Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Electronic Hand Hygiene Monitoring and ICU Infection Rates (HANDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02511925
Recruitment Status : Completed
First Posted : July 30, 2015
Last Update Posted : July 30, 2015
Sponsor:
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

Brief 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.

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.


Condition or disease Intervention/treatment
Cross Infection Other: Weekly poster of unit performance Other: Daily email of personal feedback Other: Active reminder from badge

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 1065 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: A Pragmatic Crossover Cluster Randomised Study of Electronic Compliance Monitoring of Staff Hand Sanitisation in Critical Care (HANDS Study)
Study Start Date : November 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014


Group/Cohort Intervention/treatment
ICU Cluster 1
Adult Intensive Care Unit - Royal Brompton Hospital
Other: Weekly poster of unit performance
Weekly feedback is provided to the ICU about current levels of hand hygiene compliance amongst doctors, nurses, and allied healthcare professionals

Other: Daily email of personal feedback
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
Other: Weekly poster of unit performance
Weekly feedback is provided to the ICU about current levels of hand hygiene compliance amongst doctors, nurses, and allied healthcare professionals

Other: Daily email of personal feedback
Healthcare workers receive private and personal feedback via email regarding their individual performance benchmarked against the average performance for their professional grouping.

Other: Active reminder from badge
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
Other: Weekly poster of unit performance
Weekly feedback is provided to the ICU about current levels of hand hygiene compliance amongst doctors, nurses, and allied healthcare professionals

Other: Daily email of personal feedback
Healthcare workers receive private and personal feedback via email regarding their individual performance benchmarked against the average performance for their professional grouping.

Other: Active reminder from badge
The badge the healthcare worker is wearing vibrates if opportunities to perform hand hygiene are missed




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Incidence of central line associated blood stream infections [ Time Frame: Until the end of the second calendar day following ICU discharge ]
    CDC definition

  2. Incidence of catheter associated urinary tract infections [ Time Frame: Until the end of the second calendar day following ICU discharge ]
    CDC definition

  3. Incidence of ventilator associated pneumonia [ Time Frame: Until the end of the second calendar day following ICU discharge ]
    CDC definition

  4. Incidence of surgical site infection [ Time Frame: Until the end of the second calendar day following ICU discharge ]
    Public Health England definition

  5. Incidence of clostridium difficult diarrhoea [ Time Frame: Until the end of the second calendar day following ICU discharge ]
    Public Health England definition

  6. Incidence of acquisition of new methicilllin resistant staphylococcus aureus [ Time Frame: Until the end of the second calendar day following ICU discharge ]
  7. Incidence of secondary blood stream infections [ Time Frame: Until the end of the second calendar day following ICU discharge ]
    CDC definition

  8. 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.

  9. Adverse event rate [ Time Frame: 24 weeks ]

Other Outcome Measures:
  1. Staff attitudes to electronic compliance monitoring [ Time Frame: 0 and 24 weeks ]
    Quantitative and qualitative analysis of questionnaire data

  2. Surrogate measures of hand hygiene compliance [ Time Frame: 24 weeks ]
    Alcohol hand rub usage, Soap usage and visual compliance monitoring



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients admitted to the ICU during the study period.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02511925


Locations
Layout table for location information
United Kingdom
Royal Brompton and Harefield NHS Foundation Trust
London, United Kingdom
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Investigators
Layout table for investigator information
Principal Investigator: Patricia Cattini, MSc Royal Brompton and Harefield NHS Foundation Trust
Publications:
Layout table for additonal information
Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02511925    
Other Study ID Numbers: 2013IC004B
First Posted: July 30, 2015    Key Record Dates
Last Update Posted: July 30, 2015
Last Verified: July 2015
Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Critical care
Feedback
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes