Trial document




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  DRKS00004952

Trial Description

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Title

Drug therapy safety with patients in facilities of the long-term care

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Trial Acronym

AMTS-AMPEL

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URL of the Trial

http://www.amts-ampel.de/

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Brief Summary in Lay Language

The main theme of this project funded by the Federal Ministry of Health is the safety of pharmacotherapy, as well as prescriptions, to administer medications up to the point of therapeutic observations. We want to quantify and to reduce the adverse events due to drug therapy in nursing homes by an interdisciplinary educational intervention. We will evaluate the intervention (Thürmann & Jaehde 2011) which it`s feasibility has been already developed and tested with respect to their effectiveness.
The prospective intervention study will include approximately 1000 residents in at least 15 nursing homes in North Rhine/Westphalia and Mecklenburg/Vorpommern. There will be three cross-sectional analyses carried out. Adverse drug events in the first survey (so-called ADE, e.g. falls) will be collected and be assessed concerning medicinal products. Thereafter, training for all professionals involved will take place. In the facilities of the long-term care, we establish AMTS-teams (pharmacists and nursing staff). In regional quality committees and family doctor nets, causes of treatment during the project, will be discussed by professionals and be provided for the project staff. Between the medical and pharmaceutical care there will be a continuous exchange of information. In the second survey, adverse drug events are collected again and the effectiveness of the advanced training will be proven. We will review the sustainability of the concept for advanced training and their implementation after a further 6 months.
The results of this multi-professional approach shall improve the drug therapy safety in nursing homes in Germany and will be an example for other interdisciplinary projects.

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Brief Summary in Scientific Language

Nursing home residents are at increased risk for developing adverse drug events (ADE) due to e.g. polypharmacy and multimorbidity. Whereas different interventional strategies for reducing ADE have been examined in several countries, there is only limited data for Germany. Therefore, we aimed to perform a multi-center prospective study to examine the effects of a multidisciplinary intervention on ADE in nursing homes for which feasibility was proven in a prior study (Thürmann & Jaehde, 2011).
In two German regions (North Rhine-Westphalia and Mecklenburg-Vorpommern), approximately 1.000 nursing home residents (approx. 15-18 nursing homes) will be analyzed for the presence of ADE at three time-points by trained experts. After a first pre-interventional ADE assessment, a multidisciplinary intervention including e.g. educational programs and building of drug safety teams will be performed. Six and twelve months after the beginning of the intervention, residents will be re-checked for presence of ADEs. As primary endpoint of our study, reduction of ADE will be analyzed by comparing 30-day-prevalence of ADE of the pre-interventional assessment versus 6 months after starting the intervention (adjusted for nursing homes). As secondary endpoints, newly occurring ADE and number of relevant clinical endpoints (e.g. hospitalization) will be evaluated. Furthermore, long-term effects on ADE will be examined by comparing 30-day ADE prevalence of the assessments at 6 versus 12 months after beginning of the intervention.
Results of this study will allow a quantification of ADE reduction after a multidisciplinary intervention in nursing homes for Germany (supported by the German Ministry of Health, IIA5-2512FSB503).

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Organizational Data

  •   DRKS00004952
  •   2013/05/16
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  •   yes
  •   Approved
  •   02/2013, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

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Health Condition or Problem studied

  •   All adverse drug events (ADE)!
  •   T88.7 -  Unspecified adverse effect of drug or medicament
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Interventions/Observational Groups

  •   The intervention includes training for all professional groups involved (nursing staff, family doctors, pharmacists) . In the facilities of the long-term care, we establish AMTS-teams (pharmacists and nursing staff). In regional quality committees and family doctor nets, causes of treatment during the project, will be discussed by professionals and be provided for the project staff. Between the medical and pharmaceutical care there will be a continuous exchange of information.
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Characteristics

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

As primary endpoint of our study, reduction of ADE will be analyzed by comparing 30-day-prevalence of ADE of the pre-interventional assessment versus 6 months after starting the intervention (adjusted for nursing homes).

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Secondary Outcome

As secondary endpoints, newly occurring ADE and number of relevant clinical endpoints (e.g. hospitalization) will be evaluated. After a first survey there will be a second cross-sectional analysis after 6 months and a third survey after 12 months.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2013/09/24
  •   1000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   65   Years
  •   100   Years
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Additional Inclusion Criteria

Patient consent form. Occurring ADE.

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Exclusion Criteria

No patient consent form.

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Addresses

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    • Private Universität Witten/Herdecke gGmbH
    • Alfred-Herrhausen-Strasse 50
    • 58448  Witten
    • Germany
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    • Rheinische Friedrich-Wilhelms-Universität Bonn, Klinische Pharmazie
    • Mr.  Prof. Dr.  Ulrich  Jaehde 
    • 53121  Bonn
    • Germany
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    • Universitätsmedizin Rostock, Institut für Allgemeinmedizin
    • Mr.  Prof. Dr.  Attila  Altiner 
    • 18057  Rostock
    • Germany
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    • Universitätsmedizin Rostock, Zentrum für Pharmakologie und Toxikologie, Institut für Klinische Pharmakologie
    • Mr.  Prof. Dr.  Bernd  Drewelow 
    • 18057  Rostock
    • Germany
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    • Heinrich-Heine-Universität Düsseldorf, Institut für Allgemeinmedizin
    • Mr.  Prof. Dr.  Stefan  Wilm 
    • 40225  Düsseldorf
    • Germany
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    • Direktorin des Philipp Klee-Instituts für Klinische Pharmakologie, HELIOS Klinikum Wuppertal, Lehrstuhl f. Klin. Pharmakologie der Universität Witten/Herdecke GmbH
    • Ms.  Prof. Dr.  Petra A.  Thürmann 
    • Heusnerstr. 40
    • 42283  Wuppertal
    • Germany
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    • Universität Witten/Herdecke, Inst. f. Klinische Pharmakologie, Fakultät f. Gesundheit
    • Ms.  Dr.  Simone  Bernard 
    • Heusnerstrasse 40
    • 42283  Wuppertal
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Gesundheit
    • Rochusstrasse 1
    • 53123  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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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.