Trial document




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  DRKS00006079

Trial Description

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Title

Evaluation of a collaborative smoking cessation intervention

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Trial Acronym

ENTER

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URL of the Trial

http://zpm.uke.uni-hamburg.de/4DACTION/W_projekt_detail?L=P2&prn=617&tn=10&trn=4

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Brief Summary in Lay Language

Smoking is a preventable risk factor for disease and especially patients who suffer from the negative health effects of smoking can benefit from smoking cessation advice. For this reason, the German health insurance company AOK NordWest has developed a smoking cessation intervention aimed at individuals with cardiovascular disease, chronic obstructive pulmonary disease (COPD) or heavy smokers. During the intervention, the smoking cessation program “Rauchfrei” is complemented by measures to support the collaboration between general practitioners (GP) and AOK NordWest. For instance, GP’s refer their patients to the “Rauchfrei” program, in order to facilitate access to existing smoking cessation advice.

During the present study ENTER: Evaluation of a collaborative smoking cessation intervention, 40 GP’s are recruited from five different regions in which AOK NordWest is present. After deciding to participate in the study, GP’s are randomly allocated to either the experimental or the control condition. GP’s in the experimental condition treat their patients according to the AOK intervention, whereas GP’s in the control condition treat their patients as usual (no intervention is implemented). The aim of the project ENTER is to evaluate the implementation and the effectiveness of the intervention. Hereby, it is of interest to understand if the intervention increases participation in smoking cessation programs. Moreover, the intervention’s effect on smoking status, general well-being and health costs is evaluated.

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Brief Summary in Scientific Language

Background:
Tobacco consumption is a preventable risk factor for chronic disease and complicates the treatment of medical conditions. For this reason, the German health insurance company AOK NordWest has developed a smoking cessation intervention aimed at individuals with cardiovascular disease, chronic obstructive pulmonary disease (COPD) and heavy smokers, with the purpose of increasing participation in smoking cessation programs. The aim of the project ENTER: Evaluation of a collaborative smoking cessation intervention is to evaluate the implementation and effectiveness of the AOK intervention.

Study design:
The effect of the intervention is evaluated in form of a cluster-randomized controlled trial that is conducted with 40 general practitioners (GP) of the AOK NordWest region. In the experimental condition, GP’s motivate smokers (n = 360) to participate in the smoking cessation program offered by AOK and follow-up on their participation during subsequent consultations. In the control condition, GP’s treat their patients (n = 360) as usual (no intervention is implemented). Questionnaires on smoking behaviour, motivation to quit and health status are administered at study inclusion in the medical practice and via telephone interviews at 3 and 12 months follow-up. Participants in the experimental condition take part in a specific form of smoking cessation courses which are compared to the regular AOK-courses through a quasi-experimental design. Furthermore, qualitative methods are used to evaluate the collaboration between GP’S and an economic evaluation is performed in order to determine the measure’s cost effectiveness.

Hypotheses:
The following hypotheses follow from the study design.
Primary hypothesis:
On average, patients in the experimental condition consume less cigarettes per day, compared to patients in the control condition.

Secondary hypotheses:
-Patients in the experimental condition abstain from smoking more often, compared to patients in the control condition one year after consultation with their GP.
- Patients in the experimental condition have a higher quality of life, compared to patients in the control condition one year after consultation with their GP.
- Patients in the experimental condition have less respiratory problems, compared to patients in the control condition one year after consultation with their GP.

Behavioural aspects of the intervention are investigated by assessing the processes and results of the newly implemented smoking cessation courses.
- Towards the end of the new smoking cessation courses, patients in the experimental condition abstain from smoking more frequently than participants of the regular course.
- Patients in the experimental condition complete smoking cessation courses more often than participants of the regular course.
- Patients in the experimental condition are more satisfied with the course content than participants of the regular course.

Structural aspects of the intervention are assessed by considering the measure’s cost-effectiveness and overall participation in smoking cessation courses.
- In the experimental group, around 20% of patients are referred to the smoking cessation course by their GP through a pre-printed form
- There is enough capacity within the smoking cessation courses offered by the AOK to offer every patient of the experimental condition a space.
- The amount of participants who take part in a smoking cessation course is greater in the experimental condition, compared to the control condition.
- The intervention is cost-effective (cost per reduced frequency-index) as well as cost-beneficial (cost per quality-adjusted life year; QALY).

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Organizational Data

  •   DRKS00006079
  •   2014/06/04
  •   [---]*
  •   yes
  •   Approved
  •   PV4628, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

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

  •   F17 -  Mental and behavioural disorders due to use of tobacco
  •   J44 -  Other chronic obstructive pulmonary disease
  •   I00-I99 -  Diseases of the circulatory system
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Interventions/Observational Groups

  •   Doctors ask patients about their tobacco consumption, motivate them to participate in a smoking cessation program and follow-up on the patient's smoking behaviour during subsequent consultations.
  •   Doctors treat their patients as usual (no specific intervention is implemented)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   No treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The primary outcome is that 12 months after the initial consultation with their doctors, the amount of cigarettes smoked per day by patients in the experimental condition is lower than the amount of cigarettes smoked per day by patients in the control condition. Smoking status is assessed with a questionnaire that participants fill in upon inclusion into the study in the general practice. Follow-up takes place via telephone after 3 and 12 months. Cigarette consumption is measured with Menge-Frequenz-Index (Kraus & Augustin, 2005).

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Secondary Outcome

Secondary outcomes are related to Quality of Life and general well-being. Baseline assessment takes place with a questionnaire that participants fill in upon inclusion into the study in the general practice. Follow-up takes place via telephone after 3 and 12 months. The questionnaire includes items from the Fagerström Test for Nicotine Dependence (Heatherton, Kozlowski, Frecker & Fagerström, 1991), Menge-Frequenz Index (Kraus & Augustin, 2005), SmoCess-GP (Jung et al., 2008), Fragebogen zur Änderungsbereitschaft bei Rauchern (Hannöver et al., 2002), SF-12 (Ware, Kosinski & Keller, 1996), EQ-5D-3L (EuroQol Group, 1990) and Visual Simplified Respiratory Questionnaire (Perez et al., 2009). Moreover, general practitioners document the patient's health status (e.g. severity of the chronic obstructive pulmonary disease or cardiovascular disease) on a form during consultations with patients.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Planned
  •   2014/06/30
  •   720
  •   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

- 18 years or older
- health insured by AOK
- heavy smoker (20 cigarettes per day or more) or suffering from chronic obstructive pulmonary disease (COPD)/ cardiovascular disease and smoker

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Exclusion Criteria

- younger than 18 years
- non-smoker
- illiterate
- cognitive impairments

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Addresses

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    • Director - Department of Medical Psychology, Center for Psychosocial Medicine, University Medical Center Hamburg-Eppendorf
    • Mr.  Prof. Dr. Dr.   Martin  Härter 
    • Martinistr. 52, W26
    • 20246  Hamburg
    • Germany
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    •   +49(040)/7410-52863
    •   +49(040)/7410-54965
    •   [---]*
    •   [---]*
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    • AOK NordWest
    • Mr.  Prof. Dr.  Michael  Tiemann 
    • Kopenhagener Str. 1
    • 44269  Dortmund
    • Germany
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    •   [---]*
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    • Director - Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf
    • Mr.  Prof. Dr.  Hans-Helmut  König 
    • Martinistr. 52, W37
    • 20246  Hamburg
    • Germany
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    •   [---]*
    •   [---]*
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    • Department of Medical Psychology, Center for Psychosocial Medicine, University Medical Center Hamburg-Eppendorf
    • Ms.  Dr.  Anna  Levke Brütt 
    • Martinistr. 52, W 26
    • 20246  Hamburg
    • Germany
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    • Department of Medical Psychology, Center for Psychosocial Medicine, University Medical Center Hamburg-Eppendorf
    • Ms.  Dr.  Angela  Buchholz 
    • Martinistr. 52, W 26
    • 20246  Hamburg
    • Germany
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    •   +49(0)40/7410-57705
    •   +49(0)40/7410-54940
    •   a.buchholz at uke.de
    •   [---]*
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    • University Medical Center Hamburg-Eppendorf, Center for Psychosocial Medicine, Department of Medical Psychology
    • Ms.  Dr.  Anna Levke  Brütt 
    • Martinistr. 52, W 26
    • 20246  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Gesundheit
    • Referat 425
    • 53107  Bonn
    • Germany
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Status

  •   Recruiting planned
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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.