Smoking Interventions in General Medical Practices (PRO GP)
Primary Purpose
Tobacco Smoking, Nicotine Dependence
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Counselling Intervention
Expert-system intervention
Sponsored by
About this trial
This is an interventional health services research trial for Tobacco Smoking focused on measuring primary medical care, computer expert system, motivational interviewing, health behavior change counselling, stages of change
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
3
1
2
Arm Description
A practitioner delivered counselling and an expert system intervention is implemented in practices allocated to this arm
A practitioner delivered counselling intervention was implemented in practices allocated to this arm
A computer expert system intervention was implemented in practices allocated to this arm
Outcomes
Primary Outcome Measures
Number of treated Patients by practice within study period
Point prevalence smoking abstinence of treated patients
Secondary Outcome Measures
Participation rate of practices
Quit and cut down attempts of patients
number of cigarettes smoked per day
Stages of change progress
Full Information
NCT ID
NCT00679861
First Posted
May 15, 2008
Last Updated
May 16, 2008
Sponsor
University Medicine Greifswald
Collaborators
German Federal Ministry of Education and Research, German Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00679861
Brief Title
Smoking Interventions in General Medical Practices
Acronym
PRO GP
Official Title
Different Types of Proactive Smoking Interventions for General Medical Practices: An Implementation Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2004 (undefined)
Primary Completion Date
August 2008 (Anticipated)
Study Completion Date
June 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University Medicine Greifswald
Collaborators
German Federal Ministry of Education and Research, German Research Foundation
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Smoking, Nicotine Dependence
Keywords
primary medical care, computer expert system, motivational interviewing, health behavior change counselling, stages of change
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
3215 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3
Arm Type
Experimental
Arm Description
A practitioner delivered counselling and an expert system intervention is implemented in practices allocated to this arm
Arm Title
1
Arm Type
Experimental
Arm Description
A practitioner delivered counselling intervention was implemented in practices allocated to this arm
Arm Title
2
Arm Type
Experimental
Arm Description
A computer expert system intervention was implemented in practices allocated to this arm
Intervention Type
Behavioral
Intervention Name(s)
Counselling Intervention
Intervention Description
A personal counselling by the residing practitioner of up to 10 minutes. A follow-up counselling is included for the next regular patient consultation
Intervention Type
Behavioral
Intervention Name(s)
Expert-system intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of treated Patients by practice within study period
Time Frame
7 months
Title
Point prevalence smoking abstinence of treated patients
Time Frame
24 hours, 7 days, 4 weeks, 6 months preceeding the 12 months follow-up assessment
Secondary Outcome Measure Information:
Title
Participation rate of practices
Time Frame
within recruitment phase
Title
Quit and cut down attempts of patients
Time Frame
12 months
Title
number of cigarettes smoked per day
Time Frame
4 weeks preceeding follow-up
Title
Stages of change progress
Time Frame
at 12 month follow-up compared to baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Meyer, Dr.
Organizational Affiliation
University of Greifswald
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulrich John, Prof. Dr.
Organizational Affiliation
University of Greifswald
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Smoking Interventions in General Medical Practices
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