Trial document




drksid header

  DRKS00007575

Trial Description

start of 1:1-Block title

Title

Preventing alcohol misuse in primary care: Investigation of General Practitioner's motivational barriers against Screening and Brief Intervention

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

Trial Acronym

[---]*

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

Although recommended by WHO and other institutions Screening and Brief Intervention (SBI) to reduce alcohol consumption of patients with risky or harmful alcohol consumption are rarely used by General Practitioners (GPs) in Germany. In order to improve primary care dependence prevention the motivational barriers of GPs against SBI should be investigated more thoroughly therefore. In our research we want to test the effect of insufficient compensation on GPs’ SBI motivation in compare to other barriers such as lacking adherence of patients or limited feasibility of SBI tools (e.g. screening questionnaires). Based on our results a revision of methods and strategies for SBI will be suggested.

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

Brief Summary in Scientific Language

Previous research demonstrated the efficacy of Screening and Brief Intervention in primary care (SBI) to reduce alcohol consumption of patients. However General Practitioners (GPs) rarely used SBI in the last years. To explore the problem research identified several barriers holding GPs against SBI. In particular, insufficient compensation has been identified by most GPs in Germany.
Since social desirability bias may be supposed in our research the effect of level of compensation on SBI motivation will be tested in compare to the effects lacking adherence of patients regarding SBI interventions as well as limited feasibility of SBI tools (e.g. screening questionnaires).

Method:
N=200 GPs will be asked by questionnaire (vignettes) using a 2(adherence high/low resp. feasibility high/low) by 2(compensation high/low) design with SBI motivation of GPs as dependent variable.
Hypothesis 1: GPs SBI motivation is negatively influenced by the patients’ lacking adherence regarding SBI but not by level of compensation.
Hypothesis 2: GPs SBI motivation is negatively influenced by the limited feasibility of SBI tools but not by level of compensation.

Based on our results existing SBI intervention tools (e.g. screening questionnaires) will be discussed critically. A revision of methods and strategies will be suggested to improve primary care dependence prevention in Germany.

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

Organizational Data

  •   DRKS00007575
  •   2015/02/17
  •   [---]*
  •   no
  •   Approved
  •   2014-138, Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg
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

  •   F10.1 -  Mental and behavioural disorders due to use of alcohol; Harmful use
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   General Practitioners in Germany will be asked once by a survey questionnaire.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Health care system
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

SBI Motivation of GPs, e.g. improving readiness to change of patients with risky alcohol consumption

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

Secondary Outcome

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

  • Doctor's Practice 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2015/03/01
  •   200
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

human medicine degree,
working as General Practitioner in the fields of patient care

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

Exclusion Criteria

refusal of consent and participation in the study

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Referat Drogen und Sucht 425, Bundesministerium für Gesundheit
    • Ms.  Dr.  Sandra  Dybowski 
    • Rochusstr. 1
    • 53123  Bonn
    • 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
    • SRH Hochschule für Gesundheit Gera
    • Mr.  Prof. Dr.  Thomas  Fankhänel 
    • Neue Straße 28-30
    • 07548  Gera
    • 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
    • Sektion Allgemeinmedizin, Medizinische Fakultät, Martin-Luther-Universität Halle-Wittenberg
    • Mr.  Prof. Dr.  Thomas  Fankhänel 
    • Magdeburger Straße 8
    • 06112   Halle
    • 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
    • Martin-Luther-Universität Halle Wittenberg
    • Mr.  Prof. Dr.  Thomas  Fankhänel 
    • Magdeburgerstr. 8
    • 06112  Halle
    • 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
    • Referat Drogen und Sucht 425, Bundesministerium für Gesundheit
    • Ms.  Dr.  Sandra  Dybowski 
    • Rochusstr. 1
    • 53123   Bonn
    • 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 ongoing
  •   [---]*
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.