Promoting a Culture of Safety as a Patient Safety Strategy
A Systematic Review
Sallie J. Weaver, PhD, Lisa H. Lubomksi, PhD, Renee F. Wilson, MS, Elizabeth R. Pfoh, MPH, Kathryn A. Martinez, PhD, MPH, and Sydney M. Dy, MD, MSc Johns Hopkins University, Baltimore, Maryland, and University of Michigan, Ann Arbor, Michigan
Abstract
Developing a culture of safety is a core element of many efforts to improve patient safety and care
quality. This systematic review identifies and assesses interventions used to promote safety culture
or climate in acute care settings. The authors searched MEDLINE, CINAHL, PsycINFO,
Cochrane, and EMBASE to identify relevant English-language studies published from January
2000 to October 2012. They selected studies that targeted health care workers practicing in
inpatient settings and included data about change in patient safety culture or climate after a
targeted intervention. Two raters independently screened 3679 abstracts (which yielded 33 eligible
studies in 35 articles), extracted study data, and rated study quality and strength of evidence. Eight
studies included executive walk rounds or interdisciplinary rounds; 8 evaluated multicomponent,
Requests for Single Reprints: Sallie J. Weaver, PhD, Johns Hopkins University School of Medicine, Department of Anesthesiology and Critical Care Medicine and Armstrong Institute for Patient Safety and Quality, 750 East Pratt Street, 15th Floor, Room 1544, Baltimore, MD 21202; sjweaver@jhu.edu. Current Author Addresses: Drs. Weaver and Lubomski: Johns Hopkins University School of Medicine, Department of Anesthesiology and Critical Care Medicine and Armstrong Institute for Patient Safety and Quality, 750 East Pratt Street, 15th Floor, Baltimore, MD 21202. Ms. Wilson: Johns Hopkins University, 1830 East Monument Street, Room 8061, Baltimore, MD 21287. Ms. Pfoh: Johns Hopkins University, 624 North Broadway, Baltimore, MD 21205. Dr. Martinez: University of Michigan, Department of General Medicine, 2800 Plymouth Road, Building 16, 4th Floor, Ann Arbor, MI 48109–2800. Dr. Dy: Johns Hopkins University, Health Services Research and Development Center, 624 Broadway, Room 609, Baltimore, MD 21205–1901. Current author addresses and author contributions are available at www.annals.org.
See also: Web-Only CME quiz (Professional Responsibility Credit) Supplement
Note: The AHRQ reviewed contract deliverables to ensure adherence to contract requirements and quality, and a copyright release was obtained from the AHRQ before submission of the manuscript.
Disclaimer: All statements expressed in this work are those of the authors and should not in any way be construed as official opinions or positions of the Johns Hopkins University, the AHRQ, or the U.S. Department of Health and Human Services.
Potential Conflicts of Interest: Dr. Weaver: Grant (money to institution): AHRQ, U.S. Department of Health and Human Services; Travel/accommodations/meeting expenses unrelated to activities listed (money to author): Improvement Science Research Network. Dr. Lubomski: Grant (money to institution): AHRQ. Ms. Wilson: Grant (money to institution): AHRQ. Ms. Pfoh: Grant (money to institution): AHRQ. Dr. Martinez: None disclosed. Dr. Dy: Grant (money to institution): AHRQ. Disclosures can be also viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-2567.
Author Contributions: Conception and design: S.J. Weaver, L.H. Lubomksi, K.A. Martinez, S.M. Dy. Analysis and interpretation of the data: S.J. Weaver, E.R. Pfoh, K.A. Martinez, S.M. Dy. Drafting of the article: S.J. Weaver, E.R. Pfoh, S.M. Dy. Critical revision of the article for important intellectual content: S.J. Weaver, L.H. Lubomksi, S.M. Dy. Final approval of the article: S.J. Weaver, R.F. Wilson, K.A. Martinez, S.M. Dy. Obtaining of funding: S.M. Dy. Administrative, technical, or logistic support: L.H. Lubomksi, R.F. Wilson, K.A. Martinez. Collection and assembly of data: S.J. Weaver, L.H. Lubomksi, R.F. Wilson, K.A. Martinez, S.M. Dy.
HHS Public Access Author manuscript Ann Intern Med. Author manuscript; available in PMC 2016 January 12.
Published in final edited form as: Ann Intern Med. 2013 March 5; 158(5 0 2): 369–374. doi:10.7326/0003-4819-158-5-201303051-00002.
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unit-based interventions; and 20 included team training or communication initiatives. Twenty-nine
studies reported some improvement in safety culture or patient outcomes, but measured outcomes
were highly heterogeneous. Strength of evidence was low, and most studies were pre–post
evaluations of low to moderate quality. Within these limits, evidence suggests that interventions
can improve perceptions of safety culture and potentially reduce patient harm.
The Problem
Developing a culture of safety is a core element of many efforts to improve patient safety
and care quality in acute care settings (1, 2). Several studies show that safety culture and the
related concept of safety climate are related to such clinician behaviors as error reporting
(3), reductions in adverse events (4, 5), and reduced mortality (6, 7). Accreditation bodies
identify leadership standards for safety culture measurement and improvement (8), and
promoting a culture of safety is a designated National Patient Safety Foundation Safe
Practice (9). A search of the Agency for Healthcare Research and Quality (AHRQ) Patient
Safety Net (www.psnet.ahrq.gov) yields more than 5665 articles, tips, and fact sheets related
to improving safety culture. Although much work has focused on promoting a culture of
safety, understanding which approaches are most effective and the implementation factors
that may influence effectiveness are critical to achieving meaningful improvement (10).
Drawing on the social, organizational, and safety sciences, patient safety culture can be
defined as 1 aspect of an organization’s culture (11, 12). Specifically, it can be personified
by the shared values, beliefs, norms, and procedures related to patient safety among
members of an organization, unit, or team (13, 14). It influences clinician and staff
behaviors, attitudes, and cognitions on the job by providing cues about the relative priority
of patient safety compared with other goals (for example, throughput or efficiency) (11).
Culture also shapes clinician and staff perceptions about “normal” behavior related to
patient safety in their work area. It informs perceptions about what is praiseworthy and what
is punishable (either formally by work area leaders or informally by colleagues and fellow
team members). In this way, culture influences one’s motivation to engage in safe behaviors
and the extent to which this motivation translates into daily practice.
Patient safety climate is a related term—often inadvertently used interchangeably with
culture—that refers specifically to shared perceptions or attitudes about the norms, policies,
and procedures related to patient safety among members of a group (for example, care team,
unit, service, department, or organization) (11). Climate provides a snapshot of clinician and
staff perceptions about the observable, surface-level aspects of culture during a particular
point in time (10, 15). It is measured most often using a questionnaire or survey. Clinicians
and staff are asked about aspects of their team, work area, or hospital, such as
communication about safety hazards, transparency, teamwork, and leadership. Because
climate is defined as a characteristic of a team or group, individual responses to survey items
are usually aggregated to form unit-, department-, or higher-level scores. The difference
between culture and climate is often reduced to a difference in methodology. Studies
involving surveys of clinicians and staff are categorized as studies of safety climate, and
ethnographic studies involving detailed, longitudinal observations are categorized as studies
of safety culture. The terms are often used interchangeably in practice, but it is important to
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remember that there are conceptually meaningful differences in their scope and depth. For
the purpose of this review, studies of both patient safety culture and climate were included.
We use the term patient safety culture in discussion only to simplify the reporting of results.
Given that safety culture can influence care processes and outcomes, efforts to evaluate
patient safety climate over time are being widely implemented (16). Measurement and
feedback are necessary—although likely insufficient—means to effectively promote a
culture of safety. One previous systematic review found strong face validity for
interventions to promote safety culture in health care, but heterogeneity among studies,
measures, and settings limited conclusions about intervention effectiveness (17). Results
suggested possible positive effects for leadership walk rounds and multifaceted, unit-based
interventions on survey measures of safety climate. However, the review did not assess
effects on patient outcomes or care processes. Another review done by the Cochrane
Collaboration (18) examined organizational culture–change interventions designed to
improve patient outcomes and quality of care. Only 2 studies were identified for inclusion,
both of which evaluated different outcomes, and results were inconclusive. We attempted to
address these gaps by conducting a systematic review of the peer-reviewed literature to
identify interventions used to promote safety culture in health care, assess the evidence for
their effectiveness in improving both safety culture and patient outcomes, and describe the
context and implementation of these interventions.
Patient Safety Strategies
Promotion of patient safety culture can best be conceptualized as a constellation of
interventions rooted in principles of leadership, teamwork, and behavior change, rather than
a specific process, team, or technology. Strategies to promote a culture of patient safety may
include a single intervention or several interventions combined into a multifaceted approach
or series. They may also include system-level changes, such as those in governance or
reporting structure. For example, team training, interdisciplinary rounding or executive walk
rounds, and unit-based strategies that include a series of interventions have all been labeled
as interventions to promote a culture of safety. Team training refers to a set of structured
methods for optimizing teamwork processes, such as communication, cooperation,
collaboration, and leadership (19, 20). Previous reviews show that the term has been applied
to a range of learning and development strategies, but the critical defining element is a focus
on attaining the knowledge, skills, or attitudes that underlie effective teamwork (20).
Executive walk rounds is an interventional strategy that engages organizational leadership
directly with front-line care providers. Executives or senior leaders visit front-line patient
care areas with the goal of observing and discussing current or potential threats to patient
safety, as well as supporting front-line staff in addressing such threats (21, 22). Walk rounds
aim to show leadership commitment to safety, foster trust and psychological safety, and
provide support for front-line providers to proactively address threats to patient safety.
However, walk rounds have been operationalized in diverse ways, making comparison
across studies difficult (21). For example, not all rounding interventions use a structured
format, and time intervals between rounds vary widely across studies.
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Improvement strategies that combine several intervention techniques have also been used to
promote safety culture. For example, the Comprehensive Unit-Based Safety Program
(CUSP) is a multifaceted strategy for culture change that pairs adaptive interventions (such
as continuous learning strategies or team training) with technical interventions (such as
translation and use of best available evidence-based clinical care algorithms) to improve
patient safety and quality (23, 24). The CUSP methodology includes elements of executive
engagement and team training, along with specific strategies for translating clinical evidence
into practice. Other interventions have combined unit-based interventions with broader
organizational changes, including restructuring patient safety governance (25, 26).
Review Processes
This review examines the evidence for interventions that articulate improvement in patient
safety culture as a primary outcome and intervention goal. We identified relevant articles
through searches of 5 databases from 1 January 2000 through 31 October 2012: PubMed,
CINAHL, Cochrane, EMBASE, and PsycINFO. Key search terms included patient safety
culture, safety climate, and safety attitudes (see the Supplement, available at
www.annals.org, for a description of the search strategies, an article flow diagram, and
evidence tables). The searches found 3679 records, all of which were independently
screened by 2 reviewers. One hundred sixty-two articles were identified for full screening.
Of these, 33 studies (in 35 articles) were identified for final inclusion. Two studies each
contributed 2 papers to the review (26–29).
Studies were included if they targeted health care professionals or paraprofessionals
practicing in adult or pediatric inpatient settings, explicitly indicated that the purpose of the
intervention was promoting or improving a culture or climate of patient safety, used a
psychometrically valid measure to assess patient safety culture that had previous evidence of
sound psychometric properties published in a peer-reviewed outlet (15, 30, 31), assessed
culture over at least 2 time points, and included adequate data to assess change in patient
safety culture or climate. Only English-language studies conducted in the United States, the
United Kingdom, Canada, or Australia were included. Although a growing number of
studies have translated English-language surveys of culture into other languages, evidence
that their construct validity is comparable across samples remains limited. Studies were
excluded if they examined interventions aimed at medical or nursing students, targeted other
aspects or types of culture (for example, general organizational culture), or were primarily
focused on survey development or establishing the psychometric properties of a culture
assessment. Qualitative studies were also excluded. Each article was abstracted by a primary
reviewer and checked by a second reviewer.
Strength of evidence, including risk of bias, was evaluated by both reviewers using the
Grading of Recommendations Assessment, Development and Evaluation Working Group
criteria adapted by AHRQ (32). Interventions and reported outcomes were highly
heterogeneous, and meta-analyses were not done. We present results from thematic analysis
and qualitative summaries of individual studies.
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This review was supported by the AHRQ, which had no role in the selection or review of the
evidence or the decision to submit the manuscript for publication.
Benefits and Harms
Study Characteristics
Of the 33 studies reviewed, 24 were pre–post studies; 3 were concurrent control or pre–post
with concurrent control studies; 3 were time-series studies; 2 were cluster randomized,
controlled trials (RCTs); and 1 had a quasi-stepped wedge design. The clinical care areas
studied included intensive care, perioperative, labor and delivery, radiology, and general
medical and surgical floors. Twenty-one studies measured patient safety culture or climate
with the Safety Attitudes Questionnaire (33), 10 studies used the AHRQ Hospital Survey on
Patient Safety (34), and 2 studies used the Patient Safety Climate in Healthcare
Organizations survey (35). Most studies operationalized culture at the level of the hospital
unit or work area; that is, individual survey responses from clinicians and staff in a given
work area were aggregated to form group-level patient safety climate scores for each work
area surveyed. Survey sample sizes ranged from 5461 persons working in 144 units in a
single hospital to 28 individuals working within a single hospital unit. The response rate—
the number of individuals who complete and return surveys out of the total invited to
complete the survey—is an important factor influencing the validity of survey results.
Survey response rates ranged from 23% to 100%.
Intervention Types
Heterogeneity among interventions was substantial. Most (19 studies) were multicomponent
interventions combining several improvement strategies under a single overarching initiative
to promote safety culture. For example, Blegen and colleagues (36) used a 3-component
approach that included team training, unit-based safety teams, and strategies for engaging
patients in daily goal setting. Thematic analysis identified 3 broad categories of intervention
that emerged across multiple studies: 20 studies explicitly included team training or tools to
improve team communication processes, 8 explicitly included some form of executive walk
rounds or interdisciplinary rounding, and 8 explicitly used CUSP.
Benefits
Team Training—Twenty studies explicitly examined team training or tools to support team communication as interventions to promote safety culture. Of these, 10 were conducted
in perioperative care areas, 5 in labor and delivery or pediatrics, 2 in medical general floors
or intensive care, and 3 in other care areas or a mix of care areas. Seventeen had pre–post or
pre–post with concurrent control designs. One study was a quasi-cluster RCT; however,
only 3 organizations were randomly assigned to 3 conditions. Sixteen of the 20 studies
reported statistically significant improvement in staff perceptions of safety culture. In
addition, 5 reported improvements in care processes (for example, decreased care delays or
increased use of structured communication) and 7 reported improvements in patient safety
outcomes (for example, errors resulting in harm or reductions in adverse outcomes index).
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Executive Walk Rounds—Eight studies evaluated walk rounds (either executive or interdisciplinary), including 1 cluster RCT. All reported improvement in staff perceptions of
safety culture. One study, however, showed improvement on only 2 of 30 survey items and
did not report domain scores (37). Three reported improvements in perceptions of care
processes (for example, quality of collaboration) or patient safety outcomes (for example,
improvement in mean number of days since last event). One study (27, 28) found that
adjusted care costs were $24.01 lower for intervention work areas despite an adjusted length
of stay that was 0.19 days longer. However, neither of these indices were statistically
significantly different from control work areas. The study included only 4 units (2
intervention, 2 control) and was underpowered to detect differences in these outcomes.
CUSP—Eight studies specifically evaluated the effects of CUSP. Most used medium- to larger-sample pre–post designs in intensive care unit settings, although 1 used a quasi-
stepped wedge design. Overall, 6 of the 8 studies reported statistically significant
improvements in staff perceptions of safety culture, including perceptions of teamwork. Two
studies reported improvements in care processes, such as second-stage labor care (38) and
timely resolution of safety concerns (39). Two studies reported improvements (although
statistically nonsignificant or not statistically tested) in nursing turnover (40, 41), 1 reported
a reduction in length of stay (41), and 1 reported greater reductions in infection rates
(although not statistically significant) (42). Other studies of CUSP have shown sustained
improvements in infection rates and mortality after implementation (23, 27).
Outcomes—Regarding effectiveness, 23 of 32 reviewed studies reported a statistically significant effect of the intervention on the overall safety culture score, the safety climate
score, or at least half of reported survey domains or items (if analyzed at the item level).
Several studies reported improvements in teamwork climate but did not find similar
improvements in safety culture or safety climate (27, 43).
Additional outcomes included changes in care processes, patient outcomes (for example,
indices of harm), and clinician outcomes (for example, turnover or burnout). Nineteen
studies also reported the effect of interventions on such outcomes. Statistically significant
improvements were reported in 6 of 11 studies reporting on patient outcomes. Five studies
found reductions in indices of patient harm (25, 26, 43–45), and 1 study reported
improvements in length of stay (41). One study found a decrease (0.56 vs. 0.15; P < 0.01) in
the rate of reported errors that resulted in patient harm after a multifaceted suite of
interventions that included both cultural (for example, feedback on errors in the form of
posters) and system-focused changes (for example, medication management protocols) (43).
A cluster RCT that found a marginal increase in teamwork culture (45) also found that the
experimental unit’s weighted adverse outcome score (an index of patient harm) decreased by
37% after implementation of a team training program designed to promote patient safety
culture, compared with a 43% increase in a control unit (P < 0.05). Two studies also
reported reductions in nurse turnover after interventions to promote safety culture (40, 41).
Overall, the strength of evidence was low. Risk of bias was generally high because of study
design issues; for example, we identified only 1 true cluster RCT (22). Core issues affecting
risk of bias for reviewed studies included low survey response rates and incomplete
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reporting (not reporting full results for all units or hospitals where interventions were
conducted, or not reporting results for all domains measured as part of culture surveys).
Results were inconsistent, with 56% of studies reporting statistically significant findings.
Regarding directness, or the extent to which findings generalize to different organizations or
populations, few studies discussed the logic model or conceptual foundation underlying the
intervention design. Only 2 studies comparatively evaluated the effects of different
intervention strategies, and patient safety outcomes were infrequently and heterogeneously
reported. Regarding precision, many survey instruments were used across reviewed studies
and results were often reported differently.
Harms
We did not identify any data on patient harms.
Implementation Considerations and Costs
Studies differed in the characteristics of the organizations in which they were implemented,
the level of leadership support and engagement reported, and the tools and strategies used to
support implementation into daily care processes. Thirteen studies were done in academic
hospital settings, 4 in community-based hospitals, 6 in a mix of academic and community
hospitals, and several did not address the hospital mix in their sample. One study reported
that the gain in safety climate scores was larger for faith-based hospitals (14%) than for
non–faith-based hospitals (8%) but reported no direct statistical test of these findings (46).
Only 1 study (28) examined costs of care among intervention and control work areas. No
statistically significant differences in mean care costs between control and intervention work
areas at follow-up were found.
Discussion
Our review identified 33 studies in 35 articles that evaluated interventions to promote safety
culture in inpatient care settings. Although these interventions varied greatly and often
included multiple components, 3 common types of intervention emerged: team training and
team communication tools, executive walk rounds and interdisciplinary rounding, and
CUSP. These interventions were implemented across various care areas in both academic
and community hospital settings. Most were evaluated in either perioperative or intensive
care areas.
Overall, results suggest evidence to support the effectiveness of such interventions in
improving clinician and staff perceptions of elements of safety culture (for example, general
perceptions of safety climate and teamwork). A few studies provide evidence that
interventions aiming to improve safety culture may meaningfully improve clinical care
processes (28, 47–49) and suggest the potential to improve aggregate indices of patient harm
(29, 45). However, these conclusions are tempered by the limitations of the current
evidence. Although 1 true cluster RCT was identified (22), most studies had pre–post
designs with relatively small to moderate samples (particularly at the unit or work area level
of analysis) that did not include control participants. In addition, few studies examined
potential variation in perceptions of safety culture by care provider type.
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Although this review offers a systematic analysis of strategies to promote safety culture,
clear limitations must be considered. Only studies in acute care settings using established
survey measures were included. Although qualitative studies of safety culture may offer
insight into nuances of implementation, they were outside the scope of this review. Because
several studies in outpatient settings were not included, results may not generalize beyond
inpatient settings. Relevant studies may also have been inadvertently excluded despite
extensive searches. Publication bias and selective reporting of positive findings also may
limit conclusions about the effectiveness and generalizability of the interventions evaluated.
Finally, traditional criteria for evaluating the effectiveness of clinical interventions for
individual patients are not well-suited to assessing the effectiveness of quasi-experimental
study designs conducted at the unit level of analysis. This may have introduced systematic
bias into our ratings for strength of evidence. As noted by Pizzi and colleagues in the
original “Making Health Care Safer” report (50); “the threshold for evidence may need a
different yardstick than is typically applied in medicine.”
In summary, this review suggests that evidence to support the potential effectiveness of
interventions to promote safety culture is emerging. In particular, the best evidence to date
seems to include strategies comprising multiple components that incorporate team training
and mechanisms to support team communication and include executive engagement in front-
line safety walk rounds. Organizations should consider incorporating these elements into
efforts to promote safety culture but also robustly evaluate such efforts across multiple
outcomes. Future research should also consider thorough investigation of safety culture as a
cross-cutting contextual factor that can moderate the effectiveness of other patient safety
practices, such as implementation of rapid response systems. The strength of evidence for
patient safety culture would be improved if theoretical models (31, 51, 52) were
meaningfully used in the development of interventions for improvement and those
interventions were robustly evaluated. Finally, work is needed to better understand the
contextual role that safety culture plays in implementation of other patient safety practices,
as well as how efforts to promote safety culture can best be implemented to enhance the
effectiveness of complementary or supplementary interventions for safety and care quality.
Supplementary Material
Refer to Web version on PubMed Central for supplementary material.
Acknowledgments
Financial Support: From the AHRQ, U.S. Department of Health and Human Services (contract HHSA-290-2007-10062I).
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Key Summary Points
Safety culture is foundational to efforts to improve patient safety and may respond to
intervention.
Bundling multiple interventions or tools is a common strategy to improve safety
culture.
Many programs include a form of team training or implementation of
communication tools, executive walk rounds or another form of interdisciplinary
rounding, or unit-based improvement strategies that target clinical microsystems (for
example, teams, units, or service lines) and are owned by front-line clinicians and
staff.
Low-quality, heterogeneous evidence derived primarily from pre–post evaluations
suggests that bundled, multi-component interventions can improve clinician and staff
perceptions of safety culture.
Low-quality, limited evidence derived primarily from pre–post evaluations suggests
that multifaceted interventions aimed at improving patient safety can also improve
care processes and patient outcomes.
Future research should consider investigation of safety culture as a cross-cutting
contextual factor that can moderate the effectiveness of other patient safety practices.
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