Cluster randomized trial in smoking cessation with intensive advice in diabetic patients in primary care. ITADI Study

Abstract

BackgroundIt is a priority to achieve smoking cessation in diabetic smokers, given that this is a group of patients with elevated cardiovascular risk. Furthermore, tobacco has a multiplying effect on micro and macro vascular complications. Smoking abstinence rates increase as the intensity of the intervention, length of the intervention and number and diversity of contacts with the healthcare professional during the intervention increases. However, there are few published studies about smoking cessation in diabetics in primary care, a level of healthcare that plays an essential role in these patients. Therefore, the aim of the present study is to evaluate the effectiveness of an intensive smoking cessation intervention in diabetic patients in primary care.Methods/DesignCluster randomized trial, controlled and multicentric. Randomization unit: Primary Care Team. Study population: 546 diabetic smokers older than 14 years of age whose disease is controlled by one of the primary care teams in the study. Outcome Measures: Continuous tobacco abstinence (a person who has not smoked for at least six months and with a CO level of less than 6 ppm measured by a cooximeter) , evolution in the Prochaska and DiClemente's Transtheoretical Model of Change, number of cigarettes/day, length of the visit. Point of assessment: one- year post- inclusion in the study. Intervention: Brief motivational interview for diabetic smokers at the pre-contemplation and contemplation stage, intensive motivational interview with pharmacotherapy for diabetic smokers in the preparation-action stage and reinforcing intevention in the maintenance stage. Statistical Analysis: A descriptive analysis of all variables will be done, as well as a multilevel logistic regression and a Poisson regression. All analyses will be done with an intention to treatment basis and will be fitted for potential confounding factors and variables of clinical importance. Statistical packages: SPSS15, STATA10 y HLM6.DiscussionThe present study will try to describe the profile of a diabetic smoker who receives the most benefit from an intensive intervention in primary care. The results will be useful for primary care professionals in their usual clinical practice.Trial RegistrationClinical Trials.gov Identifier: NCT00954967

Continued smoking abstinence in diabetic patients in primary care: A cluster randomized controlled multicenter study

“…The design and characteristics of the intensive advice in diabetic patients in primary care (ITADI) study have been previously reported [30]. ITADI was a cluster randomized, controlled and multicenter clinical trial, in which the primary health care team was the unit of randomization.…”

“…The phases of the study have been described elsewhere [30]. Briefly, after presenting the project to all potential primary care teams, general practitioners and nurses who wanted to collaborate signed a commitment form.…”

“…The number of intervention visits varied according to the stage of the patient (five for precontemplation, seven for contemplation and eight for preparation/action). Patients could move forward and backward in their stage over the course of the study, so that intervention visits were adapted to these changes [30]. Patients in the intervention group and controls underwent a final assessment at the end of the study (12 months).…”

Effectiveness of an intensive E-mail based intervention in smoking cessation (TABATIC study): study protocol for a randomized controlled trial

“…One of the main limitations of the study is that we will only include professionals who know how to use computers and E-mail and can assure participation in the study by using it. However we feel confident that an important number of participating professionals will run correctly the program since most of them have previously participated in other complex tobacco studies undertaken in our territory such as the ISTAPS (176 basic care units that worked in 82 Spanish primary care centers; participants: 2,827 smokers aged 14–85 years), ITADI (400 professionals and 1077 diabetic smokers) and BIBE studies (162 pediatric teams from 96 Spanish primary care centers; participants: 1101 child) [12,18,52]. No economic compensation will be offered to sanitary professionals; consequently, those who expect to be reimbursed for this extra activity will be also excluded of the study.…”

“…Other studies in our country have used this model among diabetic smokers patients attended in primary care and to confirm smoking abstinence using cooximetry [18] and another where information gathered by cooximetry is the main element to motivate smokers to quit [19]. …”