Tobacco SmokingPhase 2PRO GPNCT00679861
Smoking Interventions in General Medical Practices
A Phase 2 study testing Counselling Intervention and Expert-system intervention in people with Tobacco Smoking and Nicotine Dependence, run by University Medicine Greifswald.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Smoking, Nicotine Dependence
- What is being tested?
- Counselling Intervention and Expert-system intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,215 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Jun 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Practices planing closure within the next 12 months
- Practices opening less than 12 months ago
About this study
Official title: 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.
- Conditions
- Tobacco Smoking, Nicotine Dependence
- Being tested
- Counselling Intervention, Expert-system intervention
- Keywords
- primary medical care, computer expert system, motivational interviewing, health behavior change counselling, stages of change
- Medical subject headings
- Tobacco Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counselling InterventionBehavioural
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 interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 3 | Experimental | A practitioner delivered counselling and an expert system intervention is implemented in practices allocated to this arm Receives: Behavioral: Counselling Intervention; Behavioral: Expert-system intervention |
| 1 | Experimental | A practitioner delivered counselling intervention was implemented in practices allocated to this arm Receives: Behavioral: Counselling Intervention |
| 2 | Experimental | A computer expert system intervention was implemented in practices allocated to this arm Receives: Behavioral: Expert-system intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treated Patients by practice within study period
Measured: 7 months
Point prevalence smoking abstinence of treated patients
Measured: 24 hours, 7 days, 4 weeks, 6 months preceeding the 12 months follow-up assessment
Secondary outcomes (4)
Participation rate of practices
Measured: within recruitment phase
Quit and cut down attempts of patients
Measured: 12 months
number of cigarettes smoked per day
Measured: 4 weeks preceeding follow-up
Stages of change progress
Measured: at 12 month follow-up compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2008 (estimated)
- Study startOct 2004
- Primary completionAug 2008 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 3,215 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, German Research Foundation
- Investigators
- Christian Meyer, Dr., Principal investigator, University of GreifswaldUlrich John, Prof. Dr., Study director, University of Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679861
- Sponsor's protocol ID
- E2_P4, 01EB0420
- Acronym
- PRO GP
- Status last verified
- May 2008
- First submitted
- 15 May 2008
- Last updated
- 19 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Types of Proactive Smoking Interventions for General Medical Practices: An Implementation Study
- ClinicalTrials.gov ID
- NCT00679861
- Acronym / sponsor ID
- PRO GP / E2_P4, 01EB0420
- Conditions
- Tobacco Smoking, Nicotine Dependence
- Keywords
- primary medical care, computer expert system, motivational interviewing, health behavior change counselling, stages of change
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,215 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, German Research Foundation
- Study start
- Oct 2004
- Primary completion
- Aug 2008 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 19 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3 | Experimental | Behavioral: Counselling Intervention, Behavioral: Expert-system interventionA practitioner delivered counselling and an expert system intervention is implemented in practices allocated to this arm |
| 1 | Experimental | Behavioral: Counselling InterventionA practitioner delivered counselling intervention was implemented in practices allocated to this arm |
| 2 | Experimental | Behavioral: Expert-system interventionA computer expert system intervention was implemented in practices allocated to this arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Practices planing closure within the next 12 months
- Practices opening less than 12 months ago
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Counselling InterventionA personal counselling by the residing practitioner of up to 10 minutes. A follow-up counselling is included for the next regular patient consultation | Behavioural | 1, 3 |
| Expert-system interventionCounselling 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. | Behavioural | 2, 3 |
Primary outcome
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
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Meyer, Dr. principal investigator
University of Greifswald
Ulrich John, Prof. Dr. study director
University of Greifswald
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Counselling Intervention and Expert-system intervention in people with Tobacco Smoking and Nicotine Dependence, run by University Medicine Greifswald.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treated Patients by practice within study period (time frame: 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2008.