Overview

This trial is active, not recruiting.

Conditions tobacco smoking, nicotine dependence
Treatments counselling intervention, expert-system intervention
Phase phase 2
Sponsor University Medicine Greifswald
Collaborator German Federal Ministry of Education and Research
Start date October 2004
End date August 2008
Trial size 3215 participants
Trial identifier NCT00679861, E2_P4, 01EB0420

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking double blind (caregiver, outcomes assessor)
Primary purpose health services research
Arm
(Experimental)
A practitioner delivered counselling and an expert system intervention is implemented in practices allocated to this arm
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
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.
(Experimental)
A practitioner delivered counselling intervention was implemented in practices allocated to this arm
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
(Experimental)
A computer expert system intervention was implemented in practices allocated to this arm
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.

Primary Outcomes

Measure
Number of treated Patients by practice within study period
time frame: 7 months
Point prevalence smoking abstinence of treated patients
time frame: 24 hours, 7 days, 4 weeks, 6 months preceeding the 12 months follow-up assessment

Secondary Outcomes

Measure
Participation rate of practices
time frame: within recruitment phase
Quit and cut down attempts of patients
time frame: 12 months
number of cigarettes smoked per day
time frame: 4 weeks preceeding follow-up
Stages of change progress
time frame: at 12 month follow-up compared to baseline

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Different Types of Proactive Smoking Interventions for General Medical Practices: An Implementation Study
Principal investigator Christian Meyer, Dr.
Trial information was received from ClinicalTrials.gov and was last updated in May 2008.
Information provided to ClinicalTrials.gov by University Medicine Greifswald.