NCT02511925

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,065

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
Last Updated

July 30, 2015

Status Verified

July 1, 2015

Enrollment Period

8 months

First QC Date

November 26, 2013

Last Update Submit

July 27, 2015

Conditions

Keywords

Critical careFeedback

Outcome Measures

Primary Outcomes (1)

  • 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

    Until the end of the second calendar day following ICU discharge

Secondary Outcomes (9)

  • Incidence of central line associated blood stream infections

    Until the end of the second calendar day following ICU discharge

  • Incidence of catheter associated urinary tract infections

    Until the end of the second calendar day following ICU discharge

  • Incidence of ventilator associated pneumonia

    Until the end of the second calendar day following ICU discharge

  • Incidence of surgical site infection

    Until the end of the second calendar day following ICU discharge

  • Incidence of clostridium difficult diarrhoea

    Until the end of the second calendar day following ICU discharge

  • +4 more secondary outcomes

Other Outcomes (2)

  • Staff attitudes to electronic compliance monitoring

    0 and 24 weeks

  • Surrogate measures of hand hygiene compliance

    24 weeks

Study Arms (3)

ICU Cluster 1

Adult Intensive Care Unit - Royal Brompton Hospital

Other: Weekly poster of unit performanceOther: Daily email of personal feedback

ICU Cluster 2

Paediatric ICU - Royal Brompton Hospital

Other: Weekly poster of unit performanceOther: Daily email of personal feedbackOther: Active reminder from badge

ICU Cluster 3

Adult Intensive Care Unit - Harefield Hospital

Other: Weekly poster of unit performanceOther: Daily email of personal feedbackOther: Active reminder from badge

Interventions

Weekly feedback is provided to the ICU about current levels of hand hygiene compliance amongst doctors, nurses, and allied healthcare professionals

ICU Cluster 1ICU Cluster 2ICU Cluster 3

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

ICU Cluster 1ICU Cluster 2ICU Cluster 3

The badge the healthcare worker is wearing vibrates if opportunities to perform hand hygiene are missed

ICU Cluster 2ICU Cluster 3

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients admitted to the ICU during the study period.

You may qualify if:

  • All patients admitted to the intensive care units
  • All healthcare workers caring for the patients on the intensive care units.

You may not qualify if:

  • Healthcare workers with skin sensitivity to both alcohol hand rub and soap

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Brompton and Harefield NHS Foundation Trust

London, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 21612666BACKGROUND

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Patricia Cattini, MSc

    Royal Brompton and Harefield NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2013

First Posted

July 30, 2015

Study Start

November 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

July 30, 2015

Record last verified: 2015-07

Locations