Trial document




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  DRKS00012786

Trial Description

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Title

Further development and evaluation of a training for general practitioners in delivering brief stop-smoking advice as an implementation strategy of the S3-guideline "screening, diagnosis and treatment of harmful and addictive tobacco use" in general practice

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Trial Acronym

ABC II - Trial

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URL of the Trial

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Brief Summary in Lay Language

According to clinical guidelines, general practitioners (GP) should routinely provide their smoking patients brief advice to quit smoking. The delivery of such advice is traditionally based on the "5A" approach: ask (systematically identify and document all tobacco smokers at every visit), advise (urge all smokers to quit), assess (determine willingness to make a quit attempt), assist (provide counselling and medication) and arrange (ensure follow-up contact). The alternative "ABC" approach - ask about smoking status, brief advice to stop smoking and cessation support to do so - has several advantages but there is no evidence that it is more effective than usual care or at least as good than 5A in triggering quit attempts yet. This project focuses on further development and evaluation of a training for GPs as an implementation strategy of the S3 clinical practice guideline "screening, diagnosis and treatment of harmful and addictive tobacco use".

This study aims at exploring barriers and facilitators of implementing the content of the training into clinical practice. Subsequently, the training will be further developed and the effectiveness of both approaches (5A and ABC) will be assessed compared. Approximately 48 GP practices in North Rhine-Westphalia (Germany) will be randomised to receive training in delivering either 5A or ABC. Data will be collected in all consecutive smoking patients consulting their GP within 4 weeks prior and 4 weeks following the training. Sociodemographic data, smoking status, rates of delivery and quality of advice to quit (5A vs. ABC), including the type of treatment recommended by the GPs (behavioural, pharmacological) will be assessed directly after consultation through personal interviews.

Further outcomes will be collected in all smoking patients 4, 12 and 26 weeks following the consultation by means of follow-up questionnaires: quit attempts, rates of triggers of the last quit attempt, use of evidence-based cessation treatments and abstinence rates.

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Brief Summary in Scientific Language

According to clinical guidelines, general practitioners (GP) should routinely provide their smoking patients brief advice to quit smoking. The delivery of such advice is traditionally based on the "5A" approach (ask, advise, assess, assist, arrange). The alternative "ABC" approach (ask, brief advice, cessation support) has several advantages but there is no evidence that it is more effective than usual care or at least as good than 5A in triggering quit attempts. This project focuses on the further development and evaluation of a training for GPs in delivering brief stop-smoking advices as an implementation strategy of the S3-guideline "screening, diagnosis and treatment of harmful and addictive tobacco use" in General practice.

This study aims at exploring barriers and facilitators of implementing contents of the training into clinical practice (process evaluation). Subsequently, the training will be further developed and the effectiveness of both approaches (5A and ABC) will be assessed and compared.

A pragmatic 2-arm cluster randomised controlled trial with pre-post data collection will be conducted in approximately 48 GP practices in North Rhine-Westphalia (Germany). Practices will be randomised to receive training in delivering either 5A or ABC. Data will be collected in all consecutive smoking patients consulting their GP within 4 weeks prior and 4 weeks following the training. Sociodemographic data, smoking status, rates of delivery (=primary outcome) and quality of advice to quit and the rates of delivery of different types of treatment recommended by the GPs (behavioural, pharmacological; = secondary outcomes) will be assessed directly after consultation through personal interviews.

Further secondary outcomes will be collected in all smoking patients 4, 12 and 26 weeks following the consultation by means of follow-up questionnaires: quit attempts, rates of triggers of the last quit attempt, use of evidence-based cessation treatments and point-prevalence abstinence rates.

The primary endpoint is dichotomous (patient-reported delivery of brief advice to quit: yes or no). The primary data analysis will be conducted using a mixed-effects logistic regression model with random effects for the variable "cluster".

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Organizational Data

  •   DRKS00012786
  •   2017/08/22
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  •   yes
  •   Approved
  •   5999R, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

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Health Condition or Problem studied

  •   F17.2 -  Mental and behavioural disorders due to use of tobacco; Dependence syndrome
  •   Tobacco Smoking, tobacco addiction
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Interventions/Observational Groups

  •   Intervention ABC: GPs will receive a 3-hour training in delivering brief advice to quit smoking according to the ABC approach (ask, brief advice, cessation support).
    Data will be collected in all consecutive smoking patients consulting their GP within 4 weeks prior and 4 weeks following the training.The primary outcome and some of the secondary outcomes will be collected through personal interviews immediately following the consultation. Further secondary outcomes will be collected by means of follow-up questionnaires 4, 12 and 26 weeks after consultation.
  •   Intervention 5A: GPs will receive a 3-hour training in delivering brief advice to quit smoking according to the 5A approach (ask, advice, assess, assist, arrange).

    Data will be collected in all consecutive smoking patients consulting their GP within 4 weeks prior and 4 weeks following the training.
    The primary outcome and some of the secondary outcomes will be collected through personal interviews immediately following the counsultation. Further secondary outcomes will be collected by means of follow-up questionnaires 4, 12 and 26 weeks after consultation.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Patient-reported rates of delivery of brief advice to quit smoking by their GP during routine consultation. This parameter will be collected by personal-oral-questioning immediately after the consultation.

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Secondary Outcome

1) Patient-reported rates of delivery of behavioural treatment (single or group intervention) to assist their quit attempt by their GP during routine consultation.

2) Patient-reported rates of delivery of nicotine replacement therapy to assist their quit attempt by their GP during routine consultation.

3) Patient-reported rates of delivery of Varenicline or Bupropion to assist their quit attempt by their GP during routine consultation.

4-9) Patient-reported rates of quit attempts 4, 12 and 26 weeks following GP consultation and patient-reported smoke status 4,12 and 26 weeks after consultation.

Parameter 1-3) will be collected by personal-oral-questioning immediately after the consultation. Parameter 4-9) will be collected by paper-and-pencil follow-up survey.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2017/09/01
  •   2016
  •   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

Smoking tobacco daily or at least occasionally, consultation of a GP who participates in the trial (arm 1 or2 )

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Exclusion Criteria

Limited literacy, incapability to provide informed consent (e.g. dementia), patients who can not be interviewed due to other reasons (e.g. limited visual or auditory abilities), patients who will not see their GP in person

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Addresses

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    • Medical Faculty, Heinrich Heine University Duesseldorf
    • Werdener Str. 4
    • 40227  Duesseldorf
    • Germany
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    • Institut of General Practice; Addiction research and clinical epidemiology; Medical Faculty of the Heinrich Heine University
    • Ms.  Dr.rer.nat.  Sabrina  Kastaun 
    • Werdenerstr. 4/ 101007
    • 40227  Duesseldorf
    • Germany
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    • Institut of General Practice; Addiction research and clinical epidemiology; Medical Faculty of the Heinrich Heine University
    • Ms.  Dr.rer.nat.  Sabrina  Kastaun 
    • Werdenerstr. 4/ 101007
    • 40227  Duesseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Gesundheit (Federal Ministry of Health)
    • Referat 425
    • 53107  Bonn
    • 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.