Beruflich Dokumente
Kultur Dokumente
Background: The aim of this study was to assess the impact of a multifaceted hand
hygiene (HH) program on the infectious risk in nursing homes (NHs).
Methods: This was a 2-arm cluster randomized trial; French NHs were allocated
randomly to the intervention (13 NHs) or control (13 NHs) groups. The intervention
consisted of implementing a bundle of HH-related measures over 1 year, including
increased availability of alcohol-based handrub, HH promotion, staff education, and
localwork groups. The primary end pointwas the incidence rate of acute respiratory
infections and gastroenteritis reported in the context of clustered cases episodes.
Secondary end points were mortality, hospitalization, and antibiotic prescription
rates.
Results: Baseline characteristics did not differ between groups. The overall handrub
consumption was higher in the intervention group over the 1-year intervention period.
Because of underreporting, data on the primary end points were of insufficient quality
for analysis. Hospitalizations did not differ between the 2 groups. However, the
intervention group showed significantly lower mortality (2.10 vs 2.65 per 100
residents per month, respectively; P = .003) and antibiotic prescriptions (5.0 vs 5.8
defined daily doses per 100 resident days, respectively; P <.001). These results
were confirmed by the longitudinal multivariate analysis adjusted for NH and resident
characteristics and for seasonality (mortality rate ratio, 0.76).
Conclusions: A multifaceted HH intervention may have a short-term impact on
mortality in NHs. Nevertheless, other strategies may remain necessary to reduce
morbidity.
BACKGROUND
Nursing homes (NHs) are both care facilities and home to many older adults
in developed countries worldwide. This combination leads to a unique situation in
which the infection risk is difficult to control.1 Indeed, in addition to the effect of
aging, NH residents often have multiple comorbidities, physical disabilities, and
cognitive impairment, which all contribute to make them highly vulnerable to
infection.2 Additionally, because NHs are living places, they offer a wide range of
opportunities for socialization, includingshared meals, recreational activities, and
rehabilitation exercises, therefore increasing the probability of person-to-person
transmission of pathogens.1
This translates to a high prevalence of infections in NHs, estimated in France
at 11.2% (95% CI, 4.4%-16.2%).3 In the United States,the total number of infections
occurring in NHs was estimated at 1.6-3 million per year, figures similar to those
observed for nosocomial infections in acute care settings.1 Respiratory infections
and gastroenteritis are the most frequent infections leading to outbreaks in NH
settings, with respiratory viruses and norovirus as the most common etiologic
agents.2,4
These infections account for a large share of NH mortality, with the rate of
deathassociated with infections in NHs estimated at 0.6 per 1,000 resident days
(range, 0.04-0.71).5 They are also associated with frequent hospital transfers and
increased antimicrobial use and with high costs, that may exceed $1 billion per year
in the United States.6
For all these reasons, infection prevention and control is a majorfocus of NH
attention. In particular, hand hygiene (HH) is recognizedas one of the simplest and
most cost-effective tools for infectioncontrol in health care settings.7 However, there
are several barriersto the implementation of efficient HH policies in NH settings.First,
these policies may seem too costly for NHs, for instance becauseof increased
handrub solution expenditures.8 Second, staff educationis complicated by a high
turnover, making frequent trainingsessions mandatory.9 Third, most available HH
recommendationswere originally designed for acute care settings. Hence, a
reluctanceto apply these recommendations in NHs is often reportedbecause staff
members feel that they are not adapted to long-termcare and tend to overmedicalize
resident-staff interactions.10,11
Consequently, compliance with international HH recommendationsis low in
NH staff: it was reported as 14.7% in Canada,12 17%in Italy,13 and 11.3% in
Taiwan.14 A recent review of the evidence onHH in NHs underlined the importance
of adapting HH recommendationsand programs to NH settings to improve this
compliancerate.15 This review also showed that the current evidence on HHimpact
in long-term care settings is lacking and mostly based onsmall-scale observational
studies.
In this context, the objective of this study was to assess, througha randomized
controlled trial, the effectiveness of a participativemulticomponent HH intervention
specifically designed for NHs. Thisintervention aimed at overcoming most of the
aforementioned barriersto HH in NHs, notably by associating the staff to the design
oflocal guidelines, and by increasing their awareness of the infectiousrisk.
METHODS
Study design
This study was a 2-arm cluster randomized controlled trial, complyingwith the
Consolidated Standards of Reporting Trials guidelines.16 Each participating NH
constituted 1 cluster. The intervention was implemented in intervention NHs for a
period of 12 months, from April 1, 2014-April 1, 2015, whereas usual practice
continued in control NHs. Directors of the included NHs agreed to participate in the
study and be randomly allocated to either the intervention group or control group
before the beginning of the data collection process. Individual written consent was
not required from the residents or their relatives. However, in all intervention NHs,
information letters about the study were posted near the entry and sent to doctors,
and meetings were organized to inform residents and families. The trial was
registered in the ISRCTN Registry (study no. ISRCTN16474757).No ethics approval
was required for this study according to French legislation because no individual-
level data were collected and the intervention did not involve any additional therapy
or procedure for residents.
Participants
The study was performed in French NHs belonging to the Koriangroup, a
privately held chain of NHs. After a call for participation, a total of 27 NHs distributed
over France volunteered to take part in the study. We selected a NH in Paris for the
pilot study, and included the remaining 26 NHs, assigning 13 NHs to the intervention
group using simple randomization, whereas the other 13 NHs were assigned to the
control group.
Usual and control practices
Usual HH practices continued in NHs allocated to the controlgroup. This
included general training on infection control offered to volunteer staff, access to
handrub solution dispensers nearresident rooms, and HH promotion on the annual
World Hand Hygiene Day (May 5).
Intervention
The intervention was based on a bundle of HH-related measuresaimed at NH
staff, residents, visitors, and outside care providers. These measures included
facilitated access to handrub solution using pocket-sized containers and new
dispensers, a campaign to promote HH with posters and event organization, the
formation of local work groups in each NH to work on HH guidelines, and staff
education using e-learning on infection control and HH training performed by the
same nurse for all NHs. Online quizzes were proposed at the end of the training
program, and staff who did not achieve a high enough score were invited to go
through the e-learning again at a later date. A detailed description of the intervention
is available from the authors on request.
All aspects of the intervention started being implemented simultaneously in
April 2014 in all intervention NHs. Based on success rates for online quizzes and
personal communication with the nurse in charge of the training, 3-6 monthswere
necessary for the program to take.
Data collection
Data were collected monthly at the NH level in all participatingNHs over the 3
months preceding the intervention (baseline period), during the 1-year intervention,
and over the 3 months after the end of the intervention (follow-up period). Data
collectionwas centralized by theNHgroup headquarters in Paris, and made use of
existing computerized databases. No individual data were collected.
The collected data on NH characteristics and organization included location,
number of beds (capacity and monthly occupancy rate), and staffing levels (monthly
planned worked hours for each staff category and absenteeism data). Resident
characteristics included age distribution, proportion of men, pathology, and
dependency rates. The resident-level dependency rate was measured using the
French GIR (iso-resource group) group, based on a scale corresponding to the
length of assistance time required to help the individual accomplish daily living
activities, with a score ranging from 1 for highly dependent individuals to 6 for
independent individuals.18,19 The mean weighted GIR (GMP) was collected at the
NH level, as was the mean weighted pathology score (PMP) of residents. GMP and
PMP are commonly used in French long-term care institutions.
In NHs from the intervention group, the average success rate for online
quizzes on HH performed at the end of the education intervention was also collected.
ARI and AGE data came from a national surveillance system that was
implemented in France in 2010 as part of a national plan toreduce the infection risk
in long-term health care settings.20 Thesurveillance is based on voluntary and
standardized notifications to health authorities of any AGE or ARI clustered case
episodes. The sensitivity of this surveillance system was assessed at 81% for both
AGE and ARI during a pilot study in 2011-2012.21
Data on resident mortality, hospitalization, and antibiotic prescriptions were
collected monthly at the NH level using the national computerized database of the
Korian NH group.
Finally, the mean amount of handrub solution used per resident day was
assessed in each NH over the entire study period as a proxy for HH frequency. This
amount was estimated based on a follow-up of the quantity of handrub solution
bought by the NH, which is routinely monitored in all Korian NHs.
Statistical analyses
Sample size computation was based on recently published estimates of the
incidence rate of lower respiratory infections in NHs before and after a HH-based
intervention,22 from 0.97 to 0.53 per 1,000 resident days (a 45% reduction). Using
these data, and assuming an intracluster correlation coefficient of 0.04 (leading to an
inflation factor of 4.16 to adjust for the clustered design23), the calculation indicated
that 12 NHs had to be included in each arm to achieve a 90% power at a 2-tailed
significance level of 0.05. We overrecruited by 1 NH in each arm.
Outcomes were compared between the intervention and control groups using
χ2 tests or Fisher exact tests for categorical variables and t tests for continuous
variables. Generalized estimating equations (GEEs) were fitted to analyze monthly
longitudinal data for mortality, hospitalizations, and antibiotic prescriptions, while
taking into account the cluster structure and adjusting for resident and NH
characteristics, and for seasonality. R version 3.2.2 (R foundation for statistical
computing, Vienna, Austria) was used for all analyses.
RESULTS
HH practices
Based on the 2 quarters before implementation of the intervention,the
baseline quantity of consumed handrub solution in participating NHs was 4.5 mL per
resident per day and did not differ between the control and intervention groups. Over
the 1-year intervention period, the mean quantity of consumed handrub solution was
significantly higher in the intervention group (7.9 mL per resident per day) than in the
control group (5.7 per resident per day)(Welch t test, P = .009).
Data on AGE and ARI clustered cases episodes
Only 3 AGE clustered cases episodes were reported over the1-year study
period in the context of clustered cases episodes: 2 occurred in the intervention
group and 1 in the control group. Six ARI clustered cases episodeswere reported in
the intervention group, all taking place in January-March 2015; a single episode was
reported in the control group. Because a large influenza epidemic occurred in France
in January 2015, with a documented severe impact on older adults,24 we suspected
that underreporting occurred. The data were verified qualitatively after the end of the
intervention through individual phone interviews with each participating NH. Based
on these interviews, ARI clustered cases episodes had actually occurred in 12 out of
13 control NHs; however, only 1 had been notified to health authorities. No
unreported clustered cases episodes were identified in the intervention NHs.
Because of the lack of reliable data and suspected severe underreporting in
the control group, we decided not to analyze the available reported AGE and ARI
data.
Secondary outcomes
There was no difference at baseline (January-March 2014)between
intervention and control NHs in the mortality rate (2.3% vs 2.1% per month),
hospitalization rate (6.5% vs 6.0% per month), or antibiotic prescription rate (5.4 vs
5.2 DDDs per 100 resident days), respectively.
Over the 1-year intervention period, mortality and antibiotic prescriptions were
significantly lower in intervention than in control NHs (2.10% vs 2.65% per month,
respectively; P = .003; 5.0 vs 5.8 DDDs per 100 resident days, respectively; P
<.001). In particular, there was a 30% lower mortality in the intervention group in
January-March 2015 (2.45 vs 3.64 deaths per 100 residents per month, respectively;
P = .004). There was no significant difference in hospitalization rates between the 2
groups at any time during the study.
Figure 1 depicts changes in the quarterly mortality rate, hospitalization rate, and
antibiotic prescription rate in both groups from January 2014-March 2015. There was
a significant increase in mortality from baseline over the January-March 2015 quarter
in the control group (P <.001), but not in the intervention group. There were no
significant temporal changes in hospitalization rates. In both groups, antibiotic
prescriptions decreased during spring and summer, and increased in winter, with
significantly more prescriptions in January-March 2015 compared with baseline (P
<.001). In the controlgroup, this increase was also significant over the October
December 2014 quarter.
DISCUSSION
Conclusions
Because of the specificities of long-term care settings, reachingyear-long HH
compliance rates similar to those achieved in acute care settings seems unrealistic.
However, our results underline the importance of increasing HH compliance in NHs
during epidemic periods (eg, the January-March 2015 period in our study). Hence, a
practical strategy for infection prevention specifically adapted to NHs could be
proposed, with potentially high benefits. Because our study underlined the low
sensitivity of the current ARI and AGEFrench surveillance system, this would involve
building an improved surveillance system that would allow the detection of outbreaks
of transmissible diseases within NHs with high sensitivity. This highly sensitive
surveillance system could then be coupled with guidelines for increased HH
practices during epidemic alerts.
Acknowledgments
We thank Caroline Blochet for her help in collecting the data onantibiotic
prescriptions, and Marie Arduin for her work in providing support and training
sessions on hand hygiene in intervention nursing homes.We also thank the staff of
all participating nursing homes.
Table 1
Baseline characteristics of participating nursing homes, January-March 2014, and
influenza vaccination rates among staff and residents for the 2014-2015 season
Table 2
Predictors of all-cause mortality in nursing home residents, April 2014-March 2015
NOTE. Results are from a generalized estimating equation approach with a Poisson
distribution.