Smoking Interventions in General Medical Practices (PRO GP)

University Medicine Greifswald

Status and phase: Unknown; Phase 2

Conditions: Nicotine Dependence; Tobacco Smoking

Treatments: Behavioral: Expert-system intervention; Behavioral: Counselling Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT00679861

E2_P4, 01EB0420

Details and patient eligibility

About

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.

Enrollment: 3,215 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Exclusion criteria

• Practices planing closure within the next 12 months
• Practices opening less than 12 months ago

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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3,215 participants in 3 patient groups

3

Experimental group

Description:

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

Treatment:

Behavioral: Expert-system intervention

Behavioral: Counselling Intervention

1

Experimental group

Description:

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

Treatment:

Behavioral: Counselling Intervention

2

Experimental group

Description:

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

Treatment:

Behavioral: Expert-system intervention