ISTAPS: A Stepped Primary Care Smoking Cessation Intervention

September 29, 2009 updated by: Jordi Gol i Gurina Foundation

Effectiveness of a Stepped Primary Care Smoking Cessation Intervention Based on an Evidence Based Clinical Practice Guideline (ISTAPS Project)

Primary care centers can play a very important role in helping people to stop smoking. There is a large body of research on the effectiveness of specific interventions especially addressed to people who want to stop smoking. In addition to that, there are no studies with a large sample of individuals included that tested the complete range of interventions recommended nowadays for helping people in the different smoking cessation stages of change and with different degrees of physical and psychological dependence, especially including motivational interviewing in those not interested in cessation in the very next weeks. This study will test a complex intervention that at first classifies smokers in stages and after that treats every smoker according to what stage he/she is in at the moment, his/her degree of dependence and his/her own characteristics.

Study Overview

Detailed Description

OBJECTIVES:

  • 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.

Study Type

Interventional

Enrollment

3012

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Barcelona, Spain, 08007
        • Jordi Gol i Gurina Foundation-Primary Care Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Smokers
  • Accept participation and follow-up by phone interviews for 2 years

Exclusion Criteria:

  • Terminal illness
  • Active addictive behaviours or important health problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Secondary Outcome Measures

Outcome Measure
Health status measured by SF-36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Carmen Cabezas-Peña, MD, Jordi Gol I Gurina Foundation-ICS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Study Completion

July 1, 2006

Study Registration Dates

First Submitted

August 1, 2005

First Submitted That Met QC Criteria

August 1, 2005

First Posted (Estimate)

August 2, 2005

Study Record Updates

Last Update Posted (Estimate)

September 30, 2009

Last Update Submitted That Met QC Criteria

September 29, 2009

Last Verified

November 1, 2003

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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