Promoting Hand Hygiene Compliance: PSYGIENE—a Cluster-Randomized Controlled Trial of Tailored Interventions
A cluster-randomized controlled trial of tailored interventions
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Background: The German “Clean Hands Campaign” (an adaptation of the WHO “Clean Care is Safer Care” programme) to promote hand hygiene among hospital personnel at Hannover Medical School (MHH, Medizinische Hochschule Hannover), known as Aktion Saubere Hände (ASH), met with initial success. By 2013, however, compliance rates with hygienic hand disinfection in the hospital’s ten intensive care units (ICUs) and two hematopoietic stem cell transplantation units (HSCTUs) had relapsed to their initial levels (physicians: 48%; nurses: 56%). The cluster-randomized controlled trial PSYGIENE was conducted to investigate whether interventions tailored in ways suggested by research in behavioral psychology might bring about more sustainable improvements than the ASH.
Methods: The “Health Action Process Approach” (HAPA) compliance model specifies key psychological determinants of compliance. These determinants were assessed among health care workers in the ICUs and HSCTUs of the MHH by questionnaire (response rates: physicians: 71%; nurses: 63%) and by interviews of the responsible ward physicians and head nurses (100%). In 2013, 29 tailored behavior change techniques were implemented in educational training sessions and feedback discussions in the six wards that constituted the intervention arm of the trial, while ASH training sessions were provided in the control arm. The compliance rates for 2014 and 2015 (the primary outcomes of the trial) were determined by nonparticipating observation of hygienic hand disinfection, in accordance with the World Health Organization’s gold standard.
Results: The two groups did not differ in their baseline compliance rates in 2013 (intervention: 54%, control: 55%, p = 0.581). The tailored interventions led to increased compliance in each of the two follow-up years (2014: 64%, p<0.001; 2015: 70%, p = 0.001), while the compliance in the control arm increased to 68% in 2014 (p<0.001) but fell back to 64% in 2015 (p = 0.007). The compliance increases from 2013–2015 and the compliance rate in 2015 were higher in the intervention arm (p<0.005). This was mainly attributable to the nurses’ behavior, as the corresponding parameters for physicians did not differ significantly between the two study arms in stratified analysis.
Conclusion: Tailored interventions based on behavioral psychology principles led to more sustainable increases in compliance with hand hygiene guidelines than ASH training sessions did. This was true among nurses, and thus also for hospital ward personnel as a whole (i.e., nurses and physicians combined). Further studies are needed to identify more target group–specific interventions that may improve compliance among physicians.
Hygienic hand disinfection with an alcohol-based hand rub is regarded as the most effective, most cost-effective, and simplest measure in the prevention of nosocomial infections (NIs) (1–3). NIs in intensive care units (ICUs) are a particular problem throughout Germany (prevalence: 19%) (4) and at Hannover Medical School (MHH, Medizinische Hochschule Hannover) (prevalence: 28%) (5). Interventions to promote hand hygiene compliance have therefore increasingly been implemented, especially since Germany’s nationwide “Clean Hands Campaign” (Aktion Saubere Hände, ASH) (6, 7). Findings to date indicate a positive trend: while compliance in ICUs was previously between 41.2% and 59.8% (8–10), it appears to have increased 1.5-fold to 74% in 2014 (73% in 2015) (11, 12).
However, this compliance level implies that on average 1 of 4 hand hygiene opportunities is missed. At the same time, compliance rates are lower among physicians than among nurses (11, 13). Finally, little is known about how to deal with relapses in compliance. Compliance rates had been shown to have dropped back to their original levels in the ICUs and hematopoietic stem cell transplantation units (HSCTUs) at the MHH in 2012 and 2013 after initial successes (14).
Tailored interventions provide an option for dealing with such relapses. These are planned strategies to improve professional practice that take into account prospectively identified determinants of practice (15). The underlying principle is similar to that of individualized medicine, without the focus on biomarkers: tailored interventions are developed on the basis of typical, empirically assessed attributes of their recipients that are relevant to an outcome (16). The aim is to achieve better effects through interventions that are better suited to their recipients. The scope of tailoring goes beyond its original applications of promoting healthy behaviors in individual patients (17). The recent Cochrane Review identified 32 studies that examined health care workers’ professional behavior and investigated tailored, group-based interventions (15). Overall, the probability of success of tailored interventions was higher by a factor of 1.56 (15).
The PSYGIENE (PSYchologically optimised hand hyGIENE promotion) study presented here was a trial of the promotion of hand hygiene compliance using behavioral psychology to optimize the process. It investigated whether interventions that were tailored to individual units according to the ASH compliance model, the Health Action Process Approach (HAPA) (18–21), led to more sustained increases in hand hygiene compliance than the standard ASH in the above-mentioned relapse situation at the MHH. Tailoring was performed by selecting behavior change techniques (BCTs; eBox 1) (22) on the basis of empirically assessed factors relevant to compliance. Because compliance was monitored in individuals but aggregated for whole units, a cluster-randomized controlled trial (C-RCT) design with compliance rates for each trial arm as the outcomes was selected.
A single-center C-RCT was conducted, with the 10 ICUs and 2 HSCTUs of the MHH as the clusters. Six units received tailored interventions (the tailoring trial arm) and the others the standard ASH (the ASH trial arm). The trial design and selection criteria for clusters and individual participants remained unchanged. PSYGIENE was approved by the MHH’s ethics committee (1434–2012) and employee committee (2012–10–18) and entered in the German Clinical Trials Register (DRKS, Deutsches Register Klinischer Studien) (DRKS00010960).
Selection criteria: There were no selection criteria for clusters or individuals other than being employed at the MHH and working in one of the units (as a physician or nurse).
Setting: The MHH is a tertiary care university hospital specializing in surgery. In 2014, 60 173 fully inpatient treatment cases were recorded, and 409 solid organ transplantations and 167 bone marrow transplantations were performed. There was a total of 1459 beds. Overall, there were 5 surgical, 2 internal-medicine, 2 pediatric, and one interdisciplinary ICU and 2 HSCTUs are held available (total beds: 178).
Interventions took the form of educational training for physicians and nurses (individual-level intervention) and feedback discussions with clinical managers and head nurses (cluster-level intervention). In the tailoring arm, these were tailored on the basis of empirically assessed psychological determinants of hand hygiene compliance. These determinants were identified using data obtained in a survey between November 26, 2012 and January 25, 2013 on the wards involved in the trial (response rates: physicians 71%, nurses 63%). The survey questionnaire assessed the compliance determinants that represent the key psychological factors according to the HAPA, i.e., risk perceptions, outcome expectancies, self-efficacy expectancies, intentions, action and coping planning, action control (eBox 2), and ward-specific resources and barriers. The wording of the items in the survey is shown in eTable 1. In addition, problem-centered interviews regarding typical daily routines/activities were conducted with the responsible ward physicians and head nurses (March 19 to May 7, 2013; response rates: 100%).
The aim was a behavioral psychological analysis following the SWOT (strengths, weaknesses, opportunities, threats) method (23). Table 1 shows an example of a profile based on a ward- and profession-specific analysis of the survey data. The mean, range, range of means, and comparison with other wards (p-value) are shown for every survey item.
In the tailoring arm in 2013, appropriate BCTs (22) were selected for the training sessions and the feedback discussions, in line with profiling. This selection, which was based on the expertise of the involved medical psychologists and performed in coordination with the leading Hospital Epidemiology Department and the health economists involved in the project, defined the tailoring. eTable 2 shows the BCTs used, with examples. A total of 29 BCTs were used in the tailoring arm of the trial. Fifteen BCTs were used in the ASH arm (the trainings used in the ASH arm have also been described, for comparison) (eBox 3).
Cluster-level hand hygiene compliance rates were assessed via direct observation of employees’ hand hygiene behavior when providing patient care between 2008 and 2015, in annual cross-sectional examinations in line with the gold standard defined by the World Health Organization (WHO) (24, 25). Internal and internally trained compliance observers coded each action as follows when hygienic hand disinfection was indicated, using the ASH recording tool:
- Alcohol-based hand rub used
- Hands washed with soap
- Action omitted.
Primary outcomes were the compliance rates in 2014 and 2015 (baseline year: 2013) for each trial arm. Secondary outcomes were the changes between 2013 and 2014, between 2014 and 2015, and between 2013 and 2015. In addition, the compliance rates for 2008 to 2012 were plotted by PSYGIENE trial arm in order to enable comparison with previous compliance rates (eBox 4).
The trial included all 10 ICUs and both HSCTUs of the MHH and all 1087 physicians and nurses working there at the time of the trial (comprehensive trial).
Units were randomized by the MHH Institute for Biometry (nQuery Adviser, version 7.0) (eBox 5).
The intervention staff, compliance observers, and data analysts knew to which trial arm clusters had been allocated. The units were blinded to this.
Similarity of interventions: Feedback discussions were held only in the tailoring arm. Fifteen of the 29 BCTs used in the tailoring arm were also implemented in the ASH arm (eTable 2).
The data were analyzed only at cluster level, since only the wards had been randomized. Estimates of confidence intervals for compliance rates and differences between them, Breslow–Day tests for interactions between compliance differences in the two trial arms, and chi-square tests were performed using the software program OpenEpi 3.03a (26). Statistical significance was set at p<0.05 (two-tailed). No correction for multiple testing was performed. Because tailoring was profession-specific, all analyses were also performed separately for physicians and for nurses (post-hoc analyses). No cluster-adjusted analyses were performed, as the cluster level is the inference level, and the outcomes were aggregated for clusters. Because the cluster sizes (hand hygiene opportunities in each trial arm: eTable 3) did not generate differing sampling errors overall (2014: ±1.1 in both trial arms; 2015: ±1.3 in the tailoring arm, ±1.2 in the ASH trial arm), no weighted analyses were performed.
No clusters or individuals were excluded (eFigure 1). All clusters were allocated to the trial arms by randomization and received the corresponding interventions (tailoring arm: tailored educational training sessions and feedback discussions; ASH arm: ASH trainings). While all clinical managers and head nurses in the tailoring arm participated in feedback discussions, the individual-level participation rates for the training sessions were 44.1% (physicians) and 51.8% (nurses) in the tailoring arm and 54% and 45.9% respectively in the ASH arm. Follow-up and data analysis were performed at cluster level. There was no differentiation in outcome assessment between those who participated in interventions and those who did not, so the latter were not excluded from the analyses. No interventions were terminated. All outcomes were assessed and included in the analyses for all wards.
All interventions took place between June 20 and December 16, 2013. Compliance rates for 2013 (the baseline year) were assessed between June and December, those for 2014 between January and December, and those for 2015 between January 2015 and February 2016.
In 2013 there was no significant difference in compliance rates, in either group, between the two trial arms (Figure a–c). The changes between 2008 and 2012 reflect the fact that hand hygiene compliance had relapsed by 2012 (eBox 6).
Number of analyzed clusters
All clusters were analyzed (eFigure 1).
Outcomes and estimation
While the overall compliance rate in the ASH trial arm was higher than that in the tailoring arm in 2014, in 2015 the rate in the tailoring arm was higher, and the difference was statistically significant (Figure, a; p-values: eTable 4). Among physicians, compliance was higher in the ASH arm in 2014, while there was no difference between the two arms in 2015 (Figure, b). Among nurses, there was no significant difference between the compliance rates of the trial arms in 2014, while compliance was higher in the tailoring arm in 2015 (Figure, c).
Overall, in the tailoring arm compliance was higher both in 2014 and 2015 than in the respective preceding year (Table 2). In contrast, in the ASH arm compliance fell again in 2015 after an increase in 2014; there was no difference between this increase and the respective increase in the tailoring arm (Breslow–Day test). The increase between 2013 and 2015 was greater in the tailoring arm.
Among physicians, there was no difference between the trial arms in terms of the increase between 2013 and 2015. The increase between 2013 and 2014 was smaller in the tailoring arm than in the ASH arm, and between 2014 and 2015 there was an increase in the tailoring arm and a decrease in the ASH arm. This was also true overall and for nurses.
Among nurses, compliance increased in the tailoring arm both in 2014 and 2015. In contrast, in the ASH arm compliance fell again in 2015, following an increase in 2014 which did not differ from that in the tailoring arm. The increase between 2013 and 2015 was greater in the tailoring arm.
The procedures by which hand hygiene compliance was observed in this trial accorded with the WHO gold standard and represent the most accurate method of assessing this outcome (24, 25). Data on hand disinfectant consumption stratified by profession was not available. For these reasons, no ancillary analyses were performed.
There was no evidence of any harms or unintended effects (assessment instruments: eFigure 2).
Starting from similar hand hygiene compliance rates in 2013, interventions tailored using behavioral psychology principles led to increases in 2014 and 2015, both overall and among nurses. In contrast, in the ASH trial arm compliance rates fell again in 2015, after an initial increase. The core finding is that comparisons of the increases between 2013 and 2015 and of the rates in 2015 yielded results in favor of tailoring. Among physicians, there were no differences between the trial arms in terms of these parameters. The increase in 2014 was smaller in the tailoring arm. In addition, in 2015 compliance decreased again in the ASH arm only.
Without continuous reinforcement, hand hygiene compliance rates tend to fall back to their baseline levels even after initial successes (27). This also occurred in the ICUs and HSCTUs of the MHH up to 2013 (14). At 55%, compliance in 2013 was 17% lower than the nationwide ASH mean (7), indicating a relapse situation. It can be assumed that the PSYGIENE project, with its scientific and personnel resources, was such a reinforcement for the Hospital Epidemiology Department and led to increases in compliance rates in both trial arms in 2014. Both the interdisciplinary exchange and the additional staff available for the ASH thus acted as a booster and caused a reboot effect. This is also suggested by the fact that the wards were blinded to randomization, and trial arm-related Hawthorne effects were eliminated, particularly as every intervention was observed by a project team member for quality assurance purposes. In addition, the ASH may have been amenable to such boosters because, unlike tailoring, it had already had successes before 2012 on which they could build. This is also indicated by the higher top compliance rates in the wards in the ASH arm up to and including 2011. Finally, the survey was carried out on all wards, the findings were disseminated as ward-specific reports (without stating wards’ trial arms, to maintain blinding) and a second survey was carried out in 2014, so in 2014 the subject had been addressed more intensively.
In contrast, in 2015 tailoring led to further increases in hand hygiene compliance overall and among nurses. Compliance in the ASH arm, however, fell again. This may be due to the ASH “one size fits all”–concept, whereas in the tailoring arm of the trial the HAPA compliance model (18) had not only been updated (19–21, 28, 29) but also translated into behavior change techniques, making these interventions more sustainable. Consideration of action control as a self-regulation strategy that co-occurs with the implementation of the behavior and supports it goes beyond the standard ASH as well (18). It takes into account that hand hygiene is a behavior that is affected by both self-regulation and habituation (29–34). This may also explain why tailoring did not lead to more sustained increases in hand hygiene among physicians. Though the fact that hand hygiene is indicated 3 to 4 times less frequently for physicians on day shifts (35) can be interpreted as showing that differences in work load do not explain their lower compliance rates (35), it can also be seen to indicate that habituation of hand hygiene is more difficult because the behavior is rarer. In addition, in the tailoring arm of the trial training participation rates were lower for physicians than for nurses, making the interventions less effective. Furthermore, sustained increases in compliance among nurses only may also lead to successful prevention of nosocomial infections.
Overall, for health-care facilities in either sector (inpatient/outpatient) and of any size (e.g. university medical center, district hospital) it is important to understand that hand hygiene in everyday clinical care cannot be promoted just at the push of a button, figuratively speaking—at least not sustainably. It is an ongoing, core task of physicians and nurses; in our view, the more awareness, motivation, and competence staff devote to it, the more likely it is to be implemented in line with guidelines. As in therapeutic medicine, communication is vital in this context, so all employees should be provided with training on the subject at least annually (1, 2), and hand hygiene should be established as a team task (29, 36).
Neither intervention staff nor compliance observers could be blinded. In the former case, this may have led to the use of tailoring principles in the ASH arm of the trial. To minimize this possibility, an observer from the project team was present at all training sessions. However, this contamination effect would work against the trial hypothesis. The lack of blinding for the compliance observers is more critical, as outcome measurements may have been influenced, and biases in line with the trial hypothesis cannot be ruled out. Quality assurance was performed with particular diligence during the PSYGIENE observation period in order to prevent such bias. At the same time, the fact that compliance increased in both trial arms in 2014 suggests that there was no such effect.
Furthermore, only educational training sessions and feedback discussions were implemented as interventions. In particular, methods such as team-oriented interventions, which can be cost-effective for nurses, alongside management-related measures (36), were beyond the scope of the project. As an overall analysis of the PSYGIENE survey data showed that good collaboration with other actors on their ward was positively associated with self-reported hand hygiene compliance among physicians (29), hand hygiene–oriented team development strategies should be tested.
In addition, tailoring was limited to one intervention year, so the question of whether repeating the interventions would lead to greater increases in hand hygiene compliance remains unanswered. Further research and development are needed regarding quality criteria for tailoring interventions in terms of matching behavior change techniques to theory-based interventions (2). This is true not least for hospital epidemiology and the objective of developing a toolbox based on behavioral psychology that is supported by the highest possible level of evidence. This would also make it easier to transfer behavioral psychology–based interventions from university hospitals to other contexts. At the same time, it should be noted that, other than the manager of the Hospital Epidemiology Department and nonmedical experts, only one additional physician and one additional nurse were involved in the PSYGIENE project. Although projects to promote hand hygiene are thus not free of cost, investments in this area may pay off, as the costs associated with nosocomial infections are high.
Finally, hard outcomes such as nosocomial infections have not yet been analyzed in relation to compliance trends. The outcomes described above are therefore surrogate outcomes. At the same time, sustainable promotion of hand hygiene compliance is not an end in itself but a means of preventing infections, and although this is plausible for the PSYGIENE observation period (1–3) it has yet to be proved.
This trial was conducted in ICUs and HSCTUs of a university tertiary care facility. Whether its findings can be generalized to normal wards or general or secondary-level hospitals has yet to be tested.
As in other comparable trials, increases in hand hygiene compliance were observed in PSYGIENE, although over a relatively long follow-up period: only 2 of 16 studies reported on longer periods (37). At the same time, PSYGIENE is one of the few trials, and the first in Germany, to examine how to increase compliance again after a relapse. Another, albeit shorter Dutch study on benefit-related messages also reversed a negative trend (38). Finally, to the best of our knowledge, PSYGIENE is the first randomized controlled trial to apply the concept of tailoring to hand hygiene compliance and to test it against a one-size-fits-all approach on the basis of a behavioral psychological theory. It is thus in line not only with the call for well-grounded, behavioral science–based promotion of hand hygiene (27, 30, 31, 34, 37, 39, 40), but also with the call for standardized description of complex behavioral interventions by using the BCT taxonomy (22). At the same time, besides lower hand hygiene compliance rates, physicians’ less favorable starting conditions, as indicated by a pessimistic trend regarding hygiene in the form of lower scores on the psychological HAPA variables (28, 29), show that physicians should be a particular target group for future research.
This manuscript conforms to the extension of the Consolidated Standards of Reporting Trials (CONSORT) Statement for cluster-randomized trials (consort-statements.org).
The ethics committee of Hannover Medical School approved the trial on May 9, 2012 (vote #1434–2012). The employee committee did so on October 18, 2012.
Funding: This trial was conducted as part of the PSYGIENE research project (running from April 1, 2012 to February 11, 2016; grant ID: INFEKT-019) funded by Germany’s Federal Ministry of Health in the programme “Antibiotic resistance, hygiene and nosocomial infections.”
Conflict of interest statement
The authors declare that no conflict of interest exists.
Manuscript received on 4 July 2016, revised version accepted on
7 September 2016.
Translated from the original German by Caroline Shimakawa-Devitt, M.A.
PD Dr. phil. Dipl.-Psych. Thomas von Lengerke
Medizinische Hochschule Hannover
Zentrum Öffentliche Gesundheitspflege
Forschungs- und Lehreinheit Medizinische Psychologie (OE 5430)
30625 Hannover, Germany
eBoxes, eFigures, eTables:
Department of Diagnostics, Institute of Hygiene/Hospital Epidemiology, Leipzig University Hospital:
Dr. rer. biol. hum. Lutze, M. Sc., Prof. Dr. med. Chaberny
Center for Public Health and Healthcare, Institute for Epidemiology, Social Medicine and Health Systems Research, Hannover Medical School: Prof. Dr. rer. pol. Dipl.-Volksw. Krauth, Dr. PH Dipl.-Oec. Stahmeyer
Centre for Laboratory Medicine, Institute for Medical Microbiology and Hospital Epidemiology, Hannover Medical School: Prof. Dr. med. Chaberny
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