PRO GP: Smoking Interventions in General Medical Practices

Sponsor

University Medicine Greifswald (Other)

Overall Status

Unknown status

CT.gov ID

NCT00679861

Collaborator

German Federal Ministry of Education and Research (Other), German Research Foundation (Other)

3,215

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Smoking Nicotine Dependence	Behavioral: Counselling Intervention Behavioral: Expert-system intervention	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

3215 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

Different Types of Proactive Smoking Interventions for General Medical Practices: An Implementation Study

Study Start Date :

Oct 1, 2004

Anticipated Primary Completion Date :

Aug 1, 2008

Anticipated Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 3 A practitioner delivered counselling and an expert system intervention is 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 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.
Experimental: 1 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
Experimental: 2 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.

Arm

Intervention/Treatment

Experimental: 3

A practitioner delivered counselling and an expert system intervention is 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

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.

Experimental: 1

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

Experimental: 2

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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