Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00004933

Trial Description

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Title

Optimizing risk-communication by presenting convertability of of individual life expectancy or rather cost-effectiveness

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Trial Acronym

OptRisk

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URL of the Trial

http://www.uni-marburg.de/fb20/allgprmed/forschung/projekte/optrisk/optrisk.html

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Brief Summary in Lay Language

The decision aid arriba shows based on individual patient data a 10-year prognosis for suffering a cardiovascular event. It has been criticized, that a 10-year-prognosis most likely does not capture high-risk behaviour in younger patients, which might result in cardiovaskular eents beyond this time-frame.
Hence, other risk representations were developed, among those the time-to event-repreentation.
In this study, different forms of risk representations are investigated from patients' and physicians' perspective. The aim ist to optimize the risk representations and figure out, which are the most appropriate ones for daily practice.

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Brief Summary in Scientific Language

Decision-aids are nowadays a recognized and effective part of patient-centered care of chronically ill patients. The understandable and valid representations of prognosis and intervention effects play a major role. In the field of cardiovascular disease, we plan a comparative study of different representations from the perspective of affected patients, but also the physicians concerned.
We focus, on the one hand on the absolute risk versus event-free survival, and cost information for medications on the other hand.
The investigation follows the framework of the British Medical Research Council to evaluate complex interventions.
The investigators can resort on the now 10-year experience in developing and evaluating of the decision- aid arriba® of the main applicant . Arriba is mostly used in primary care practices. While the first study phases are more explorative, phase III shows a randomized comparison of different risk representations in real counseling situations.
The aim is to improve the risk and cost representation in a widespread decision-aid for cardiovascular diseases. The focus is on the comparison of the representation on the basis of 1) the absolute risk and 2) the event-free survival.

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Organizational Data

  •   DRKS00004933
  •   2016/02/02
  •   [---]*
  •   yes
  •   Approved
  •   167/12, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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Secondary IDs

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

  •   I25.19 -  [generalization I25.1: Atherosclerotic heart disease]
  •   I63.0 -  Cerebral infarction due to thrombosis of precerebral arteries
  •   E11 -  Non-insulin-dependent diabetes mellitus
  •   I10 -  Essential (primary) hypertension
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Interventions/Observational Groups

  •   Counseling patients with the 10-year- absolute risk representation in arriba to demonstrate the probability of suffering a cardiovascular event
  •   Counseling patients with the time-to-event representation in arriba to demonstrate the probability of suffering a cardiovascular event
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Shared Decision Making (PEF-FB-9)

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Secondary Outcome

Decisional Conflict(Decisional Conflict Scale, DCS)
Subjective risk (Analog scale)
Preparedness for Decision (Preparation for Decision Making Scale, PDMS-D)
Accessibility, Comprehension (Accessibility Scale)
Adherence to the decision 3 months after consultation (phone call)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2012/11/01
  •   300
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   30   Years
  •   80   Years
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Additional Inclusion Criteria

patients who consulted their GP for questions regarding their cardiovascular status

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Exclusion Criteria

insufficient knowlege of the German language
- cognitive impairment which hinders patients to actively take part in the decision-making process

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Abteilung für Allgemeinmedizin
    • Mr.  Univ.-Prof. Dr. med.  Norbert  Donner-Banzhoff 
    • Karl-von-Frisch-Str. 4
    • 35032  Marburg
    • Germany
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    • Mr.  Prof. Dr.  Uwe  Siebert 
    • Hall, Tirol
    • Austria
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Philipps-Universität Marburg, Abteilung für Allgemeinmedizin
    • Mr.  Prof. Dr. med.  Norbert  Donner-Banzhoff 
    • Karl-von-Frisch-Str. 4
    • 35032  Marburg
    • Germany
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    • Philipps-Universität MarburgAbteilung für Allgemeinmedizin
    • Mr.  Prof. Dr. med.  Norbert  Donner-Banzhoff 
    • Karl-von-Frisch-Str. 4
    • 35032  Marburg
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/05/06
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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.