Smoking Interventions in General Medical Practices (PRO GP)
May 16, 2008 updated by: University Medicine Greifswald
Different Types of Proactive Smoking Interventions for General Medical Practices: An Implementation Study
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
3215
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 3
A practitioner delivered counselling and an expert system intervention is implemented in practices allocated to this arm
|
A personal counselling by the residing practitioner of up to 10 minutes.
A follow-up counselling is included for the next regular patient consultation
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
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of treated Patients by practice within study period
Time Frame: 7 months
|
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
|
24 hours, 7 days, 4 weeks, 6 months preceeding the 12 months follow-up assessment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Participation rate of practices
Time Frame: within recruitment phase
|
within recruitment phase
|
|
Quit and cut down attempts of patients
Time Frame: 12 months
|
12 months
|
|
number of cigarettes smoked per day
Time Frame: 4 weeks preceeding follow-up
|
4 weeks preceeding follow-up
|
|
Stages of change progress
Time Frame: at 12 month follow-up compared to baseline
|
at 12 month follow-up compared to baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christian Meyer, Dr., University of Greifswald
- Study Director: Ulrich John, Prof. Dr., University of Greifswald
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2004
Primary Completion (Anticipated)
August 1, 2008
Study Completion (Anticipated)
June 1, 2009
Study Registration Dates
First Submitted
May 15, 2008
First Submitted That Met QC Criteria
May 16, 2008
First Posted (Estimate)
May 19, 2008
Study Record Updates
Last Update Posted (Estimate)
May 19, 2008
Last Update Submitted That Met QC Criteria
May 16, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E2_P4, 01EB0420
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.