient (Franҫolin et al. 2015). There are a lot of barriers which decrease willingness to report patient safety-related

incidents. It may be that staff do not know what should be reported, they do not know how to report it, there is a lack of feedback about reporting, or they think that

reporting is not worth it, because reporting cannot prevent the same kind of patient safety incident from happening again (AbuAlRub et al. 2015; Hatoun et al. 2016; Martin et al. 2018; Siman et al. 2017; Sinclair et al. 2018; Stewart et al. 2016; Sujan 2015;

Turyahabwe et al. 2020). HCPs might also not know who is going to look at an incident report (Borz-Baba et al. 2020; Sujan 2015). One barrier to reporting patient safety incidents is lack of time. Sometimes the reporting forms can be complex to fill in, which takes even more time (Hong and Qiujie 2017; Sinclair et al. 2018; Sujan 2015).

Professionals also might forget to report an incident if they are busy (AbuAlRub et al.

2015).

Poor PSC can also be a barrier to reporting patient safety incidents. Staff may feel afraid to report because of blame, punishment or a loss of respect from colleagues, managers or other HCPs. Some professionals already have experience of reports being dealt with punitively. They may also be afraid that participation in an AE will appear in their professional record, or there may be some legal ramifications (AbuAlRub et al.

2015; Franҫolin et al. 2015; Granel et al. 2020; Harrison, Lawton et al. 2014; Martin et al.

2018; Siman et al. 2017; Sinclair et al. 2018; Turyahabwe et al. 2020; White and Delacroix 2020)

Being required by law to report patient safety incidents pushes professionals

towards reporting as they think it is important and part of their job (Vinther et al. 2017).

2.6 ANALYSING INCIDENT REPORTS TO LEARN FROM THEM

When an error occurs, an HCO has to balance non-punitive and punitive approaches by investigating and analysing the event (White and Delacroix 2020). A main component of organisational learning is patient safety incident reporting (Sujan 2015), but the reporting alone is not enough: after that, there has to be action and implementation of change (Naveh and Katz-Navon 2014). Continuity of management is important for

from AEs (Chan et al. 2016) and should be a permanent agenda item in team meetings (Carson-Stevens and Donaldson 2017).

When analysing reports, patients’ points of view also have to be taken into account.

HCPs have only a partial view of the patient care process. Patients and their families have an overall view of the event and can provide valuable information about the facts behind an AE. Including the engagement of patients and families adds to the

transparency of our actions when analysing AEs (Etchegaray et al. 2016; Mira et al.

2017; Vincent and Amalberti 2016). Although patients’ role seems to be important in clinical practice, however, there is still a lack of patient participation in patient safety (Sahlström et al. 2016).

A system approach to safety has been effective in aviation and other industries (Leveson et al. 2020), and healthcare managers have to focus on details of events and support professionals after an AE (Edrees and Wu 2017). A supportive attitude on the part of managers allows professionals to share, process and cope with their emotions (Chan et al. 2016). An AE is rarely the result of one professional’s mistake, but is rather a system fault (Rafter et al. 2015). That is why, when analysing reports, managers should ask what happened, how did it happen and why did it happen, rather than who failed (Franҫolin et al. 2015; Vincent and Amalberti 2016). Positive changes have taken place and nowadays managers focus more on a system approach rather than a person approach (Correia et al. 2017).

Patient safety AEs are associated with prolonged hospitalisation and are therefore expensive (Rafter et al. 2015). Also, because of costs, solutions based on patient safety incident reports will be shared locally and even nationally (Howell et al. 2017). A very important thing is to keep all staff members informed. Patients may ask questions about an incident, and it leaves staff in a difficult situation if they do not know what is going on and what has been agreed in terms of solutions (Elwy et al. 2014).

2.7 DISCLOSING AFTER AN ADVERSE EVENT

When an AE occurs, it affects patients, their families and HCPs. One important action is disclosing the event to all participants. Many organisations have programmes for disclosing. Managers have to remember how an AE can effect second victims and take care that HCPs get the support they need (Brook et al. 2015). It is important to bear in mind that the coping mechanisms of HCPs may vary—for example, between nurses and physicians. Nurses are more likely to want to speak to peers in own unit, while

2.7.1 Disclosing adverse events with patients and families is incomplete

Depending on the seriousness of the AE, patients feel fear, confusion and anger. It may also be the case that their trust in healthcare is decreased (Mira et al. 2017; Rafter et al.

2015). However, when an AE occurs, patients want to know what has happened and why (Wu et al. 2017) and they have to be kept updated about what has been done and what has been learned in the organisation to avoid this kind of AE in the future

(Carson-Stevens and Donaldson 2017; Kim and Lee 2020).

It is a common feeling among patients who have experienced an AE that there is no discussion about the event. If discussion is not held, then patients and families feel frustrated and in need of more answers. Often they feel that they tried to speak up but no one listened (Bishop and Cregan 2015). Patients and families think that disclosure is the right way to proceed after an AE (Harrison, Lawton et al. 2014), even if it can cause distress (Elwy et al. 2014; Maguire et al. 2016).

There is a consensus that HCPs should talk with patients and families when an AE has occurred. There is a need for education, training and a disclosure protocol (Kim and Lee 2020), but because of attitude and a lack of disclosure skills, this is often not done (Harrison, Birks et al. 2014; Wu et al. 2013). Nurses think that it is primarily down to senior professionals such as the nurse manager or leading doctor to lead the process of disclosing serious AEs. However, they want to be included in the planning and delivery of such disclosures. Nurses generally lead disclosures when the AE is a nursing error (Harrison, Birks et al. 2014).

2.7.2 Healthcare professionals’ disclosure needs and skills

HCPs feel themselves confused and surprised immediately after an AE; they can ask how this could have happened (Ferrús et al. 2016). They might have negative feelings such as self-blame, shame, guilt and anxiety (Borz-Baba et al. 2020; Burlison et al. 2017;

Cabilan and Kynoch 2017; Chan et al. 2016; Delacroix 2017; Kim and Lee 2020). They often want to speak with somebody. The most valuable support is from peers who have had a similar experience, their families or friends, or another HCP: they want to hear that their competence is not being questioned and they are still respected team members (Burlison et al. 2017; Cabilan and Kynoch 2017; Chan et al. 2016; Delacroix 2017; Edrees and Wu 2017; Ferrús et al. 2016; Harrison, Lawton et al. 2014; Kable and

there is a named contact person or combination of people and functions for second victim support (Van Gerven et al. 2014). Barriers to develop a support programme in organisations are stigma, funding, trust and uncertainty about what is the best kind of support programme. There is also a lack of interest on the part of professionals (Edrees and Wu 2017).

Often HCPs are not prepared to disclose with patients and their families (White and Delacroix 2020) and their feelings about disclosure with patients vary: some are satisfied and comfortable with the disclosure (Borz-Baba et al. 2020; Harrison, Lawton et al. 2014), but not everybody feels the same (Elwy et al. 2014). This is often related to how previous events have been handled (Cabilan and Kynoch 2017). Elwy et al. (2014) assert that the primary reason for not being satisfied to disclose with a patient is that HCPs feel patients lose trust in the organisation where the AE has occurred. Willingness to disclose depends on the seriousness of the event. Professionals think that it is their responsibility to inform patients, but if an event causes only a little harm or no harm at all, disclosure is not likely to occur (Cabilan and Kynoch 2017).

2.7.3 Disclosure impact on organisations’ reputation

Managers think that reporting incidents increases patient safety and they know the principles behind incident reporting: it should be non-punitive, voluntary and

anonymous. Still, the incident reporting process is not implemented well enough in the services (Correia et al. 2017).

It is also important to share experiences of patient safety incidents in an organisation so that staff can learn not only from their own but from others’

experiences (Sinclair et al. 2018). An organisation’s reputation is related to safety (Mira et al. 2017). AEs can indirectly impact on finance, but the greatest cost can be an organisation’s loss of trust and people starting to seek health services elsewhere.

Disclosure after an AE increases patients’ trust in healthcare organisations (Maguire et al. 2016).

2.8 SUMMARY OF LITERATURE

Ensuring PS starts from a good PSC. A positive attitude towards patient safety, a system for incident reporting, openness, good teamwork and better communication are important factors to achieve better PSC, as well as leaders’ communication and

opportunity to learn. AE occurs, it affects patients, their families and HCPs. One important action is disclosing the event with all participants. HCPs who have been involved in an AE often want to speak with somebody. Most valuable is support from peers who have had a similar experience. For learning and the reputation of the organisation, patients and their families should be heard after an AE. They can often provide information and ideas on how to prevent the same kind of AE in future (Figure 3).

tie nt fe ty c ul tu re

In ci de nt re po rt in g

An al ys in g & le ar ni ng

Di sc lo si ng

Part of HCPs’ job System easy to use Feedback Education: what? when? how? who receive?

Team meetings A system approach Patients’ participation Sharing

First victim Second victim Third victim Ensuring patient safety

penness Blame-freeNon-punishment 3. Summary of the study framework

3 PURPOSES OF THE STUDY

The purposes of this study were to describe the levels of and differences in patient safety culture in acute and long-term care and clarify how patient safety incident reports are analysed and what kind of developments have been proposed based on those reports. A further purpose was to explain how an adverse event affects those involved in the event and managers’ role after an adverse event. The aim was to produce information that can could be used in health care professionals’ and

managers’ education and practices when adverse event occur. This information could also be useful in organisations to understand the effects of adverse events.

Specific research questions are as follows:

1) How do PSC perceptions differ

a) between managers and other professionals?

b) between long-term and acute care from management’s point of view? (Article 1)

2) What are the trends in PSI over a five-year period?

a) How many of these reports led to recommendations to improve patient safety?

b) Which aspects of PS are these recommendations related to? (Article 2)

3) What kinds of element related to TFL are there in nursing managers’ (NM) action after an AE? (Article 3)

4) What are the key elements of action after AEs in HCOs in hospital and primary care? (Article 4)

4 SUBJECTS AND METHODS

This study consists of four sub-studies (Articles I–IV). Differences in PSC between HCP, acute and long-term care are studied in sub-study I. In sub-study II, the trends in PSI reports over a five-year period is described. Action after AEs based on previous literature and NMs’ action is studied in sub-studies III and IV. All sub-studies have different samples, designs, data collection and analysis methods, as shown in Table 3.

4.1 STUDY DESIGN AND SETTINGS

Table 3. Description of sub-studies

Sub- study/

Article

Design Sample and setting Data collection

Data analysis I A descriptive, cross-

sectional study and a register study

Health care

professionals (n=374) in acute hospital and long-term care (wards and nursing homes) in one integrated social and healthcare organisation.

Data (n=3755) from the one integrated social and healthcare organisation’s incident reporting system (HaiPro)

Web-based HSOPSC questionnaire in 2016.

Patient safety incident reports in 2016.

Descriptive statistics, Kolmogorov- Smirnov test, Kruskall-Wallis test, Mann- Whitney U-test

II Retrospective descriptive register study

Data (n=16 019) from the one integrated social and healthcare organisation’s incident reporting system (HaiPro)

Patient safety incident reports in 2011-2015

Descriptive statistics, percentages and

frequencies III Descriptive,

qualitative study

Nursing managers (n=11) from one acute hospital and one primary care

Semi- structured interviews in 2013–2014

Inductive content analylsis

methods (n=2) and literature review (n=5) First victim

phenomena (n=6), second victim phenomena (n=21) and third victim phenomena (n=4)

CINAHL, Cochrane and PubMed in 2009-2018

4.2 SAMPLE, DATA COLLECTION AND ANALYSIS

4.2.1 Cross-sectional and register-based study, Article I

Sub-study I is a cross-sectional study to assess HCPs’ views on PSC in the hospital where they worked. The data were gathered in one integrated social and healthcare organisation in Finland using the HSOPSC questionnaire. Study organisation produces health services, family and social welfare services, and services for senior citizens.

HSOPSC was selected because of previously use in study organisation. Contents of HSOPSC is described in section 2.3.2. Measuring patient safety culture and in appendix 2. The HSOPSC questionnaire was translated into Finnish and pilot-tested in Finland (Turunen et al. 2013).

The link was sent to 1,404 HCPs; doctors, registered and practical nurses, managers, investigation and rehabilitation staff. One reminder was sent to the study participants after two weeks. After processing all of the completed questionnaires, 374

questionnaires were included in the study, translating to a response rate of 27 per cent.

Questionnaires included represent both long-term (n=196) and acute care (n=168) professionals. The amount of the missing data was low – under ten in all dimensions.

The focus of the analysis was management-related dimensions. Frequencies and percentages were calculated for all items. Data were analysed with SPSS for Windows (version 24.0). In this study, a statistically significant difference was set at p<0.05.

(Grove et al. 2013). Composite variables were analysed and compared as means.

Normal distribution of the composite variables was tested using the Kolmogorov- Smirnov test. The Kruskall-Wallis test was used to compare differences between

items where PRR is at least 75 per cent; items with 50% or less PRR need improvement (Sorra et al. 2018).

Data (n=3755) from the organisations’ incident reporting system HaiPro were also used to determine the number of reported PS incidents in 2016. It was reported as amount of 1) reports in long-term care and acute care, 2) near misses, 3) adverse events, 4) most reported incident types and 5) reports per HCP groups.

4.2.2 Register study, Article II

Sub-study II was performed to analyse trends in incident reporting in 2011–2015 and define how many reports had led to recommendations. Data were collected from a web-based incident reporting database (HaiPro) in the same integrated social and healthcare organisation in Finland as in sub-study I. The data included reports from a five-year period, January 2011 to December 2015 (n=16,019). The quantitative data were analysed using descriptive statistics.

In each unit, managers are responsible for dealing with HaiPro-reports. They have to suggest measures to ensure such incidents do not happen again. Having suggested these measures, managers can choose to take one or more of the following actions: 1) to be informed about the event; 2) to refer to a higher level for a decision; or 3) to design a development measure. In addition, managers have to write recommendations for development or explain why recommendations are not needed. In this study, reports where “develop a plan” was the only selected option were categorised according to their content. In cases where more than one recommendation was selected, we considered only the first.

The data used in this study included amount of PSI reports, reports waiting for analysis and written recommendations. The reports which had written

recommendations for development were analysed qualitatively and quantitatively, and classified into various categories.

4.2.3 Qualitative study, Article III

In sub-study III, nursing managers’ views and experiences of their actions after adverse events were described. All 22 nurse mangers were invited via email to participate in the study and eleven were willing to take part.

Nursing managers were interviewed individually using a semi-structured format during the winter of 2013–2014. The interview protocol focused on discussing AEs in

Interviews were audio recorded and were conducted in the nursing managers’ own office or in the hospital’s meeting rooms. The duration of the interviews varied between 20 to 90 minutes. The interviews were transcribed by the researcher and reviewed several times to ensure accuracy (Vaismoradi et al. 2013). Participants were not asked to give feedback on the findings.

The data were analysed using inductive content analysis (Grove et al. 2013). The transcribed raw text was categorised into subthemes, and the subthemes categorised into themes. An example of the analysis process is described in Figure 4.

Figure 4. An example of analysis

4.2.4 Integrative literature review, Article IV

Scopus, CINAHL, Cochrane and PubMed databases were searched for relevant articles for an integrative literature review. Articles were included if they reported on first, second or third victims and related disclosure of AEs. Articles focusing, for example, on

Courage to reform operational models

to prevent future adverse events Encouragement to report

and discuss PS Discussion about

PS issues Open reporting

Encouragement to talk about PS

Abandoning old practices and developing new ones Changing operating

models No leaning to old operating models

Condensed

meaning unit Subtheme Theme

Systematic literature search resulted total of 2009 articles. Dublicates (n=57) and articles with eligibility title (n=1831) were excluded. 34 of remaining 121 articles were included based on abstract. The last rejection was made based on eligibility of full text or quality score gave less than 12 points.

The quality of papers was evaluated using a tool developed from an amalgamation of previous work (Hawker et al. 2002; Jokelainen et al. 2011; Pearson et al. 2010; Tella et al. 2014), refined via international research group discussions. Evaluation was based on ten categories: 1) background, 2) aim and research questions, 3) sample, 4) data collection, 5) data analysis, 6) results, 7) ethical issues, 8) reliability, 9) usefulness of the results, and 10) strengths and limitations. Each category was scored from 0 to 2 points, 0 points meaning that the paper did not meet the aim or lacked data, while inaccurate or superficial papers were scored with 1 point, and relevant and systematically

presented papers were scored with 2 points. The minimum score was therefore 0 and the maximum 20.

Two researchers independently scored the quality of each paper and total scores for each paper were compared. A third member of the research group was consulted if scores differed by three or more points. The authors held discussions and offered feedback on the importance and quality of each selected paper. Content and face validity were followed throughout the systematic review process. Data was analysed using inductive content analysis (Vaismoradi et al. 2013). First, the studies were read several times and valuable text was listed in a table. Data were categorised to sub- categories and further grouped to categories. Discussion about categorisation was held between research group.

5 RESULTS

5.1 DIFFERENCES IN PATIENT SAFETY CULTURE

A cross-sectional study about PSC included 374 HCPs from acute care (46,5%) and long-term care (54,3%) (table 4.) Other characteristics of the participants are shown in Table 2, article I.

Table 4. Participants’ working area and professional group

Occupation Long-term care Acute care Total

Managers 7 3,5 16 9,2 23 6,2

Registered nurse 37 18,5 100 57,5 137 36,8

Practical nurse 152 76 11 6,3 163 43,8

Physician 0 0 19 10,9 19 5,1

Investigation and

rehabilitation staff 0 0 26 14,9 26 7

The most positive responses of all participants for PSC were given to ”Handoffs and transitions” (78.9%) and ”Teamwork across units” (75.1%). ”Managers’ expectations and actions promoting patient safety” (51.3%) and ”Management support for patient safety” (51.6%) had the fewest positive responses (table 5).

Table 5. Positive response rates in working area

Dimension Long -term

care Acute care All together

Teamwork with in units 57.0 47.7 52.7

Supervisor/Manager Expectations &

Actions Promoting Patient Safety 54.5 47.7 51.3

Organizational Learning—Continuous

Improvement 55.5 69.0 61.8

Management Support for Patient

Safety 50.5 52.9 51.6

Overall Perceptions of Patient Safety 72.0 62.6 67.6

Feedback & Communication About

Error 56.0 74.7 64.7

Communication Openness 65.0 78.2 71.1

Frequency of Events Reported 73.5 58.6 66.6

Teamwork Across Units 77.0 79.3 75.1

Staffing 64.5 62.6 63.6

Handoffs & Transitions 78.5 79.3 78.9

over 90 per cent for the PSC composites feedback and communication about errors (91.3%) and handoffs and transitions (91.3%). Other professional groups did not reach over 90% PRR in any PSC composite. Practical nurses’ answers were alarmingly low (under 50%) in two composites, management support for patient safety and non- punitive response to errors. Furthermore, practical nurses had the lowest mean and lowest number of PRRs compared to the other professional groups.

Acute care professionals have better views about PSC than long-long term care professionals in 8 out of 12 dimensions. In long-term care professionals scored only

“Frequency of events reported” significantly better than acute care (mean 3.63 vs. 3.47, p=0,05) The lowest mean was scored in “Non-punitive response to error”, mean was in both areas below 3,00.

In the study healthcare settings, the professionals had made 3755 incident reports in 2016, including 679 (18.1%) near misses and 3076 (819%) adverse events. Many of the incident reports (75%) were made in long-term care.

5.2 BENEFITS OF INCIDENT REPORTING

Register-study about trends in PCI reporting indicate that HCPs report more and more patient safety incidents every year. The most reported incidents were falls, medication- related AEs and near misses, and communication problems. At the same time, written recommendations for developing action to avoid patient safety incidents happening again have decreased (4,1% in 2011 and 1,3% in 2015). Over 10 per cent of reports have not been analysed. (see Figure 5).

Figure 5. Number of incident reports, reports awaiting analysis, and written recommendations

Recommendations (n=426) were related to 1) education (5.6%), 2) introduction and information (9.9%), 3) introduction to work (2.1%), 4) patients (24.6%), 5) guidelines (43.7%), 6) instruments and IT programmes (10.1%), and 7) the environment (4.0%) (Table 6).

Table 6. Classification of written recommendations

Category (n; %) Examples of recommendations

Guidelines (186; 43.7%)  Patient identification

 Double-check in medication process

Patients (105; 24.6%)  Strength and balance training for patients

 Mobility aids

Instruments and IT programmes (43; 10.1%)

 Suggestions for programme updates

 The acquisition of new instruments and tools.

Introduction and information (42; 9.9%)

 Create new guidelines or update valid guidelines

 Checklists—for example, for medication processes or

discharging

Education (24; 5.6%)  Team meetings with consultants

0 1000 2000 3000 4000 5000 6000

2011 2012 2013 2014 2015

Number of reports Awaiting analysis Written recommendation

5.3 NURSING MANAGERS’ TRANSFORMATIONAL LEADERSHIP AFTER ADVERSE EVENTS

Based on qualitative study, it seems that nursing managers have a partly TFL style in their action when it concerns AEs. Eleven NMs was interviewed. Four themes were found based on NMs’ actions after AEs: patient-centredness as a principle for common action; courage to reform operational models to prevent future adverse events; nursing staff’s encouragement of open and blame-free discussion; and the challenge to

recognise adverse events.

NMs see that staff have to understand that patient-centredness is a principle for common action and patients’ interests should be considered in all actions in the organisation. NMs also describe that it is everybody’s responsibility to ensure safe care for patients, and if there is a problem with PS, staff have to have the courage to reform operational models to prevent future AEs. Managers understand that they have an important role to play in creating an open and blame-free, non-punitive culture, and encouragement of nursing staff to enter into open and blame-free discussion is nursing managers’ responsibility. Using questions such as why did this error happen, when did things go wrong, and what should we do to ensure this does not happen again, both NMs and staff can look forward and think of new ways to work.

Without good PSC, NMs may find it challenging to recognise AEs; nursing staff may feel fear, and that is why they will not report incidents. They may also feel ashamed and blame themselves for events. NMs also noticed that staff may worry what their

colleagues will think of them after an AE. That may be one reason why they not do report all PSIs if they will be discussed with co-workers.

5.4 ACTION AFTER AN ADVERSE EVENTS IN HEALTH CARE ORGANISATIONS

The integrative literature review included 25 studies published from 2009 to 2018. The largest number was published in 2015 (n=5) and 2018 (n=5). Studies were from nine different countries: USA (n=11), Spain (n=4), Canada (n=2), Australia (n=2), Sweden, China, Norway, the UK and Belgium (one study from each country); one study was from the UK/USA. Methodologies used in the studies were quantitative (n=10), qualitative (n=8), multiple methods (n=2) and literature reviews (n=5). The majority (n=21) of the articles were about second victim, (n=6) were about first victim and (n=4) were about

Key themes were related to first, second and third victim elements. The first victim elements comprised intention to reveal an AE, communication after an event, first victim support and complete apology. The second victim elements included second victim support types and services, coping strategies, professional changes after AEs, and learning about AE phenomena. The third victim elements consisted of

organisational action after AEs, strategy, infrastructure and training, and open communication about AEs.

5.5 SUMMARY OF THE RESULTS

In long-term care, the majority of professionals are practical nurses and the number of PSI reports is higher than in acute care. But it is alarming that in long-term care, staff scored management support for PS and non-punitive response to error low. Managers were most positive in many PSC dimensions. They understand that good PSC

encourages staff to report more AEs. NMs are encouraged to reform their operational model to avoid such events in future. Still, development and written recommendations based on PSI reports are low. After an AE, three kind of victim are recognised: patient and families as first victims, HCPs as second victims, and HCOs as third victims. All of them need disclosure after an AE, but there is a lack of a comprehensive model for disclosing (see Figure 6).

Figure 6. Summary of the results Patient safety

culture

• Managers’ perceptions were most positive and practical nurses’ most negative in many PSC dimensions.

• Acute care units had a better view of patient safety culture than long-term units.

• Many of the incident reports (75%) were made in long-term care.

Learning from patient safety- related incident

reports

• Healthcare professional report more and more patient safety incidents every year.

• The number of reports waiting for analysis decreases every year.

• Recommendations based on incident reports are alarming low.

Leadership after adverse events

• Nursing managers had elements of transformational leadership when adverse events occurred in their unit.

• Four themes emerged relating to nursing managers’ actions following adverse events:

• Patient-centredness as a principle for common action

• Courage to reform operational models to prevent future adverse events

• Nursing staff’s encouragement of open and blame-free discussion

• Challenge to recognise adverse events

• Managers see that the patient has to be number one in all actions.

• Managers understand that a good patient safety culture helps staff to report adverse events

Disclosing an adverse event

• Three kind of victim have been defined in literature after an AE has occurred:

•The first victim: communication after an event, first victim support and complete

• apology.

•The second victim: support types and services, coping strategies, professional

• changes after adverse events, and learning.

•The third victim: organisational action after adverse events, strategy, infrastructure and training, and open communication.