Trial document





This trial has been registered retrospectively.
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  DRKS00004239

Trial Description

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Title

Intervention Study on the Development and Implementation of a Practice Guideline for the Appropriate Pain Management of Older Persons in Nursing Homes

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Trial Acronym

PAIN Intervention

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URL of the Trial

http://www.ama-consortium.de/ama_ii/forschungsprojekte/pain_ii/

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Brief Summary in Lay Language

Almost every second resident in nursing homes suffers from pain (Dräger et al., 2012).
The main objective of the project is to develop an inter-professional practice guideline on pain management in nursing home residents and to test its efficacy. This study will be conducted in cooperation with an organization that operates residential care facilities in Berlin.
Whereas the treatment group will be given extensive training on the implementation of the practice guideline, the control group will only receive general information on pain management.

Data reflecting the efficacy of the intervention will be collected from the perspective of residents. Nurses will participate in an evaluation of the process of the study.

These data will be assessed at three points of measurement over a 6-month period, making it possible to determine both short- and longer-term effects.

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Brief Summary in Scientific Language

Pain is an important phenomenon in the German population. Almost every second resident in nursing homes suffers from pain (Dräger et al., 2012).
The main objective of the project is to develop an inter-professional practice guideline on pain management in nursing home residents and to test its efficacy in a cluster- randomized trial. The practice guideline on pain has the following structure: (1) pain assessment, (2) non-pharmacological therapy, (3) pharmacological therapy, (4) structural and personal aspects in the institution.

The major aims of this study are:
1. Reducing pain intensity of nursing homes residents.
2. Maintaining autonomy in nursing home residents.
3. Optimization of caring processes and –results as well as organisation and information.

This study will be conducted in cooperation with an organization that operates residential care facilities. Randomization to the two study groups will take place at the nursing home level. Whereas the treatment group will be given extensive training on the implementation of the practice guideline, the control group will only receive general information on pain management. Data reflecting the efficacy of the intervention will be collected from the perspective of residents. Data on pain, autonomy, the level of mobility (outcomes) and medication (resource) will be obtained from each resident. These data will be assessed at three points of measurement over a 6-month period. Data collection will start before the intervention and will be continued 3 and 6 months afterwards. From the perspective of the nurses, the focus will be on perceived changes in the medical and nursing treatment process and outcomes.

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Organizational Data

  •   DRKS00004239
  •   2012/07/25
  •   [---]*
  •   yes
  •   Approved
  •   EA2/150/11, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   R52 -  Pain, not elsewhere classified
  •   pain management
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Interventions/Observational Groups

  •   Intervention group: Nurses (workshop, 360 minutes) and general practitioners (online-module, 360 minutes) receive a comprehensive intervention on appropriate pain management for elderly people in nursing homes.
  •   Control group: Nurses and general practitioners receive basic information (max. 1 hour) on pain management for elderly people in nursing homes
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver
  •   Active control (effective treament of control group)
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

changes in perceived pain, Numeric Rating Scale (NRS) within the Brief Pain Inventory (BPI) © Radbruch et al. 1999; Loick et al. 2004
Data collection will start before the intervention and will be continued 3 and 6 months afterwards.

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Secondary Outcome

Perceived Enactment of Autonomy of Nursing Home Residents (HPEAS, Hertz 1991, 1996; Wulff et al., 2012)
Appropriateness of Medication (PMAS,
Hutt et al. 2006, Kölzsch et al, 2012)

Improving knowledge of pain management for general practitioners and nurses. In order to measure that, documentation of care, e. g. non-pharmacological and pharmacological treatment will be analysed. Furthermore, nurses will be evaluated regarding their attitude towards pain management.

Data collection will start before the intervention and will be continued 3 and 6 months afterwards.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2012/02/13
  •   192
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

MMST >= 18

at least living in the nursing home for 3 months

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Exclusion Criteria

MMST<18
persons in vegetative state, rehabilitation phase F, or terminal phase

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Addresses

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    • Charité - Universitätsmedizin Berlin Institut für Medizinische Soziologie
    • Ms.  Dr.   Dagmar  Dräger 
    • Luisenstraße 13
    • 10117  Berlin
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Charité - Universitätsmedizin Berlin Institut für Medizinische Soziologie
    • Ms.  Dr.  Dagmar  Dräger 
    • Luisenstraße 13
    • 10117  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin Institut für Medizinische Soziologie
    • Ms.  Dr.  Andrea  Budnick 
    • Luisenstraße 13
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Hannoversche Straße 28-30
    • 10115  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/12/31
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.