Clinical trial NCT03032887: Reducing Visitors- and Personnel-associated Infection Risk on Perinatal Care Station
Official title: Reducing Visitors- and Personnel-associated Infection Risk by Special Agitation Incl. Voice Prompts for Hand Disinfection on Perinatal Care Stations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hygiene
Keywords: hygiene
prenatal care
postnatal care
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 300
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Minimum age: 7 years
* informed consent
* Member of target group: Visitor or staff

Exclusion Criteria:

* Insufficient language skills

Primary outcomes:
measure: Total consumption of disinfectants per visitor
timeFrame: 9 months
Secondary outcomes:
measure: Prevalence of highly positive Impact tests (swab tests)
timeFrame: 9 months
measure: Total consumption of disinfectants (only children) per visitor
timeFrame: 9 months
measure: Infection rate of typical maternal, fetal and newborn infections
timeFrame: 9 months
Other outcomes:
Locations:
city: Halle (Saale)
country: Germany
facility: Maternity Clinic/Perinatal Treatment Center, university hospital, Martin-Luther-Universität Halle-Wittenberg
state: Sachsen-Anhalt
Study officials:
References:
citation: 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.
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.
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. doi: 10.1016/j.ajic.2006.09.009.
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.