Trial document




drksid header

  DRKS00008789

Trial Description

start of 1:1-Block title

Title

Prescribing medication in consideration of shared decision making and aspects of drug therapy

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

AMPEL

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Patients are often unsatisfied with the information about a prescribed drug they get from their doctor. On the other hand, physicians are sometimes unhappy with the medication taking behavior of their patients. To enhance satisfaction on both sides we developed a doctor’s guide for communication about drug prescription. This guide aims to help physicians to communicate the most important things about medications and to structure their talk. It also aims to assist doctors and patients in preparing and making decisions about therapies together. Within this research study we want to check whether the guide is applicable to everyday-situations. To this aim, we want doctors to eventually use this guide in conversations about medications with metabolic patients. In addition, doctors’ and patients’ satisfaction will be surveyed with corresponding questionnaires. Answers will be compared with those of patients from a control group who had medication prescription talks in a conventional way, i.e. without doctors using the guide. As to start, the intended research is a pilot-study.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The objective of the intended research is to test whether a doctor’s guide for medication prescription talks is applicable to routine clinical practice. In this Pilot-Study doctors will use the guide during prescription talks with metabolic patients. We will explore whether it is feasible to use the guide with different kinds of patients and under common time pressure. The guide provides structure to the prescription talk and supports preparation and sharing of decisions about drug therapies between doctors and patients. Furthermore, we want to explore whether the quality of prescription talks can be improved from a doctor’s and patient’s perspective by measuring satisfaction and patients’ (perceived) knowledgeability with questionnaires. The same investigation will be conducted in a control group where the guide was not used.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00008789
  •   2015/10/01
  •   [---]*
  •   yes
  •   Approved
  •   15-298, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   E00-E90 -  Endocrine, nutritional and metabolic diseases
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   medication prescription talk (routine clinical practice)
  •   medication prescription talk (using the guide)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Other
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

the guide's feasibility: is the guide feasible for clinical practice? Physicians will be surveyed by questionnaire after using the guide.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

satisfaction (physicians): questionnaire before and after using the guide, Satisfaction (patients): questionnaires (SIMS-D, KPF-A) applied to interventional and control-patients

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2015/10/15
  •   48
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

consent to participating in the study; subject of consultation is either prescription of new medication or adjustment of preexisting pharmaco-therapy; Patients suffer from lipometabolic disorder and / or diabetes mellitus; minimum age 18 years; duration of therapy will be several weeks at least

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

limitation of linguistic, physical or cognitive functioning that could possibly preclude appropriate informing about the study or affect the prescribed medication therapy negatively; Patient initially refuses new prescription or adjustment of preexisting medication; new prescription or adjustment of preexisting medication are not subject of the actual conversation between patient and physician;
the reason for the consultation is a therapy of an acute condition that will last less than two weeks

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Pharmakologie der Universität zu Köln
    • Mr.  Priv.-Doz. Dr. med.  Jan  Matthes 
    • Gleueler Straße 24
    • 50931  Köln
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Institut für Pharmakologie der Universität zu Köln
    • Ms.  MSc  Katarina  Hauser 
    • Gleueler Straße 24
    • 50931  Köln
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Institut für Pharmakologie der Universität zu Köln
    • Mr.  Priv.-Doz. Dr. med.  Jan  Matthes 
    • Gleueler Straße 24
    • 50931  Köln
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Institut für Pharmakologie der Universität zu Köln
    • Mr.  Priv.-Doz. Dr. med.  Jan  Matthes 
    • Gleueler Straße 24
    • 50931  Köln
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Institut für Pharmakologie der Universität zu Köln
    • Gleueler Straße 24
    • 50931  Köln
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.