Ginsburg 2010
Ginsburg 2010
Ginsburg 2010
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608 HSR: Health Services Research 45:3 ( June 2010)
LITERATURE
Leadership and Patient Safety Improvement
Several recent theory papers by experts in the field of patient safety have
suggested that visible leadership supporting patient safety improvement
efforts is required in order to improve patient safety and reduce AEs (Barach
and Small 2000; Reinertsen 2000; Mohr, Abelson, and Barach 2002; Firth-
Cozens 2003; Frankel, Leonard, and Denham 2006; Leape 2007). Some
progress in subjecting theoretical models of what is needed to create safer
systems to more rigorous empirical examination is being made. For instance, a
hands-on formal leadership style was found to be one of the hallmarks of
academic medical centers receiving high quality and safety scores (Keroack
et al. 2007). Visible and involved formal leadership was also identified as being
key to implementing an effective patient safety program in a VHA case study
(Bagian 2005). Others have shown that success in making changes aimed at
reducing adverse drug events was associated with strong formal leadership,
among other variables (Leape et al. 2000). By and large, however, very little
empirical research focusing on the relationship between formal leadership and
safety has been carried out in health care settings (Flin and Yule 2004;
Weingart and Page 2004).
Other literature suggests that informal leaders——patient safety ‘‘cham-
pions’’——play a critical role in establishing a culture of safety (Anonymous
2002), and that, in the context of anesthesia, informal champions have been a
critical success factor for effecting broad-scale improvement in patient safety
(Lanier 2006). However, we were unable to find any empirical papers that
examined the relationship between informal leadership for patient safety and
improved patient safety processes or outcomes. The current empirical study
focuses on the concept of leadership, both formal and informal, for patient
safety. The present study contributes by presenting an empirical examination
of the relationship between organization-level leadership for patient safety and
patient safety behavior in organizations. We focus further by looking specifi-
cally at the outcome of learning from PSEs.
patient experience (Young, Meterko, and Desai 2000) and health care provid-
ers’ behaviors (Frankel et al. 2005). Accordingly, we further investigate the
moderating effect of organizational size on the relationships between formal and
informal leadership for patient safety and learning from PSEs.
Finally, in this study we define and operationalize learning from PSEs
as learning responses to PSEs (Ginsburg et al. 2009b). That is, learning re-
sponses taken by organizations following PSEs related to the identification and
analysis of events as well as change and dissemination activities designed to
help reduce re-occurrence of similar events in the future. This definition of
learning is rooted in and consistent with theoretical models of learning from
failure (Argote 1999; Sasou and Reason 1999). While PSE learning responses
can take place at the level of the individual provider, the team, or patient care
unit, as well as the organization, we focus on learning from PSEs at the or-
ganization level.
METHODS
Sample and Questionnaire Administration
This study uses data from two cross-sectional surveys conducted in general
acute care hospitals in Ontario, Canada. One survey was conducted with the
senior person responsible for patient safety in each organization (the patient
safety officer [PSO]). Another survey was conducted with patient care
managers (PCMs) in the organization. In Winter 2006, a letter was sent to the
CEO of all 118 general acute care hospitals in Ontario describing this study and
inviting each organization to participate by having the PSO and PCMs com-
plete a mail questionnaire. CEOs agreeing to have their organization participate
were asked to provide the researchers with the names and contact information
for the PSO and all PCMs, excluding those responsible solely for outpatient
clinics. Questionnaires and cover letters were subsequently mailed to the PSO
and PCMs in 69/1181 organizations that agreed to participate. Surveys were
followed up by reminder cards 2 weeks later and a second mailing to all non-
respondents 4 weeks after that. Fifty-four out of 682 PSOs returned a completed
questionnaire for a PSO response rate of 79 percent. Two hundred and eighty-
two out of 621 PCMs (46 percent) returned a completed questionnaire.
Study Questionnaires
The PSO and PCM questionnaires incorporated both new and validated items
designed to measure a number of factors that have been hypothesized
The Relationship between Organizational Leadership for Safety and Learning 611
Study Measures
Independent Variables. As noted, data on informal leadership for patient safety
and formal organizational leadership for patient safety were collected using
the PCM questionnaire. The section of the questionnaire concerning informal
leadership for patient safety began with a description of this construct:
Healthcare organizations sometimes have informal ‘‘champions’’ or ‘‘opinion leaders’’
who have additional expertise related to patient safety. These individuals tend to
provide natural leadership for patient safety that is beyond their formal authority.
PCMs were then asked whether there was one or more patient safety
champions in their organization. If their response was ‘‘yes,’’ they were asked
to provide the individual’s title, and to rate how influential this individual (or
these individuals as a group) had been at driving and encouraging patient
safety using a five-point Likert-type response scale ranging from ‘‘not at all
influential’’ to ‘‘exceptionally influential.’’ Based on these data the informal
leadership variable was calculated with six response levels ranging from 0 (no
champion) to 5 (extremely influential champion[s]).
The measure of formal organizational leadership for patient safety was
derived from a broader item-set used previously (Ginsburg et al. 2005,
2009c). The organizational leadership for patient safety measure reflects the
extent to which respondents perceive that patient safety is valued by an
organization’s senior leadership and is a priority in the organization. This
organizational leadership dimension is one of the most salient dimensions of
patient safety culture that is commonly measured in health care (Flin et al.
2006; Zohar et al. 2007) and other industries (Flin et al. 2000; Zohar 2000).
Formal organizational leadership for patient safety is a seven-item scale
(a 5 0.86). Sample items include ‘‘Senior management has a clear picture of
the risk associated with patient care,’’ ‘‘My organization effectively balances
612 HSR: Health Services Research 45:3 ( June 2010)
the need for patient safety and the need for productivity,’’ ‘‘Senior
management provides a climate that promotes patient safety,’’ and ‘‘Senior
management considers patient safety when program changes are discussed.’’
The scale score is computed as the mean of all seven items measured using a
five-point agree–disagree Likert-type response scale. This measure of
organizational leadership for patient safety has been previously described
where it was shown to have strong internal consistency (a 5 0.88) and strong
test–retest reliability (r 5 0.82) (Ginsburg et al. 2009c).
PCM data on formal and informal leadership for patient safety were
aggregated to the organization level so that each organization received an
informal leadership for patient safety score calculated as the mean of informal
leadership scores provided by each responding PCM in the organization and
a formal leadership for patient safety score, also calculated as the mean of all
responding PCMs.
Dependent variables——learning from PSEs is defined and operationalized
as learning responses taken by organizations following PSEs related to (1) event
identification, (2) event analysis, (3) implementation of changes, and (4)
dissemination of learning (Ginsburg et al. 2009b). As noted, this definition of
learning is rooted in theoretical models of learning from failure from the broader
organizational literature (Argote 1999; Sasou and Reason 1999) and is also
consistent with definitions of double-loop learning (Argyris and Schon 1978).
Development of the measure is described in detail elsewhere (Ginsburg et al.
2009b). Learning from PSEs was measured for four types of PSEs of varying
severity previously found to be meaningful to providers and managers (minor
events, moderate events, major events, and major near-misses——see Ginsburg
et al. 2009a). Minor event learning responses, moderate event learning
responses, major event learning responses, and major near-miss learning
responses are measured using 12, 11, 13, and 13 items, respectively. Sample
items for each event type include ‘‘In this organization, a process is followed for
identifying those minor events that require in-depth review,’’ ‘‘Individuals
involved in moderate events contribute to the understanding and analysis of the
event,’’ ‘‘Major near misses are reported to a reporting system that is internal to
the hospital,’’ and ‘‘The patient and family are invited to be directly involved in
the processes that follow major events (analyzing what occurred and making any
necessary changes).’’ All items use a four-point frequency-based Likert-type
response scale (always/almost always, usually, sometimes, never/almost never). Based
on exploratory factor analysis, minor, moderate, and near-miss learning
response measures were previously found to be unidimensional and major
event learning was found to have two dimensions (factor 1 5 nine items related
The Relationship between Organizational Leadership for Safety and Learning 613
Analysis
Multivariate regression analysis was used to test the unique effect of (a) hospital
size, (b) informal leadership for patient safety, (c) formal organizational lead-
ership for patient safety, and (d) the interaction between hospital size and each
leadership variable on learning from PSEs. Teaching status was not included as
an explanatory variable because there were only six teaching hospitals in our
sample (and its inclusion did not alter our results). Analyses were performed
using seemingly unrelated regression (SUR) (Zellner 1962). SUR is a statistical
Mean SD 1 2 3 4 5 6 7
Major event learning—— 3.63 0.56 0.91
factor 1
Major event learning—— 2.86 0.80 0.57nn 0.79
factor 2
Moderate event 3.03 0.76 0.54nn 0.74nn 0.96
learning
Minor event learning 2.53 0.67 0.40nn 0.65nn 0.82nn 0.93
Major near-miss event 3.03 0.75 0.56nn 0.63nn 0.77nn 0.65nn 0.94
learning
Large hospital (4100 —— —— 0.11 0.31n 0.22 0.18 0.26
beds)
Formal organizational 3.90 0.44 0.21 0.39nn 0.43nn 0.29n 0.32n 0.20 0.86
leadership for safety
Informal 2.34 1.28 0.20 0.05 0.09 0.08 0.06 0.22 0.00
organizational
leadership for safety
w
Coefficient a’s are italicized and reported in the diagonal where applicable.
z
N 5 49. Although 54 patient safety officers returned a completed questionnaire, no patient care
managers provided data for five of these organizations, leaving 49 cases with complete data for
model testing.
n
po.05.
nn
po.01.
614 HSR: Health Services Research 45:3 ( June 2010)
RESULTS
Table 1 shows the means, standard deviation, and correlations among all in-
dependent, dependent, and control variables. Correlations among the indepen-
dent variables in Table 1 are low——the correlation with the greatest magnitude
was 0.43. We further examined the variance inflation factor (VIF) of each in-
dependent variable and the interaction terms. The average VIF was 1.57 with
the largest VIF of 1.94, thus indicating that multicollinearity was not a problem.
Table 1 shows that organizations engaged most frequently in learning
responses related to major event analysis (mean 5 3.63, SD 5 0.56).
Organizations engaged least often in learning responses following minor
events (mean 5 2.53, SD 5 0.67) and dissemination/communication learning
responses following major events (mean 5 2.86, SD 5 0.80). The mean formal
leadership for patient safety score shows that PCMs ‘‘agree’’ positively with
most statements regarding organizational leadership for safety (mean 5 3.90,
SD 5 0.44, where 1 is strongly disagree and 5 is strongly agree with all seven
items in the scale). The mean informal leadership for patient safety score
shows that, on average, PCMs in the organizations we studied believe that
informal patient safety champions exist but they are only somewhat influential
at driving and encouraging patient safety (mean 5 2.34, SD 5 1.28, where
0 5 no champion and 5 5 extremely influential patient safety champion).
Tables 2a–e report the SUR models estimating learning from minor
events (Table 2a), learning from moderate events (Table 2b), learning from
major near misses (Table 2c), major event analysis (Table 2d), and major event
dissemination/communication (Table 2e). For each of our SUR analysis, we
simultaneously included the same predictors in all five equations. Our first
Table 2a: Learning from Minor Events
po.10;
nn
po.05;
nnn
po.01.
Values are presented as b (SE).
Table 2c: Learning from Near-Miss Events
po.10;
nn
po.05;
nnn
po.01.
Values are presented as b (SE).
Table 2e: Learning from Major Events (Factor 2——Dissemination/Communication)
SUR analysis included a large hospital dummy variable for hospital size as the
only predictor (Model 1 in Tables 2a–e); we then gradually included formal
leadership perceived by PCMs, informal leadership perceived by PCMs, and
their interactions with hospital size as predictors to derive the full models
(Model 7 in Tables 2a–e). In Model 8, insignificant interaction terms were
dropped. The w2 for Model 8 were significant at the po.05 level for all types of
learning we examined except major event analysis. Tables 2a and b show that
formal leadership was positively related to learning from minor events and
learning from moderate events (po.01), and the interaction between formal
leadership and hospital size was negatively related to learning from these two
types of events (po.10), while informal leadership had no effect.
In Table 2c, our results show that hospital size was negatively related to
learning from major near misses (b 5 0.339, po.10), and formal leadership
was positively related to learning from major near misses (b 5 0.467, po.05).
However, neither informal leadership nor the two interaction terms had
effects. Turning to the two types of learning from major events, our results
show neither formal leadership nor informal leadership had impact on major
event analysis (Table 2d). In contrast, the coefficient estimate for the inter-
action between formal leadership and hospital size was negatively associated
with major event dissemination/communication (b 5 1.106, po.001).
In addition to their statistical significance, the magnitude of these inter-
action effects is meaningful. Figures 1, SA1, and SA2 show learning scores for
small and large hospitals under conditions of high and low formal leadership
3.5
2.5
1.5
1
low high
Formal organizational leadership for safety
The Relationship between Organizational Leadership for Safety and Learning 621
(1 SD above and 1 SD below the mean) while holding other variables at their
means. Figure 1 shows the effect of the interaction between formal leadership
and hospital size on learning from minor events and shows that, in small
hospitals, an increase of 2 SDs in formal leadership increased learning from
minor events by approximately 27 percent. Similar patterns are seen with
respect to the effect of interactions between formal leadership and hospital size
on learning from moderate events and major event dissemination/commu-
nication (Figures SA1 and SA2, respectively). However, in these two cases
small hospitals with high formal leadership scores (1 SD above the mean)
achieve learning scores that are 34 percent higher than small hospitals with
low formal leadership scores (1 SD below the mean) (e.g., small hospitals with
high formal leadership scores achieve major event dissemination/communi-
cations scores of 3.5 while small hospitals with low formal leadership scores
receive major event dissemination/communications scores of 2.6). Figures
SA1 and SA2 can be found in the journal’s supporting information.
Table 3 summarizes our results based on the reduced models (Model 8).
Our overall results indicate that formal leadership exerts a positive influence on
four of the five types of learning we examined. Moreover, the positive effects are
notably stronger for small hospitals for learning from minor events, learning
from moderate events, and for major event dissemination/communication.
DISCUSSION
Our results are interesting for several reasons. First, hospital size appears to
play a significant role in influencing learning from major near misses and
learning related to major event dissemination/communication activities. The
negative regression coefficients show that it is the smaller hospitals in our
sample (those with fewer than 100 beds) that are engaging in greater learning
from major near misses and in greater major event dissemination/commu-
nication activities.
In terms of the leadership variables we studied, PCM perceptions of formal
organizational leadership for patient safety play a significant role in influencing
four of the five types of PSE learning we studied. These results lend empirical
support to important theoretical papers that have argued that leadership for
safety, and a culture where safety is seen as a priority for the organization, is
critical for improving safety processes and outcomes (Barach and Small 2000;
Reinertsen 2000; Frankel, Leonard, and Denham 2006; Leape 2007).
In addition to these main effects, we found significant interactions be-
tween hospital size and PCM perceptions of formal organizational leadership
for patient safety for learning from minor events, learning from moderate
events, and for major event dissemination/communication activities. These
interactions show that formal leadership for patient safety (perceived by
PCMs) is particularly effective for promoting learning in smaller hospitals such
as those we studied with fewer than 100 beds. Small hospitals with low formal
leadership scores (1 SD below the mean) versus those with high formal lead-
ership scores (1 SD above the mean) had learning scores that were nearly one
full point apart (and 2 SDs) on the four-point learning scale for moderate
events and for major event dissemination/communication. In small organi-
zations, formal leadership support for patient safety may compensate for the
fact that small hospitals are less likely to use QI and related safety tools (Nau
et al. 2004). This is consistent with work suggesting that the economic burden
of safety programs is disproportionately large for small organizations (Fukuda
et al. 2009)——work which also showed that perceived lack of administrative
leadership was associated with engagement in fewer patient safety and infec-
tion control activities. Our findings are also consistent with other research
highlighting the structural benefits that smaller organizations enjoy such as
leadership that is more visible and proximal to the front lines. For instance,
one study showed that, following leadership walkrounds, actions could occur
more rapidly in small hospitals than in large hospitals where formal processes
were required to address issues (Frankel et al. 2005). And just as the perception
that patients may find large hospitals impersonal or intimidating may explain
why patient experience data tends to be more positive in small hospitals
(Young, Meterko, and Desai 2000), strong leadership for patient safety may be
more effective for learning from PSEs in small hospitals because CEOs and
senior leaders in those organizations can be more in touch with key stake-
holders, including staff and managers at the frontlines (Wells et al. 2004). In
The Relationship between Organizational Leadership for Safety and Learning 623
other words, small hospitals, by virtue of their size, may be more structurally
conducive to having senior leaders visible to front-line staff as they try to
improve safety——this need for visibility has been suggested by Pronovost et al.
(2003). In contrast, the influence of strong formal leadership for patient safety
may be felt less across large organizations.
Put differently, and in keeping with literature on culture as a control
mechanism, formal leadership may be more important for bringing about
learning in small hospitals because it can more easily be used as a kind of
cultural tool to control/promote desirable behaviors in these resource con-
strained organizations (Ray 1986; Weick 1987). This view reminds us that
closely related to the role of leadership in improving safety is the role of patient
safety culture. Although the construct of patient safety culture has been defined
in numerous ways inside and outside of health care (Ginsburg et al. 2009c), one
of the most salient and widely used definitions focuses on the extent to which
leadership prioritizes safety relative to other priorities such as efficiency, cost
effectiveness, and other organizational imperatives (Zohar 2000). Others have
also noted that leadership is undoubtedly ‘‘a key theme in improving patient
safety and an inherent part of a safety culture’’ (Mohr 2005; p. 42). While we
noted earlier that very little empirical research focusing on the relationship
between formal leadership and safety outcomes has been carried out in health
care settings (Flin and Yule 2004; Weingart and Page 2004), empirical evidence
regarding the relationship between safety culture and safety outcomes is grow-
ing in the broader organizational literature (Hofmann and Stetzer 1996; Neal,
Griffin, and Hart 2000; Zohar 2000) and emerging in the context of health care
(Gershon et al. 2000; Hofmann and Mark 2006; Vogus and Sutcliffe 2007;
Zohar et al. 2007). However, evidence from the broader organizational liter-
ature suggests that relationships between safety climate4 and safety behavior/
safety outcomes are not perfectly clear (Cooper and Phillips 2004). Indeed, part
of this lack of clarity stems from the kind of mediating relationships identified
by Barling, Loughlin, and Kelloway (2002), who found that not only is safety
climate a significant predictor of safety performance, but it is itself a function of
safety-specific transformational leadership. Health services researchers should
not lose sight of the fact that the constructs of formal organizational leadership
for patient safety and patient safety culture are intimately related and the con-
cept of formal leadership for patient safety can be reasonably framed as both a
leadership concept as well as a key dimension of patient safety culture. In either
case, in this study we find empirical support for the relationship between or-
ganization-level leadership for patient safety and the outcome of PSE learning
responses in organizations.
624 HSR: Health Services Research 45:3 ( June 2010)
CONCLUSION
It has been suggested that individuals’ actions and attitudes toward safety can
change, but that this change is unlikely to be sustained without a strong
organizational commitment to safety (Firth-Cozens 2003). This organizational
commitment to safety is precisely the kind of formal organizational leadership
for patient safety we studied. Our results lend empirical support to the im-
portance of this type of leadership for safety for achieving learning from
different kinds of PSEs. The role and impact of informal leadership for patient
safety on various patient safety processes and outcomes remains an area that
requires further research.
By showing that formal leadership for safety is of particular importance
in small hospitals, our results also have important practice implications for
these organizations that, on one hand may be disadvantaged in terms of hu-
man and financial safety resources, and on the other hand are advantaged by
close leadership proximity to those at the sharp end. Leaders of larger orga-
nizations may need to find ways to more effectively communicate and dem-
onstrate their safety commitment and support to managers at the frontlines to
better engage this group in PS learning activities. In addition, the literature
suggests that having well-defined PS structures is important in large organi-
zations (Frankel, Gandhi, and Bates 2003), provided there is local empow-
erment to address and respond to PS events (Frankel et al. 2005). Finally, in
terms of policy implications, national accreditation agencies such as JCAHO
and Accreditation Canada currently require hospitals to assess their patient
safety cultures. Similarly, they may wish to consider developing standards that
require organizations to measure the extent to which they are learning from/
responding to PSEs. Indeed, recent research (Devers, Pha, and Liu 2004) has
shown that rather than professionalism or market forces, hospital patient
safety initiatives are primarily driven by regulation such as JCAHO require-
ments related to improving processes for responding to sentinel events,
The Relationship between Organizational Leadership for Safety and Learning 627
improving PS culture (as just noted), and improving medication safety. Ac-
cordingly, accreditation bodies can play an influential role in compelling
hospital leaders to promote patient safety learning practices within organiza-
tions (DiMaggio and Powell 1983).
ACKNOWLEDGMENTS
Joint Acknowledgment/Disclosure Statement: This study was funded by a grant
from the Canadian Institutes of Health Research (CIHR) and the lead author
is supported by an Ontario Ministry of Health and Long Term Care Career
Scientist award. We would like to acknowledge and thank our key contact
people in each of the organizations surveyed for helping to facilitate data
collection as well as those PCMs who provided survey data. We would also
like to thank Zoe Chan and Diana Jung for coordinating the survey data
collection process.
Disclosures: None.
Disclaimers: None.
NOTES
1. Sixty-nine CEOs agreed to have their organization participate in the study. Many
of the CEOs that declined to have their organization participate in the study cited
lack of sufficient resources for study participation and survey fatigue as the most
common reasons for declining based on a one-page fax survey.
2. One of the 69 hospitals that agreed to participate in the survey was excluded in
error at the time of data collection.
3. Copies of the study questionnaires are available from the authors.
4. It is generally accepted that culture and climate are closely related concepts and that
safety climate consists of the surface manifestations of the safety culture and can be
measured using quantitative measures. See Schein (1990) and Guldenmund (2007)
for a detailed description of the layers of culture. We use the term patient safety culture
except where quoting or citing the work of others who use the term climate.
5. We previously noted there were six teaching hospitals in our respondent group.
This number is based on The Ontario Public Hospitals Act Classification of
Hospitals, which applies a designation of teaching hospital to a more restricted
group of hospitals that are approved by the Royal College of Physicians and
Surgeons to provide postgraduate education leading to specialist certification. We
use COTH membership to define teaching status at this juncture in an effort to use
a more comparable definition to AHA.
6. First, Canada has a national sentinel event reporting system and many organizations
are trying to implement other local reporting systems. Second, Canada does not use
628 HSR: Health Services Research 45:3 ( June 2010)
any notable financial or other incentives that reward safety practices. Third, Canada
is increasingly introducing formal disclosure policies and creating senior positions
devoted to patient safety such as the PSO position. Finally, while the malpractice
environment is different from the United States, issues relevant to learning from PS
failures, such as physician’s error disclosure attitudes and experiences, have been
found to be the same in Canada and the United States (Gallagher et al. 2006).
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