ISTAPS: A Stepped Primary Care Smoking Cessation Intervention
Behavioral: Motivational Interviewing
Drug: Nicotine Gum and Patch
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effectiveness of a Stepped Primary Care Smoking Cessation Intervention Based on an Evidence Based Clinical Practice Guideline (ISTAPS Project)|
- Self reported abstinence confirmed by an expired air carbon monoxide concentration of 10 parts per millions or less
- Point prevalence at the end of intervention, 1 and 2 years after the beginning of intervention
- Continuous abstinence rate for 1 year
- Change of stage in the smoking cessation process
- Health status measured by SF-36
|Study Start Date:||October 2003|
|Estimated Study Completion Date:||July 2006|
- To evaluate the effectiveness of a stepped smoking cessation intervention based on a transtheoretical model of change that uses the pharmacological and no-pharmacological methods proposed by evidence based Clinical Practice Guidelines for smoking cessation from primary care centers.
- To assess the health status change in relationship with the smoking cessation process.
DESIGN: Cluster randomized clinical trial
Unit of Randomization: Care basic unit (family physician or nurse that cares for the same group of patients). Intention to treat analysis.
PARTICIPANTS: 2911 smokers (ages 14-75 years) consulting for any reason to primary care centers
INTERVENTION: 6-month implementation of recommendations of a Clinical Practice Guideline that includes motivational consulting for smokers at the precontemplation - contemplation stage; brief intervention for smokers in preparation-action who do not want help; intensive intervention with pharmacotherapies for smokers in preparation-action who want help; and reinforcing intervention in the maintenance stage.
CONTROL: Usual care
MEASUREMENT: Self reported abstinence confirmed by an expired air carbon monoxide concentration of 10 parts per millions or less; Point prevalence at the end of intervention, 1 and 2 years after the beginning of intervention; Continuous abstinence rate for 1 year; Change of stage in the smoking cessation process; Health status measured by SF-36.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00125905
|Jordi Gol i Gurina Foundation-Primary Care Research Institute|
|Barcelona, Spain, 08007|
|Principal Investigator:||Carmen Cabezas-Peña, MD||Jordi Gol I Gurina Foundation-ICS|