Condition category
Infections and Infestations
Date applied
09/03/2016
Date assigned
10/03/2016
Last edited
20/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Infection control is a major concern in patient care and particularly so in neonatal intensive care.
Infection control (preventing patients from getting infections) is a major concern in patient care, especially for newborn babies (neonates) in neonatal intensive care (a ward to look after ill or premature babies). These patients are extremely vulnerable to infections for a number of reasons, including an undeveloped immune (defense) system, fragile skin, having tubes in place attached to supportive equipment (invasive lines) and even the warmer temperature that is necessary in the unit. Infections gained in hospital (nosocomial infections) are responsible for a significant risk of illness and death, with the most premature infants experiencing the highest rates of all hospitalised patients. It is estimated by the Centres for Disease Control and Prevention that one third of all hospital acquired infections are caused by people not following infection control practices, such as hand washing, properly. There are many strategies designed to help improve hand hygiene in those who work in NICU, including placement of hand hygiene tools (alcohol hand gel, soap and water), training and education, evaluation and feedback of performance, provision of work place reminders and a culture of safety, however strategies aims directly at patient visitors are limited. The aim of this study is to find out if a computerised audiovisual infection control initiative (CAVICI) system (a computerised system designed to encourage visitors to better adhere to infection control practices) is able to help improve hand hygiene in patient visitors and lower nosocomial infection rates in NICUs.

Who can participate?
Any visitor to the NICU aged 16 years and over.

What does the study involve?
A computerised multilingual audio-visual display monitor (CAVICI) instructing on correct hand washing and infection control standards (ICS) is installed at entrance to NICUs in the study hospitals. Participating parents and visitors are asked some questions to assess their knowledge of infection control and are then asked whether they would mind having their hands sponged to assess the organisms on their hands. Parents are also watched while they are on the ward discretely in order to assess their hand washing technique and adherence to correct infection control.

What are the possible benefits and risks of participating?
Participants will benefit from learning correct infection control methods which will lower the risk of them infecting their baby. There are no risks involved with taking part in the study.

Where is the study run from?
Bolton NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
January 2014 to December 2016

Who is funding the study?
Cow and Gate and Say Communications (UK)

Who is the main contact?
Miss Jean Walker

Trial website

Contact information

Type

Public

Primary contact

Miss Claire Fish

ORCID ID

Contact details

Bolton NHS Foundation Trust
Minerva Road
Farnworth
Bolton
BL4 0JR
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

19174

Study information

Scientific title

Prospective interventional study to increase infection control compliance and decrease nosocomial infection rates across Greater Manchester tertiary NICUs by the installation of a computerised audiovisual infection control initiative (CAVICI) system.

Acronym

Study hypothesis

The aim of this study is to:
1. Increase knowledge and adherence to infection control by parents and patient visitors to the tertiary NICUs across the Greater Manchester Region, by the installation of a multilingual computerised audiovisual infection control initiative (CAVICI) system
2. Improve hand hygiene by reducing bacterial hand contamination
3. Determine whether the installation of a CAVICI system can decrease nosocomial infection rates in neonates admitted to NICUs across Greater Manchester

Ethics approval

North West - Greater Manchester East Research Ethics Committee, 19/03/2015, ref: 15/NW/0230

Study design

Non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Children; Subtopic: Children (all Diagnoses); Disease: All Diseases

Intervention

A total of 64 covert patient visitor observations for adherence to 5 infection control standards (ICS) to be studied across the hospital sites, namely:
1. Removal of jackets
2. Rolling up of sleeves
3. Removal of all hand & wrist jewellery/watches
4. Thorough hand washing, defined as 30 second hand wash +/- emulation of correct method as on video screen. Namely 6 steps, rub palms together to create lather, rub backs of hands with palms with fingers interlaced, wash between fingers, group fingers together and rub tips in lather on palm of opposite hand, rotational rubbing of left thumb clasped in right palm and vice versa and rub backs of fingers against opposite palm prior to rinsing.
5. Thorough hand gelling (30 seconds)

A computerised multilingual audio-visual display monitor (CAVICI) instructing on correct hand washing and the 5 infection control standards (ICS) will be installed at entrance to NICUs in the study hospitals. Covert observation of patient visitor on entrance to NICU and observation until patient visitor reaches patient cot-side and +/- handles patient. Observation of adherence to 5 ICS on entrance to NICU to the cot-side. Bacteriological surveillance involving sterile sponges rubbed over participants hands which then are cultured for organisms present.

Participants are followed up one and six months after the CAVICI is installed.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Adherence rates by patient visitors to NICU, of the 5 infection control standards pre-, 1 month and 6 months post-intervention
2. Awareness rates amongst visitors of the 5 infection control standards, pre- and 6 months post-intervention
3. Hand bacteriological contamination rates of patient visitors to NICU, pre- and 6 months post-intervention
4. Nosocomial infection rates on NICUs pre- and post- intervention

Secondary outcome measures

No secondary outcome measures

Overall trial start date

05/01/2014

Overall trial end date

01/02/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Any visitor to the NICU over age of 16.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 128; UK Sample Size: 128

Participant exclusion criteria

Under 16 years of age.

Recruitment start date

06/03/2016

Recruitment end date

01/12/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Bolton Hospital
Minerva Road Farnworth
Bolton
BL4 0JR
United Kingdom

Trial participating centre

Royal Oldham Hospital
Rochdale Road Oldham
Manchester
OL1 2JH
United Kingdom

Sponsor information

Organisation

Bolton NHS Foundation Trust

Sponsor details

Minerva Road
Farnworth
Bolton
BL4 0JR
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Cow and Gate and Say Communications

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of study results in a peer reviewed journal.

Intention to publish date

01/06/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

20/04/2016: Verified study information with principal investigator.