ABSTRACT
BACKGROUND: The wide scale and severity of consequences of tobacco use, benefits derived from cessation, low rates of intervention by healthcare professionals, and new opportunities stemming from novel communications technologies are the main factors motivating this project. Thus, the purpose of this study is to assess the effectiveness of an intervention that helps people cease smoking and increase their nicotine abstinence rates in the long term via a chat-bot, compared to usual practice, utilizing a chemical validation at 6 months. METHODS: Design: Randomized, controlled, multicentric, pragmatic clinical trial, with a 6-month follow-up. SETTING: Healthcare centers in the public healthcare system of the Community of Madrid (Madrid Regional Health Service). PARTICIPANTS: Smokers > 18 years of age who attend a healthcare center and accept help to quit smoking in the following month. N = 460 smokers (230 per arm) who will be recruited prior to randomization. Intervention group: use of a chat-bot with evidence-based contents to help quit smoking. CONTROL GROUP: Usual treatment (according to the protocol for tobacco cessation by the Madrid Regional Health Service Main variable: Continuous nicotine withdrawal with chemical validation (carbon monoxide in exhaled air). Intention-to-treat analysis. Difference between groups in continuous abstinence rates at 6 months with their corresponding 95% confidence interval. A logistic regression model will be built to adjust for confounding factors. RESULTS: First expected results in January 2020. DISCUSSION: Providing science-based evidence on the effectiveness of clinical interventions via information technologies, without the physical presence of a professional, is essential. In addition to being more efficient, the characteristics of these interventions can improve effectiveness, accessibility, and adherence to treatment. From an ethics perspective, this new type of intervention must be backed by scientific evidence to circumvent pressures from the market or particular interests, improve patient safety, and follow the standards of correct practices for clinical interventions. TRIAL REGISTRATION: ClinicalTrials.gov, reference number NCT03445507.
Subject(s)
Artificial Intelligence , Smoking Cessation/methods , Software , Telemedicine/methods , Adult , Cell Phone , Female , Humans , Male , Mobile Applications , Primary Health Care , Smoking/therapy , SpainABSTRACT
INTRODUCTION: Advice can have a small but clinically important effect in promoting smoking cessation. Where studied, the rate of delivery has been found to be low. Training has been found to increases this rates, but there is little research on effectiveness in terms of smoking cessation rates. This study aimed to assess the effectiveness and cost-effectiveness of an health professionals educational program to increase long-term rates of nicotine abstinence in smoking outpatients. METHODS: We conducted a pragmatic cluster-randomized, controlled trial in 35 primary health care centers in Spain. Participants were all 830 health professionals who attended 5,970 smokers during recruiting period. After that we measured continuous abstinence 6 months after the intervention and biochemically validated (saliva cotinine test) 1 year following intervention. Cost-effectiveness was measured in terms of cost per life year gained. RESULTS: After 6 months, the rate of continuous abstinence was significantly higher in the intervention group (2.1% vs. 0.3%, p > .0001) with an odds ratio of 6.5 (95% CI = 3.3-12.7). After 1 year, biochemical validation was performed on 31 of the 67 patients previously registered as abstinent. All of them were abstinent and belonged to intervention group. The incremental cost per life year gained after 6 months was 969. CONCLUSIONS: A primary care training program on smoking cessation based on scientific evidence, behavioral theory, and active learning methods increases long-term continuous nicotine abstinence rate among outpatients in a significant way. These may be relevant for planning training of professionals, clinical assistance, and public health programs.
Subject(s)
Smoking Cessation/methods , Tobacco Use Disorder/therapy , Adult , Cost-Benefit Analysis , Female , Humans , Male , Middle Aged , Smoking Cessation/economics , Surveys and QuestionnairesABSTRACT
No disponible
Subject(s)
Humans , Tobacco Use Disorder/therapy , Clinical Protocols , Primary Health CareABSTRACT
No disponible
