Clinical trial NCT00679861: Smoking Interventions in General Medical Practices
Official title: Different Types of Proactive Smoking Interventions for General Medical Practices: An Implementation Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Tobacco Smoking
Nicotine Dependence
Keywords: primary medical care
computer expert system
motivational interviewing
health behavior change counselling
stages of change
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
name: German Research Foundation
First posted: 2008-05-19
Enrollment: 3215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of treated Patients by practice within study period
timeFrame: 7 months
measure: Point prevalence smoking abstinence of treated patients
timeFrame: 24 hours, 7 days, 4 weeks, 6 months preceeding the 12 months follow-up assessment
Secondary outcomes:
measure: Participation rate of practices
timeFrame: within recruitment phase
measure: Quit and cut down attempts of patients
timeFrame: 12 months
measure: number of cigarettes smoked per day
timeFrame: 4 weeks preceeding follow-up
measure: Stages of change progress
timeFrame: at 12 month follow-up compared to baseline
Other outcomes:
Locations:
Study officials:
affiliation: University of Greifswald
name: Christian Meyer, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Greifswald
name: Ulrich John, Prof. Dr.
role: STUDY_DIRECTOR
References: