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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02937493
Other study ID # IPV
Secondary ID
Status Completed
Phase N/A
First received October 17, 2016
Last updated October 18, 2016
Start date January 2008
Est. completion date December 2015

Study information

Verified date October 2016
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Observational [Patient Registry]

Clinical Trial Summary

A total of around 351.500 consecutive patients admitted to Dep. of Trauma Surgery, Medical University Vienna, from 01/2008 to 12/2015 have been considered eligible for inclusion. Out of this patient population a total of 1.406 cases associated with IPV have been consecutively and prospectively included in our in-house screening service for IPV cases. Data collection was performed prospectively and statistical evaluation was performed retrospectively, approved by local IRB (1453/2016).


Description:

All cases with association to IPV during inclusion period. 40 individuals had to be excluded due to missing data resulting in 1.366 individuals that were included in our analysis. Patients were identified from hospital in-patient enquiry system and in-house screening service for IPV. The IPV in-house screening service was established in 2008, and our Department represents a leading figure in detection and servicing victims of domestic violence. Our IPV in-house screening service is a routine procedure established 24/7 at clinics for all admitted patients.

If the slightest suspicion rose up, patients were asked by the attending physician or nurse, in a private and respectful manner, if a certainty of IPV exists, related to the actual presentation. If the patient admits the fact of IPV, this is noted in the hospital in-patient enquiry system, and a notification is sent to the local police station - as required by Austrian law. Part of our IPV in-house screening service, is the admission to the victim protection program and photographic documentation for legal utilization on behalf of the victim in an upcoming law claim, both services can be joined voluntarily by the victims.

Classification of migration background Patients´ clinical and demographic data were retrieved from our database. Migration background was defined according to current law (MighEV §6, Sozialgesetzbuch). In detail this means that migration background is fulfilled, if (1) the person does not possesses the national citizenship, or (2) the origin of birth is outside the borders of the national country, and emigration to the national territory was after 1949, or (3) origin of birth of one of the two parents is outside the current borders of the national territory plus emigration of one of the two parents occured after 1949.

The reason for using German law in an Austrian study is justified by a more practical and veridical approach of the German law in this particular matter. The corresponding Austrian law for defining migration background is almost identical, except for (3), where compared to Germany both parents have to be affected instead of one. The reason for explaining this matter in such a detail is to avoid any misleading conclusions, based on false assumptions.

Study population was divided into the following sub-groups: patients with migration background (MB), and patients without migration background (NMB), according to data retrieved from patient's medical records and inclusion criteria.

Classification of lunar phases Adjustment of our dataset according to lunar phases was performed in collaboration with the Central Institute for Meteorology and Geodynamics (Zentralanstalt für Meteorologie und Geodynamik, ZAMG), Vienna, Austria.

Classification of socioeconomic status Socioeconomic status of the victim was assumed according to their zip code in correlation with a data adjustment with Statistics Austria, Vienna, Austria. The 23 districts of Vienna were subdivided in three groups: rich, middle class, and poor, according to data from Statistics Austria and government reports. Rich was defined as > 110% of average income; middle class 90-110% of average income; and poor <90% of average income; Districts for "rich" were considered: 1., 4., 7., 13., 18., 19., 23.; Middle class: 2., 3., 6., 9., 11., 14., 17., 21., 22.; Poor: 5., 10., 12., 15., 16., 20.; Outcome measurement The primary outcome measured was the association between migration background and IPV.

Acceptance of the victim protection program and photographic documentation, relationship between the occurrence of IPV and moon´s phase, significant linkage between poverty and IPV, and other epidemiological facts were also observed.

RIPV score implementation Based on our hypothesis for possible influencing factors and existing findings in the literature, we generated the RIPV score to detect possible IPV victims in the ED [5,9,11,35,38]. The score is characterised by 8 simple questions and covers the most prominent factors associated with IPV in women. Therefore the 8 questions are: 1. Is there any history of IPV? 2. Is there a substance abuse in your environment? 3. Is there a migration background? 4. Is there a poor socioeconomic status? 5. Absent moon? 6. Are you pregnant? /. Female gender? 8. Age below 35 years? This score was retrospectively utilized in our study population to proof its possible effectiveness. (Table 2)

Statistical analysis For statistical analyses we used the SPSS 16.0 software package (SPSS, Chicago, Ill., USA). Mean value and standard error of the mean were given unless otherwise indicated for continuous variables. Discrete data are presented as counts and percentages. A two-tailed p-value < 0.05 was considered statistically significant.


Recruitment information / eligibility

Status Completed
Enrollment 351000
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group N/A to 100 Years
Eligibility Inclusion Criteria:

Migration background was defined according to current law (MighEV §6, Sozialgesetzbuch) [45]. In detail this means that migration background is fulfilled, if (1) the person does not possesses the national citizenship, or (2) the origin of birth is outside the borders of the national country, and emigration to the national territory was after 1949, or (3) origin of birth of one of the two parents is outside the current borders of the national territory plus emigration of one of the two parents occured after 1949.

Exclusion Criteria:

If other than inclusion

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Behavioral:
Lunar phases
Observation if lunar phases had an influence on occurrence of IPV

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Outcome

Type Measure Description Time frame Safety issue
Primary Lunar Phases Adjustment for dataset according to lunar phases was performed with the data provided by the Central Institute for Meteorology and Geodynamics, Vienna, Austria. 01/2008 - 12/2015 No
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