NCT03032887

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

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

March 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

1.8 years

First QC Date

January 17, 2017

Last Update Submit

April 16, 2019

Conditions

Hygiene

Keywords

hygieneprenatal carepostnatal care

Outcome Measures

Primary Outcomes (1)

  • Total consumption of disinfectants per visitor

    Total consumption of disinfectants per visitor (electronically counted)

    9 months

Secondary Outcomes (3)

  • Prevalence of highly positive Impact tests (swab tests)

    9 months

  • Total consumption of disinfectants (only children) per visitor

    9 months

  • Infection rate of typical maternal, fetal and newborn infections

    9 months

Study Arms (2)

voice prompts

EXPERIMENTAL

Agitation (education, reminders and optimising materials) plus voice prompts

Behavioral: voice promptsBehavioral: agitation

no voice prompts

OTHER

only Agitation (education, reminders and optimising materials); no voice prompts

Behavioral: agitation

Interventions

voice promptsBEHAVIORAL

voice prompts on disinfectant dispenser

voice prompts
agitationBEHAVIORAL

Education, reminders and optimising materials

no voice promptsvoice prompts

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Insufficient language skills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternity Clinic/Perinatal Treatment Center, university hospital, Martin-Luther-Universität Halle-Wittenberg

Halle, Saxony-Anhalt, 06120, Germany

Location

Related 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.

    PMID: 21864941BACKGROUND

  • 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.

    PMID: 22285710BACKGROUND

  • 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.

    PMID: 17765560BACKGROUND

  • 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.

    PMID: 22978722BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief resident

Study Record Dates

First Submitted

January 17, 2017

First Posted

January 26, 2017

Study Start

March 1, 2016

Primary Completion

December 1, 2017

Study Completion

April 1, 2019

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations

DE(1)