Trial document




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  DRKS00027172

Trial Description

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Title

Participatory Development and Evaluation of a Multimodal Concept for Violence Prevention in Nursing Care in Hospital and Outpatient Settings

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Trial Acronym

PEKo 2.0

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URL of the Trial

https://peko-gegen-gewalt.de/

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Brief Summary in Lay Language

Incidents of violence in the context of health care are common occurrences that can affect staff, but also persons in need of care or relatives in the outpatient sector and in hospitals.
Nevertheless, violence was a taboo subject for a long time. Care insurance funds support companies in developing measures to prevent and deal with violence.

The aim of the PEKo 2.0 project is to develop sustainable concepts for violence prevention in 9 outpatient care services and 12 hospitals. The project locations include Fulda, Halle (Saale), Cologne and Lübeck.
Employees of the facilities are to be sensitised to the topic, measures are to be developed jointly and implemented as sustainably as possible.

We assume that jointly developed measures to prevent and deal with violence in the outpatient sector and in hospitals will strengthen the staff and lead to sustainable confidence in dealing with the issue of violence.

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Brief Summary in Scientific Language

Violence in care is a relevant issue not only in inpatient long-term care, but also in hospitals and outpatient settings. However, the needs for targeted prevention measures are as diverse as the settings themselves. Building on the previous PEKo violence prevention project, the PEKo 2.0 project "Violence Prevention in Hospitals and Outpatient Settings" aims to develop sustainable violence prevention concepts with employees in a participatory manner and to implement them in hospitals and outpatient organizations as well as to evaluate them scientifically. The guiding principles are transparency and participation, a systematic approach, and sustainable integration into facility structures.

Hospital setting
The project will be carried out in twelve hospitals at the study sites in Cologne, Lübeck, Fulda and Halle (Saale). The following standardized intervention components will guide action while maintaining the participatory character of the project:
• Kick-off event in the participating hospitals
• Appointment of PEKo representatives as contact person(s)
• Formation of a hospital-internal PEKo team with interested employees
• Monthly PEKo team meetings moderated by study team members
• Quarterly, cross-facility meetings of representatives of the PEKo teams (PEKo circles)

Outpatient setting
Unlike in the inpatient setting, the project in the outpatient setting proceeds in two phases.
1) In the first phase, a violence prevention concept is developed within six months with representatives of various outpatient organizations (outpatient care services, counseling centers, self-help groups/volunteer organizations).
2) In the second phase, this violence prevention concept will be implemented on a demand-oriented basis in nine organizations at the three study centers Cologne, Fulda and Halle over a project period of 12 months.
Focus groups, individual interviews, standardized surveys and a structured evaluation of the study documentation will be conducted as part of the process evaluation.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00027172
  •   2021/11/12
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  •   yes
  •   Approved
  •   2021-136, Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg
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Secondary IDs

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Health Condition or Problem studied

  •   Violence prevention, health promotion, occupational safety, quality of life, employee satisfaction
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Interventions/Observational Groups

  •   participatory development and implementation of needs-oriented, setting- and target group-specific violence prevention measures
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

• Outpatient sector:
Frequency of experienced incidents of violence (in relation to people in need of care and relatives).
• Hospital: frequency of experienced and observed incidents of violence (by patients towards employees and vice versa)
• Staff of both settings: experience of stress and strain, job satisfaction

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Secondary Outcome

Staff in both settings:
• Awareness and understanding of violence
• Competences and self-efficacy

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • other 
  • Medical Center 
  • other 
  • Medical Center 
  • Medical Center 
  • other 
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Recruitment

  •   Actual
  •   2021/12/01
  •   21
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Outpatient setting:
- Outpatient care services: care within the framework of SGB V in Germany
For the development phase, actors of the outpatient care setting are included, e.g. counselling centres, self-help groups, social care institutions, institutions of civic engagement.

Hospitals:
- Care within the framework of SGB V in Germany
- Types of care:
o Maximum care hospital/ university hospital
o Basic and standard care providers
Specialised care providers or specialist clinics
Characteristics of wards:
- Bedded wards
- Delivery rooms

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Exclusion Criteria

Outpatient setting:
- Outpatient paediatric nursing services
- Out-of-hospital intensive care facilities
- Specialised outpatient palliative care
Hospitals:
- Private clinics without care within the framework of SGB V
- Rehabilitation clinics
- Psychiatric hospitals
Characteristics Wards:
- Psychiatric wards
- Non-bedded wards and functional areas
- Paediatric wards
- Intensive care/intermediate care wards

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Addresses

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    • Medizinische Fakultät der Universität zu KölnInstitut für Pflegewissenschaft
    • Mr.  Prof. Dr.  Sascha  Köpke 
    • Gleueler Straße 176-178
    • 50935  Köln
    • Germany
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    • Martin-Luther-Universität Halle-Wittenberg Medizinische Fakultät Institut für Gesundheits- und Pflegewissenschaft
    • Ms.  Prof. Dr.  Gabriele  Meyer 
    • Magdeburger Str. 8
    • 06112  Halle (Saale)
    • Germany
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    • Universität zu LübeckInstitut für Sozialmedizin und Epidemiologie Sektion für Forschung und Lehre in der Pflege
    • Ms.  Prof. Dr.  Katrin  Balzer 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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    • Hochschule FuldaPublic Health Zentrum Fulda
    • Ms.  Prof. Dr.  Henny Annette  Grewe 
    • Leipziger Str. 123
    • 36037  Fulda
    • Germany
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    • Universität zu KölnMedizinische FakultätInstitut für Pflegewissenschaft
    • Ms.  Anja  Bergmann 
    • Gleueler Straße 176-178
    • 50935  Köln
    • Germany
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    • Martin-Luther-Universität Halle-WittenbergMedizinische FakultätInstitut für Gesundheits- und Pflegewissenschaft
    • Dr. rer. medic.  Christin  Richter 
    • Magdeburger Straße 8
    • 06112  Halle
    • Germany
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    • Hochschule FuldaPublic Health Zentrum Fulda
    • Ms.  Stefanie  Freytag 
    • Leipziger Straße 123
    • 36037  Fulda
    • Germany
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    • Universität zu LübeckInstitut für Sozialmedizin und EpidemiologieSektion für Forschung und Lehre in der Pflege
    • Ms.  Laura   Püschel 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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    • Universität zu KölnMedizinische FakultätInstitut für Pflegewissenschaft
    • Ms.  Anja  Bergmann 
    • Gleueler Straße 176-178
    • 50935  Köln
    • Germany
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    end of 1:1-Block address contact public-contact
  • start of 1:1-Block address public-contact
    • Martin-Luther-Universität Halle-WittenbergMedizinische FakultätInstitut für Gesundheits- und Pflegewissenschaft
    • Dr. rer. medic.  Christin  Richter 
    • Magdeburger Straße 8
    • 06112  Halle
    • Germany
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    • Hochschule FuldaPublic Health Zentrum Fulda
    • Ms.  Stefanie  Freytag 
    • Leipziger Straße 123
    • 36037  Fulda
    • Germany
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    • Universität zu LübeckInstitut für Sozialmedizin und EpidemiologieSektion für Forschung und Lehre in der Pflege
    • Ms.  Laura  Püschel 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Techniker Krankenkasse
    • Bramfelder Str. 140
    • 22305  Hamburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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