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Multicentric randomized clinical trial to evaluate the long-term effectiveness of a motivational intervention against smoking, based on the information obtained from spirometry in primary care: the RESET study protocol.

ABSTRACT: Spirometry is the recommended method of evaluating pulmonary function when respiratory disease is suspected in smokers. Nonetheless, no evidence exists of the usefulness of information obtained from this test as a motivational strategy for smoking cessation. The primary objective of this study is to evaluate the effectiveness of a motivational intervention based on spirometry results in achieving long-term smoking cessation.We propose a multicenter randomized clinical trial in the primary care setting.We will recruit active smokers of both sexes, aged 35-70 years, with a cumulated smoking habit exceeding 10 packs/year and who consult for any reason with their primary care physician in the 20 health centers in the province of Tarragona (Spain). Patients with a history of lung disease or who have undergone exploratory measures of pulmonary function in the preceding 12 months will be excluded. All patients who agree to participate will provide signed informed consent prior to their inclusion. A total of 1000 smokers will be consecutively randomized to a control or intervention group (1:1).Participants in both groups will receive brief (5-minute) health counseling, in accordance with usual clinical practice. In a consultation lasting about 15 minutes, participants in the intervention group will also receive detailed, personalized information about the results of a spirometry test and about their lung age compared with their chronological age. Both groups will be followed up for 12 months. Main variables and analysis: The main variable will be sustained smoking abstinence at 12 months after the intervention, as confirmed by CO breath testing and urine cotinine test. Results will be analyzed based on intention to treat, using the chi-square test and logistical regression if necessary to adjust for confounding variables.We expect the rate of prolonged smoking abstinence in the intervention group will be at least 5% higher than in the control group. If this strategy proves effective, it could easily be included in the health promotion activities offered in primary care settings.ClinicalTrials.gov Identifier: NCT02153047 . Registered on 28/05/2014.

SUBMITTER: Martin-Lujan F

PROVIDER: S-EPMC4743363 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature

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Multicentric randomized clinical trial to evaluate the long-term effectiveness of a motivational intervention against smoking, based on the information obtained from spirometry in primary care: the RESET study protocol.

Martin-Lujan Francisco F Santigosa-Ayala Antoni A Piñol-Moreso Josep-Lluis JL Sorli-Aguilar Mar M Flores-Mateo Gemma G Bladé-Creixenti Jordi J Basora-Gallisà Josep J Sola-Alberich Rosa R

BMC family practice 20160204

<h4>Background</h4>Spirometry is the recommended method of evaluating pulmonary function when respiratory disease is suspected in smokers. Nonetheless, no evidence exists of the usefulness of information obtained from this test as a motivational strategy for smoking cessation. The primary objective of this study is to evaluate the effectiveness of a motivational intervention based on spirometry results in achieving long-term smoking cessation.<h4>Methods/design</h4>We propose a multicenter rando ...[more]

PMID: 26846522

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Project description:There is current controversy about the efficacy of smoking cessation interventions that are based on information obtained by spirometry. The objective of this study is to evaluate the effectiveness in the primary care setting of structured motivational intervention to achieve smoking cessation, compared with usual clinical practice.Multicentre randomized clinical trial with an intervention and a control group.12 primary care centres in the province of Tarragona (Spain).600 current smokers aged between 35 and 70 years with a cumulative habit of more than 10 packs of cigarettes per year, attended in primary care for any reason and who did not meet any of the exclusion criteria for the study, randomly assigned to structured intervention or standard clinical attention.Usual advice to quit smoking by a general practitioner as well as a 20-minute personalized visit to provide detailed information about spirometry results, during which FEV1, FVC, FEF 25-75% and PEF measurements were discussed and interpreted in terms of theoretical values. Additional information included the lung age index (defined as the average age of a non-smoker with the same FEV1 as the study participant), comparing this with the chronological age to illustrate the pulmonary deterioration that results from smoking.Spirometry during the initial visit. Structured interview questionnaire administered at the primary care centre at the initial visit and at 12-month follow-up. Telephone follow-up interview at 6 months. At 12-month follow-up, expired CO was measured in patients who claimed to have quit smoking.Smoking cessation at 12 months.Data will be analyzed on the basis of "intention to treat" and the unit of analysis will be the individual smoker.Among active smokers treated in primary care we anticipate significantly higher smoking cessation in the intervention group than in the control group.Application of a motivational intervention based on structured information about spirometry results, improved abstinence rates among smokers seen in actual clinical practice conditions in primary care.ClinicalTrial.gov, number NCT01194596.

Project description:BackgroundSmoking is the main preventable cause of morbidity and mortality in our region, it being the main causative agent of chronic obstructive pulmonary disease. There still is no consensus on the use of spirometry as a strategy for smoking cessation, given that there is insufficient scientific evidence from high quality studies to recommend the use of this technique.Methods/designThis is to be a randomized, multicentre, open-label clinical trial. A total of 444 smokers over 40 years of age will be recruited by 39 general practitioners from 22 health centers. Primary objective of this study is to assess the effectiveness of spirometry together with information regarding the test for smoking cessation after 1 year in smokers over 40 years of age with a more than 10 pack-year history and no previous diagnosis of chronic obstructive pulmonary disease. Groups of 45 patients who smoke will be randomly selected from the lists of the participating doctors. The names will be sent to the corresponding doctors who will contact candidate patients and assess whether they meet the selection criteria. Patients who meet these criteria will be randomly allocated to an intervention or control group. For patients in both groups, a nurse will conduct an interview and perform a spirometry test to measure forced vital capacity. Then, all patients will be referred for an appointment with their doctor for brief anti-smoking intervention, patients from the intervention group additionally being informed about the result of the spirometry test. After 1 year, smoking status will be assessed and, in those who report that they have quit smoking, abstinence will be confirmed by co-oximetry. Data will be analyzed on an intention-to-treat basis using the chi-squared test for outcomes and binary logistic regression if it is considered to be necessary to adjust for confounding variables.DiscussionPerforming a spirometry test and providing information on pulmonary function may increase awareness of the effect of smoking among smokers who are asymptomatic or have few symptoms and make them decide to quit. Specifically, in patients with chronic obstructive pulmonary disease it might increase levels of motivation to quit smoking in early stages of the disease. If this strategy were to be effective, it could be included in the health promotion activities offered in primary care.Trial registrationClinicalTrials.gov Identifier: NCT01821885.

Project description:IntroductionAddressing tobacco use is an important issue in general health care. In order to improve smoking cessation advice, spirometry values can be displayed to the smoker to demonstrate possible lung function impairment. The estimate of so-called lung age may show a decrease in lung function associated with smoking. It has been suggested that performing spirometry on patients who smoke but are asymptomatic can be a useful way to show the adverse effects of smoking. The aim of this systematic review was to determine if providing spirometry results in combination with smoking cessation counselling can increase smoking cessation rates compared to what is achieved through counselling alone.MethodsIn this systematic review, we included randomized controlled trials (RCTs) evaluating smoking cessation interventions for adult smokers. The systematic search was performed in PubMed, Medline, Cochrane Library, Cinahl, Embase, Amed and PsycInfo.ResultsThe literature search resulted in 946 studies, which, after reading by two independent reviewers, were reduced to seven trials that matched the inclusion criteria. Two RCTs showed significant improvement in smoking cessation when giving patients feedback on spirometry results in combination with smoking cessation counselling, compared to patients who received only smoking cessation counselling. In both studies, the spirometry results were expressed as lung age. In the other five studies no difference was found. Five further published study protocols for ongoing RCT studies in the field have been found, and therefore this systematic overview will likely need to be updated within a few years.ConclusionsFew studies have been undertaken to examine the efficacy of spirometry in increasing smoking quit rates. Studies conducted to date have shown mixed results, and there is currently limited evidence in the literature that smoking cessation counselling that includes feedback from spirometry and a demonstration of lung age promotes quit rates.

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Multicentric randomized clinical trial to evaluate the long-term effectiveness of a motivational intervention against smoking, based on the information obtained from spirometry in primary care: the RESET study protocol.

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Multicentric randomized clinical trial to evaluate the long-term effectiveness of a motivational intervention against smoking, based on the information obtained from spirometry in primary care: the RESET study protocol.

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