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APPENDIX 1-

The results of the National Observational Study to Evaluate the

“cleanyourhands” Campaign (NOSEC) in England & Wales 2004-2008: a four

year prospective ecological interrupted time series.

ABSTRACT

Introduction: The WHO’s First Global Patient Safety Challenge aims to reduce

healthcare associated infection (HCAI) through improved hand hygiene and offers

the 139 nations participating in its “SAVE LIVES: clean your hands” a multi-modal

hand-hygiene intervention not previously implemented or evaluated at a national

level. England and Wales rolled out a similar intervention, the “cleanyourhands”

campaign (CYHC), from 2004, to all 187 acute hospitals, following government and

public concern at levels of meticillin-resistant/sensitive S.aureus bacteraemia

(MRSAB &MSSAB) and Clostridium difficile infection (CDI). Here we report results of

an independent study evaluating its effectiveness and sustainability.

Method: The campaign comprised bedside alcohol hand-rub (AHR), posters, audit

and patient empowerment materials. Quarterly data on MRSAB, MSSAB and CDI,

procurement of soap and AHR, hospital type, and bed occupancy were collected for

each hospital together with data on other national interventions targeting these

infections. A mixed-effects Poisson regression model assessed associations

between procurement and HCAI rates, testing for hospital heterogeneity. Six

questionnaires (five voluntary, the last mandatory) assessed CYHC implementation

and sustainability six-monthly post roll out.

Findings: Combined soap & AHR procurement tripled from 21.8mls to 59.8 mls per

patient-bed-day. MRSAB rates fell from 1.878 to 0.909 cases/10,000 bed-days and

CDI from 16.75 to 9.49. MSSAB rates did not fall. Each extra ml/patient-bed-day of

soap was strongly associated with a 0.7% reduction in CDI throughout the study (IRR

0.993 [0.99,0.996] p<0.0001). Each extra ml/patient-bed-day of AHR was strongly

associated with a 1% reduction in MRSAB (IRR) 0.990[0.985,0.995]; p<0.0001) but

only in the last four quarters of the study These associations remained after

adjusting for the other variables significantly associated with reduction of MRSAB

and CDI: publication of the Health Act and Department of Health Improvement

Teams visits. Questionnaire response rates gradually fell from 134 (71%) at 6

months to 82 (44%) at 30 months, rising to 167 (90%) for the final mandatory one

with no evidence of attritional or selection bias from falling response rates. There was

widespread early implementation of bedside AHR and posters and a gradual rise in

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audit. At 36 months, 90% of respondents reported CYHC to be a top hospital priority,

with implementation of AHR, posters and audit reported by 96%, 97% and 91%

respectively. Patient empowerment was implemented less successfully.

Interpretation: The CYHC appears to have been effectively implemented and

sustained. Strong associations were found between use of AHR and soap and

reductions in MRSAB and CDI, which remained after adjustment for other variables

and interventions. Although the campaign’s central funding and co-ordination in the

context of a high profile political drive may affect generalisability of these findings, it

may provide a model for other countries to adopt or adapt to implement the WHO

“SAVE LIVES” initiative.

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The results of the National Observational Study to Evaluate the

“cleanyourhands” Campaign (NOSEC) in England & Wales 2004-2008: a four

year prospective ecological interrupted time series.

INTRODUCTION

The World Health Organisation’s (WHO) First Global Patient Safety Challenge,

launched in 2005 (1), aimed to reduce the international burden of healthcare

associated infection (HCAI) through sustained improvement in hand hygiene. This

lead, in 2009, to the WHO’s “SAVE LIVES: cleanyourhands”(2) initiative which

offered nations signing up to it a multi-modal hand hygiene intervention. The annual

global day publicising the SAVE LIVES initiative reported that 139 countries had

signed up to the initiative by May 2010 (3).

The intervention is very similar to the English and Welsh “cleanyourhands campaign”

(CYHC) (4) that was rolled out to healthcare workers (HCWs) in all acute hospitals in

2004 to combat high endemic levels of healthcare associated infection (HCAI) (5-7)

and low levels of hand hygiene compliance (8). Centrally funded by the Department

of Health (DoH) and co-ordinated by the National Patient Safety Agency, the

campaign, recognised as the first such national campaign in the world (9) was

introduced at a time when reduction of HCAI, and in particular, meticillin-resistant

Staphylococcus aureus bacteraemia (MRSAB) and Clostridium difficile infection

(CDI), had become a national priority. This followed a period (1999-2004) during

which a DOH funded study (5), two National Audit Office reports (8,10) and

subsequent Parliamentary Accounts Committee responses (11,12), resulted in

national mandatory reporting of MRSAB, meticillin-sensitive S.aureus bacteraemia

(MSSAB) and CDI (6,7), and NHS plans (13,14) emphasising the importance of hand

hygiene.

The NPSA carried out and evaluated a pilot (15) of the campaign, whose main

components were interventions reported (16-18) to be effective at the level of the

single hospital (17) or individual unit (18). These were provision of alcohol hand rub

(AHR) at the bedside, distribution of posters reminding HCWs to clean their hands,

regular audit and feedback of compliance, provision of materials empowering

patients to remind HCWs to clean their hands, and detailed guidance to help secure

institutional engagement. However, such interventions had not previously been

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implemented or evaluated at a national level (19) and questions about their

generalisability remained. Full details of the CYHC can be found elsewhere (3,20).

Whilst the CYHC was being planned, the Department of Health tendered for

independent research to evaluate its sustainability and effectiveness. The resulting

study, a prospective ecological interrupted time series study assessed the

campaign’s implementation, sustainability and effects on hand hygiene and rates of

MRSAB, MSSAB and CDI from 1st July 2004 to 30th June 2008. The null hypothesis

was that initial uptake of the intervention would not be sustained and that there would

be little effect on levels of hand hygiene, MRSAB, MSSAB and CDI.

METHODS

Study design: A prospective ecological observational interrupted time series design

using widely available routinely collected data at the acute trust level was used. A

cluster randomized controlled trial was not feasible because the DoH wanted all

trusts to participate in CYHC, and the policy imperative was to roll the intervention

out quickly, which precluded a stepped wedge time series analysis. An ecological

design was therefore chosen as the most pragmatic option, as such studies, which

recognize the influence of environmental determinants of disease (in this case hand

hygiene), can assess public health interventions (29) and have the advantages of

lower cost, use of data that already exists, a wider range of exposures than is

possible in a trial and its potential generalisability. Data was collected at the acute

trust level.

Study phases and setting: The intervention was applied to the first six trusts in

December 2004 and to the remaining 181 by the end of June 2005 in four waves. As

the intervention was applied to so few trusts in December 2004, mostly those that

had been involved in the pilot, national roll out was considered to have begun on 1st

January with the NOSEC study divided into three pre-defined phases: from 1st July

2004-31st December 2004 (6 months prior to roll out of CYHC), 1st January - 30th

June 2005 (CYHC roll out), and 1st July 2005 - 30th June 2008 (post roll out) (Table

1). It was designed and has been reported according to the ORION statement for the

publication of infection control intervention studies (21), with formal implementation of

a predefined protocol, approved by Multi-centre Research Ethics Committee

(reference number 04MRE/10/66 Scotland).

Outcome measures:

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(i) Campaign implementation: Implementation of the main components of the

campaign was assessed by a voluntary postal questionnaire sent to infection control

teams in all acute NHS trusts in England and Wales after roll out in Dec 2005 (N1),

June 2006 (N2) Dec 2006 (N3) June 2007 (N4), Dec 2007 (N5) and June 2008 (N6).

Respondents were asked to state whether they strongly agreed, agreed, neither

agreed or disagreed, disagreed or strongly disagreed with statements made about

implementation of the campaign. The questionnaire was piloted in 8 acute trusts

before the first questionnaire was distributed for the study and the NPSA wrote to

chief executives asking that they facilitate compliance with the study ahead of the

first and fourth questionnaires. Trusts were given two months to respond after which

they received two postal reminders. In line with a national agreement to avoid

questionnaire “overload” for trusts, the National Audit Office, which was conducting

the third mandatory national survey of infection control practice, included the NOSEC

questions in their own questionnaire, sent out in October 2008, for those trusts which

had failed to respond to the final NOSEC questionnaire (N6). There were three extra

questions inserted into the final questionnaire for all trusts to answer: one seeking

information on the specialty of wards where bedside AHR was not available, one

asking how often audits were carried out and one asking what the average hand

hygiene compliance in the previous year had been.

(ii) Hand hygiene compliance: Monthly procurement data (volume) for AHR and

liquid soap for each individual trust acted as a proxy marker of hand hygiene

compliance and were collected prospectively via the central suppliers (NHS Supply

Chain in England, and Welsh Health Supplies in Wales). Hand hygiene consumable

use was used in preference to direct observation of hand hygiene as the original

Geneva study (17) upon which CYHC was largely based, had shown a rise in both

consumables and compliance data, and it is a more practical objective and reliable

way to assess quantitative change in hand hygiene behaviour and compare trusts

(22), unaffected by Hawthorn effects, reflecting 24 hour seven days a week use with

trust level data widely available before and after roll out of the intervention. In

addition, it would not have been practical to collect directly observed compliance data

in a standardised way across so many sites.

(iii) MRSAB, MSSAB and CDI rates: The study had access to the national

mandatory reporting scheme database for England held by the Health Protection

Agency and collected trust-level quarterly count data for trust acquired MRSAB

(using a more than 48 hour post admission cut off), trust acquired CDI in patients

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aged 65 years and above (using a more than 48 hrs post admission cut off), and

MSSAB which was not clearly differentiated between trust and community acquired.

Trust acquired CDI in patients under 65 years old was not included in this study as

this data was not required under mandatory reporting until April 2007. Data for Welsh

Trusts were collected from www.wales.nhs.uk/site3 their open access data base, but

had to be discounted as this case mix was not the same as that from England being

an amalgam of acute and community trust and primary care cases, which could not

be differentiated. Acute trusts in England were categorised as acute, teaching and

specialist as in the national mandatory reporting scheme.

(iv) Denominator: The number of occupied bed days for each month or quarter was

estimated using national KH03 data, collated by the Department of Health, which

measures average daily bed occupancy for each acute trust from their returns of the

number of beds available and occupied at midnight. This acted as a denominator for

MRSAB and MSSAB count data and for procurement data. In the case of CDI data

that concerned only patients over 65 years, this only provided an estimate of the

incidence, as there are no age related KHO3 data.

(v) Potential confounders: Over the period of the study there were other national

infection control interventions which had a potential confounding effect on hand

hygiene and/or infection rates and whose dates at national level or trust level were

recorded by the study. The interventions and their timing are summarised in Table 1.

They comprised the Saving Lives Campaign (23), for which each trust registered, the

announcement of a national target of a 50% reduction in MRSAB over three years

(November 2005), visits by Department of Health (DoH) Improvement Teams (Table

1) to 153 trusts and the publication of the Health Act (24) on 1st October 2006. The

dates that individual trusts registered with Saving Lives or received an Improvement

Team visit were recorded. Neither the new national guidelines for management and

prevention of CDI (25), published seven months after the study, nor its earlier

consultation version released on line only four months before the end of the study,

were considered as potential confounders, nor were the healthcare commission

reports into the CDI outbreaks at Stoke Mandeville (26) and Tunbridge Wells trusts

(27), as neither of these were interventions with which trusts had to comply or

register with. Trust level data on mupirocin usage was collected via IMS Systems for

trusts, as a surrogate marker for MRSA screening and eradication, as it was not

possible to collect trust level data on the numbers of patients screened for MRSA or

given eradication therapy. Routine data on trends in trust level antibiotic prescribing

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were not available across the study period and could not be supplied by IMS.

Average length of stay data was recorded for each trust from Hospital Episode

Statistics.

ANALYSIS

(i) The proportion of trusts responding to each NOSEC questionnaire was recorded,

and the responses to questions on campaign implementation were expressed as a

percentage of the total number of responses. The results were assessed for

attritional bias, as response rates fell, by comparing responses to from consistent

responders (trusts who responded to all questionnaires) with those from inconsistent

responders, using Pearson’s Chi Squared (χ²) and Fisher’s Exact tests for each

voluntary questionnaire. The same calculations were done to compare the

questionnaire returns of those who responded to the sixth voluntary questionnaire

with those that responded to the mandatory version. Selection bias with respect to

trust type, was examined by comparing the proportions of acute, teaching and

specialist trusts responding to each questionnaire for significance (Z scores), and by

comparing the amount of AHR and soap procured in responding and non responding

trusts for each questionnaire in case responders might also be those using more

hand hygiene consumables and therefore more compliant with the campaign.

(ii) Smoothed trends in monthly procurement data were estimated by applying a

series of median smoothers to the time series of AHR and soap from each trust and

expressed as mls per patient bed day for soap, AHR and both in each quarter.

Twenty-three trusts were excluded from the analysis of AHR data as they either had

a sequence of at least 18 months with missing data or the volumes purchased

through NHS Supply Chain were very low and the remaining procurement

information from other sources was not available. Forty-four acute trusts were

excluded from the soap data as they had at least two years of missing data or were

supplied by another source. The rate of change was assessed in a mixed effects

linear regression analysis with usage per bed day as the outcome variable, with the

roll out, Year 2 refreshment of the campaign, Year 3 re-launch and quarter as fixed

effects and trust as a random effect.

(iii) Trends in quarterly MRSAB, MSSAB and CDI rates were expressed in cases per

10,000 patient bed days for 170 English acute trusts. There were five English trusts

excluded from the MSSAB data due to mergers and re-organisations that disrupted

the continuity of data from those trusts. Four children’s trusts were excluded from the

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CDI figures, because mandatory surveillance of CDI was for patients aged 65 years

and older for most of this study.

(iv) The quarterly counts of incident MRSAB, MSSAB and CDI for each trust over the

study period were obtained from the HCAI mandatory surveillance system. These

were used as the outcome variables in a series of mixed effects Poisson regression

models to assess the associations with estimated concurrent hand hygiene

consumable usage. The consistency of the associations between infections and

consumables was assessed by incorporating interaction terms for quarter and

consumables. Other interventions aimed at reducing the level of these infections and

which required trusts to register or comply with (date of registration with Saving

Lives, publication dates of the Saving Lives care bundles, date of the announcement

of national MRSAB target, the date of a DoH improvement team visit, date of

publication of the Health Act) together with category of trust (specialist, acute and

teaching), average length of stay and mupirocin usage were included in the

regression models as fixed effects to control for any potential confounding. To allow

for a lag in the effectiveness in some of the above interventions, the data were

categorised to include periods immediately pre and post intervention. The quarter

and trust were included into the regression models as random effects. The KH03

estimated number of occupied bed was used to provide the estimated occupied bed

days in each trust each quarter and its natural logarithm was used as an offset in the

regression model to directly obtain estimates of incidence rate ratios Those trusts for

which the hand hygiene consumable data was missing as described above were

excluded from these models. All models were fitted to the data using the

xtmepoisson command within Stata 11. Funnel and scatter plots explored whether

particular trusts made a large contribution to any changes in MRSAB. The effect of

trust type was explored for MRSAB, MSSAB and CDI with a three way interaction.

RESULTS

(i) Campaign implementation (Table 2)

Response rates to the voluntary NOSEC questionnaires (N1-5) are shown in Table 2.

They declined from 71% to 44% but rose to 90% for the final questionnaire (N6)

when 77 respondents to the voluntary version were added to the 90 who responded

to the mandatory version distributed by the NAO. This gave a national “snap shot” of

campaign implementation at three or more years post roll out. For N1 and N2 there

were 189 acute trusts but due to mergers, this fell to 187 (N3 and N4) and 185 (N5

and N6).

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Throughout the study, infection control teams responded positively to the statement

“Management have, by their actions, shown that the campaign is a top priority in the

Trust” and reported widespread implementation of bed side AHR and ward display of

posters, with a steady rise in audit and feedback. At three years or more post-roll out

the campaign still appeared a top priority, with near universal implementation of

bedside AHR, ward posters, and audit and feedback. In response to questions

included only in the NAO questionnaire, trusts reported that the frequency of audit

and feedback was weekly in 46%, monthly in 36% and quarterly in 7% of trusts. The

average (standard deviation) reported hand hygiene compliance in trusts over the

past year was 83% (11%) with a median (interquartile range) of 87% (78-92%) (total

range 50%-100%). Where there were wards with no AHR or posters, these wards

were, in 83% of trusts, paediatric, liver, or psychiatric wards. Patient empowerment

was the least successfully implemented component and most trusts did not think it

had altered patients’ behaviour.

There were 53 trusts that responded to all six questionnaires. Comparison of their

responses with those of other trusts responding to each individual voluntary

questionnaire, and comparison of those of the 77 responders to the voluntary N6 with

those of the 90 responders to the mandatory version of N6, showed no significant

differences suggestive of attritional bias. There was no evidence selection bias with

respect to category of trust responding to different questionnaires or the amount of

AHR or soap procured (results available from authors)

(ii) Trends in AHR and soap procurement (Figure 1 and Table 3)

Figure 1 shows the procurement of soap and AHR with the roll out, year 2

refreshment and Year 3 re-launch marked. Average AHR “usage” or procurement

increased from 3.43 to 26 mls per bed per day. Average soap use doubled from 17.4

to 33.8 mls per patient per bed per day. Combined consumable usage almost tripled

from 21.8mls to 59.8 mls. After an initial rise in AHR and soap procurement, during

roll out, which was significantly greater than that in the pre-intervention phase, the

level of procurement plateaued (Figure 1). There was a significant rise after the year

2 refreshment of the campaign, although that of AHR was significantly slower than

that seen in the roll out phase (Table 3). The rises seen after the Year 2 refreshment,

were maintained after the Year 3 re-launch, although the rate of rise of AHR was

slower than that of the roll out phase (Table 3). There were no differences in

procurement of AHR and soap in relation to NOSEC questionnaire findings.

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(iii) Trends in HCAI rates (Figures 2, 3 and 5)

MRSAB data was available for 170 acute English trusts and the rate was at its

highest in January to March 2005 at 1.878 infections per 10,000 bed days and

continued at similar levels for five quarters after which a steady decline occurred to

less than half this rate at 0.909 MRSA bacteraemias per 10,000 bed days (Figure 2).

For a 500 bed acute trust this is equivalent to a fall from 34 to 16 cases a year.

Histograms of the distribution of the estimated average incidence rate ratio and

average MRSAB rate for each trust (figures 3 and 4) and a scatter plot of the

estimated the average quarterly change in incidence rate ratio against the pooled

MRSAB rate over all quarters (Figure 5) shows no particular trusts making a

disproportionately large contribution to the reduction in MRSAB. The two trusts with

incidence rate ratios below 0.8 are trusts with small numbers of MRSAB that have

reduced to zero. The trust with the third highest MRSAB rate appears to have an

increasing problem but, on inspection of the data, this trust’s most recent KH03 bed

day estimate is clearly incorrect going from above 800 occupied bed days in the first

years to 253 in the last.

MSSAB data was available in 165 trusts (Figure 2) with the rate rising from 2.67 to

3.23 incident cases per 10,000 bed days in July to September 2007, and

subsequently falling slightly to 3.0. For a 500 bed acute trust this is equivalent to a

rise from 40 to 55 cases a year.

CDI data for patients aged 65 and over was available for 165 trusts and showed a

seasonal pattern with peaks in the first quarter of each year (Figure 6). CDI gradually

rose and reached a peak of 16.75 cases per 10,000 bed days in January-March

2007, after which it steadily declined to 9.49 cases of CDI per 10,000 bed days in

April to June 2008, with no seasonal peak that year. This is however an

underestimate as we have no age related KHO3 bed occupancy data for this

population. For a 500 bed acute trust this is equivalent to a fall from approximately

306 to 174 cases per year.

(iv) Associations between HCAI, Hand Hygiene Consumables and other

interventions.

a. MRSA bacteraemia (Table 4 and Figure 7)

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There were116 trusts with AHR and soap data which contributed a total of 1727

quarters of observations. For the remaining quarters a least one of the predictor

variables were missing.

Increased use of AHR was strongly associated with a reduction in MRSAB (Table 4).

This changed over time, becoming significant in the last four quarters of the study,

with an estimated reduction in MRSAB of 1.3% for each additional ml used per bed

per day (Figure 7). Publication of the Health Act and receipt of an Improvement Team

Visit were significantly associated with a reduction, the latter two or more quarters

after the visit. There was no association with soap, Saving Lives, publication of the

care bundles, mupirocin procurement, length of stay or the national MRSAB target.

Trust category was significantly associated (p=0.001) reflecting the fact that the initial

burden of MRSAB was highest in teaching and lowest in specialty trusts. The three-

way interaction between trust category, AHR and quarter was not significant (chi

square 37,70, 30 degrees of freedom, p=0.16), indicating that the association

between MRSAB and AHR over time did not differ between the trust categories.

(b) MSSA bacteraemia (table 5)

A total of 115 trusts contributed a total of 1685 quarters of observations. There was a

significant association between increasing use of liquid soap and increasing MSSA

bacteraemia, which may be due to co-linear trends. There were no associations with

AHR, Saving Lives, Improvement Team Visits, Health Act, MRSAB target, length of

stay or mupirocin procurement. There was a significant association with trust

category (p<0.0001), reflecting the fact that the initial burden of MSSAB was

significantly higher in teaching trusts than acute and speciality.

(c) CDI rates (Figure 8, table 6 and Figure 6)

A total of 112 trusts contributed a total of 1658 quarters of observations. There was

strong evidence that increasing soap use was associated with a reduction in CDI. For

each extra ml used per patient per day there was a 0.33% (95% CI 0.49% to 0.18%)

reduction in CDI [IRR, 95% CI: 0.9967 (0.9951, 0.9982); p<0.0001] (Figure 8). There

was no strong evidence that this changed over time when comparing the overall

estimates with those obtained in each of the four years (likelihood ratio test; chi

square=1.89, 3 degrees of freedom, p=0.6). There was a strong association between

increased AHR use and increased CDI, (IRR 1.013 (1.009, 1.017); p<0.0001) which

changed over time, being most marked during periods of high CDI incidence (Figure

6).

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The Health Act was significantly associated with a reduction (IRR, 95% CI 0.75 (0.67,

0.84); p<0.0001) as were Improvement Team visits two or more quarters post visit

(IRR, 95% CI 0.80 (0.71, 0.90); p<0.01). Specialist trusts were associated with

significantly lower levels (p<0.0001), partly because there were many fewer patients

over 65. The three way interaction between trust category, liquid soap and time was

not significant (chi square 25,54, 16 degrees of freedom, p=0.06), indicating there

was no strong evidence to suggest that the association between CDI and soap over

time, did not differ between the trust categories.

There were no other significant associations.

(v) Association between hand-hygiene consumables and improvement team

visits

(Table 7)

Associations between improvement team visits and consumables were assessed

using a mixed effects model taking into account the increasing temporal trend in

consumables and trust type, and differentiating between CDI visits, which might be

expected to reinforce soap use, and MRSA visits, which might be expected to

emphasise AHR use. There were no such associations.

DISCUSSION AND CONCLUSIONS

This study has shown that the cleanyourhands campaign, the first (9) national multi-

modal hand hygiene improvement strategy appears to have been successfully

implemented and sustained, disproving the original null hypothesis. There were

strong associations observed between reductions in MRSAB and the amount of AHR

used, and between CDI and the amount of soap used per patient per day, which

remained after adjusting for other variables and interventions. Procurement of hand

hygiene consumables increased three-fold, rises being associated with both roll out

and re-launches of the campaign. At three years or more years post roll out, CYHC

was still considered a top priority in nearly all acute trusts. Given the similarities

between the campaign and the WHO’s multi-modal hand hygiene improvement

strategy (2), this study has important implications for the 139 countries that have

signed up to the WHO initiative. It also has important implications for the design and

conduct of future studies to evaluate national infection control interventions.

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The strengths of the study include the high ascertainment rate for MRSAB, MSSAB

and CDI, the use of trust level data for procurement data and potential confounders,

use of a mandatory final questionnaire with a high response rate to provide a national

“snapshot” of institutional engagement and campaign implementation at 3 years post

roll out, and the use of a consensus statement setting standards for the design and

reporting of infection control interventions (21). Data on contextual changes was

collected, such as legislation (Health Act), national targets and interventions (Saving

Lives and Improvement Team visits) aimed at reducing HCAI in general and MRSAB

and CDI in particular. Other relative strengths include the fact that measures were

taken to maximise the voluntary questionnaire response rate (shortening the

questionnaire, asking the NPSA to write to chief executives, issuing two reminders to

late returning trusts) something reported as not being done in 85% of health care

worker questionnaire surveys (28). Similarly the efforts to assess attritional and

selection bias throughout the study provide reassurance that the questionnaire

responses are representative of the national picture and count as a relative strength

of the study as only 16% of studies using postal questionnaires for HCWs are

reported to have done this (28). The study also reflects the inherent strengths of the

ecological design: simplicity, convenience, use of routinely available data, and a

much wider range of exposures, over a long period of time than is possible for a

randomised trial of a public health intervention, which increases its potential

generalisability. Widely used in injury prevention (29), they are eminently suitable to

study infection control interventions, which alter the environment affecting

transmission of disease, through changing healthcare worker behaviour. The

inherent disadvantages of the design are that data sources may be flawed and

confounding factors hard to control for. Nonetheless, when measurement, analysis

and interpretation are at the group level, and the data is reliable and available, and

inferences from group to individual level are avoided, as in this study, such limitations

can be minimised.

Potential limitations of the study include use of self-reporting questionnaires, the

questionnaire response rate, the lack of directly observed hand hygiene compliance

data, the possibility that not all AHR is used at the bedside or by HCWs, and the lack

of some baseline data and data on antibiotic use. Self-report questionnaires are a

standard tool of health service research. It is possible that respondents over-estimate

the quality of their service but experience of many questionnaire-based national

audits (30,31) and of all three National Audit Office reports on HCAI (8,10,32) show

that respondents often make clear where services are deficient. The falling response

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rate over the three years, until the final questionnaire was made mandatory, probably

represents a well recognised trend in questionnaire based research over the last

decade attributed to the increased demands for information in general from HCWs

(28). The initial response rate of 71% by the infection control teams, usually the

infection control nurse, was well above the median (IQR) of 50% (37-71%) reported

in the literature for nurse directed questionnaires (28), and remained so for the first

four questionnaires. Although this was below the 75% conventionally thought

necessary to minimise bias but extensive analyses were undertaken to exclude this.

The main reasons why data on directly observed hand hygiene compliance was not

collected and consumables data preferred are summarised in the methods. Current

opinion seems to endorse this decision (22) with the most detailed recent study

showing that direct observation substantially over-estimates compliance calculated

from consumables use (33). There is little reason to suspect that consumables use

would rise but not hand hygiene compliance, based on the original Geneva study

(17) and on subsequent similar studies (34-37) which all reported rises in both. A

recent study in 10 trusts indicates that patient and visitors use accounts for no more

than 15% of AHR and 4 % of soap use (38). While consumables can only be a proxy

for compliance, and there is debate within the literature (19), we were able to

overcome the main limitation of procurement data, procurement spikes caused by

infrequent bulk orders, by using smoothing techniques and excluding trusts where

data was absent or unreliable. Ideally, this would have been supplemented with

directly observed hand hygiene data from a small number of sentinel trusts.

Unfortunately, there were insufficient research funds and time to recruit and train

observers to assess directly observed compliance using a rigorously validated

method. Compliance data collected by trusts as part of CYHC was considered

unreliable due to the variety of audit tools used which lack standard operating

procedures and the proven reliability (39-41) required to ensure inter-and intra- trust

consistency. There was also no routinely available trust level compliance data prior to

CYHC to allow pre and post comparison. Although the data should be interpreted

with caution, the levels of compliance reported in the NAO questionnaire are

substantially higher than the pre-intervention level of 25% noted in the CYHC pilot

study (15) and the usual level of 40% noted in most studies (19).

The study was partially able to address the lack of adequate baseline data for

procurement of AHR and soap, which was not available from before July 2004. Best

practice for infection control intervention studies requires at least three pre-

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intervention time points to assess outcomes (21) and data was available for only two

for all trusts. However, the campaign was rolled out to 100 (53%) of trusts in the

fourth quarter of the study which meant that just over half had the minimum pre-

intervention time points, which is more than most studies of hand hygiene

campaigns, which often have just one pre-intervention point (17,34-37,42,43). The

original intention of the study was to use monthly procurement data, which would

have given at least six pre-intervention time points for all trusts. Requisition patterns

necessitated smoothing to provide quarterly data, and this was required to examine

the association with infection rates, which could only be widely collected quarterly.

However, an earlier published analysis of the first year of the study used monthly

procurement data, and thus at least six pre-intervention time points per trust, and

demonstrated a significant rise in AHR with a trend for increased soap procurement

during the roll out (44). Although national MRSAB, MSSAB and CDI data was

available for a much longer pre-intervention time period and the ideal (21) would be

to have one year’s baseline data to be sure there were no seasonal variations, it was

not collected in order to ensure that consumables and infection data was

contemporaneous. Concerns however that seasonal variations would act as another

confounder are probably more theoretical than real as inspection of the data shows

no obvious seasonality in infection or consumables data except for the clear winter

rise in CDI which was abolished by the end of the study.

The most important limitation is the unavailability of data on broad spectrum antibiotic

use, changes in which might have contributed to the falls in MRSAB and CDI and

therefore be an important confounder for the strong associations between reduction

of MRSAB and CDI and increases in AHR and soap respectively. There were no

robust systems to collect antibiotic data this in almost all trusts at the start of the

study, a longstanding problem highlighted as in the 2009 NAO report into HCAI (32)

and its subsequent Parliamentary Accounts Committee response (45). Data on

expenditure on antibiotics was not collected as this is affected by frequent changes in

contracts and price agreements between trusts and suppliers, impairing calculation of

use. No English or Welsh trusts took part in the ESAC (46) prevalence study of

antibiotic use before 2009, so it was not even possible to examine trends in use in a

sample of trusts. IMS systems were not able to provide this data on request.

However, there would have to be a strong correlation between rises in consumables

and decreases in selected antibiotics to abolish the strong independent associations

between consumables and infections. Studies reporting significant independent

associations between MRSA reduction and a rise in AHR and a fall in broad-

16

16

spectrum antibiotics, did not find that the association with antibiotics abolished that

with increased use of AHR (47,48).

Finally, one might argue that the MSSAB data should not be considered in this study

because trust and community acquired infections cannot be separated. However, it

was not clear at the start of the study that this would be a problem and reporting this

draws attention to a rise in an infection with substantial mortality and reinforces the

need identified by the NAO for better mandatory reporting (10,32,45). Its rise makes

it less likely that the fall in MRSAB is due to widespread “gaming”, as reporting of

both infections was mandatory. Moreover, MRSAB returns were subject to several

quality checks by the HPA who believes the data to be accurate with no indication of

widespread under-reporting of infections. The data is signed-off monthly by Chief

Executives who have to verify that the data reported is accurate. Gaming sufficient to

explain such large reductions in MRSAB would represent fraud on a massive scale.

The findings of this study are consistent with the findings of other evaluations of other

similar hand hygiene campaigns (17,34-37) conducted in smaller studies that a multi-

modal intervention resulted in improved hand hygiene compliance and increased

consumption of AHR. They are consistent with those studies reporting a fall in MRSA

infections (35,37) and an association of this, but not CDI (47,48) with AHR

(35,47,48). However, it differs from previous published and unpublished (42)

evaluations in that this is a nationwide study, with a much larger number of trusts,

conducted over a much longer period. It collected procurement data not only for AHR

but for soap, which gives a comprehensive assessment of consumables use. It

collected data on infectious outcomes and potential confounders, including other

national infection control interventions, at the individual trust level. It was designed

using the forerunner (49) of a consensus statement (21) setting standards for the

design and reporting of infection control interventions. As such it is a novel study, and

differs from other evaluations of infection control interventions in both scale and

scope (50).

The amount of AHR used per patient bed day was strongly associated with

reductions in MRSAB, with a 1.3% reduction for every extra ml used. There was no

such relationship with soap, consistent with it being a less effective hand disinfectant.

The association was seen later in the study, which may reflect the importance of the

community reservoir in determining the long-term dynamics of MRSA infection, and is

consistent with models predicting that effective trust interventions may take years to

17

17

exert their full effects on HCAI rates (51,52). The delay may also reflect a non linear

relationship between hand hygiene and MRSA transmission, or possible threshold

effects for hand hygiene compliance, as predicted by modelling studies (53,54) and

recently reported in hand hygiene intervention studies (55,56)

Soap use was strongly associated with reduction in CDI, each extra ml being

associated with a 0.33% fall in CDI, whereas AHR use was associated with a rise,

especially during periods of high CID incidence. This is consistent with the removal of

CD spores by soap and water but not by AHR (57). The lack of effect of soap and

AHR on MSSAB, may reflect the higher colonisation pressure of MSSA, as predicted

by modelling studies (51-53), and the possibility that the endogenous transmission of

infection, which is more likely for MSSA, is harder to interrupt with a simple measure

like hand hygiene, than the exogenous transmission more likely to be associated with

MRSA. This differential effect on MRSA and MSSA infections has been reported in

other studies (17,58). The rise in MSSAB is hard to interpret. Mandatory MSSAB

reporting does not require separation of trust and community acquired, unlike the CDI

and MRSAB data, and nosocomial MSSAB could not be separated in this study. A

high proportion of MSSAB are community acquired (59) so trust interventions are

less likely to have an impact on MSSAB than MRSAB. The observed rise in MSSAB

may be part of a more generalised increase in community-acquired staphylococcal

infections reported in England (60) and elsewhere (61), although this is speculative,

as are possible ecological interactions with MRSA.

The key finding of the study comes not from the before/after analysis but from the

interactions with consumables over time, namely a strong and independent

association with levels of procurement of AHR and soap with levels of MRSAB and

CDI respectively. These associations are derived at the individual trust level, making

the analysis much stronger than a simple analysis of national trends in hand hygiene

and HCAI. Whilst the limitations imposed on the study preclude strong statements

about causality, these findings meet many of Bradford Hill’s original (62) and updated

(63) criteria for causality, although it remains likely that there are multiple causes for

the reductions in MRSAB and CDI. The association is very strong, coheres with

existing theory and knowledge (51-57) and is biologically plausible. Importantly, there

is evidence of specificity, with AHR associated with MRSAB but not MSSAB

reduction, and soap not AHR being associated with CDI reduction. This strong

association with resistant but not sensitive organisms is consistent with theory which

predicts that non-specific measures that reduce patient-to-patient transmission will

have a disproportionate effect on resistant organisms for which exogenous infection

18

18

is likely to be more important (64). There is evidence of temporality and a dose-

response relationship at an environmental level that includes the possibility of a

threshold effect as discussed above. The association is consistent with findings in

different experimental settings for MRSA infection (17,40,35,37,47,48). We have not

been however been able to exclude all plausible alternative explanations, a limitation

of all non-randomised studies. In particular, the potential confounding effect of a

change in broad spectrum antibiotic consumption has not been addressed for

reasons stated above, but studies reporting reduced antibiotic use and increased

AHR procurement to be associated with reductions in MRSA, did not find the

association with one abolished the association with the other (47,48).

The Department of Health Improvement Team visits and the Health Act were also

associated with reductions in MRSAB and CDI, but did not affect MSSAB. Further

work is required to understand if there is any interaction between the campaign and

the visits, but this is hard to disentangle without prospectively collected information

on the exact interventions resulting from each trust visit. It was not feasible to collect

such detailed information, nor information on other local interventions at trusts or

even strategic health authority level, but such interventions are likely to comprise

activities central to either Saving Lives or the Health Act, which are both included in

the model. The improvement team visits, however, were not associated with

additional use of soap or AHR. This suggests that the campaign itself was the main

driver of increased use of consumables, possibly facilitated by the central co-

ordination of the campaign’s roll out and maintenance. Systematic review of smaller

scale interventions has suggested that frequent refreshment of interventions may be

needed (16). The piloting of the intervention in a small number of trusts and the

evaluation of that pilot prior to roll out, the preceding patient safety alert, the three

month preparation time given to infection control teams to engage their institution,

and the ongoing support given by a dedicated national CYH team with two

refreshments or re-launches of the campaign may all have been factors in securing

sustained implementation of the campaign’s key components. The exception to this

was patient empowerment, for which there appear to be more barriers than

facilitators (Ian Watt, personal communication).

The study has implications for future studies evaluating national infection control or

other patient safety interventions. These arise from its potential limitations, reflecting

the study’s background, that of a national health system reviewing the evidence base

on infection control to design an intervention, implementing it as national policy, and

19

19

funding a simultaneous evaluation to inform future health policy. Although this

effected a welcome synthesis between evidence, policy, practice and research, it

also imposed limitations on study design and conduct. The policy imperatives of

ensuring the intervention be rolled out to all acute trusts as quickly as possible

forestalled any attempt at a randomised controlled trial or stepped wedge trial. In

these circumstances ecological studies are a good option but the NOSEC study

faced three particular difficulties carrying out this design. Firstly, participation by

acute trusts in the evaluation, as distinct from the intervention, was not mandatory.

This limited the questionnaire response rates and the ability to collect non-mandatory

infection data. Secondly, the intervention was rolled out both earlier and more quickly

than originally anticipated, which limited the collection of baseline data, in particular

of hand hygiene consumables, which was not available from before July 2004.

Thirdly, data sources were incomplete or absent for important variables such as

antibiotic prescription or for mandatory data on a wider range of infections that would

have extended the generalisability of the study findings. NAO reports (10,32) and the

Parliamentary Accounts Committee (12,45) have called for extension of mandatory

reporting to other organisms and to antibiotic prescribing. It is essential that future

national interventions in infection control are evaluated. Consideration should be

given to making compliance with studies mandatory for trusts undertaking the

intervention, co-ordinating the timing of the intervention and the evaluation to balance

the competing needs of implementation and evaluation. Consideration should also be

given to extending the requirements for national reporting to other common

organisms, procurement of hand hygiene consumables, and antibiotic use. It is of

interest to note that the last two are national requirements in France (9).

The overall findings of the study provide evidence that a national campaign that

offers a multi-modal hand hygiene improvement strategy similar to that of the WHO

can meet the goals of the WHO’s first Global Patient Safety Challenge (1), namely a

sustained improvement in hand hygiene and a lower burden of HCAI. However,

some caution should be exercised in generalising these findings. The campaign and

the study took place in the context of a high profile political drive to reduce MRSAB

and CDI (24,65). In particular, legal responsibility for a trust’s compliance with the

Health Act lay with the chief executive and board, and the DoH Improvement Team

plans had to be signed off by the chief executive. Although government support for

hand hygiene campaigns has been identified in other unpublished studies in France,

Belgium and Germany (32,42,43) as central to their success, the degree of

government commitment in the UK to achieving reductions in specific infections,

20

20

which were important to both the electorate and to Parliament, should be taken into

account when generalising from this study. Replicating the campaign’s success in the

139 nations seeking to implement the WHO’s “SAVE LIVES: clean your hands” (2)

initiative may depend on countries’ ability to fund, co-ordinate and maintain the

intervention. This is likely to vary with local health service structures, available

resources, and the priority given to it by policy makers. A full cost effectiveness study

is underway but a preliminary economic model suggested that the campaign would

prove cost effective if it reduced HCAI by 0.1% (66). The NOSEC study has been of

necessity pragmatic and its limitations have been documented above. Bradford Hill

observed that all scientific work was incomplete but that did not confer freedom to

ignore the knowledge currently available or postpone the action that it suggests is

needed at the time (63). In that context, the independent association of consumables

use and reductions in MRSAB and CDI may provide a convincing rationale to

persuade funders to provide the resources necessary to implement the WHO

initiative.

In conclusion, CYHC is acknowledged to be the first campaign to be implemented

nationally throughout a country’s acute care trusts system (9). The evaluation has

shown that the campaign was effectively implemented and sustained long term and

that increased use of consumables was significantly and independently associated

with reductions in the burden of MRSAB and CDI nationwide. It is not known whether

this will generalise to other HCAIs. CYHC provides a model for other countries to

adopt or adapt to implement the WHO initiative.

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27

Setting: 185 acute hospitals in England & Wales X teaching, y

acute, z speciality

Intervention: National “Cleanyourhands campaign” (CYHC) comprising (i) placement of AHR at the bedside, (ii) ward posters (iii) patient

empowerment materials (iv) regular audit (v) institutional engagement.

Phase 1

6 months

(1st Jul-31st Dec

2004)

Phase 2

6 months

(1stJan-30th

June 2005)

Phase 3

36 months

(1stJul 2005

30th Jun 2008)

Cleanyourhands campaign Other national infection control interventions

Pre-roll out of CYHC intervention nil

September 2004: Patient Safety Alert

mandating bedside AHR.

Roll out of CHYC in four waves June 2005: Saving Lives campaign launched

(January, March, April, June) (www. clean-safe-care. nhs.uk)

Post roll-out: End June 2006 CYHC “refreshed” July 2005 onwards: Acute Hospitals Register for Saving Lives

with maintenance handbook

reiterating main components; November 2005: National MRSAB target announced

increased emphasis on audit

& feedback, use of soap for CDI, April 2006 on: Department of Health Improvement Team Visits

further guidance on institutional

engagement October 2006: passge of Health Act by Parliament

Oct 2007: CYHC Year 3 “re-launch” with

new posters designed in collaboration

with infection control teams

Summary of Saving Lives Campaign: delivery programme designed to support acute hospitals in reducing common HCAIs through the use

of a care bundle embedding infection control within a clinical governance framework.

Lives Campaign approach embedding infection control within a clinical governance framework.

National MRSAB Target: announcement of a national target of a 50% reduction in MRSAB over three years, to be achieved by each acute

hospital.

Dates: 1st July 2004-30th June 2008

Summary of Improvement Team visits: tailored package of support to help hospitals deliver Saving Lives and ensure that ultimate

responsibility for HCAI lay with the Chief Executive. One hundred and three hospitals targeted because of high or rising levels MRSA or CDI,

or likely failure to achieve MRSA target. A further 50 requested a visit.

Health Act: new legislation setting statutory criteria by which managers, chief executives and boards ensure prevention & control of HCAI managers of NHS organisations are to ensure that patients are cared for in a clean environment, where the risk of healthcare associated infection is kept as low as possible. associated infections.

Table 1: Phases of the study, key components of the campaign and timing of other national infection

control interventions.

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28

Table 2: Percentage of respondents to questionnaires 1-6 (N1-6) agreeing or strongly agreeing with statements:

N1 6 months

post roll out

N2 12

months post roll

out

N3 18

months post roll

out

N4 24

months post roll

out

N5 30

months post roll

out

N6 36

months post roll

out

Management’s actions show that CYHC is a top priority in Trust

78 71 75 78 74 90

AHR near-patient in >75% wards 94 88 85 83 86 96

Posters on >75% wards 88 79 79 74 79 97

Patient empowerment materials reaching patients on wards

68 48 41 38 65 65

Materials are changing patient’s behaviour

46 49 46 34 41 35

Audit &feedback in last 6 months on >75% wards

47 51 53 64 75 91

Total number (%) of responses

134 (71%)

126 (67%)

108 (58%)

99 (53%)

82 (44%)

167 (90%)

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Figure 1: Estimated quarterly hand hygiene consumable usage by quarter

Campaign roll-out period

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30

Table 3: estimated increase in hand hygiene consumables during roll out, Year 2 “refreshment” of the campaign and Year 3 “re-launch”.

Average increase

AHR per quarter

(95% C.I.)

Average increase

soap per quarter

(95% C.I.)

Average increase

both per quarter

(95% CI)

Roll out 1.83 (1.60, 2.07) 0.99 (0.41, 1.56) 2.80 (1.89 to 3.72)

Year 2 refresh 1.40 (1.10, 1.70)* 1.22 (0.38, 2.07) 2.71 (1.40, 4.03)

Year 3 re-launch 1.28 (1.16,1.41)* 1.08 (0.69, 1.48) 2.42 (1.93, 2.90)

* p< (roll out v year 2) < (roll out v year 3)

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31

Figure 2: Estimated quarterly rate of MRSAB and MSSAB infections per 10,000 bed days.

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32

Figure 3: Histogram of estimated average incidence rate ratio

0

51

01

5

pe

rce

nta

ge

.7 .75 .8 .85 .9 .95 1 1.05 1.1 1.15 1.2incidence rate ratio

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33

Figure 4. Histogram of estimated MRSAB rate

0

51

01

5

pe

rce

nta

ge

0 1 2 3 4MRSA bacteramia rate per 10,000 bed days

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34

Figure 5: scatter plot of average quarterly change in incidence rate ration

against pooled MRSAB rate over all quarters

.7.8

.91

1.1

ave

rag

e q

ua

rte

rly in

cid

en

ce

ra

te r

atio

0 1 2 3 4MRSA bacteramia rate per 10,000 bed days

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35

Figure 6: Estimated quarterly rate of C. difficile infection per 10,000 bed days

04

81

21

62

0

C. difficile

rate

per

10,0

00 b

ed d

ays

Jul 0

4 to

Sep

04

Oct

04

to D

ec 0

4

Jan

05 to

Mar

05

Apr

05

to J

un 0

5

Jul 0

5 to

Sep

05

Oct

05

to D

ec 0

5

Jan

06 to

Mar

06

Apr

06

to J

un 0

6

Jul 0

6 to

Sep

06

Oct

06

to D

ec 0

6

Jan

07 to

Mar

07

Apr

07

to J

un 0

7

Jul 0

7 to

Sep

07

Oct

07

to D

ec 0

7

Jan

08 to

Mar

08

Apr

08

to J

un 0

8

Quarter

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36

Table 4: Associations from the Poisson mixed effects model for mandatory MRSA bacteraemia

Predictor Estimated

Incidence

rate ratio

95% confidence

interval

P value

AHR rate per ml per day

July 2004 to June 2005 1.005 0.999 to 1.012

<0.0001 July 2005 to June 2006 1.003 0.998 to 1.008

July 2006 to June 2007 1.002 0.997 to 1.008

July 2007 to June 2008 0.990 0.985 to 0.995

Soap rate per ml per day 1.0004 0.9979 to 1.0030 0.8

Saving lives

Prior quarters Referent

Quarter implemented 1.02 0.93 to 1.12 0.9

Subsequent quarters 1.02 0.92 to 1.12

Improvement team visit (MRSA)

Prior quarters Referent

Quarter before visit 1.07 0.98 to 1.17

0.03 Quarter of visit 1.00 0.91 to 1.11

Quarter post visit 1.02 0.92 to 1.13

Subsequent quarters 0.91 0.83 to 0.99

Health Act 0.86 0.75 to 0.98 0.02

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Figure 7: Estimated IRR for MRSA bacteramia for a 1 ml per bed day increase in AHR by quarter

.97

.98

.99

1

1.0

11

.02

1.0

3

incid

en

ce

ra

te r

atio

Jul-A

ug 2

004

Oct-D

ec 2

004

Jan-

Mar

200

5

Apr

-Jun

200

5

Jul-S

ep 2

005

Oct-D

ec 2

005

Jan-

Mar

200

6

Apr

-Jun

200

6

Jul-S

ep 2

006

Oct-D

ec 2

006

Jan-

Mar

200

7

Apr

-Jun

200

7

Jul-S

ep 2

007

Oct-D

ec 2

007

Jan-

Mar

200

8

Apr

-Jun

200

8

quarter

Estimate 95% Confidence interval

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38

Table 5: Associations from the Poisson mixed effects model for mandatory MSSA bacteraemia

Predictor Estimated

Incidence

rate ratio

95% confidence

interval

P value

AHR rate per ml per bed-day 0.999 0.997 to 1.002 0.6

Soap rate per ml per bed per day 1.0029 1.0014 to 1.0043 0.0001

Saving lives

Prior quarters Referent

Quarter implemented 1.01 0.94 to 1.09 0.5

Subsequent quarters 1.05 0.97 to 1.11

Improvement team visit (MRSA)

Prior quarters Referent

Quarter before visit 1.03 0.95 to 1.11

0.3 Quarter of visit 0.92 0.85 to 1.00

Quarter post visit 0.97 0.89 to 1.05

Subsequent quarters 0.98 0.92 to 1.04

0.13 Health Act 1.05 0.99 to 1.13

Trust category: Speciality (referent to acute) IRR 0.91 [.78,.1.07] p= 0.3

Teaching (referent acute) IRR 1.3 (1.15,1.48) p<0.0001

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Table 6: Associations from the Poisson mixed effects model for C. difficile infections

Predictor Estimated

Incidence

rate ratio

95% confidence

interval

P value

Soap rate per ml per bed per day 0.993 0.990 to 0.996 <0.0001

AHR rate (mls per bed per day) 1.010 1.006 to 1.013 <0.0001

Saving lives

Prior quarters Referent

Quarter implemented 1.01 0.92 to 1.12 0.9

Subsequent quarters 1.00 0.90 to 1.11

Improvement team visit (C. difficile)

Prior quarters Referent

Quarter before visit 0.97 0.81 to 1.16

0.01 Quarter of visit 0.96 0.79 to 1.15

Quarter post visit 0.90 0.74 to 1.10

Subsequent quarters 0.80 0.71 to 0.90

<0.0001 Health Act 0.75 0.67 to 0.84

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Figure 8: Estimated IRR for CDI for a 1 ml per bed increase in soap by year

.99

.99

5

1

1.0

05

1.0

1

incid

en

ce

ra

te r

atio

Jul 0

4 to

Jun

05

Jul 0

5 to

Jun

06

Jul 0

6 to

Jun

07

Jul 0

7 to

Jun

08

year

Estimate 95% Confidence interval

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41

Figure 9: Estimated IRR for CDI for a 1 ml per bed day increase in AHR by quarter

.97

.98

.99

1

1.0

11

.02

1.0

3

incid

en

ce

ra

te r

atio

Jul-A

ug 2

004

Oct-D

ec 2

004

Jan-

Mar

200

5

Apr

-Jun

200

5

Jul-S

ep 2

005

Oct-D

ec 2

005

Jan-

Mar

200

6

Apr

-Jun

200

6

Jul-S

ep 2

006

Oct-D

ec 2

006

Jan-

Mar

200

7

Apr

-Jun

200

7

Jul-S

ep 2

007

Oct-D

ec 2

007

Jan-

Mar

200

8

Apr

-Jun

200

8

quarter

Estimate 95% Confidence interval

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42

Table 7: Associations between additional use of consumables and MRSA or

CDI improvement team visits

Time relative to

visit

Estimated additional quarterly usage of AHR

MRSA visit CDI visit

Prior quarters referent referent

Quarter of visit 0.96 (-1.22 to 3.13) p=0.39 -0.46 (-4.69 to 3.77) p=0.83

Post visit 0.81 (-0.67 to 2.29) p=0.28 0.53 (-1.99 to 3.05) p=0.68

Estimated additional quarterly usage of soap

Prior quarters referent referent

Quarter of visit -1.47 (-7.15 to 4.20) p=0.61 0.14 (-10.56 to 10.85) p=0.98

Post visit -0.90 (-4.80 to 3.00) p=0.65 -0.67 (-7.26 to 5.91) p=0.84

Estimated additional quarterly usage of soap & AHR combined

Prior quarters referent referent

Quarter of visit -1.71 (-9.94 to 6.52) p=0.68 0.95 (-14.46 to 16.36) p=0.90

Post visit -1.16 (-6.79 to 4.47) p=0.69 1.13 (-8.21 to 10.47) p=0.81

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43

APPENDIX 1: CAMPAIGN PREPARATION, CO-ORDINATION, ROLL OUT AND

MAINTAINENCE

The campaign was centrally funded by the Department of Health. Its preparation, roll

out and maintenance were centrally co-ordinated by the National Patient Safety

Agency (www.npsa.nhs.uk/cleanyourhands).

Preparation (2002-4): In 2002-3 the NPSA, together with the Procurement and Supplies

Agency (PASA), invited companies producing soap and alcohol hand rub to tender

for contracts to supply the National Health Service. Products had to meet efficacy,

safety and acceptability standards set by PASA (website references).

: In 2003 the NPSA conducted a six month pilot study in 12 wards in six

hospitals in England and Wales, which was rigorously evaluated (4) to inform the

future format and roll out of the campaign.

: In September 2004 the NPSA released a National Patient Safety Alert

mandating all acute hospitals to place of AHR at the patient’s bedside (website

reference). All acute hospitals were encouraged to register for the campaign and

185/187 hospitals did so. Roll out dates were randomly assigned to each hospital.

Roll out (December 2004-June 2005): The NPSA established a team of three people to

co-ordinate and support the campaign nationally. After the original 6 hospitals had

the campaign rolled out across all wards in their hospitals in December 2004, the

campaign was rolled out to 44 hospitals in January 2005, 40 hospitals in March 2005,

44 in April and 56 in June 2005. An implementation pack (11), which took account of

the findings of the pilot study, was designed to help hospitals prepare for and roll out

the campaign. This was issued to the infection control team in each hospital three

months before their roll out date and was available on line (11). The campaign

recommended that trusts order supplies from a central supplier, NHS Supply Chain in

England, and Welsh Health Supplies in Wales.

The key components of the campaign were

(i) ensuring bedside placement of AHR

(ii) ensuring adequate distribution of soap

(iii) distributing posters on each ward to remind HCWs to clean their hands

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44

(iv) distributing “patient empowerment materials” (leaflets for patients and “Its

OK to Ask” stickers and badges for HCWs to wear) to let patients know

that it was OK to ask if HCWs had cleaned their hands

(v) regular audit and feedback of hand hygiene compliance

(vi) a strategy to secure institutional engagement.

The implementation pack (11) gave full details on each of the main components and

detailed guidance on securing institutional engagement. Wards were advised to

conduct a baseline audit of hand hygiene compliance in the period before roll out,

and then repeat this and feed back the results to staff and managers at least every

six months and if possible monthly. Each hospital was expected to have a senior

management champion for the campaign, whilst each ward had a lead

implementer, a housekeeper who ensured that AHR and soap dispensers were

replenished, and a HCW in charge of changing posters every month. Each ward

received a year’s supply of posters, which had been specially commissioned by the

NPSA.

Campaign maintenance (July 2005-June 2008): The cleanyourhands team regularly

visited regions and hospitals to support the local champions and infection control

teams. Through the campaign website local champions and co-ordinators could

receive updates, download useful materials and ask advice. Local and regional

workshops, unstructured opportunistic interviews with HCWs, site visits and telephone

surveys facilitated feedback to the CYHC team.

June 2006-September 2007: At the end of June 2006 the campaign was officially

“refreshed” with publication of a campaign maintenance hand book “Flowing with

the go” (12) that incorporated much of the above feedback. It re-iterated the main

components of the campaign and gave infection control teams a chart to measure

their progress by. In particular it reminded teams that the emphasis should be on

placement of AHR at the bedside and not at ward entrances, and that soap and

water should be used when hands were soiled or when HCWs had been caring for

patients with Clostridium difficile. Teams were encouraged to repeat or follow up

steps taken to secure institutional engagement. More detailed guidance on audit

and feedback of hand-hygiene compliance was given. A new range of posters were

designed with input from acute staff. “Flowing with the go” (12) provided Q and As

about the campaign for infection control teams, and gave them “scripts” to address

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45

common misconceptions by HCWs. From July 2007, the CYHC website also featured

a newly developed, reliable and sensitive hand hygiene observation tool with

detailed standard operating procedures (www.idrn.org/nosec.php) (41).

October 2007-June 2008: In October 2007, Year three of the campaign was officially

launched with new posters that had been designed after a national workshop

facilitated an interaction between hospital campaign leads and a design agency.

These reflected the infection control community’s desire for “harder-hitting posters” to

emphasise the seriousness of HCAI and the importance of hand hygiene. These used

eye-catching visuals and bold messaging, with a black background giving a strong,

distinctive look that stands out in a hospital environment

(www.npsa.nhs.uk/cleanyourhands/timeline).