If you don't remember your password, you can reset it by entering your email address and clicking the Reset Password button. You will then receive an email that contains a secure link for resetting your password
If the address matches a valid account an email will be sent to __email__ with instructions for resetting your password
Corresponding author. Address: Institute of Hygiene and Environmental Medicine, Ferdinand-Sauerbruch-Str., University Medicine, D-17475 Greifswald, Germany. Tel.: +49 3834-864830.
Institute of Hygiene and Environmental Medicine, University Medicine, Greifswald, GermanySection Antiseptic Stewardship of the German Society of Hospital Hygiene, Berlin, Germany
Institute of Nursing Science, Faculty of Medicine, University of Freiburg, Freiburg, GermanyFederal Institute for Vocational Education and Training (VET), Bonn, Germany
Institute of Nursing Science, Faculty of Medicine, University of Freiburg, Freiburg, GermanyInstitute of Medical Biometry and Statistics, University of Freiburg, Freiburg, Germany
Institute of Hygiene and Environmental Medicine, University Medicine, Greifswald, GermanySection Antiseptic Stewardship of the German Society of Hospital Hygiene, Berlin, Germany
Pathogens causing infections are in many cases transmitted via the hands of personnel. Thus, hand antisepsis has strong epidemiological evidence of infection prevention. Depending on various factors, hand antisepsis adherence ranges between 9.1% and 85.2%.
Aim
To evaluate a new transponder system that reminded medical staff to use an alcohol-based hand rub based on indication by giving real-time feedback, to detect hand antisepsis adherence.
Methods
The monitoring system consisted of three components: a portable transponder detecting alcohol-based hand rub and able to give feedback; a beacon recognizing entries to and exits from the patient's surroundings; and a sensor placed at the hand-rub dispensers to count the number of hand rubs. With these components, the system provided feedback when hand antisepsis was not conducted although it was necessary according to moments 1, 4, and 5 of hand antisepsis. Adherence was measured in two use-cases with five phases, starting with the baseline measurement followed by intervention periods and phases without intervention to test the sustainability of the feedback.
Findings
Using the monitoring system, hand antisepsis adherence was increased by up to 104.5% in comparison to the baseline measurement. When the intervention ceased, however, hand antisepsis adherence decreased to less than or equal to the baseline measurement.
Conclusion
A short-term intervention alone is not sufficient to lead to a long-term change in hand antisepsis adherence. Rather, permanent feedback and/or the integration in a multi-modal intervention strategy are necessary.
Data from the German prevalence study of 2016 revealed that in the overall group representing 11.4% (2013) of the hospitals in Germany, 5.1% of patients suffer nosocomial infections. In intensive care units, with 17.1%, the rate was more than four times higher [
]. The consequences of nosocomial infections depend on the type of infection, e.g. ventilator-associated pneumonia (VAP), central line-associated bloodstream infection (CLABSI), surgical site infection (SSI), or catheter-associated urinary tract infection (CAUTI). Generally, consequences are prolonged hospitalization, increased morbidity, and higher costs of care [
]. That is why no other infection control measure but hand antisepsis has such strong epidemiological evidence of infection prevention benefits for patients.
In a large number of studies, it has been unanimously confirmed that hand antisepsis reduces the number of patients colonized with multidrug-resistant organisms (MDRO) and patients with nosocomial infection. The effectiveness of hand antisepsis has been proven by the reduction of the nosocomial infection rate by 40% overall [
Händehygiene in Einrichtungen des Gesundheitswesens: Empfehlung der Kommission für Krankenhaushygiene und Infektionsprävention (KRINKO) beim Robert Koch-Institut (RKI).
]. The implementation of care bundles improves the adherence for each bundle measure including hand antisepsis. Hand hygiene was also an essential part of bundles for the prevention of VAP [
A simplified prevention bundle with dual hand hygiene audit reduces early-onset ventilator-associated pneumonia in cardiovascular surgery units: an interrupted time-series analysis.
]. Furthermore, a meta-analysis by Ista et al. showed a decrease in the incidence of CLABSI from 6.4 to 2.5 per 1000 catheter-days using insertion and maintenance bundles [
Effectiveness of insertion and maintenance bundles to prevent central-line-associated bloodstream infections in critically ill patients of all ages: a systematic review and meta-analysis.
]. Therefore, hand antisepsis by alcohol-based hand rubs is the most cost-effective measure to prevent nosocomial infection and has the advantage of simple, fast implementation [
Ethanol is indispensable for virucidal hand antisepsis: memorandum from the alcohol-based hand rub (ABHR) Task Force, WHO Collaborating Centre on Patient Safety, and the Commission for Hospital Hygiene and Infection Prevention (KRINKO), Robert Koch Institute, Berlin, Germany.
]. However, certain pathogens such as non-enveloped viruses, spores, and protozoa are not susceptible to all kinds of alcohol-based hand rub and in some situations, e.g. when staff are faced by blood or body fluids, hand wash with water and soap is required. However, hand antisepsis before hand washing is recommended when possible.
However, hand hygiene adherence refers to a complex concept targeting the dynamics of behavioural change on both the individual and the institutional level. These complex dynamics acknowledge psychosocial parameters changing hand-hygiene behaviour, including intention, attitude towards the behaviour (change), perceived social norms and perceived social control, perceived risk of infection, habits of hand-hygiene practice, along with perceived knowledge, and motivation [
]. Taking the complexity of behavioural change into account, the World Health Organization (WHO) introduced the ‘5 moments of hand hygiene’ as a basis to monitor adherence with the following indications:
(1)
before touching a patient;
(2)
before clean/aseptic procedures;
(3)
after body-fluid exposure/risk;
(4)
after touching a patient;
(5)
after touching patient surroundings.
Depending on the ward type, geographic region, and type of healthcare workers, hand antisepsis adherence differs between 9.1% and 85.2% [
]. They include regular staff training, consumption measurement with feedback, improving the availability of alcohol-based hand rubs, use of reminder and promotional materials, and support from administrative levels. A requirement for targeted intervention is the recording of hygiene performance data, as mainly performed by direct observation [
]. Although this method is traditionally accepted as the ‘gold standard’ hand-hygiene auditing method, some disadvantages, such as a high need for considerable expertise, observations lasting only short periods of time, and rapid decision-making, are associated with it [
]. Furthermore, direct observation has limited comparability between different observers (observer bias) and the Hawthorne effect might influence the outcome [
]. The Hawthorne effect is based on an influence of the observation itself on the observed data, resulting in data that do not reflect everyday reality, because people behave differently when they are aware of being observed [
Compliance ethnography: what gets lost in compliance measurement.
in: Rorie M. van Rooij B. Measuring compliance: assessing corporate crime and misconduct prevention. Cambridge University Press,
Cambridge2021: 218-238
]. An indicated method to acquire hygiene performance data is to measure the consumption of alcohol-based hand rubs as a surrogate parameter. However, this method does not allow any conclusions about general adherence, because it presupposes that the number of indications according to the moments of hand hygiene has been accurately recorded through direct observation [
Impact of psychologically tailored hand hygiene interventions on nosocomial infections with multidrug-resistant organisms: results of the cluster-randomized controlled trial PSYGIENE.
]. To measure exactly the consumption of alcohol-based hand rubs and combine it with a feedback function, initial tools for adherence observation using transponder systems became popular [
The latest legislation to come into effect in Germany is the Law on the Digital Modernization of Healthcare and Nursing Care (DVPMG). This promotes and regulates digitalization of healthcare; thus, new technologies must be developed to improve the quality and availability of healthcare.
In the present study, we tested a new transponder system developed as an interactive feedback system to remind medical staff to perform hand antisepsis and monitor adherence using real-time feedback. The system reminds the staff member to perform hand antisepsis in case the person did not perform it within a certain time-interval before or after an indication. Additionally, the system monitors the consumption of alcohol-based hand rub and the number of times it was used.
Methods
Transponder system
The hand-hygiene monitoring system used in this study consisted of three components. A portable transponder, which can be carried on the working clothes, monitored the number and duration of hand antisepsis with alcohol-based hand rubs by means of a gas detector. Backtracking to the person who wore the transponder was not possible, because every transponder could have been used randomly by each staff member per shift or day at work. The transponder had the optional function of giving feedback via vibration, blinking LED, or sound (for haptic, acoustic, and visual sensory perception), if the healthcare worker did not perform a hygienic hand rub within a certain time-interval before or after an indication.
The transponder communicates with a beacon, which was installed above the patient's bed. The beacon recognized the entries into and exits from the patient's surroundings by healthcare workers who carried a transponder.
The third component was a sensor placed at the hand-rub dispenser, counting the number of hand rubs and allowing a spatial allocation to assign each hand rub to its specific patient surroundings.
The described hand-hygiene monitoring system thus combined hand antisepsis with three of the five moments (1, 4, 5) according to WHO. Moment 1 is approximated by analysing use of alcohol-based hand rub when entering the patient's zone since touching the patient cannot be monitored. Moments 4 and 5 are comprised and approximated by analysing hand antisepsis when leaving the patient's surroundings.
Study design
The study was composed of two use-cases. In use-case 1, a crossover design study was implemented in an intensive care unit (ICU) (Table I). Use-case 2 was implemented in a medium care unit without crossover design (Table II). Before starting phase 1, hand hygiene adherence was determined using direct observation in the absence of an electronic hand-hygiene monitoring system. Furthermore, the timeframe for hand antisepsis before/after entering the patient's zone and before/after leaving it was determined.
Table ICrossover design of use-case 1 with two groups (A, B) in a crossover design and five different phases
All participants were briefed about the aim of the study, the use of the device, and the anonymity of the data. The study was approved by the ethics committee of the University of Greifswald (registration no. BB 156/17).
In the intensive care unit in use-case 1, 18 beds were available. The medium intensive care unit in use-case 2 holds 12 rooms with two beds each. When possible, rooms were used as single rooms.
In both cases – direct observation and monitoring adherence by the transponder system – just alcohol-based hand rub use was analysed. Hand washing with water and soap were not considered.
In use-case 1, 44 volunteers (healthcare professionals including nurses and physicians) were randomly assigned to the control and the intervention group (22 volunteers each). The investigation period of 197 days was divided into five phases of 24–50 days (Table I). The staff members wore portable transponders during their shift in all five phases but without the use of the sensors at the hand-rub dispensers. In phases 1 and 4, no intervention was conducted. During phase 1, the number of hand rubs in everyday work was measured as baseline. In phases 2, 3, and 5, intervention (vibration, blinking LED) was practised in one (phases 2, 3) or both groups (phase 5), when no alcohol-based hand rubs were used in the given timeframe when entering or leaving the patient's surroundings as recognized by a beacon. The staff members were informed about the measurement in all phases.
In use-case 2, in addition to transponders and beacons, the sensors at the dispensers were applied in order to monitor the number of hand rubs. Up to 15 volunteers per day used the transponders. Use-case 2 was investigated for a period of 137 days in five phases (Table II). In contrast to use-case 1, in phase 1, baseline measurement was executed without the knowledge of the staff members, then followed by phase 2, in which information on baseline measurement was given beforehand to identify a possible Hawthorne effect. In phases 3 and 5, intervention (vibration, blinking LED) was used as in use-case 1. Phase 4 served as proof of a learning effect; application of alcohol-based hand rubs was measured without intervention, similar to phase 2.
Participants
All volunteers were staff members (nurses, physicians, physiotherapists). Staff of other occupational groups and from other hospital wards were excluded. Participation was voluntary and anonymous. Detailed descriptive statistics on participants which would have disclosed their profession were not assessed due to the delicacy of the topic and anonymous data collection. A small subset of the participants presented in this study are described in more detail by Meng et al. [
To detect an increase in hand antisepsis adherence with a confidence level of 95% (P = 0.05), a minimum of 310 indications recorded per shift were calculated. The analysis was performed with a linear mixed model. The outcome variable hand antisepsis/zone event (zone event = entry/exit of patient surroundings) is the part of hand antisepsis and zone event per transponder and shift per day. The intervention is the independent effect. Random effects are transponder ID, shift, and day.
The null hypothesis was defined as: the average count of hand antisepsis/zone event will not increase from phases 1 and 2 to phase 3.
Direct observation
Before introduction of the transponder system, adherence was analysed by direct observation. According to the WHO recommendations, the observer introduced him/herself to the healthcare workers and the patients and informed them about his/her task. Every session lasted not more than 20 min (±10 min). A maximum of three healthcare workers were observed simultaneously. In contrast to the analysis with the transponder system, in direct observation the entry/exit of the patient's surroundings was not considered, whereas touching of the patient or their surroundings was recognized, as defined by the WHO 5 moments.
Determination of timeframe of hand antisepsis
As prerequisite for an adequate intervention if hand antisepsis is not performed, the average time typically needed before and after an indication for hand antisepsis was measured in clinical routine. Time was measured before and after entering and exiting the near-patient surroundings. Ten test persons were observed and time was measured with a timer. The results were used to set the time for the intervention if hand antisepsis was not carried out.
Results
Timeframe for hand antisepsis and adherence by direct observation
The timeframe for the intervention was set to 60 s before entering the patient's zone and 30 s after entry. Upon leaving the patient's zone, hand antisepsis must be conducted within 20 s before or 30 s after exiting. By direct observation, 2098 indications were recorded. The adherence was highest at moments 1, 4, and 5 (Table III).
Table IIIAdherence of hand antisepsis measured by direct observation
In both use-cases, an increase in hand-antisepsis adherence was observed when feedback was given by the transponder system in comparison to the baseline measurement.
To test the sustainability of the intervention, after the intervention phase, a phase without feedback was integrated. In this phase in both use-cases, adherence markedly decreased (up to –64%, Table IV, Table V).
Table IVPerformed hand rubs (%) of necessary hand rubs according to moments 1, 4, and 5, recorded by the feedback device during use-case 1
For 197 days, hand antisepsis was performed a total of 27,606 times as counted by the transponder system. In all phases, adherence upon entering the patient's zone was higher than when leaving the patient's surroundings (Table IV).
Group A, phase 1 versus phase 2
The intervention with real-time feedback from the transponder increased hand antisepsis in moments 1 and 5 (entry/exit of patient surroundings) about 0.018 when comparing intervention and control phases (t = 1.29; P = 0.2). Thus, no significant increase in hand antisepsis was observed.
Group A, phase 2 versus phase 3
The intervention with real-time feedback increased hand antisepsis-adherence (hand antisepsis/zone event) significantly by 0.049 in the intervention phase compared to the second control phase (t = 3.53; P < 0.001).
Group B, phases 1 and 2 versus phase 3
The intervention significantly increased the hand antisepsis/zone event value by 0.099 when comparing the prolonged control phase (baseline + phase 2) to phase 3 (t = 7.12; P < 0.0005).
Group A, phase 2 with group B phase 2
The intervention increased the hand antisepsis/zone event value significantly by 0.099 when comparing the prolonged control phase of group B with the intervention phase of group A (t = 7.12; P < 0.0005).
Overall observation
When comparing all phases with and without intervention, hand-antisepsis adherence (hand antisepsis/zone event) significantly increased by 1.037 (t = 10.15; P < 0.0005). Regarding the first intervention phase with the phases without intervention (phases 1, 2 and 3), a significant increase by 0.764 was observed in hand antisepsis/zone event (t = 6.55; P < 0.0005).
Use-case 2
For 137 days, hand antisepsis was performed a total of 11,931 times. In all phases, adherence was lower when entering a patient's zone than when leaving the patient's surroundings (Table V).
The real-time feedback increased the hand antisepsis/zone event value significantly (z = 4.34; P < 0.0005) when comparing intervention phase 3 with combined values of phases 1 and 2 (Table V).
Comparing phases 1 and 2 of group B makes it possible to calculate whether a Hawthorne effect existed. The descriptive statistical analysis reveals a slight decrease of hand antisepsis/zone event from phase 1 to phase 2, indicating a lack of Hawthorne effect.
The statistical analysis revealed a clear decrease of hand antisepsis/zone event in phase 4 without intervention in comparison to phase 3 with feedback. A relapse to the former hand-antisepsis routine was already visible within a few days (Figure 1). When the intervention started in phase 5 again, the hand antisepsis/zone event value increased.
Figure 1Hand antisepsis per zone event (HA/ZE) in chronological order, divided into five phases of use-case 2. In phases 3 and 5, feedback via vibration was activated, leading to increased adherence.
Using a new system which provides feedback via vibration when medical staff do not use alcohol-based hand rubs when necessary (approximating to moments 1, 4, and 5 of hand antisepsis), hand-antisepsis adherence was significantly increased. Thus, transponders with a feedback function can be seen as a simple, cost-effective, and non-judgmental device to improve hand-hygiene adherence behaviour. Staff members participating in this study intentionally improved their hand-hygiene related behaviour. However, this behavioural change was not sustained.
In the present study, hand-antisepsis adherence obtained by the gold standard (direct observation) was better than hand-antisepsis adherence obtained with the new feedback system. Direct observation detected an adherence of 54–99% depending on the hand-antisepsis moment, whereas the baseline adherence detected with the transponder system was about 13–17%.
When using direct observation, adherence to hand antisepsis was very high in comparison to other studies, which might result from the observation made at an intensive care unit, since data from two other wards of the same hospital revealed a lower adherence, and the fact that the direct observation was conducted in an academic teaching hospital [
Anwendungsbeobachtung zur Ermittlung der Anzahl erforderlicher Händedesinfektionen auf zwei Nichtrisikostationen unter Zugrundelegung der WHO-Indikationen zur Händedesinfektion.
Furthermore, direct observation did not measure hand antisepsis when entering/leaving the patient's zone without touching the patient or the surroundings. That is why adherence might be higher than for the feedback system that additionally records these cases that do not require hand antisepsis according to the WHO 5 moments. Unfortunately, until now no data exist clarifying in detail in how many cases the patient's surroundings are entered without touching the patient or the surroundings. Further research to optimize the adherence observation may be necessary.
When entering the patient's surroundings, adherence was slightly higher than when leaving the patient's zone. This result might be associated with a positive external perception by the patient, and the fact that using the transponder system represents a professional responsibility [
Technological innovations in infection control: a rapid review of the acceptance of behavior monitoring systems and their contribution to the improvement of hand hygiene.
The relatively low adherence when measured by the feedback system might result from additional protective equipment that is especially worn in intensive care units which may cover the alcohol sensor, thus resulting in apparently low adherence. This disadvantage might be overcome by using the feedback system as one part of a multi-modal intervention. As part of this multi-modal intervention, training courses and observations can help improve adherence. Additionally, the role-model effect of the supervisor should be considered. Another point explaining the lower adherence measured by the transponder system might be a possible Hawthorne effect during direct observation, as the staff members are more aware of being observed and are thus more compliant [
Technological innovations in infection control: a rapid review of the acceptance of behavior monitoring systems and their contribution to the improvement of hand hygiene.
]. In reverse, a Hawthorne effect when using the transponder system was excluded by demonstrating adherence in a further phase of use-case 2. Thus, the feedback system provides reliable data overcoming a possible effect due to the observation itself.
However, short-term interventions do not lead to long-term changes in behaviour. Using a feedback system for longer periods of time, a learning process might lead to the acquiring of new behavioural patterns. Short-term effects were also shown by Ibrahim et al., for instance [
]. They tested the effect of a voice reminder, requesting participants to bear hand antisepsis in mind at certain times to increase the adherence in two hospitals. They recorded a baseline adherence of 31.4% and 48.0% and a post-intervention adherence of 78.0% and 65.2%; increases of 148% and 36%, respectively. However, the increased adherence was not statistically significant. Zhong et al. observed an immediate increase of >12% in hand antisepsis after implementation of a feedback system in the first month [
]. Afterwards, adherence increased at a rate of about 1.242% per month in comparison to adherence without use of the feedback function. An increase in hand-hygiene adherence from 16–39% to 42–78% by use of an automated monitoring system was also observed by Iversen et al. [
]. After a baseline measurement of two months, two intervention phases of 12 months (group intervention, team data) and four months (individual intervention) followed.
Unfortunately, the intervention period in our study was relatively short, thus not reinforcing the enhanced adherence to maintain behavioural change. When the intervention was not continued, positive effects disappeared; a relapse to the former hand-antisepsis routine was already noticeable within a few days (Figure 1). Thus, sustainability could not be proven. When the intervention was started in phase 5 again, the hand antisepsis/zone event value increased again.
Long-lasting high adherence is only possible when medical staff are motivated to change their behaviour. The possibility of intentional non-adherence has not been considered. Problems such as the resistance to change have been documented in previous studies, e.g. by Al Salman et al., although an average increased adherence from 38–42% to 60% was observed due to the use of sensors at soap and hand-antisepsis dispensers for 28 days [
]. Scepticism about the device possibly monitoring the healthcare workers was overcome by further explanations and emphasizing the advantages, such as the system being a measure to prevent infectious diseases, which would thus also protect the staff. However, concerns could never completely be allayed [
]. As in other studies, the acceptance of the transponder system used in our study was likewise moderate, as shown before correlating to the experience with technologies in general [
]. Practical support and an increase in experience may lead to higher acceptance.
Resistance to change is defined as a counterproductive behaviour towards a change initiative, which results in a negative impact on the change effort [
]. Among others, disagreement within a group about the nature of the problem and its consequences, embedded routines, or a lack of capabilities were mentioned. Furthermore, the relationship between the value of the change initiative and its importance for the individual and the organization are important. Further problems may arise when the validity of the automated readings is questioned [
This might result from distrust of the device or the data security. Instead of feeling monitored by the device, it should be seen as a positive-feedback system supporting the patient's and staff's maintenance of health.
Granqvist et al. found a change in opinion about a pilot implementation comprising direct observations, interviews, and a monitoring system from sceptical to more accepting over time [
Learning to interact with new technology: health care workers’ experiences of using a monitoring system for assessing hand hygiene – a grounded theory study.
]. A prerequisite, however, is optimal functioning of the device to support daily work. During our study, the use of the feedback devices fluctuated. On some days, no device was used. To overcome the resistance to change, more information about the utility of the device and its anonymity are necessary.
In conclusion, new technologies for changing the hand-hygiene behaviour only work when feedback is constantly switched on. Just as traffic lights need to be in operation, the interactive feedback system is needed during the work shift. However, it cannot be ruled out that positive effects may be diminished by an habituation effect. Thus, testing a longer intervention period might yield deeper insight. Additionally, differences in adherence – both with and without feedback – by profession, age, and gender may be worth future study.
Conflict of interest statement
T. Gebhardt is managing director of GWA Hygiene GmbH. He was the negotiator of the technology acquisition of HyHelp AG (former project coordinator) in 2019. As a consequence, GWA Hygiene has become the new coordinator of the related funding project PräBea. Afterwards they received the remaining funding amount.
Funding sources
This work was supported by the German Federal Ministry of Education and Research, joint project: ‘Interaktives Feedbacksystem zur Händedesinfektion in der stationären Intensivpflege – PräBea’ (grant nos. 16SV7748, 16SV7749, 16SV8135).
Acknowledgements
The authors thank R. Baguhl and S. Lemke for project organization, as well as Iris Brenig for her contribution on direct observation of hand-antisepsis adherence.
References
Behnke M.
Aghdassi S.J.
Hansen S.
Diaz L.A.P.
Gastmeier P.
Piening B.
The prevalence of nosocomial infection and antibiotic use in German hospitals.
Händehygiene in Einrichtungen des Gesundheitswesens: Empfehlung der Kommission für Krankenhaushygiene und Infektionsprävention (KRINKO) beim Robert Koch-Institut (RKI).
A simplified prevention bundle with dual hand hygiene audit reduces early-onset ventilator-associated pneumonia in cardiovascular surgery units: an interrupted time-series analysis.
Effectiveness of insertion and maintenance bundles to prevent central-line-associated bloodstream infections in critically ill patients of all ages: a systematic review and meta-analysis.
Ethanol is indispensable for virucidal hand antisepsis: memorandum from the alcohol-based hand rub (ABHR) Task Force, WHO Collaborating Centre on Patient Safety, and the Commission for Hospital Hygiene and Infection Prevention (KRINKO), Robert Koch Institute, Berlin, Germany.
Compliance ethnography: what gets lost in compliance measurement.
in: Rorie M. van Rooij B. Measuring compliance: assessing corporate crime and misconduct prevention. Cambridge University Press,
Cambridge2021: 218-238
Impact of psychologically tailored hand hygiene interventions on nosocomial infections with multidrug-resistant organisms: results of the cluster-randomized controlled trial PSYGIENE.
Anwendungsbeobachtung zur Ermittlung der Anzahl erforderlicher Händedesinfektionen auf zwei Nichtrisikostationen unter Zugrundelegung der WHO-Indikationen zur Händedesinfektion.
Universität Greifswald,
Greifswald2021 ([Dissertation])
Technological innovations in infection control: a rapid review of the acceptance of behavior monitoring systems and their contribution to the improvement of hand hygiene.
Learning to interact with new technology: health care workers’ experiences of using a monitoring system for assessing hand hygiene – a grounded theory study.