Trial document




This trial has been registered retrospectively.
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  DRKS00006153

Trial Description

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Title

QUIPS - Quality improvement in post operative pain treatment

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Trial Acronym

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URL of the Trial

http://www.quips-projekt.de

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Brief Summary in Lay Language

QUIPS (quality improvement in postoperative pain management) is a multicentric, interdisciplinary benchmark project that aims at improving acute pain treatment in hospitals and outpatient clinics. The overall goal of this project is to improve treatment outcomes of postoperative pain therapy by collecting a standardized set of quality data, analyzing them and sending an immediate feedback to the hospitals. This webbased, automatic feedback system enables an internal and external benchmarking as well as an ongoing monitoring of processes.

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Brief Summary in Scientific Language

Postoperative pain is not only an unpleasant sensory experience but carries the risk of a number of potentially dangerous consequences. Severe pain can delay postoperative mobilisation and prolong rehabilitation. Postoperative pain increases endocrine stress reactions and has negative effects on wound healing. There is strong evidence that severe postoperative pain leads to chronic pain. For this reason, resolving pain according to state of the art standards should be a moral obligation for every healthcare provider.

Unfortunately, the quality outcome of postoperative pain therapy is far from being optimal in the clinical day-to-day business and is described: "as ineffective, inadequate and without the necessary organizational and scientific background" (Neugebauer 1998).

As pain therapy is not a particularly complex medical problem, the reason for this negative outcome is likely to be caused by the numerous non-medical obstacles that prevent an efficient implementation of pain therapy.

QUIPS's main objective is to improve postoperative pain therapy by collecting data on pain treatment quality outcomes, analyzing them and sending an immediate feedback to the participating hospitals. This system works independently from the hospitals' infrastructural conditions (i.e. IT or documentation systems) and guarantees an ongoing quality assurance by its internal and external benchmarking.

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006153
  •   2014/05/12
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  •   yes
  •   Approved
  •   1184-08/03, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

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Health Condition or Problem studied

  •   Postoperative pain treatment
  •   R52.0 -  Acute pain
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Interventions/Observational Groups

  •   On postop day 1, patients are asked about their pain/their assessment of the pain therapy
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Outcome quality in postoperative pain therapy, assessed by the parameters pain intensity and side effects. Patient reported outcomes. Questionnaire filled in on postop day 1.


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Secondary Outcome

Patient satisfaction, process- and structure parameters of postoperative pain therapy (e.g. pain measurement, adequate medication, involving patients)

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Countries of Recruitment

  •   Germany
  •   Austria
  •   Luxembourg
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2004/08/02
  •   1000000
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

- Patient consents to participate, - patient is post-op day 1, - patients speaks German, patient is able to fill in the questionnaire

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Exclusion Criteria

- patient refuses participation
- patient doesn't speak German
- patient is not post-op day 1
- patient is not able to fill in the questionnaire (sedated, confused, fast asleep)

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Addresses

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    • Deutsche Gesellschaft für Anästhesiologie und Intensivmedizin
    • Roritzerstraße 27
    • 90419  Nürnberg
    • Germany
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    • Universitätsklinikum JenaKlinik für Anänsthesiologie und Intensivmedizin
    • Mr.  Prof.  Winfried  Meissner 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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    • Universitätsklinik JenaKlinik für Anästhesiologie und Intensivmedizin
    • Ms.  Claudia  Weinmann 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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    • nach BMBF Förderung: Projektfinanzierung durch Jahresgebühr, die von teilnehmenden Kliniken gezahlt wird
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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