Trial document




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  DRKS00010995

Trial Description

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Title

Development and evaluation of an algorithm in Medication Management for best practice. Effectiveness of the intervention and translation into standard care for nursing home residents-AMBER study

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Trial Acronym

AMBER-Study

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URL of the Trial

http://amber-study.de/en/amber-study

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Brief Summary in Lay Language

The study is conducted in a nursing home setting and aims to increase medication safety. An important aspect of the study is the collaboration of physicians, pharmacists and nurses.

In a first step, expert interviews are conducted and relevant problems in the medication process are rated.
In step two, a review of the current literature is performed to analyse previous interventions and detect frequent and relevant problems. Based on the results, an algorithm is created, which aims to support Medication Reviews for nursing home residents.
The algorithm is applied and tested for practicability and effectiveness in the third step.

It is expected that the algorithm detects relevant drug-related problems, reduces medication risks and optimizes drug therapy.

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Brief Summary in Scientific Language

Study patients are residents of nursing home facilities.

Phase I: expert interviews
Patients, physicians, pharmacists and nurses in North Rhine-Westphalia are interviewed with the aim of addressing problems of medication.


Phase IIa: literature review
A systematic review is performed. It includes three consecutive steps.

Phase IIb: developing an algorithm for Medication Review.
Based on the results of the expert interviews and taking the outcomes of international studies into account, an algorithm for Medication Review is developed. The aspects of the algorithm are discussed with an expert panel, using Delphi method. Results are incorporated into the algorithm.

Phase III: evaluation of the algorithm

The algorithm is applied on Medication Reviews in nursing home facilities. Detection and reduction of the drug-related problems are analyzed. An acceptance analysis is performed to estimate the implementation of the interventions at patient side.
A second approach on effectivity is done by conducting an advanced Medication Review in some patients and by comparing the results to the conclusions of a Medication Review supported by the algorithm.

Feasibility and interrater reliability are tested on several patient cases, which are reviewed by pharmacists in daily practise using the algorithm.




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Organizational Data

  •   DRKS00010995
  •   2017/08/23
  •   [---]*
  •   yes
  •   Approved
  •   2017-350-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  •   U1111-1186-5784 
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Health Condition or Problem studied

  •   Multimorbidity
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Interventions/Observational Groups

  •   A Medication Management for residents of nursing homes will be performed by pharmacists in collaboration with physicians and nurses by means of an innovative algorithm. There is no control group.
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Characteristics

  •   Interventional
  •   [---]*
  •   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

The primary endpoint is the reduction of the detected drug-related problems (DRPs), using the algorithm. DRPs are measured at time of the Medication Review (t0) and classified according PCNE (Pharmaceutical Care Network Europe) version 8.01. A follow-up is performed three month after the intervention (t1).

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Secondary Outcome

- Drug-related problems classified according to PCNE version 8.01 (number and type)
- Measurement of physicians’ and nurses’ acceptance by using an acceptance form, classified according to PCNE version 8.01
- Number of drug-related problems classified according to PCNE version 8.01, detected by an Advanced Medication Review
- Reproducibility of analysis and feasibility of the algorithm (feedback survey, time spending, inter-rater reliability)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Planned
  •   2017/08/25
  •   100
  •   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

Residency in a nursing home facility, multimorbidity (at least 2 chronic diseases), polymedication (at least 5 chronic systemic available medications), signed informed consent

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Exclusion Criteria

participation in other clinical studies at present time

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Addresses

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    • Elefanten-Apotheke
    • Ms.  Susanne  Erzkamp 
    • Steinstr. 14
    • 48565  Steinfurt
    • Germany
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    • Elefanten-Apotheke
    • Mr.  Olaf  Rose 
    • Steinstr. 14
    • 48565  Steinfurt
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Elefanten-Apotheke
    • Ms.  Susanne  Erzkamp 
    • Steinstr. 14
    • 48565  Steinfurt
    • Germany
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    • Elefanten-Apotheke
    • Ms.  Susanne  Erzkamp 
    • Steinstr. 14
    • 48565  Steinfurt
    • Germany
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Sources of Monetary or Material Support

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    • Apothekerstiftung Westfalen-Lippe
    • Bismarkallee 25
    • 48151  Münster
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.