Smoking Interventions in General Medical Practices (PRO GP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by University Medicine Greifswald.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
German Research Foundation
Information provided by:
University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT00679861
First received: May 15, 2008
Last updated: May 16, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Tobacco Smoking
Nicotine Dependence
Behavioral: Counselling Intervention
Behavioral: Expert-system intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Different Types of Proactive Smoking Interventions for General Medical Practices: An Implementation Study

Resource links provided by NLM:


Further study details as provided by University Medicine Greifswald:

Primary Outcome Measures:
  • Number of treated Patients by practice within study period [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Point prevalence smoking abstinence of treated patients [ Time Frame: 24 hours, 7 days, 4 weeks, 6 months preceeding the 12 months follow-up assessment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Participation rate of practices [ Time Frame: within recruitment phase ] [ Designated as safety issue: No ]
  • Quit and cut down attempts of patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • number of cigarettes smoked per day [ Time Frame: 4 weeks preceeding follow-up ] [ Designated as safety issue: No ]
  • Stages of change progress [ Time Frame: at 12 month follow-up compared to baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 3215
Study Start Date: October 2004
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3
A practitioner delivered counselling and an expert system intervention is implemented in practices allocated to this arm
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
Behavioral: 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.
Experimental: 1
A practitioner delivered counselling intervention was implemented in practices allocated to this arm
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
Experimental: 2
A computer expert system intervention was implemented in practices allocated to this arm
Behavioral: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679861

Sponsors and Collaborators
University Medicine Greifswald
German Federal Ministry of Education and Research
German Research Foundation
Investigators
Principal Investigator: Christian Meyer, Dr. Humboldt-Universität zu Berlin
Study Director: Ulrich John, Prof. Dr. Humboldt-Universität zu Berlin
  More Information

No publications provided

Responsible Party: Christian Meyer (principal Investigator), Sabina Ulbricht (co-investigator), Ulrich John (study director), University of Greifswald, Institute of Epidemiology and Social Medicine
ClinicalTrials.gov Identifier: NCT00679861     History of Changes
Other Study ID Numbers: E2_P4, 01EB0420
Study First Received: May 15, 2008
Last Updated: May 16, 2008
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by University Medicine Greifswald:
primary medical care
computer expert system
motivational interviewing
health behavior change counselling
stages of change

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2014