American Journal of Infection Control 48 (2020) 1204−1210

Contents lists available at ScienceDirect

American Journal of Infection Control

journal homepage: www.ajicjournal.org

Major Article

Effectiveness of implementing link nurses and audits and feedback to

improve nurses’ compliance with standard precautions: A cluster
randomized controlled trial
Daniele Donati RN, MSN a,*, Ginevra Azzurra Miccoli MD, PhD b, Claudia Cianfrocca RN, MSN a,
Enrico Di Stasio MD c, Maria Grazia De Marinis RN, MSN d, Daniela Tartaglini RN, MSN d
a
Department of Biomedicine and Prevention, Tor Vergata University of Rome, Rome, Italy
b
Infection Prevention and Control Team, Campus Bio-Medico University of Rome, Rome, Italy
c
Cattolica del Sacro Cuore, Rome, Italy
Institute of Biochemistry and Clinical Biochemistry, Universita
d
Research Unit Nursing Science, Campus Bio-Medico University of Rome, Rome, Italy

Key Words: Background: To prevent health care-associated infections, health organizations recommend that health care
Health care-associated infections workers stringently observe standard precautions (SPs). Nevertheless, compliance with SPs is still suboptimal,
Improvement intervention emphasizing the need for improvement interventions.
Nursing Methods: A cluster randomized controlled trial with a pretest-post-test design was conducted with 121 clinical
Patient safety
nurses who worked in different wards of a university hospital. The intervention group (n = 61) had 3 infection
Occupational health
control link nurses nominated and attended systematic audits and feedback. The control group (n = 60)
Infection control
received only the standard multimodal approach used in the hospital. Pre- and post-test assessment of
SPs compliance was performed via the World Health Organization observational hand hygiene form and
Compliance with Standard Precaution Scale Italian version.
Results: At the post-test, nurses in the intervention group reported significantly increased compliance with
hand hygiene, whereas no significant improvement was found in the control group. Nurses in both groups
reported significantly increased Compliance with Standard Precaution Scale Italian version scores; however,
a higher increase and practical significance was observed in the intervention group. Participants who
improved their scores were also compared between groups, showing a significantly greater increase of
individual scores in intervention group compared to the control group.
Conclusions: The findings of this study provide significant practical implications for hospitals seeking to
improve compliance with SPs among nurses, showing the effectiveness of using infection control link nurses
combined with systematic audits and feedback.
© 2020 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All
rights reserved.

Health care-associated infections (HAIs) are one of the most communities.3,4 According to the World Health Organization
important threats in public health worldwide.1-3 These infections (WHO), an HAI is an infection that is acquired by a patient during
represent the most frequent adverse event in health care and are the process of care that was not present or incubating on admission.
associated with patients’ mortality and morbidity, longer hospital Furthermore, they include occupational infections among health
stays, increased health care costs, and psychosocial and economic care workers (HCWs).3
burdens on the individuals involved, their families, and their It was estimated that in acute care hospitals, out of every 100
patients, seven in developed and 15 in developing countries will
acquire at least 1 HAI.1,3 Worldwide, it was also estimated that more
* Address correspondence to Daniele Donati, RN, MSN, Department of Biomedicine than 3 million HCWs experience the stressful event of a percutaneous
and Prevention, Tor Vergata University of Rome, Via Montpellier 1, Rome 00133, Italy injury with a contaminated sharp object each year, with the danger-
E-mail address: d.donati@unicampus.it (D. Donati).
ous risk of contracting blood-borne infections.5 Nurses are among the
Funding: This research received no specific grant from any funding agency in the
public, commercial, or not-for-profit sector.
most involved in such occupational injuries,6,7 perhaps because the
Conflicts of interest: The authors declared no potential conflicts of interest with direct, repeated, and longer duration of nursing care8,9 leads to a
respect to the research, authorship, and/or publication of this article.

https://doi.org/10.1016/j.ajic.2020.01.017
0196-6553/© 2020 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.
 D. Donati et al. / American Journal of Infection Control 48 (2020) 1204−1210 1205

potentially greater risk of exposure to microorganisms associated Several studies reported the range of benefits from introducing
with cross-infections.10 ICLNs to decrease HAIs30,31 and using audits and feedback to achieve
Infectious agents are most frequently spread by direct contact different infection prevention and control goals,32-35 but to our
with contaminated hands or indirect contact via contaminated knowledge, no study has been conducted to improve compliance
objects, such as patient care equipment, HCWs’ uniforms, and envi- with SPs by combining both strategies. Therefore, the aim of this
ronmental surfaces. Factors related to patients’ characteristics (eg, study was to assess the effectiveness of implementing ICLNs and sys-
compromised immune system, exposure to invasive procedures) tematic audits and feedback to improve clinical nurses’ compliance
and HCWs’ practices (eg, hand hygiene, needle management, personal with SPs. We made the following hypotheses: nurses who complete
protective equipment [PPE] use) contribute to HAIs.11,12 the intervention will have a higher observed compliance with hand
In 1996, the US Centers for Disease Control and Prevention intro- hygiene and greater self-reported compliance with SPs guidelines
duced guidelines, called “Standard Precautions” (SPs), as practical compared with the control group.
guidelines to prevent transmission of microorganisms in health care
settings.12 SPs refer to a system of actions that applies to all patients,
METHODS
regardless of their known or presumed infectious status, and repre-
sent the basic practices for infection prevention and control. These
This study was approved by the medical directorate of the uni-
practices include but are not limited to appropriate hand hygiene,
versity hospital. The participants were informed about the study
use of gloves and other PPE, appropriate cleaning and disinfection
and received clear explanations about its objectives and methods.
of patient care equipment and environmental surfaces, correct
Explicit informed consent was required of all participants. Permis-
waste disposal, and correct management of used needles and other
sion to reproduce the CSPS Italian version (CSPS-It) was obtained
sharp objects.11,12
from the author of the original English version (APPROVAL CODE:
To ensure staff and patient safety, health organizations worldwide
C999N99201901).
have recommended, with periodic updates, a stringent observance of
SPs.12-14 Nevertheless, compliance with these measures is still subop-
Study design
timal among HCWs.10,15-17 Recent literature from different countries
(Saudi Arabia, Brazil, Hong Kong, Italy) reported that clinical nurses’
A cluster randomized controlled trial with a pretest-post-test
compliance with SPs, measured via the same self-assessment instru-
design was used. There was no random assignment for participants,
ment used in this study (Compliance with Standard Precaution Scale
but groups were formed by randomly combining different hospital
[CSPS]18,19), ranged from 57.4% in Hong Kong to 69.9% in Italy.16,20,21
wards. This design was appropriate to generate an experimental
Examples of inadequate compliance include failures of hand hygiene,
group of nurses exposed to the intervention and a second control
inappropriate PPE use, and ineffective needle management.16 The
group of nurses who received no intervention and maintained their
main factors that can affect nurses’ compliance with SPs are inadequate
usual practice.
infrastructure, poor knowledge, lack of proper training, insufficient or
In the intervention group, one nurse per ward was selected and
not readily available PPE, their own risk behaviors, inadequate working
trained as an ICLN with the aim to promote SP guidelines for their
conditions (lack of time, work overload), emergencies, insufficient
team and collect internal observational data. ICLNs reported and dis-
management support, and poor safety climate.17,22-25
cussed data with their respective teams quarterly, performing audits
A recent systematic literature review on the interventions
and feedback. The head nurse and hospital infection control nurse
directed to HCWs to improve compliance with SPs reports unclear
(ICN) participated in every audit and feedback session.
evidence as to which interventions should be recommended, and
The control group received only the standard multimodal
it encourages health organizations to develop, implement, and
approach used in the hospital, which included an annual educational
evaluate interventions relevant for their needs.14 The most used
and interactive training open to all health care professionals, colored
were education, education with infection control support, peer
cues, campaigns (particularly for hand hygiene), and monitoring and
evaluation, audits and feedback, link professionals, and checklists
feedback activities.
and colored cues.14 With the need to implement and closely follow
Pretest assessment of SPs compliance was performed in March
a new strategy to achieve greater clinical nurses’ compliance with
2018 with the WHO observational hand hygiene form36 and the self-
SPs, the infection control team of the hospital where this study
assessment instrument CSPS-It.16,18,19 The intervention started in
was conducted, considering current literature and resources, chose
April 2018 and lasted 12 months. In April 2019, a post-test evaluation
to plan an intervention that combined link professionals and audits
was performed that collected the data with the same instrument and
and feedback.
method used for the pretest phase.
The link professional strategy was mainly applied by health
organizations, which implemented infection control link nurses
(ICLNs) who were targeted to build a link between the infection Sample and setting
control department and clinical wards, with the aim to improve
infection control practices.26,27 According to the Royal College of The study was conducted at a university hospital in Rome, Italy
Nursing, the role of the ICLN was defined with 4 core themes: “act that has about 280 beds and is funded by the National Health System.
as a role model and visible advocate, enable individuals and teams We adopted a purposive sampling strategy. Six medical-surgical
to learn and develop infection prevention and control practice, act wards, similar in terms of nursing care provided, patient types and
as a local communicator, and support in audit and surveillance.”28 work organization, were selected; 3 were randomly assigned to the
Infection control teams can follow and support ICLNs’ activities, intervention group and 3 to the control group. Random selection was
planning systematic audits and feedback as a part of the program. conducted using a simple randomization technique, based on single
Audits and feedback were defined as a strategy based on the sequence random assignment. All allocations of units randomized
belief that health care professionals are prompted to modify their were possible.
practices when given performance feedback showing that their clin- One hundred and twenty-six nurses who worked in the identified
ical practice is inconsistent with a desirable target.29 This strategy wards were involved in the study, 64 in the intervention group and
has been considered relevant to improving the professional practice 62 in the control group. Three participants from the intervention
and behavior of health care professionals.29 group and 2 from the control group were lost to follow-up during the
1206 D. Donati et al. / American Journal of Infection Control 48 (2020) 1204−1210

study due to maternity leave and changes in the work setting. Figure 1 support continuous improvement of the compliance rates registered
presents a flowchart of the sampling process. by the ICLN. The team positioning with respect to the compliance
goals and previous collected data were always shown and delivered
Intervention in written format.
During the audit, the hospital ICN, as an expert with a position of
The intervention group had 3 ICLNs nominated, one per ward, seniority, also reinforced the rationale of maintaining an optimal
who were identified by the respective head nurses for their avail- level of compliance with SPs during clinical practice, particularly for
ability and predisposition to the role. The ICLNs attended a specific goals that were more critical, and also provided educational material
3-hour interactive training program held by the hospital’s ICN, who to the staff. Head nurses had to consider and address any critical
was also a university lecturer. The program included, in addition to organizational problems reported by the participants during the
basic ideas of infection control and SP guidelines, teaching and relational audit.
skills and a clear definition of the role and duty of the ICLN following the
framework proposed by the Royal College of Nursing.28 Measure
The training was explained, and it provided a practical observa-
tional checklist that aimed to assess common SPs in the daily nursing We used direct observation of compliance with hand hygiene and
routine, such as hand hygiene, use of protective devices, disposal of the self-reported compliance with SPs.
sharps and waste, and decontamination of spills and used articles. A nurse collaborator of the hospital ICN, who was blinded to the
This instrument was in line with the Centers for Disease Control and purpose of the study, collected direct observational data in each
Prevention and WHO SPs guidelines and the local infection control group before and after the intervention using the WHO form based
policies. on the “My Five Moments for Hand Hygiene.”36 To support the reli-
Ongoing training and coaching was also provided to the ICLNs. ability of the resulting scores the observer was previously trained in
The hospital ICN was available during working time for the entire the observation technique. Moreover, the observation form for data
period of the intervention by telephone, email, and planned short collection included only operationalized behavior categories.
meetings. The ICLNs’ training and involvement always took place The observations were collected during the morning shift in slots
during paid working time. of 20 minutes per ward on 3 alternate days (Monday-Wednesday-
The head nurses were responsible for promoting the ICLNs’ activ- Friday). This timing was established by the head nurses of the wards
ity among their respective teams and organizing their shift work to to observe the greatest variety of nurses in the respective teams.
support, for example, their educational and surveillance activities. Participants were always made aware of the observer activity (open
The ICLNs were asked to collect observational data for their team observation) and that any observation was registered anonymously.
using the checklist provided during the training session. This data Direct observation data were calculated as a percentage (number of
collection was mentioned to the ward nurses, who also knew which instances of hand hygiene performed/number of hand hygiene
items were investigated. opportunities).36
Data collected by the ICLNs were discussed among the respective Self-reported compliance with SPs was collected using the CSPS-It.
teams in the presence of the head nurse and the ICN (a member of Participants were invited to complete the CSPS-It and a sociodemo-
the hospital's infection control committee) every 3 months by orga- graphic questionnaire through an online survey. The psychometric
nizing a 30-minute audit and feedback, repeated on 3 different days, properties of the original English tool and its Italian version were
near the end of the morning shift, in order to encourage the presence comprehensively evaluated with satisfactory results in previous
of the most possible nurses on the team. During the audit and feed- studies.16,18,19 In particular, CSPS-It showed a sound internal consis-
back, the successes and critical issues encountered were discussed to tency and reliability (Cronbach’s a, 0.84; item-total correlation,

Fig 1. Flowchart.
 D. Donati et al. / American Journal of Infection Control 48 (2020) 1204−1210 1207

0.311-0.608; intraclass correlation coefficient, 0.86). The scale’s con- of the sample achieved one or more first-level professional master
tent validity was 0.95, and its construct validity was successfully programs, and almost 10% of participants had a master's degree or a
verified testing a unidimensional model in confirmatory factor higher. Participants’ average clinical experience was 7.5 § 5.5 years.
analysis.16 Just over 70% of participants had attended at least 1 training course
The scale is composed of 20 items describing the use of protective on SPs during the last 2 years, and just over 60% had a motivation to
devices, disposal of sharp instruments and waste, decontamination participate. Potential confounding factors of nurses in the experimental
of spills and used articles, and prevention of cross-infection. The and control group are shown in Table 1. No significant differences in
CSPS-It includes both positively and negatively worded statements terms of demographic and professional characteristics were observed.
that can be answered with a 4-point Likert scale ranging from 1
(never) to 4 (always). To compute the total score, item scores were Baseline assessment
summed together: only the maximum compliance option (“always”
for positive items and “never” for negative items) was scored 1, while The baseline assessment did not show significant differences
the other options were scored 0. Thus, the total score can range from between control and intervention group outcomes. The percentage
0 to 20, with higher values indicating better compliance. In addition, of hand hygiene compliance in the control group was 61.9%, while it
it was possible to calculate the average compliance rate for each was 63% in the intervention group (Table 2). The average pretested
item, which is the percentage of maximum compliance among all CSPS-It total score in the control group was 13.95 § 3.31 (a compli-
participants.16,18,19 ance rate of 69.8%), while it was 13.92 § 2.72 for the intervention
group (a compliance rate of 69.6%; Table 3).
Participant characteristics Hand hygiene stratified by the WHO 5 moments reveals a lower
compliance with moment 5 (“after touching patient surroundings”;
The following sociodemographic data were collected: gender, age, compliance = 51.2%; number of observations = 41) and moment 1
education, clinical experience, SPs training during the last two years, (“before touching a patient”; compliance = 54.1%; number of observa-
and motivation to be trained. tions = 61). Higher compliance was found for moment 4 (“after touching
a patient”; compliance = 69.1%; number of observations = 68), moment
Data analysis 2 (“before a clean/aseptic procedure”; compliance = 70%; number of
observations = 20), and moment 3 (“after body fluid exposure risk”;
Statistical analysis was performed with the Statistical Package compliance 74.2%; number of observations = 31).
for Social Science (SPSS), release 15.0. Continuous variables were The CSPS-It items compliance rate varied from 38.8% to 90.9%. The
expressed as mean § SD and categorical variables displayed as fre- 3 items with lowest compliance rate were “I take a shower in case of
quencies. All data were first analyzed for normality of distribution extensive splashing even after I have put on PPE” (38.8%), “The sharps
using the Kolmogorov-Smirnov test of normality. Differences box is only disposed when it is full” (46.3%), and “I wear a gown or
between groups and timing differences were compared by means of apron when exposed to blood, body fluids, or any patient excretions”
the Student's t test, paired t test, and x2test, as appropriate, and the (53.7%). Five items showed a ceiling effect because the endorsement in
corresponding effect size (ES) calculated. A P value of less than .05 the upper extreme responses was >80%37: “I put used sharp articles
was considered statistically significant. into sharps boxes” (90.9%), “I wear gloves when I am exposed to body
fluids, blood products, and any excretion of patients” (90.1%), “My
RESULTS mouth and nose are covered when I wear a mask” (89.3%), “I wear
gloves to decontaminate used equipment with visible soils” (89.3%),
Participant characteristics and “I change gloves between each patient contact” (87.6%).

The sample included all 121 clinical nurses working in the hospi- Intervention result
tal wards where the study was conducted. All subjects enrolled in
the study completed the CSPS-It. The majority of the sample was Pre- and postintervention within-group comparisons were ana-
female (88.4%), and the average age was 29.9 § 5.5 years. About 40% lyzed (Tables 2 and 3). Nurses in the intervention group reported

Table 1
Demographic characteristics of the sample (n = 121)

Participants Control group Intervention group

Variables (n = 121) (%) (n = 60) (%) (n = 61) (%) P Value ES

Sex .802 0.10

Male 14 (11.6) 6 (10) 8 (13.1)
Female 107 (88.4) 54 (90) 53 (86.9)
Age (years) 29.9 §5.5 29.5 §4.7 30.3 §6.2 .467 0.15
Education .691 0.08
Degree 61 (50.4) 32 (53.3) 29 (47.5)
Master 49 (40.5) 22 (36.7) 27 (44.3)
Master’s degree 11 (9.1) 6 (10) 5 (8.2)
Clinical experience (years) 7.5 §5.5 7.4 §5.1 7.6 §5.9 .917 0.04
SPs training* .732 0.10
Yes 86 (71.1) 44 (73.3) 42 (68.9)
No 35 (28.9) 16 (26.7) 19 (31.1)
Motivation to be trained .501 0.16
Yes 74 (61.2) 39 (65) 35 (57.4)
No 47 (38.8) 21 (35) 26 (42.6)
Note: Values are presented as mean § standard deviation or n (%).
*Participation at least in 1 training course on SPs during the last 2 years.
1208 D. Donati et al. / American Journal of Infection Control 48 (2020) 1204−1210

Table 2
Intervention data (observed compliance with hand hygiene)

Control group Intervention group

Pretest Post-test Pretest Post-test

Variable (n = 113)* (n = 117)* (n = 108)* (n = 110)*

Hand hygiene compliancez 70 (61.9) 76 (65.0) P = .736 68 (63.0) 85 (77.3) P = .031

ES = 0.06 ES = 0.31
Pretest control vs intervention group: P = .986; ES = 0.02
Post-test control vs intervention group: P = .058; ES = 0.27
Note: Values are presented as n (%).
*Number of hand hygiene opportunities.
z
Number of instances of hand hygiene performed.

significantly increased compliance with the WHO 5 moments of hand hygiene and lower than 70% on the CSPS-It in both groups. These
hygiene (63% vs 77.3%, P = .031, ES = 0.31 “small”), whereas no signifi- findings were in line with several previous studies that reported sub-
cant improvement was found in the control group (61.9% vs 65%, optimal nurses’ compliance with SP guidelines.8,16,20,21
P = .736, ES = 0.06 “very small”; Table 2). The main improvement was We hypothesize from our data that 1 factor related to this subop-
registered in compliance with the moment 1 (“before touching a timal compliance could be the missed SPs cyclical training reported
patient”), which increased from 53.3% (number of observations = 30) by participants. In fact, as regards nurses’ characteristics, this study
to 71.9% (number of observations = 32) in the intervention group. revealed that over a quarter of participants did not attend a SPs train-
Nurses in the control and intervention groups reported signifi- ing course during the last 2 years but also that a relevant subset were
cantly increased CSPS-It scores; however, a higher increase and motivated to participate in one. Our hospital repeated the annual
practical significance was observed in the intervention group training for at least 5 dates, but this was insufficient to ensure nurses’
(Table 2). The control group increased from 13.95 § 3.31 to 14.32 § easy access. Managers should regularly encourage and facilitate
3.05 (P < .01; ES = 0.11 “very small”), while the intervention group nurses’ participation in training programs aimed to reduce the the-
increased from 13.92 § 2.72 to 15.43 § 2.22 (P < .01; ES = 0.61 ory-practice gap that affects compliance. Providing all HCWs with
“medium”). The post-test CSPS-It total compliance rate was 71.6% in ongoing education and training was also recommended as an impor-
the control group and 77.2% in the intervention group. tant standard of hospital quality,38 and it was demonstrated that
Participants who improved their scores were also compared nurses’ participation in such a course could positively influence their
between groups, showing a significantly greater increase of individ- compliance with SPs.10,16,39
ual scores for the intervention group compared to the control group This study evaluated an improvement intervention designed in
(80.3% vs 35%, P < .01; ES = 0.95 “large”; Table 3). The 3 CSPS-It items consideration of the current evidence and hospital resources, as sug-
that registered the highest compliance rate improvement in the gested by a previous study.14 The research hypotheses of this study
intervention group were “waste contaminated with blood, body flu- were supported, and the implemented intervention was considered
ids, secretion, and excretion are placed in red plastic bags irrespective effective in improving compliance with SPs among clinical nurses.
of patient’s infective status” (from 57.4% to 78.7%), “the sharps box is Hand hygiene compliance and CSPS-It total score were significantly
only disposed when it is full” (from 45.9% to 63.9%), and “I wear a increased in the intervention group. Regarding hand hygiene, observed
gown or apron when exposed to blood, body fluids, or any patient compliance with the first moment (“before touching a patient”) had
excretions” (from 50.8% to 67.2%). the greatest increase. With respect to CSPS-It items, the proper use
of PPE, the correct disposal of sharps boxes, and the correct disposal
DISCUSSION of contaminated waste had a major increase in the respective
scores. Pre- and post-test CSPS-It total scores were also compared at
This study aimed to assess the effectiveness of ICLNs and system- the individual level between groups, showing that more than three-
atic audits and feedback in improving clinical nurses’ compliance quarters of participants in the intervention group improved their
with SPs. Although SP guidelines represent the foundation of best total scores, significantly more than participants in the control
practices in infection prevention and control, data reported by the group did.
nurses involved in this study, especially in the pretest assessment, Although this study was the first to combine such interventions
revealed a compliance gap. At the pretest assessment, the overall and outcomes, other authors supported the effectiveness of ICLNs
compliance rate was lower than 65% from direct observation of hand and audits and feedback in improving infection control practices. For

Table 3
Intervention data (self-reported compliance with SPs)

Control group Intervention group

Pretest Post-test Pretest Post-test

Variable (n = 60) (n = 60) (n = 61) (n = 61)

CSPS-It total score* 13.95 § 3.31 14.32 §3.05 P < .001 13.92 § 2.72 15.43 § 2.22 P < .001
ES = 0.12 ES = 0.61
Participants who improved their score 21 (35.0) 49 (80.3) P < .001
ES = 0.96
Pretest control vs intervention group: P = .954; ES = 0.01
Post-test control vs intervention group: P = .024; ES = 0.42
Note: Values are presented as mean § standard deviation or n (%).
*Score ranges from 0 to 20.
 D. Donati et al. / American Journal of Infection Control 48 (2020) 1204−1210 1209

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CONCLUSIONS
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