Trial document





This trial has been registered retrospectively.
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  DRKS00000418

Trial Description

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Title

Implementation of Resident Assessment Instrument (RAI) as an instrument to improve and steer quality of care in German nursing homes

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Trial Acronym

RAI

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Is the RAI effective in improving physical functioning and other resident related outcomes of nursing home residents.

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Brief Summary in Scientific Language


In a cluster-randomized trial Resident Assessment Instrument (RAI) is implemented in German nursing homes to examine, whether there is an improvement in nursing care quality
compared to nursing homes that don’t use RAI. In the intervention group, health care staff members receive comprehensive schoolings, based on a programme that has proved to be prosperous in Switzerland.
Investigators provide support and counselling to nurses and nurse managers during the implementation and use of RAI.
In the control group assessment, documentation, and care planning are done in institution’s usual manner. RAI-Assessments of control group residents are done by a study nurse, without communicating the results to health care staff. Quality of care is being measured by Outcomes that can be derived from the RAI-data.

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Organizational Data

  •   DRKS00000418
  •   2010/05/21
  •   [---]*
  •   yes
  •   Approved
  •   XXX, 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

  •   In-patient long-term care
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Interventions/Observational Groups

  •   Implementation of Resident Assessment Instrument by (1) schoolings, (2) counselling and supporting nurses and nurse managers, (3) providing telephone support, (4) audit and feedback concerning the correct use of RAI and sufficient transmission of the findings into nursing documentation and care planning
  •   Usual nursing assessment and care planning
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Single blind
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  •   Active control
  •   Supportive care
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

Physical functioning after 12 months, based on the ADL-Score

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Secondary Outcome

All secondary outcomes will be assess after 12 months.
Prevalence of weight loss: RAI/MDS BMI,
Prevalence of pressure ulcers: RAI/MDS data,
Health related quality of life (residents and nurses): Nottingham Health Profile (NHP) (Hunt, McKenna, McEwen 1989; german version: Kohlmann et al. 1997),
Transitions to higher levels of required nursing care: “Pflegestufe” according to nursing documentation,
Number of hospitalizations,
Quality of nursing documentation: Checklist, specifically developed by the research team

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2008/03/10
  •   700
  •   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

For nursing homes:
• Institution of long term care according to § 71, SGB XI (11th book of German social legislation)
• Location in one of the following German states: Saxony, Saxony-Anhalt or Thuringia

Residents:
• Resident of one of the included nursing homes
• Written agreement (informed consent), by themselves or by a legally authorized person

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Exclusion Criteria

none

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Martin-Luther-Universität Halle-Wittenberg Medizinische Fakultät Institut für Gesundheits- und Pflegewissenschaft
    • Mr.  Prof. Dr. phil. habil.  Johann  Behrens 
    • Magdeburger Str. 8
    • 06097  Halle(Saale)
    • Germany
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    • Martin-Luther-Universität Halle-Wittenberg Medizinische Fakultät Institut für Gesundheits- und Pflegewissenschaft
    • Ms.  Diplom Pflege- und Gesundheitswissenschaftlerin  Christiane  Becker 
    • Magdeburger Straße 8
    • 06097  Halle (Saale)
    • Germany
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    • Martin-Luther-Universität Halle-Wittenberg Medizinische Fakultät Institut für Gesundheits- und Pflegewissenschaft
    • Ms.  Diplom Pflege- und Gesundheitswissenschaftlerin  Christiane  Becker 
    • Magdeburger Straße 8
    • 06097  Halle (Saale)
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung - BMBF Dienstsitz Berlin
    • Hannoversche Straße 28-30
    • 10115  Berlin
    • Germany
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    •   +49 (0)30/ 1857-0
    •   +49 (0)30/ 1857-83601
    •   [---]*
    •   http://www.bmbf.de
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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