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Smoking Interventions in General Medical Practices

NCT ID: NCT00679861

Last Updated: 2008-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

3215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Tobacco Smoking Nicotine Dependence

Keywords

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primary medical care computer expert system motivational interviewing health behavior change counselling stages of change

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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3

A practitioner delivered counselling and an expert system intervention is implemented in practices allocated to this arm

Group Type EXPERIMENTAL

Counselling Intervention

Intervention Type BEHAVIORAL

A personal counselling by the residing practitioner of up to 10 minutes. A follow-up counselling is included for the next regular patient consultation

Expert-system intervention

Intervention Type BEHAVIORAL

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.

1

A practitioner delivered counselling intervention was implemented in practices allocated to this arm

Group Type EXPERIMENTAL

Counselling Intervention

Intervention Type BEHAVIORAL

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

A computer expert system intervention was implemented in practices allocated to this arm

Group Type EXPERIMENTAL

Expert-system intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Practices with regular office hours
* Practices predominantly providing primary medical care for adults
* Patients with age 18 and older
* Patients with sufficient German language and cognitive capabilities to complete assessment
* Patients smoking within the preceding six month

Exclusion Criteria

* Practices planing closure within the next 12 months
* Practices opening less than 12 months ago
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

German Research Foundation

OTHER

Sponsor Role collaborator

University Medicine Greifswald

OTHER

Sponsor Role lead

Responsible Party

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University of Greifswald, Institute of Epidemiology and Social Medicine

Principal Investigators

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Christian Meyer, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Greifswald

Ulrich John, Prof. Dr.

Role: STUDY_DIRECTOR

University of Greifswald

Other Identifiers

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E2_P4, 01EB0420

Identifier Type: -

Identifier Source: org_study_id