ISTAPS: A Stepped Primary Care Smoking Cessation Intervention

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00125905
• Other study ID #: PI021471
• Secondary ID: PI021471G03/170
• Status: Active, not recruiting
• Phase: N/A
• First received: August 1, 2005
• Last updated: September 29, 2009
• Start date: October 2003
• Est. completion date: July 2006

Study information

• Verified date: November 2003
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3012
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Advice

• Motivational Interviewing

Drug:
• Nicotine Gum and Patch

• Bupropion

Locations

Country	Name	City	State
Spain	Jordi Gol i Gurina Foundation-Primary Care Research Institute	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Preventive Services and Health Promotion Research Network

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self reported abstinence confirmed by an expired air carbon monoxide concentration of 10 parts per millions or less
Primary	Point prevalence at the end of intervention, 1 and 2 years after the beginning of intervention
Primary	Continuous abstinence rate for 1 year
Primary	Change of stage in the smoking cessation process
Secondary	Health status measured by SF-36