Study protocol
Effectiveness of a stepped primary care smoking cessation intervention (ISTAPS study): design of a cluster randomised trial
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* Corresponding author: Carmen Cabezas carmen.cabezas@gencat.cat
1 Departament de Salut, Generalitat de Catalunya, Spain. Institut d'Investigació en Assistència Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain
2 Department de Medicina, Universitat Autònoma de Barcelona, ICS, ABS Passeig de Sant Joan, SAP Dreta Barcelona, IDIAP Jordi Gol, Barcelona, Spain
3 Escola d'infermeria, Universitat de Barcelona, Institut Català de la Salut, Barcelona, Spain
4 ICS. Àrea d'Avaluació, Serveis d'Atenció Primària, Àmbit Territorial Girona, Spain
5 ICS. ABS Florida Nord, L'Hospitalet de Llobregat, Spain
6 ICS. SAP Hospitalet. Barcelona, Barcelona, Spain
7 ICS. ABS Jaume I, SAP Tarragona, Valls, Spain
8 ICS. ABS Les Borges del Camp, Tarragona, Spain
9 ICS. ABS Penedès rural, Tarragona, Spain
10 IDIAP Jordi Gol. Barcelona, Barcelona, Spain
BMC Public Health 2009, 9:48 doi:10.1186/1471-2458-9-48
Published: 4 February 2009Abstract
Background
There is a considerable body of evidence on the effectiveness of specific interventions in individuals who wish to quit smoking. However, there are no large-scale studies testing the whole range of interventions currently recommended for helping people to give up smoking; specifically those interventions that include motivational interviews for individuals who are not interested in quitting smoking in the immediate to short term. Furthermore, many of the published studies were undertaken in specialized units or by a small group of motivated primary care centres.
The objective of the study is to evaluate the effectiveness of a stepped smoking cessation intervention based on a trans-theoretical model of change, applied to an extensive group of Primary Care Centres (PCC).
Methods/Design
Cluster randomised clinical trial. Unit of randomization: basic unit of care consisting of a family physician and a nurse, both of whom care for the same population (aprox. 2000 people). Intention to treat analysis.
Study population: Smokers (n = 3024) aged 14 to 75 years consulting for any reason to PCC and who provided written informed consent to participate in the trial.
Intervention: 6-month implementation of recommendations of a Clinical Practice Guideline which includes brief motivational interviews for smokers at the precontemplation – contemplation stage, brief intervention for smokers in preparation-action who do not want help, intensive intervention with pharmacotherapy for smokers in preparation-action who want help, and reinforcing intervention in the maintenance stage.
Control group: usual care.
Outcome measures: Self-reported abstinence confirmed by exhaled air carbon monoxide concentration of ≤ 10 parts per million. Points of assessment: end of intervention period and 1 and 2 years post-intervention; continuous abstinence rate for 1 year; change in smoking cessation stage; health status measured by SF-36.
Discussion
The application of a stepped intervention based on the stages of a change model is possible under real and diverse clinical practice conditions, and improves the smoking cessation success rate in smokers, besides of their intention or not to give up smoking at baseline.
Trial Registration
Clinical Trials.gov Identifier: NCT00125905