Trial document




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  DRKS00007844

Trial Description

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Title

MetropolMediplan 2016 - MMP16:
Testing and further development of a medication plan in practice with respect to acceptance and practicability

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Trial Acronym

MMP16

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URL of the Trial

http://www.emedikationsplan.de

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Brief Summary in Lay Language

In October 2014 the Drug Commission of the German Medical Association (AkdÄ) presented the “federal patient oriented medication plan” which had the aim to inform patients better about their medications and to standardize the exchange of medication data between doctor’s surgeries, pharmacies and hospitals and thereby to facilitate and make it safer
The federal patient oriented medication plan contains information about individual medication of the patient. This information can be printed on paper or also be transmitted electronically.
The printed version of the medication plan used by the patients contains all relevant information in plain text format and additional as a machine readable barcode. If a medication plan is submitted to a participating doctor’s surgery, pharmacy or hospital, the plan can be read in with a barcode reader and the access to the electronically stored medication plan will be permitted.
The electronic data transfer and central data storages (located at a server in Germany) take place in an encrypted way using state of the art technology.
The aim of this research project is to evaluate the acceptance, the practicability and the use of the medication plan and its specifications.from the view of the patients and of the involved health care provider.
The research is divided in three project phases with two stages: In stage 1 the simple use of the medication take place. In stage 2 a subgroup of the participating patients and the physicians and pharmacists will be interviewed additionally in each phase about the medication plans and the whole project.

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Brief Summary in Scientific Language

In October 2014 the German Drug Commission of the German Medical Association (AkdÄ) presented the “federal patient oriented medication plan” which had the aim to inform patients better about their medications and to standardize the exchange of medication data between doctor’s surgeries, pharmacies and hospitals and to make it easier. The medication plan was primarily developed as a source of information for the patient
All Doctor’s surgeries, pharmacies or hospitals, which participate in this research project, are able to and should provide a federal patient oriented medication plan (will be mentioned medication plan in the following text) to their patients.
In this project the medication plan also shall be used to exchange medication data by the participating doctor’s surgeries, pharmacies or hospitals.
The medication plan can be created, modified and exchanged in various manners, from paper-based to electronically stored plans.
The medication plan does not replace the regular drug anamnesis, that is done unchanged by the health professionals in best practices based on local standard operation procedures.
The aim of this research project is to evaluate data in context with:
1. User acceptance, practicability and use of the medication plan from the patient’s point of view.
2. User acceptance, practicability and use of the medication plan from the health care providers point of view (physicians, pharmacists and their assistants).
3. Technical requirements and content-related quality attributes of medication plans, especially in consideration of the usability for detecting medication risks.
a. The correctness and completeness of medication plans will be investigated within a partial sample by the comparison with source data for medication of the patients. Aspects of protection of privacy considering the data transfer and storage of data have been agreed with the responsible privacy officer involving the commissioner of the state privacy agency. Although the privacy responsible persons don’t have any concerns, privacy aspects shall be monitored in the project due to the fast progress of information technology.

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Organizational Data

  •   DRKS00007844
  •   2015/07/15
  •   [---]*
  •   yes
  •   Approved
  •   45_15 B, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

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

  •   Patients of doctor’s surgeries, pharmacies and hospitals, participating in the research project with unspecified diseases.
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Interventions/Observational Groups

  •   Phase I (1st-8th month): In the first two weeks of the first trial phase the participating doctor's surgeries and pharmacies will be traines in using standard operating procedures for the following topics:
    - creating updating und archiving medication plans
    - inclusion of patients according to the study protocol.
    In the first trial phase the current specification and the update rules of the federal patient oriented medication plan will be evaluated.
    Phase II (9th-14th month): In the second trial phase the results of the first trial phase will be used to improve the specification and implementation of medication plans. The improved medication plan shall be evaluated.
    Phase III (15th-21th month): In the third trials phase the results of the evaluation of the second trial phase will be used to optimize the specification am implementation of medicatin plan. The optimized medication plan shall be evaluated. The resluts of all trial phases summarized in a final report.
    Stage 1 (all patients in all 3 study phases): Using of medication plans. All patients have the possibility to participate, if they agree using medication plans in their treatment. It shall be examined whether medication plans are suitable for the use in pharmacotherapy safety by examining anonymized data. The minimal aim is to include a minimum of 300 patients using medication plans.
  •   Stage 2 (Interview with 110 patients in all 3 study phases): In this stage an additional interview will be performed with extended data collection. These patients have to be informed separately before giving their informed consent. The interviews will be performed by participating doctor’s surgeries. Using a random sample (about 60) of these patients, a data verification will be performed comparing the medication plan data with the patient record and the documentation of pharmacies.
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Characteristics

  •   Interventional
  •   [---]*
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Health care system
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Evaluation of the federal patient oriented medication plan with respect to user acceptance, practicability and application of medication plans from the viewpoints of patients and health care providers (physicians, pharmacists and their assistants).

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Secondary Outcome

Evaluation of the federal patient oriented medication plan with respect to completeness and usability for improving medication safety and identification of medication risks.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2015/06/29
  •   1010
  •   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

Stage 1: Anonymous data collection by using of medication plans:
- Written informed consent by patient or his legal representative
- Patient takes actually at least 5 medications
Stage 2: patient interview:
- At least 5 contacts with primary health care providers per year
- Patient takes actually at least 5 medications
- able to give consent
- Written informed consent

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Exclusion Criteria

Patient under 18 years. Stage 2: Patient interview: not able to give consent.

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Addresses

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Sources of Monetary or Material Support

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    • Bundesministerium für Gesundheit (BMG)
    • Ms. 
    • Rochusstraße 1
    • 53107  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/03/31
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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.