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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
University Medicine Greifswald
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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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