Effectiveness of a new multi-component smoking cessation service package for patients with hypertension and diabetes in northern Thailand: a randomized controlled trial (ESCAPE study).

BACKGROUND: Smoking cessation is an achievable behavioral change, which reduces the risks of cardiovascular diseases, cancers and tobacco-related diseases. There is a need for an effective smoking cessation service for low and middle income country settings where the smoking rate is generally very high whilst a cessation service is not usually accessible. This study devised a new smoking cessation service package and assessed its effectiveness in the primary health care setting of northern Thailand. METHODS: This randomized controlled trial was centered at Maetha district hospital, Lampang province, Thailand, and its network of mobile non-communicable disease clinics at seven primary care units. A total of 319 eligible patients who consented to participate in the study, were randomly allocated to an intervention arm (160) and a control arm (159), applying block randomization. The multi-component intervention service consisted of: (1) regular patient motivation by the same nurse over a 3-month period; (2) a monthly piCO+ Smokerlyzer test for 3 months; (3) continual assistance from a trained family member, using a smoking-cessation- diary; and (4) optional nicotine replacement chewing gum therapy. The control group received the routine service comprising of brief counseling and casual follow-up. Smoking cessation, confirmed by six months of abstinence and the piCo+ Smokerlyzer breath test, was compared between the two services after a year follow-up. The trial is registered as an international current control trial at the ISRCTN registry. ISRCTN89315117. RESULTS: The median age of the participants was 64 years, with females constituting 28.84%. Most of the participants smoke hand-rolled cigarettes (85%). The intervention arm participants achieved a significantly higher smoking cessation rate than the control arm 25.62% vs 11.32%, with an adjusted odd ratio of 2.95 and 95% confidence interval 1.55-5.61. CONCLUSION: In relation to accessing smoking cessation services within the primary health care setting, participants who received the evidence-based intervention package were about three times more likely to succeed in giving up smoking than those who received the routine service. Utilizing community resources as major intervention components, the evidence from this trial may provide a useful and scalable smoking cessation intervention for low and middle income countries. TRIAL REGISTRATION: Current controlled trials ISRCTN89315117 . WHO international clinical trial identifier number: U1111-1145-6916; 3/2013.

Evidence-based new service package vs. routine service package for smoking cessation to prevent high risk patients from cardiovascular diseases (CVD): study protocol for randomized controlled trial.

BACKGROUND: Smoking cessation is a high-priority intervention to prevent CVD events and deaths in developing countries. While several interventions to stop smoking have been proved successful, the question of how to increase their effectiveness and practicality in developing countries remains. In this study, a newly devised evidence-based smoking cessation service package will be compared with the existing service in a randomized controlled trial within the community setting of Thailand. METHOD/DESIGN: This randomized control trial will recruit 440 current smokers at CVD risk because of being diabetic and/or hypertensive. Informed, consented participants will be randomly allocated into the new service-package arm and the routine service arm. The study will take place in the non-communicable disease clinics of the Maetha District Hospital, Lampang, northern Thailand. The new smoking-cessation service-package comprises (1) regular patient motivation and coaching from the same primary care nurse over a 3-month period; (2) monthly application of piCO + smokerlyzer to sustain motivation of smoker's quitting attempt and provide positive feedback over a 3-month period; (3) assistance by an assigned family member; (4) nicotine replacement chewing gum to relieve withdrawal symptoms. This new service will be compared with the traditional routine service comprising the 5A approach in a 1-year follow-up. Participants who consent to participate in the study but refuse to attempt quitting smoking will be allocated to the non-randomized arm, where they will be just followed up and monitored. Primary outcome of the study is smoking cessation rate at 1-year follow-up proven by breath analysis measuring carbomonoxide in parts per million in expired air. Secondary outcomes are smoking cessation rate at the 6-month follow-up, blood pressure and heart rate, CVD risk according to the Framingham general cardiovascular risk score, CVD events and deaths at the 12-month follow-up, and the cost-effectiveness of the health service packages. Intention-to-treat analysis will be followed. Factors influencing smoking cessation will be analyzed by the structure equation model. DISCUSSION: This multicomponent intervention, accessible at primary healthcare clinics, and focusing on the individual as well as the family and social environment, is unique and expected to work effectively. TRIAL REGISTRATION: Current Controlled Trials ISRCTN89315117.