- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02511925
Electronic Hand Hygiene Monitoring and ICU Infection Rates (HANDS)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom
- Royal Brompton and Harefield NHS Foundation Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients admitted to the intensive care units
- All healthcare workers caring for the patients on the intensive care units.
Exclusion Criteria:
- Healthcare workers with skin sensitivity to both alcohol hand rub and soap
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ICU Cluster 1
Adult Intensive Care Unit - Royal Brompton Hospital
|
Weekly feedback is provided to the ICU about current levels of hand hygiene compliance amongst doctors, nurses, and allied healthcare professionals
Healthcare workers receive private and personal feedback via email regarding their individual performance benchmarked against the average performance for their professional grouping.
|
ICU Cluster 2
Paediatric ICU - Royal Brompton Hospital
|
Weekly feedback is provided to the ICU about current levels of hand hygiene compliance amongst doctors, nurses, and allied healthcare professionals
Healthcare workers receive private and personal feedback via email regarding their individual performance benchmarked against the average performance for their professional grouping.
The badge the healthcare worker is wearing vibrates if opportunities to perform hand hygiene are missed
|
ICU Cluster 3
Adult Intensive Care Unit - Harefield Hospital
|
Weekly feedback is provided to the ICU about current levels of hand hygiene compliance amongst doctors, nurses, and allied healthcare professionals
Healthcare workers receive private and personal feedback via email regarding their individual performance benchmarked against the average performance for their professional grouping.
The badge the healthcare worker is wearing vibrates if opportunities to perform hand hygiene are missed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
Until the end of the second calendar day following ICU discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of central line associated blood stream infections
Time Frame: Until the end of the second calendar day following ICU discharge
|
CDC definition
|
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
|
CDC definition
|
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
|
CDC definition
|
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
|
Public Health England definition
|
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
|
Public Health England definition
|
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
|
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
|
CDC definition
|
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
|
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.
|
Until the end of the second calendar day following ICU discharge
|
Adverse event rate
Time Frame: 24 weeks
|
24 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Staff attitudes to electronic compliance monitoring
Time Frame: 0 and 24 weeks
|
Quantitative and qualitative analysis of questionnaire data
|
0 and 24 weeks
|
Surrogate measures of hand hygiene compliance
Time Frame: 24 weeks
|
Alcohol hand rub usage, Soap usage and visual compliance monitoring
|
24 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Patricia Cattini, MSc, Royal Brompton and Harefield NHS Foundation Trust
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013IC004B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cross Infection
-
Erasmus Medical CenterAmbu A/S; Maag Lever Darm StichtingCompletedEsophagogastroduodenoscopy | Gastroscopy | Equipment Design | Equipment Contamination / Prevention & Control | Cross Infection / Prevention & Control | Disposable Equipment | Infection Control / MethodsNorway, Netherlands
-
Southeast University, ChinaUnknown
-
Federico II UniversityCompleted
-
Dartmouth-Hitchcock Medical CenterHarbor Medical Inc.CompletedNosocomial InfectionUnited States
-
Mahidol UniversityUnknown
-
Bnai Zion Medical CenterUnknown
-
Second Affiliated Hospital, School of Medicine,...The Second Affiliated Hospital of Jiaxing University; Changxing People's Hospital and other collaboratorsRecruiting
-
University of AlbertaCompleted
-
Mahidol UniversityUnknown
-
3MEurotrials Brasil Consultores Cientificos LtdaCompleted
Clinical Trials on Weekly poster of unit performance
-
Universidade do PortoUnknown
-
Istanbul University - Cerrahpasa (IUC)RecruitingMetabolic SyndromeTurkey
-
University of DundeeUniversity of Strathclyde; Chief Scientist Office of the Scottish Government; Information Services Division, NHS ScotlandCompletedComplications of Surgical and Medical Care: General TermsUnited Kingdom
-
University of PennsylvaniaU.S. Department of Transportation Federal Highway AdministrationCompletedAutomobile AccidentUnited States
-
Poitiers University HospitalCompleted
-
Centre Hospitalier National d'Ophtalmologie des...Recruiting
-
Hvidovre University HospitalCompletedEmergency High-risk Abdominal SurgeryDenmark
-
University of Dublin, Trinity CollegeSt. James's Hospital, IrelandSuspendedNarcolepsy | Hypersomnolence | Narcolepsy Type 1 | Narcolepsy Without Cataplexy | Narcolepsy With Cataplexy | Narcolepsy 1 | Narcolepsy and HypersomniaIreland
-
Centre Henri BecquerelCompleted