Cross InfectionHANDSNCT02511925
Electronic Hand Hygiene Monitoring and ICU Infection Rates
An observational study of Cross Infection, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
If patients acquire a new infection whilst in hospital this can cause significant morbidity, prolonged hospitalisation and even death. Indeed, there is much public concern about infections such as MRSA. Patients who require intensive care are probably at the greatest risk. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cross Infection
- What is being tested?
- Weekly poster of unit performance, Daily email of personal feedback and Active reminder from badge
- How many people
- 1,065 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2013to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients admitted to the ICU during the study period.
Who may be able to join
- All patients admitted to the intensive care units
- All healthcare workers caring for the patients on the intensive care units.
Who cannot join
- Healthcare workers with skin sensitivity to both alcohol hand rub and soap
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Brompton and Harefield NHS Foundation Trust
London
About this study
Official title: A Pragmatic Crossover Cluster Randomised Study of Electronic Compliance Monitoring of Staff Hand Sanitisation in Critical Care (HANDS Study)
If patients acquire a new infection whilst in hospital this can cause significant morbidity, prolonged hospitalisation and even death. Indeed, there is much public concern about infections such as MRSA. Patients who require intensive care are probably at the greatest risk.
Appropriate hand hygiene by healthcare workers can reduce infection rates and is a key goal of many patient safety initiatives. Worldwide, hand hygiene compliance has been estimated at only 38.7% despite the intervention being simple and cheap. Reasons for poor compliance include lack of time, skin irritation, lack of facilities, intensity of workload and forgetfulness. Furthermore, since cross infection may not be apparent for some days, staff may not associate their (lack of) actions with having caused harm.
Measuring compliance levels enables staff to understand whether they could improve. Direct observation of staff is labour intensive and is not continuous or universal. We will monitor hand hygiene compliance with a newly developed electronic system (MedSense, General Sensing Inc.). We will use the data to provide feedback to the staff in several ways. We hypothesise that comprehensive personalised feedback will reduce healthcare associated infections. We will undertake the study in three intensive care units.
Read the detailed description
All patients admitted to three intensive care units will be monitored for healthcare associated infections. In parallel the units will be cluster randomised to implement the electronic compliance monitoring in three different ways:
- Unit level feed back every week of current compliance for each of three staff groupings (doctors, nurses, allied health professionals)
- Personalised feedback in the form of an email at the end of a shift stating an individuals performance relative to the average for their professional grouping.
- Real time feedback in the form of a badge worn by the healthcare worker that vibrates when the system thinks they have missed or are about to miss an opportunity for hand hygiene.
All healthcare workers will receive the level of feedback defined in the randomisation for the duration of the three intervention periods. The units will cross-over with an interventing two week wash out period.
All personal feedback will be confidential and private to the individual.
- Conditions
- Cross Infection
- Being tested
- Weekly poster of unit performance, Daily email of personal feedback, Active reminder from badge
- Keywords
- Critical care, Feedback
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly poster of unit performanceOther
Weekly feedback is provided to the ICU about current levels of hand hygiene compliance amongst doctors, nurses, and allied healthcare professionals
Daily email of personal feedbackOther
Healthcare workers receive private and personal feedback via email regarding their individual performance benchmarked against the average performance for their professional grouping.
Active reminder from badgeOther
The badge the healthcare worker is wearing vibrates if opportunities to perform hand hygiene are missed
| Study group | Role | What they receive |
|---|---|---|
| ICU Cluster 1 | Adult Intensive Care Unit - Royal Brompton Hospital Receives: Other: Weekly poster of unit performance; Other: Daily email of personal feedback | |
| ICU Cluster 2 | Paediatric ICU - Royal Brompton Hospital Receives: Other: Weekly poster of unit performance; Other: Daily email of personal feedback; Other: Active reminder from badge | |
| ICU Cluster 3 | Adult Intensive Care Unit - Harefield Hospital Receives: Other: Weekly poster of unit performance; Other: Daily email of personal feedback; Other: Active reminder from badge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite health care infection rate
One of the following three:
Bacteriological proven infection at a normally sterile site. The sterile sites vein considered are a prior defined as blood, broncho-alveolar lavage, urine sampled from a catheter, chest drain fluid, and surgical wounds. Blood cultures that grow normal skin commensals will be included Endotracheal secretions that culture organisms other than normal upper respiratory tract flora Clostridium difficult related diarrhoea
Measured: Until the end of the second calendar day following ICU discharge
Secondary outcomes (9)
Incidence of central line associated blood stream infections
CDC definition
Measured: Until the end of the second calendar day following ICU discharge
Incidence of catheter associated urinary tract infections
CDC definition
Measured: Until the end of the second calendar day following ICU discharge
Incidence of ventilator associated pneumonia
CDC definition
Measured: Until the end of the second calendar day following ICU discharge
Incidence of surgical site infection
Public Health England definition
Measured: Until the end of the second calendar day following ICU discharge
Incidence of clostridium difficult diarrhoea
Public Health England definition
Measured: Until the end of the second calendar day following ICU discharge
Incidence of acquisition of new methicilllin resistant staphylococcus aureus
Measured: Until the end of the second calendar day following ICU discharge
Incidence of secondary blood stream infections
CDC definition
Measured: Until the end of the second calendar day following ICU discharge
Incidence of antibiotic resistance infections
Pre-defined as Acinetobacter baumanii, Pseudomonas aeroginosa (Extended-Spectrum Beta Lacatamase [ESBL] producing), Klebsiella penumoniae (ESBL producing), Escherichia coli (ESBL producing), Stenotrophomonas maltophilia, Serratia marcescens, Clostridium difficile, or MRSA.
Measured: Until the end of the second calendar day following ICU discharge
Adverse event rate
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startNov 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cross InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 1,065 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Cattini, MSc, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511925
- Sponsor's protocol ID
- 2013IC004B
- Acronym
- HANDS
- Status last verified
- Jul 2015
- First submitted
- 26 Nov 2013
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Cheng VC, Tai JW, Ho SK, Chan JF, Hung KN, Ho PL, Yuen KY. Introduction of an electronic monitoring system for monitoring compliance with Moments 1 and 4 of the WHO "My 5 Moments for Hand Hygiene" methodology. BMC Infect Dis. 2011 May 26;11:151. doi: 10.1186/1471-2334-11-151.
PubMed 21612666
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Crossover Cluster Randomised Study of Electronic Compliance Monitoring of Staff Hand Sanitisation in Critical Care (HANDS Study)
- ClinicalTrials.gov ID
- NCT02511925
- Acronym / sponsor ID
- HANDS / 2013IC004B
- Conditions
- Cross Infection
- Keywords
- Critical care, Feedback
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,065 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
If patients acquire a new infection whilst in hospital this can cause significant morbidity, prolonged hospitalisation and even death. Indeed, there is much public concern about infections such as MRSA. Patients who require intensive care are probably at the greatest risk.
Appropriate hand hygiene by healthcare workers can reduce infection rates and is a key goal of many patient safety initiatives. Worldwide, hand hygiene compliance has been estimated at only 38.7% despite the intervention being simple and cheap. Reasons for poor compliance include lack of time, skin irritation, lack of facilities, intensity of workload and forgetfulness. Furthermore, since cross infection may not be apparent for some days, staff may not associate their (lack of) actions with having caused harm.
Measuring compliance levels enables staff to understand whether they could improve. Direct observation of staff is labour intensive and is not continuous or universal. We will monitor hand hygiene compliance with a newly developed electronic system (MedSense, General Sensing Inc.). We will use the data to provide feedback to the staff in several ways. We hypothesise that comprehensive personalised feedback will reduce healthcare associated infections. We will undertake the study in three intensive care units.
Detailed description
All patients admitted to three intensive care units will be monitored for healthcare associated infections. In parallel the units will be cluster randomised to implement the electronic compliance monitoring in three different ways:
- Unit level feed back every week of current compliance for each of three staff groupings (doctors, nurses, allied health professionals)
- Personalised feedback in the form of an email at the end of a shift stating an individuals performance relative to the average for their professional grouping.
- Real time feedback in the form of a badge worn by the healthcare worker that vibrates when the system thinks they have missed or are about to miss an opportunity for hand hygiene.
All healthcare workers will receive the level of feedback defined in the randomisation for the duration of the three intervention periods. The units will cross-over with an interventing two week wash out period.
All personal feedback will be confidential and private to the individual.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ICU Cluster 1 | – | Other: Weekly poster of unit performance, Other: Daily email of personal feedbackAdult Intensive Care Unit - Royal Brompton Hospital |
| ICU Cluster 2 | – | Other: Weekly poster of unit performance, Other: Daily email of personal feedback, Other: Active reminder from badgePaediatric ICU - Royal Brompton Hospital |
| ICU Cluster 3 | – | Other: Weekly poster of unit performance, Other: Daily email of personal feedback, Other: Active reminder from badgeAdult Intensive Care Unit - Harefield Hospital |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admitted to the ICU during the study period.
Key inclusion criteria (2 listed)
- All patients admitted to the intensive care units
- All healthcare workers caring for the patients on the intensive care units.
Key exclusion criteria (1 listed)
- Healthcare workers with skin sensitivity to both alcohol hand rub and soap
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weekly poster of unit performanceWeekly feedback is provided to the ICU about current levels of hand hygiene compliance amongst doctors, nurses, and allied healthcare professionals | Other | ICU Cluster 1, ICU Cluster 2, ICU Cluster 3 |
| Daily email of personal feedbackHealthcare workers receive private and personal feedback via email regarding their individual performance benchmarked against the average performance for their professional grouping. | Other | ICU Cluster 1, ICU Cluster 2, ICU Cluster 3 |
| Active reminder from badgeThe badge the healthcare worker is wearing vibrates if opportunities to perform hand hygiene are missed | Other | ICU Cluster 2, ICU Cluster 3 |
Primary outcome
Composite health care infection rate
Time frame: Until the end of the second calendar day following ICU discharge
One of the following three: Bacteriological proven infection at a normally sterile site. The sterile sites vein considered are a prior defined as blood, broncho-alveolar lavage, urine sampled from a catheter, chest drain fluid, and surgical wounds. Blood cultures that grow normal skin commensals will be included Endotracheal secretions that culture organisms other than normal upper respiratory tract flora Clostridium difficult related diarrhoea
9 secondary outcomes
Incidence of central line associated blood stream infections
Time frame: Until the end of the second calendar day following ICU discharge
Incidence of catheter associated urinary tract infections
Time frame: Until the end of the second calendar day following ICU discharge
Incidence of ventilator associated pneumonia
Time frame: Until the end of the second calendar day following ICU discharge
Incidence of surgical site infection
Time frame: Until the end of the second calendar day following ICU discharge
Incidence of clostridium difficult diarrhoea
Time frame: Until the end of the second calendar day following ICU discharge
Incidence of acquisition of new methicilllin resistant staphylococcus aureus
Time frame: Until the end of the second calendar day following ICU discharge
Incidence of secondary blood stream infections
Time frame: Until the end of the second calendar day following ICU discharge
Incidence of antibiotic resistance infections
Time frame: Until the end of the second calendar day following ICU discharge
Adverse event rate
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
- Background: PubMed 21612666Cheng VC, Tai JW, Ho SK, Chan JF, Hung KN, Ho PL, Yuen KY. Introduction of an electronic monitoring system for monitoring compliance with Moments 1 and 4 of the WHO "My 5 Moments for Hand Hygiene" methodology. BMC Infect Dis. 2011 May 26;11:151. doi: 10.1186/1471-2334-11-151.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Cattini, MSc principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cross Infection, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite health care infection rate (time frame: Until the end of the second calendar day following ICU discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02511925, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.