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SYSTEMATIC REVIEW

Strategies for improving patient

safety culture in hospitals:
a systematic review
Renata Teresa Morello,1 Judy A Lowthian,1 Anna Lucia Barker,1
Rosemary McGinnes,1 David Dunt,2 Caroline Brand1

▸ Additional data are published ABSTRACT INTRODUCTION

online only. To view these files
Purpose To determine the effectiveness of There is a current focus on measuring and
please visit the journal online
(http://dx.doi.org/10.1136/bmjqs- patient safety culture strategies to improve improving patient safety culture to enhance
2011-00582). hospital patient safety climate. patient safety in hospitals.1 This is reflected
1 Data sources Electronic search of the Cochrane in the increasing number of literature
Centre of Research Excellence
in Patient Safety, Department of Library, OVID Medline, Embase, CINAHL, reports on patient safety culture perform-
Epidemiology and Preventive proQuest and psychinfo databases, with manual ance.2–13 Patient safety culture is encour-
Medicine, Monash University, searches of quality and safety websites, aged at jurisdictional and organisational
Victoria, Australia
2
Centre for Health Policy,
bibliographies of included articles and key levels by national health policy makers,
Programs and Economics, journals. with hospitals routinely administering
Melbourne School of Population Study selection English language studies surveys in many countries.14–16 Patient
Health, University of Melbourne, published between January 1996 and April 2011 safety culture (figure 1), a component of
Victoria, Australia
that measured the effectiveness of patient safety organisational culture, includes the shared
Correspondence to culture strategies using a quantitative measure of beliefs, attitudes, values, norms and behav-
Renata Teresa Morello, Centre of patient safety climate in a hospital setting. Studies ioural characteristics of employees17 and
Research Excellence in Patient included were randomised controlled trials (RCTs), influences staff member attitudes and beha-
Safety (CRE-PS), School of Public
Health and Preventive Medicine, non-RCTs, controlled before and after studies, viours in relation to their organisation’s
Department of Epidemiology and interrupted time series and historically controlled ongoing patient safety performance.18–21
Preventive Medicine, Monash studies. Accurate measurement of patient safety
University, The Alfred Centre, 99
Data extraction Data extraction and critical culture is limited by the ability to define
Commercial Road, Melbourne,
VIC 3004, Australia; appraisal were conducted by two independent measureable components of culture.22
renata.morello@monash.edu reviewers. Study design, intervention, level of Therefore the demand for relatively
application, setting, study participants, safety low-cost, quick and easy to use assessments
Received 16 October 2011
Revised 3 July 2012
climate outcome measures and implementation of patient safety culture has resulted in a
Accepted 4 July 2012 lessons were extracted from each article. reliance on patient safety climate question-
Published Online First Results of data synthesis Over 2000 articles naires.6 23–28 Patient safety climate
31 July 2012 were screened, with 21 studies meeting the (figure 1) describes employee perceptions
inclusion criteria, one cluster RCT, seven and attitudes about the surface features of
controlled before and after studies, and 13 patient safety culture at a given point in
historically controlled studies. There was marked time.29 A number of patient safety climate
methodological heterogeneity amongst studies. questionnaires have been developed29 30
Impacts of 11 different strategies were reported. and used within healthcare organisations
There was some evidence to support that to measure performance for benchmark-
leadership walk rounds ( p=0.02) and multi- ing, diagnosis and planning of internal
▸ http://dx.doi.org/10.1136/ faceted unit-based programmes ( p < 0.05) may quality improvement. More recently they
bmjqs-2011-000446 have a positive impact on patient safety climate. have been used to examine the effective-
▸ http://dx.doi.org/10.1136/ Conclusions Despite strong face validity for a ness of strategies designed to improve
bmjqs-2012-001572
variety of patient safety culture strategies, there is patient safety culture.
limited evidence to support definitive impacts on Positive patient safety climate has been
To cite: Morello RT,
patient safety climate outcomes. Organisations reported to be associated with enhanced
Lowthian JA, Barker AL, et al. are advised to consider robust evaluation designs patient safety.31–34 Therefore, targeting
BMJ Qual Saf 2013;22:11– when implementing these potentially resource practice change through patient safety
18. intensive strategies. climate is considered to be a key strategy

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Systematic review

Figure 1 Patient safety culture model.

for strengthening and enhancing patient safety and out- Data extraction and analysis
comes in hospitals.1 14 35 However, it is important that Data extraction and critical appraisal of included studies
enthusiasm to introduce strategies for improving patient were conducted by two independent reviewers (RM and
safety culture and climate is informed by evidence of JL), with disagreements settled by a third reviewer (AB).
effectiveness. Despite the application of a variety of Assessment of risk of bias and study critical appraisal
patient safety culture strategies within hospitals there has was conducted using a tool based on National Health
been no prior systematic review of their effectiveness. As and Medical Research Council (NHMRC)37 and the
some strategies may entail significant resource commit- Cochrane Collaboration’s Effective Practice and
ment to implement, embed and sustain, it is important Organisation of Care (EPOC) Group guidelines.38 39
to determine the extent to which there is evidence to Study setting, design, selection and measurement bias,
support their effectiveness, generalisability and sustain- baseline outcome measurements and characteristics, risk
ability to enable rational allocation of resources.36 of contamination, data analysis, selective outcome
The aim of this systematic review was to critically reporting, other risks of bias and issues relating to gener-
assess the evidence for the effectiveness of patient alisability and sustainability were extracted and
safety culture strategies for improving patient safety recorded. Implementation lessons and data from studies
climate in hospitals, to support decision-making by using mixed method evaluations were also extracted
organisations and funding providers. and reviewed. A meta-analysis was not possible due to
insufficient homogeneity (populations, interventions,
METHODS outcome measures and follow-up periods) of studies.
Data sources Consequently, data were reviewed looking for common
An electronic search was conducted of the Cochrane themes and presented in a narrative format.
Library, OVID Medline, Embase, CINAHL, proQuest
and psychinfo databases. Medical subject heading search
terms and keywords were used (online appendix 1).
RESULTS
The Medline search strategy was translated for other
Over 2000 articles were screened for inclusion, of which
databases as appropriate. Additionally, bibliographies of
21 studies (22 publications), one cluster RCT, seven con-
included articles and key journals were hand searched.
trolled before and after studies and 13 historically con-
trolled studies met the inclusion criteria (figure 2).
Study selection
Included studies (see online supplementary table S1)
Inclusion criteria
were conducted in the USA (15 studies),34 40–53 UK (3
English language studies published between January
studies),54–57 Canada (1 study),58 Europe (1 study)59 and
1996 and April 2011 were considered. Assessment of
Australia (1 study).60
effectiveness was based on randomised controlled trials
Study periods ranged from 2 months to 3 years.
(RCTs), non-RCTs, controlled before and after studies,
Seven of the 21 studies had observation periods
interrupted time series and historically controlled
longer than 12 months.43 47 49 51 53 54 59 Surveys
studies.
used (or adaptations of ) included the Safety Attitudes
Studies were included if they measured effectiveness
Questionnaire (SAQ),40 42 44 47 49–53 55 56 the Safety
of patient safety culture strategies using a quantitative
Climate Survey (SCSu),45 Patient Safety Cultures in
patient safety climate tool and were conducted within
Healthcare Organizations,43 58 the Hospital Survey on
a hospital, hospital department or clinical unit.
Patient Safety Culture,41 46 59 60 and the National
Exclusion criteria Health Service National Staff Survey.54 57 All tools
Studies without a quantitative measure of patient had undergone varying levels of validation.29 30 Four
safety climate; studies in community, primary health- studies conducted factor analysis to assess internal
care services or residential care facilities; and case consistency and content reliability of items included
studies that presented only cross-sectional data. on tools used.34 43 58 59

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Figure 2 Search results.

There were a number of different safety culture strat- patient safety climate was detected for nurses partici-
egies tested, including leadership walk rounds,42 47 55 pating in leadership walk rounds compared with those
structured educational programmes,55 58 team-based in the control group ( p=0.02).
strategies,41 44 53 simulation-based training pro- Frankel et al’s historically controlled study sup-
grammes,43 45 48 56 multi-faceted unit-based pro- ported these findings,47 reporting an increase in mean
grammes40 46 49–53 and multi-component organisational safety climate scores following introduction of leader-
interventions54 (see online supplementary table S1). Six ship walk rounds.
studies specifically focused on teamwork within the clin-
Structured educational programmes
ical area,41 44 55 56 60 while others focused on varying
Bleakley et al’s controlled before and after study
factors of patient safety culture, such as incident report-
examined the effectiveness of a structured educational
ing, environment, human factors and leadership. One
programme on teamwork collaboration delivered to
two-phase study involved an intervention implemented
operating theatre staff.55 There was a positive effect
at the organisational level,54 57 while the remaining 20
on teamwork climate (one of six dimensions of the
studies implemented interventions at the unit or depart-
SAQ) ( p=0.04), however there were significant differ-
ment level. Four of the eight studies that incorporated a
ences in baseline measures between groups. Ginsburg
contemporary control group reported limited or no
et al’s controlled before and after study examined the
effects on measures of patient safety climate.42 44 55 58
effectiveness of a nurse clinical leader education pro-
gramme,58 finding an effect on one of three dimen-
Summary of study findings
sions of the patient safety climate survey (valuing
Leadership walk rounds
safety: p<0.001).
Thomas et al’s cluster RCT examined the effectiveness
of leadership walk rounds,42 finding no effect on Team-based strategies
patient safety climate scores reported by doctors, O’Leary et al’s controlled before and after study
nurses and clinicians. However, a positive effect on examined the effectiveness of daily structured

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interdisciplinary rounds, reporting no effect on Qualitative data and implementation lessons

patient safety climate scores.44 However, a positive Six studies contributed qualitative data about imple-
effect was found for the SAQ team work climate mentation issues to support quantitative findings of
dimension ( p=0.01). effectiveness of patient safety culture interventions
Weaver et al’s controlled before and after study (see online supplementary table S1),40 41 52 57 58 60
examined the effectiveness of TeamSTEPPS (team with only three studies using formal mixed methods
strategies and tools to enhance performance and evaluation.41 54 60 Benning et al’s controlled before
patient safety),41 finding a positive trend to improve- and after study conducted a series of focus groups,
ment of patient safety climate scores over time for interviews and observations with clinical ward staff.57
both intervention and control groups ( p < 0.001), These data highlighted gaps between management
with no significant difference between the two level engagement, ward practice and clinical staff
groups.41 engagement and practice change, in relation to effect-
Stead et al’s historically controlled study reported a ive implementation of a multi-component organisa-
positive effect on 2 of 12 dimensions of patient safety tional intervention across all hospitals in phase I of
culture (frequency of event reporting, p=0.04 and the trial. The authors stated that, in general, it was
organisational learning, p=0.01).60 thought hospitals had underestimated the resource
and organisational support required to make the
Simulation-based training programmes patient safety initiatives work and achieve culture and
Cooper et al’s controlled before and after study exam- practice change.
ined the effectiveness of a simulation-based training Stead et al and Weaver et al conducted observational
programme, and reported no effect on patient safety analyses on team behaviours following the implementa-
climate scores.43 Four historically controlled studies tion of TeamSTEPPS.41 60 These studies reported
reported varying levels of effectiveness of simulation- improvements in team behaviours and the structure and
based training on patient safety climate.45 48 53 56 process of team meetings post implementation.

Multi-faceted unit-based programmes Critical appraisal

Pronovost et al’s controlled before and after study The evaluation of the studies has been presented in a
examined the effectiveness of a structured multi- summary table (online appendix 2), which includes
faceted unit-based safety programme (structured information regarding study characteristics, a
framework for assessing, identifying, reporting and summary of key findings, the effect of the interven-
improving patient safety concerns),40 finding a posi- tion and assessment of the quality of evidence.
tive effect on safety climate scores ( p<0.05). All studies had a number of methodological limita-
Six historically controlled studies supported these tions. These included non-equivalent contemporary
positive findings of effectiveness for multi-faceted control groups or use of a historical control group,
unit-based programmes.46 49–53 All studies reported risk of selection bias, small sample sizes, limited
varying levels of improvements in at least one dimen- follow-up response rates, short observational periods,
sion of patient safety climate over time. and use of post hoc statistical analysis for examination
of effect. Most studies failed to adequately control for
Multi-component organisational interventions potential threats of bias or confounding factors, which
Benning et al’s two-phase controlled before and after threatens their internal validity. The factors identified
study examined the effectiveness of a multi- were sufficient to impact on the interpretation of
component organisational intervention, the Safer study results. Furthermore, 9 of the 21 studies were
Patient Initiative, involving organisational wide and conducted in single hospital or clinical units, limiting
targeted components in designated clinical areas, such generalisability of results.
as approaches to build safety culture and good leader-
ship, reducing medication errors, and enhancing com- DISCUSSION
munication to reduce adverse events.61 A negligible This systematic review found limited evidence to
effect on patient safety climate scores was support the effectiveness of a variety of in-hospital
reported.54 57 patient safety culture strategies, the impact of which
was assessed using patient safety climate scores. A
Other patient safety culture strategies variety of strategies were tested that targeted a diverse
Two historically controlled studies reported positive range of issues, including leadership, accountability,
impacts with other patient safety culture strategies, communication and teamwork, identification of safety
surgical safety checklists and improvement approach concerns, reporting of near misses and reliability. This
strategies (see online supplementary table S1).34 59 array may reflect the complexity of the construct we
Online supplementary table S2 summarises the evi- intuitively understand as ‘culture’ and the current lack
dence for the effectiveness of patient safety culture of understanding of the priority of certain elements
strategies. and their potential interdependencies.

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Leadership walk rounds and multi-faceted unit-based level,42 57 and limited implementation of safety initia-
strategies were the two strategies for which some stron- tives due to competing priorities and resource
ger evidence could be found to support a positive constraints.51 58
impact. Leadership walk rounds engage executives and It should also be noted that the patient safety
clinical leaders and use direct communication to break culture strategies identified in this review are likely to
down barriers surrounding patient safety, whilst be highly dependent on the personnel conducting
engaging frontline care givers and demonstrating them and the organisation in which they are con-
organisational commitment.62 Thomas et al concluded ducted. Intrinsic organisational elements such as the
that the positive impact on patient safety climate was level of executive support, extent of implementation,
limited to the nursing staff who actually participated in the size of the organisation and the personnel facilitat-
the leadership walk rounds.42 The limited effectiveness ing change may limit the generalisability of evidence.
and the relatively short observation period of 3 months Even strategies with a strong evidence base will fail in
may be reflective of the time it takes for culture an organisation when they have been poorly imple-
changes to become embedded within an organisation. mented or supported.
However, it may also raise implementation issues for Three areas worthy of further discussion are the
organisations with large numbers of agency staff or methodological rigour of the studies, the limited
high staff turnover, when some staff may be rarely number of studies in this area, and the robustness of the
exposed to a walk round. Frequency of rounding may safety climate measures used. Over 60% of identified
also be relevant as supported by data from a historic- studies relied on historically controlled study designs,
ally controlled study47 in which weekly walk rounds often in single organisations, making it difficult to dir-
were undertaken for 18 months compared with the ectly attribute the observed effect on patient safety
Thomas study in which they were conducted monthly climate to the patient safety culture strategies implemen-
for 3 months. ted.36 Such studies are highly exposed to potential
There is also some evidence to support the use of sources of bias and confounders. Underlying factors can
multi-faceted unit-based programmes for improving produce large fluctuations in the outcomes of interest.
patient safety climate and patient outcomes. These pro- As such inferences of causal associations are difficult to
grammes apply a structured framework to assess, iden- determine due to the variety of variables that may exist
tify, report and improve patient safety defects and the within an organisation or clinical unit. Of note, some
strategy is specifically designed to improve unit studies found a time effect but not an intervention effect
culture.40 The clear relationship between this strategy on patient safety climate.41 54 This suggests that survey
and patient safety climate is likely to underpin the tool administration alone may have a positive impact on
observed positive impacts compared with other strat- safety climate because it may sufficiently increase staff
egies when the relationship with patient safety climate awareness about positive culture and patient safety,
outcomes is not clear or may be indirect. A number of enticing cultural change.
historically controlled studies have been conducted While we recognise the difficulties in designing,
using both small and large cohorts of clinical conducting and financing health service research of
units.49–52 While the lack of data from a contemporary complex interventions, such as patient safety culture
control group limits assessment of efficacy, it does strategies, a relatively small number of studies were
support feasibility for implementing and transferring identified addressing their effectiveness. It can be
this unit-based safety programme. argued that potentially costly and resource-intensive
Many of the remaining strategies were examined by quality improvement programmes should be subject to
only a small number of studies with conflicting the same scrutiny as clinical practice.36 In an industry
results. It has been recognised that there is a need for with limited resources, implementation of a
culture strategies to be more selective and flexible, non-evidence-based practice should be approached
and able to be adapted to contextual factors and the with caution. It is important to note that limited evi-
climate in which they are being delivered.19 63 dence in this area does not equate to lack of effective-
Developing a culture within which an organisation ness of patient safety culture strategies. However,
can achieve patient safety is challenging5 and the sus- while there may appear to be sufficient face validity
tainability of many of these strategies over time is for these strategies, there is always a danger that strat-
unclear. Hospitals are dynamic in nature and inher- egies may not be as effective as first thought and may
ently hierarchical in structure.1 Culture is often deeply also pose high costs.64 As such, further research in
embedded within various levels and sub-groups.8 19 20 this area is required. Ideally, patient safety culture
Therefore, to modify culture it is important to first strategies would benefit from evaluation using quanti-
understand the current hierarchy of these elements in tative and qualitative methodology.22 65 66 Qualitative
the target group for the intervention.17 Commonly data can be used to support quantitative findings and
reported explanations for limited effectiveness were the contextual factors influencing effectiveness. Only
gaps between what managers reported they were 3 of the 21 included studies conducted formal mixed-
doing and what was actually happening at the local methods evaluations.57 60

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Reviews of safety climate tools used within health- appropriate evaluation. At an organisational level,
care have indicated a large disparity between the when such designs are not feasible, continued efforts
levels of measured psychometric properties, safety by healthcare organisations to pursue improvements in
climate dimensions and the theoretical underpinning patient safety culture are recommended, within a struc-
for questionnaires.29 30 67 There was considerable tured evaluation using time series analyses and well
diversity in the patient safety climate measurement planned programme evaluation. This will contribute to
tools used by studies and this limits the degree to understanding the impact of changes over time and the
which between-study comparisons can be made. sustainability of chosen strategies.
Emerging evidence links safety climate score with
patient outcomes,31–34 however the extent to which
these measures can predict patient safety outcomes CONCLUSION
remains somewhat unclear. There also appears to be The evidence is limited to support the effectiveness of
limited understanding of survey tools’ sensitivity and strategies to improve patient safety culture within hos-
specificity to detect change and the evidence to associ- pitals. However, there is a rationale for further investi-
ate changes in patient safety climate with changes in gating executive walk rounds and multi-faceted
patient safety outcomes is scarce. Organisations unit-based programmes. Organisations considering
looking to evaluate patient safety culture using patient the implementation of potentially costly and resource-
safety climate tools should consider the degree to intensive strategies should evaluate programmes within
which that tool has been validated within their juris- a robust study design.
diction and application of these tools and their appro-
Acknowledgements We would like to acknowledge the
priateness for evaluating effectiveness should also be
considered in future research. comments made by the Editor in Chief, BMJ Quality
The strengths of this review, which focused on quan- and Safety. We would also like to thank the reviewers
titative measures of effectiveness, include a systematic of this manuscript for their comments which have
search of 15 years of peer-reviewed literature with a been used to assist in the revision of this paper.
rigorous approach to critical appraisal of study design, Contributors RM: primary reviewer of included studies
bias and contamination, outcome measures, methods (data extraction and critical appraisal), drafting and
of analysis and reporting. However, the limitations of finalisation of manuscript. JL: secondary reviewer of
this review must also be considered. First, the exclusion included studies (data extraction and critical appraisal)
of studies without any quantitative measure of patient and revision of manuscript. AB: third reviewer and
safety climate meant that studies solely conducting review of critical appraisal of studies, revision of the
qualitative research or measures of patient safety, such manuscript and finalisation of the discussion section
as mortality rates, medication errors, and patient com- of the manuscript. RMc: assisted with data extraction
plaints, were not included. We acknowledge that quali- and critical appraisal of included studies and revision
tative research does provide useful insight, particularly of the manuscript. DD: review and revision of the
into barriers and facilitators for implementation, and manuscript, in particular the introduction and
identifying the effectiveness of patient safety culture methods sections. CB: overseeing the drafting and
strategies on measures of patient safety is important to finalisation of the manuscript, with particular focus
consider. However, it was beyond the scope of this on the introduction and discussion sections.
review to include these studies. Future systematic Competing interests None.
reviews should include such measures to augment the
Provenance and peer review Not commissioned;
findings of this review. Second, while the search strat-
egy appeared comprehensive, other relevant studies externally peer reviewed.
may have been inadvertently excluded; however, our Data sharing statement Data extraction and critical
manual search yielded only six additional studies, sug- appraisal of included studies are available on request
gesting recall sensitivity and precision were adequate. from the corresponding author.

Implications for future research

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Strategies for improving patient safety

culture in hospitals: a systematic review
Renata Teresa Morello, Judy A Lowthian, Anna Lucia Barker, et al.

BMJ Qual Saf 2013 22: 11-18 originally published online July 31, 2012
doi: 10.1136/bmjqs-2011-000582

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