Reducing Visitors- and Personnel-associated Infection Risk on Perinatal Care Station

Hygiene Clinical Trial

Official title:

Reducing Visitors- and Personnel-associated Infection Risk by Special Agitation Incl. Voice Prompts for Hand Disinfection on Perinatal Care Stations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03032887
• Other study ID #: Hygienic voice
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: April 2019

Study information

• Verified date: April 2019
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The rate of infectious diseases (amnioninfection syndrome (AIS), fetal inflammatory response syndrome (FIRS), early-onset neonatal sepsis (EONS)) in perinatal care / neonatology is steadily rising in Germany. The hands of the staff and visitors are the most important transmission vehicle of pathogens. Hence hand hygiene is one of the most important measures for the prevention of hospital infections. The different measures of hand hygiene serve to protect against the spread of contamination of the skin with obligate or potentially pathogenic pathogens. Since the use of antibiotics is generally only possible to a limited extent (especially in pregnant women and neonates in perinatal care centers) the primary prophylactic measures are of great importance.

While the importance of hand disinfection in the staff has been undisputed, there is no data on the rate of hand disinfection for visitors of perinatal care centers. Visitor at these stations are common non-compliant persons (especially children!). On the other hand, pregnant women and young mothers and newborn babies are "exposed" to a large number of visitors compared to other stations.

The investigators examine whether special measures (such as voice prompts) have a positive effect on the rate of performed hand disinfections or consecutively on the infection rate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: April 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years and older

Eligibility

Inclusion Criteria:

• Minimum age: 7 years

• informed consent

• Member of target group: Visitor or staff

Exclusion Criteria:

• Insufficient language skills

Related Conditions & MeSH terms

• Hygiene

Intervention

Behavioral:
• voice prompts
voice prompts on disinfectant dispenser
• agitation
Education, reminders and optimising materials

Locations

Country	Name	City	State
Germany	Maternity Clinic/Perinatal Treatment Center, university hospital, Martin-Luther-Universität Halle-Wittenberg	Halle (Saale)	Sachsen-Anhalt

Sponsors (1)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Birnbach DJ, Nevo I, Barnes S, Fitzpatrick M, Rosen LF, Everett-Thomas R, Sanko JS, Arheart KL. Do hospital visitors wash their hands? Assessing the use of alcohol-based hand sanitizer in a hospital lobby. Am J Infect Control. 2012 May;40(4):340-3. doi: 10.1016/j.ajic.2011.05.006. Epub 2011 Aug 23. — View Citation

Huis A, van Achterberg T, de Bruin M, Grol R, Schoonhoven L, Hulscher M. A systematic review of hand hygiene improvement strategies: a behavioural approach. Implement Sci. 2012 Sep 14;7:92. doi: 10.1186/1748-5908-7-92. Review. — View Citation

Swoboda SM, Earsing K, Strauss K, Lane S, Lipsett PA. Isolation status and voice prompts improve hand hygiene. Am J Infect Control. 2007 Sep;35(7):470-6. — View Citation

Tromp M, Huis A, de Guchteneire I, van der Meer J, van Achterberg T, Hulscher M, Bleeker-Rovers C. The short-term and long-term effectiveness of a multidisciplinary hand hygiene improvement program. Am J Infect Control. 2012 Oct;40(8):732-6. doi: 10.1016/j.ajic.2011.09.009. Epub 2012 Jan 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total consumption of disinfectants per visitor	Total consumption of disinfectants per visitor (electronically counted)	9 months
Secondary	Prevalence of highly positive Impact tests (swab tests)	Prevalence of highly positive Impact tests (swab tests)	9 months
Secondary	Total consumption of disinfectants (only children) per visitor	Total consumption of disinfectants (only children) per visitor	9 months
Secondary	Infection rate of typical maternal, fetal and newborn infections	Infection rate of typical maternal, fetal and newborn infections	9 months