Reducing Visitors- and Personnel-associated Infection Risk on Perinatal Care Station
Primary Purpose
Hygiene
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
voice prompts
agitation
Sponsored by

About this trial
This is an interventional prevention trial for Hygiene focused on measuring hygiene, prenatal care, postnatal care
Eligibility Criteria
Inclusion Criteria:
- Minimum age: 7 years
- informed consent
- Member of target group: Visitor or staff
Exclusion Criteria:
- Insufficient language skills
Sites / Locations
- Maternity Clinic/Perinatal Treatment Center, university hospital, Martin-Luther-Universität Halle-Wittenberg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
voice prompts
no voice prompts
Arm Description
Agitation (education, reminders and optimising materials) plus voice prompts
only Agitation (education, reminders and optimising materials); no voice prompts
Outcomes
Primary Outcome Measures
Total consumption of disinfectants per visitor
Total consumption of disinfectants per visitor (electronically counted)
Secondary Outcome Measures
Prevalence of highly positive Impact tests (swab tests)
Prevalence of highly positive Impact tests (swab tests)
Total consumption of disinfectants (only children) per visitor
Total consumption of disinfectants (only children) per visitor
Infection rate of typical maternal, fetal and newborn infections
Infection rate of typical maternal, fetal and newborn infections
Full Information
NCT ID
NCT03032887
First Posted
January 17, 2017
Last Updated
April 16, 2019
Sponsor
Martin-Luther-Universität Halle-Wittenberg
1. Study Identification
Unique Protocol Identification Number
NCT03032887
Brief Title
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
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
April 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Martin-Luther-Universität Halle-Wittenberg
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hygiene
Keywords
hygiene, prenatal care, postnatal care
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
voice prompts
Arm Type
Experimental
Arm Description
Agitation (education, reminders and optimising materials) plus voice prompts
Arm Title
no voice prompts
Arm Type
Other
Arm Description
only Agitation (education, reminders and optimising materials); no voice prompts
Intervention Type
Behavioral
Intervention Name(s)
voice prompts
Intervention Description
voice prompts on disinfectant dispenser
Intervention Type
Behavioral
Intervention Name(s)
agitation
Intervention Description
Education, reminders and optimising materials
Primary Outcome Measure Information:
Title
Total consumption of disinfectants per visitor
Description
Total consumption of disinfectants per visitor (electronically counted)
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Prevalence of highly positive Impact tests (swab tests)
Description
Prevalence of highly positive Impact tests (swab tests)
Time Frame
9 months
Title
Total consumption of disinfectants (only children) per visitor
Description
Total consumption of disinfectants (only children) per visitor
Time Frame
9 months
Title
Infection rate of typical maternal, fetal and newborn infections
Description
Infection rate of typical maternal, fetal and newborn infections
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Minimum age: 7 years
informed consent
Member of target group: Visitor or staff
Exclusion Criteria:
Insufficient language skills
Facility Information:
Facility Name
Maternity Clinic/Perinatal Treatment Center, university hospital, Martin-Luther-Universität Halle-Wittenberg
City
Halle (Saale)
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21864941
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.
Results Reference
background
PubMed Identifier
22285710
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.
Results Reference
background
PubMed Identifier
17765560
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.
Results Reference
background
PubMed Identifier
22978722
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.
Results Reference
background
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Reducing Visitors- and Personnel-associated Infection Risk on Perinatal Care Station
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