Smoking Interventions in General Medical Practices

Nicotine Dependence Clinical Trial

— PRO GP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00679861
• Other study ID #: E2_P4, 01EB0420
• Status: Active, not recruiting
• Phase: Phase 2
• First received: May 15, 2008
• Last updated: May 16, 2008
• Start date: October 2004
• Est. completion date: June 2009

Study information

• Verified date: May 2008
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3215
• Est. completion date: June 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Smoking

Intervention

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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University Medicine Greifswald	German Federal Ministry of Education and Research, German Research Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treated Patients by practice within study period		7 months	No
Primary	Point prevalence smoking abstinence of treated patients		24 hours, 7 days, 4 weeks, 6 months preceeding the 12 months follow-up assessment	No
Secondary	Participation rate of practices		within recruitment phase	No
Secondary	Quit and cut down attempts of patients		12 months	No
Secondary	number of cigarettes smoked per day		4 weeks preceeding follow-up	No
Secondary	Stages of change progress		at 12 month follow-up compared to baseline	No