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Sponsors and Collaborators: |
Ernst Moritz Arndt University of Greifswald German Federal Ministry of Education and Research German Research Foundation |
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Information provided by: | Ernst Moritz Arndt University of Greifswald |
ClinicalTrials.gov Identifier: | NCT00679861 |
Primary care physicians can play an important role in reducing tobacco smoking in the population. The general practice is a suitable setting for implementing proactive smoking interventions, because a large proportion of the population can be regularly reached in a favorable psychological state. Further, a trustful interpersonal relationship between the practitioners and their patients is supposed to increase the susceptibility to preventive measures. However, currently general practitioners are not capitalizing this advantage although evidence based treatments are available, which are effective and cost-effective. Outreach programs combining educational and practice-based measures have been found to be effective in engaging practitioners in screening and in giving advice. Computer expert-system and brief counseling interventions, which are based on the Transtheo-retical Model of behavior change (TTM), are promising approaches for the entire population of practitioners and smoking patients. For large scale implementation, data are needed about the degree of integration in every day routine clinical practice that could be achieved by implementing such interventions. Objectives: Evaluating different strategies for the implementation of proactive smoking interventions in general practices. Methods: In a randomized controlled trial, 150 randomly selected general practices of a defined German region will be included. The procedure comprises the implementation of 1) an on-site computer expert-system intervention, 2) a counseling intervention provided by the practitioner, or 3) the computer expert-system plus the counseling intervention. During an implementation phase of one month, two on site training sessions and support by phone will be provided. Routine use of the interventions will be monitored for the following 6 months. Main outcome measures are the number and rate of identified and treated smokers. A follow-up assessment will be realized 12 months after practice attendance to determine the smoking status of the treated smokers.
Condition | Intervention | Phase |
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Tobacco Smoking Nicotine Dependence |
Behavioral: Counselling Intervention Behavioral: Expert-system intervention |
Phase II |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Double Blind (Caregiver, Outcomes Assessor), Active Control, Factorial Assignment, Efficacy Study |
Official Title: | Different Types of Proactive Smoking Interventions for General Medical Practices: An Implementation Study |
Estimated Enrollment: | 3215 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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3: Experimental
A practitioner delivered counselling and an expert system intervention is implemented in practices allocated to this arm
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Behavioral: Counselling Intervention
A personal counselling by the residing practitioner of up to 10 minutes. A follow-up counselling is included for the next regular patient consultation
Behavioral: Expert-system intervention
Counselling letter of three to four pages will be generated by an expert-system base on the assessment of the patient. A second and third letter will be generated at follow-up consultations.
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1: Experimental
A practitioner delivered counselling intervention was implemented in practices allocated to this arm
|
Behavioral: Counselling Intervention
A personal counselling by the residing practitioner of up to 10 minutes. A follow-up counselling is included for the next regular patient consultation
|
2: Experimental
A computer expert system intervention was implemented in practices allocated to this arm
|
Behavioral: Expert-system intervention
Counselling letter of three to four pages will be generated by an expert-system base on the assessment of the patient. A second and third letter will be generated at follow-up consultations.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Christian Meyer, Dr. | Humboldt-Universität zu Berlin |
Study Director: | Ulrich John, Prof. Dr. | Humboldt-Universität zu Berlin |
Responsible Party: | University of Greifswald, Institute of Epidemiology and Social Medicine ( Christian Meyer (principal Investigator), Sabina Ulbricht (co-investigator), Ulrich John (study director) ) |
Study ID Numbers: | E2_P4, 01EB0420 |
Study First Received: | May 15, 2008 |
Last Updated: | May 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00679861 |
Health Authority: | Germany: Federal Ministry of Education and Research |
primary medical care computer expert system motivational interviewing health behavior change counselling stages of change |
Smoking Mental Disorders Tobacco Use Disorder Substance-Related Disorders Disorders of Environmental Origin |
Habits |