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Smoking Interventions in General Medical Practices

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00679861
Acronym
PRO GP
Enrollment
3215
Registered
2008-05-19
Start date
2004-10-31
Completion date
2009-06-30
Last updated
2008-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nicotine Dependence, Tobacco Smoking

Keywords

primary medical care, computer expert system, motivational interviewing, health behavior change counselling, stages of change

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.

Interventions

A personal counselling by the residing practitioner of up to 10 minutes. A follow-up counselling is included for the next regular patient consultation

BEHAVIORALExpert-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.

Sponsors

German Federal Ministry of Education and Research
CollaboratorOTHER_GOV
German Research Foundation
CollaboratorOTHER
University Medicine Greifswald
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of treated Patients by practice within study period7 months
Point prevalence smoking abstinence of treated patients24 hours, 7 days, 4 weeks, 6 months preceeding the 12 months follow-up assessment

Secondary

MeasureTime frame
Participation rate of practiceswithin recruitment phase
Quit and cut down attempts of patients12 months
number of cigarettes smoked per day4 weeks preceeding follow-up
Stages of change progressat 12 month follow-up compared to baseline

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026