Although most hospitalized smokers receive some form of cessation counseling during hospitalization, few receive outpatient cessation counseling and/or pharmacotherapy following discharge, which are key factors associated with long-term cessation. US Department of Veterans Affairs (VA) hospitals are challenged to find resources to implement and maintain the kind of high intensity cessation programs that have been shown to be effective in research studies. Few studies have applied the Chronic Care Model (CCM) to improve inpatient smoking cessation.
The primary objective of this protocol is to determine the effect of a nurse-initiated intervention, which couples low-intensity inpatient counseling with sustained proactive telephone counseling, on smoking abstinence in hospitalized patients. Key secondary aims are to determine the impact of the intervention on staff nurses' attitudes toward providing smoking cessation counseling; to identify barriers and facilitators to implementation of smoking cessation guidelines in VA hospitals; and to determine the short-term cost-effectiveness of implementing the intervention.
Pre-post study design in four VA hospitals
Hospitalized patients, aged 18 or older, who smoke at least one cigarette per day.
The intervention will include: nurse training in delivery of bedside cessation counseling, electronic medical record tools (to streamline nursing assessment and documentation, to facilitate prescription of pharmacotherapy), computerized referral of motivated inpatients for proactive telephone counseling, and use of internal nursing facilitators to provide coaching to staff nurses practicing in non-critical care inpatient units.
The primary endpoint is seven-day point prevalence abstinence at six months following hospital admission and prolonged abstinence after a one-month grace period. To compare abstinence rates during the intervention and baseline periods, we will use random effects logistic regression models, which take the clustered nature of the data within nurses and hospitals into account. We will assess attitudes of staff nurses toward cessation counseling by questionnaire and will identify barriers and facilitators to implementation by using clinician focus groups. To determine the short-term incremental cost per quitter from the perspective of the VA health care system, we will calculate cessation-related costs incurred during the initial hospitalization and six-month follow-up period.
Objective To determine whether a nurse led smoking cessation intervention affects smoking cessation rates in patients admitted for coronary heart disease.
Design Randomised controlled trial.
Setting Cardiac ward of a general hospital, Norway.
Participants 240 smokers aged under 76 years admitted for myocardial infarction, unstable angina, or cardiac bypass surgery. 118 were randomly assigned to the intervention and 122 to usual care (control group).
Intervention The intervention was based on a booklet and focused on fear arousal and prevention of relapses. The intervention was delivered by cardiac nurses without special training. The intervention was initiated in hospital, and the participants were contacted regularly for at least five months.
Main outcome measure Smoking cessation rates at 12 months determined by self report and biochemical verification.
Results 12 months after admission to hospital, 57% (n = 57/100) of patients in the intervention group and 37% (n = 44/118) in the control group had quit smoking (absolute risk reduction 20%, 95% confidence interval 6% to 33%). The number needed to treat to get one additional person who would quit was 5 (95% confidence interval, 3 to 16). Assuming all dropouts relapsed at 12 months, the smoking cessation rates were 50% in the intervention group and 37% in the control group (absolute risk reduction 13%, 0% to 26%).
Conclusion A smoking cessation programme delivered by cardiac nurses without special training, significantly reduced smoking rates in patients 12 months after admission to hospital for coronary heart disease.
Smoking is the world's fourth most common risk factor for disease, the leading preventable cause of death, and it is associated with tremendous social costs. In the Netherlands, the smoking prevalence rate is high. A total of 27.7% of the population over age 15 years smokes. In addition to the direct advantages of smoking cessation for the smoker, parents who quit smoking may also decrease their children's risk of smoking initiation.
A randomized controlled trial will be conducted to evaluate the effectiveness of proactive telephone counselling to increase smoking cessation rates among smoking parents. A total of 512 smoking parents will be proactively recruited through their children's primary schools and randomly assigned to either proactive telephone counselling or a control condition. Proactive telephone counselling will consist of up to seven counsellor-initiated telephone calls (based on cognitive-behavioural skill building and Motivational Interviewing), distributed over a period of three months. Three supplementary brochures will also be provided. In the control condition, parents will receive a standard brochure to aid smoking cessation. Assessments will take place at baseline, three months after start of the intervention (post-measurement), and twelve months after start of the intervention (follow-up measurement). Primary outcome measures will include sustained abstinence between post-measurement and follow-up measurement and 7-day point prevalence abstinence and 24-hours point prevalence abstinence at both post- and follow-up measurement. Several secondary outcome measures will also be included (e.g., smoking intensity, smoking policies at home). In addition, we will evaluate smoking-related cognitions (e.g., attitudes towards smoking, social norms, self-efficacy, intention to smoke) in 9-12 year old children of smoking parents.
This study protocol describes the design of a randomized controlled trial to evaluate the effectiveness of proactive telephone counselling in smoking cessation. It is expected that, in the telephone counseling condition, parental smoking cessation rates will be higher and children's cognitions will be less favorable about smoking compared to the control condition.
The protocol for this study is registered with the Netherlands Trial Register NTR2707.
Intensive smoking cessation interventions initiated during hospitalisation are effective, but currently not widely available. Strategies are needed to integrate smoking cessation treatment into routine inpatient care. Pharmacist-led interventions for smoking cessation are feasible and efficacious in both ambulatory and community pharmacy settings. However, there is a lack of evidence from large scale studies of the effectiveness of pharmacist guided programs initiated during patient hospitalisation in achieving long-term abstinence. This study aims to evaluate the effectiveness of a pharmacist-led system change intervention initiated during hospitalisation in Australian public hospitals.
A multi-centre, randomised controlled trial will be conducted with 12 months follow-up. Smokers, 18 years or older, will be recruited from the wards of three Victorian public hospitals. Participants will be randomly assigned to a usual care or intervention group using a computer generated randomisation list. The intervention group will receive at least three smoking cessation support sessions by a trained pharmacist: the first during the hospital stay, the second on or immediately after discharge and the third within one month post-discharge. All smoking cessation medications will be provided free of charge during the hospital stay and for at least one week after discharge. Participants randomised to usual care will receive the current care routinely provided by the hospital. All measurements at baseline, discharge, one, six and 12 months will be performed by a blinded Research Assistant. The primary outcome measures are carbon monoxide validated 7-day point prevalence abstinence at six and 12 months.
This is the first large scale study to develop and test a pharmacist-led system change intervention program initiated during patient hospitalisation. If successful, the program could be considered for wider implementation across other hospitals.
Smoking; Tobacco dependence; Quitting; Hospital; Randomised controlled trial; Pharmacist; System change
Gender-specific smoking cessation strategies have rarely been developed. Evidence of effectiveness of physical activity (PA) promotion and intervention in adjunct to smoking cessation programs is not strong. SPRINT study is a randomized controlled trial (RCT) designed to evaluate a counselling intervention on smoking cessation and PA delivered to women attending the Italian National Health System Cervical Cancer Screening Program. This paper presents study design and baseline characteristics of the study population.
Among women undergoing the Pap examination in three study centres (Florence, Turin, Mantua), participants were randomized to the smoking cessation counselling [S], the smoking cessation + PA counselling [S + PA], or the control [C] groups. The program under evaluation is a standard brief counselling on smoking cessation combined with a brief counselling on increasing PA, and was delivered in 2010. A questionnaire, administered before, after 6 months and 1 year from the intervention, was used to track behavioural changes in tobacco use and PA, and to record cessation rates in participants.
Out of the 5,657 women undergoing the Pap examination, 1,100 participants (55% of smokers) were randomized in 1 of the 3 study groups (363 in the S, 366 in the S + PA and 371 in the C groups). The three arms did not differ on any demographic, PA, or tobacco-use characteristics. Recruited smokers were older, less educated than non-participant women, more motivated to quit (33% vs.9% in the Preparation stage, p < 0.001), smoked more cigarettes per day (12 vs.9, p < 0.001), and were more likely to have already done 1 or more quit attempts (64% vs.50%, p < 0.001). The approach of SPRINT study appeared suitable to enrol less educated women who usually smoke more and have more difficulties to quit.
Trial registration number
Smoking is a known risk factor for coronary artery disease (CAD) and recurrent cardiac events in patients with established CAD. Although cessation can lead to a risk reduction of up to 50% following an initial myocardial infarction, at least 20% of cardiac patients continue to smoke.
To describe and evaluate the effects of a comprehensive, multifactorial smoking cessation programme in outpatients with CAD, and to delineate variables that impede smoking cessation.
Patients with a confirmed diagnosis of CAD recruited from the outpatient cardiology clinic, Dijkzigt University Hospital, Rotterdam, participated in the cessation programme and were followed for three months. Endpoint was smoking cessation.
Purpose-designed and validated questionnaires were used to assess smoking history, sociodemographic and psychological parameters. Information on cardiac history was sampled from medical records. Height and blood pressure were measured at baseline, and weight and expiratory CO at every group session of the cessation programme.
One third of the patients recruited for the programme achieved cessation at three months. Quitters generally smoked less, were less addicted, scored lower on anxiety and depression, and had more recently been diagnosed with CAD. Type D personality was an impediment to cessation (OR:3.50; 95% CI: 0.40-35.48).
Thirty-two percent of the patients achieved cessation at three months. Cessation efforts should be started in-hospital or as early as possible following diagnosis. An interdisciplinary and multifactorial approach seems warranted, in particular given the negative influence of anxiety, depression, and Type D personality on cessation.
coronary artery disease; intervention; smoking cessation programme; Type D personality
Smoking cessation counseling by health professionals has been effective in increasing cessation rates. However, little is known about smoking cessation training and practices in transition countries with high smoking prevalence such as Armenia. This study identified smoking-related attitudes and behavior of physicians and nurses in a 500-bed hospital in Yerevan, Armenia, the largest cancer hospital in the country, and explored barriers to their effective participation in smoking cessation interventions.
This study used mixed quantitative and qualitative methods. Trained interviewers conducted a survey with physicians and nurses using a 42-item self-administered questionnaire that assessed their smoking-related attitudes and behavior and smoking cessation counseling training. Four focus group discussions with hospital physicians and nurses explored barriers to effective smoking cessation interventions. The focus group sessions were audio-taped, transcribed, and analyzed.
The survey response rate was 58.5% (93/159) for physicians and 72.2% (122/169) for nurses. Smoking prevalence was almost five times higher in physicians compared to nurses (31.2% vs. 6.6%, p < 0.001). Non-smokers and ex-smokers had more positive attitudes toward the hospital’s smoke-free policy compared to smokers (90.1% and 88.2% vs. 73.0%). About 42.6% of nurses and 26.9% of physicians reported having had formal training on smoking cessation methods. While both groups showed high support for routinely assisting patients to quit smoking, nurses more often than physicians considered health professionals as role models for patients.
This study was the first to explore differences in smoking-related attitudes and behavior among hospital physicians and nurses in Yerevan, Armenia. The study found substantial behavioral and attitudinal differences in these two groups. The study revealed a critical need for integrating cessation counseling training into Armenia’s medical education. As nurses had more positive attitudes toward cessation counseling compared to physicians, and more often reported having cessation training, they are an untapped resource that could be more actively engaged in smoking cessation interventions in healthcare settings.
Smoking cessation; Smoke-free hospital policy; Survey research; Qualitative research; Healthcare professionals; Physician smoking; Armenia; Transition economies
Programs for smoking cessation for cardiac patients are underused in Canada. We examined the efficacy of an intervention for smoking cessation for patients admitted to hospital for coronary artery bypass graft (CABG) or because of acute myocardial infarction (MI).
Nurses randomly assigned 276 sequential patients admitted because of acute MI or for CABG who met the inclusion criteria. Participants received an intensive or minimal smoking-cessation intervention. The minimal intervention included advice from physicians and nurses and 2 pamphlets. The intensive intervention included the minimal intervention plus 60 minutes of bedside counselling, take-home materials and 7 nurse-initiated counselling calls for 2 months after discharge. The outcomes were point prevalence of abstinence at 3, 6 and 12 months after discharge.
The 12-month self-reported rate of abstinence was 62% among patients in the intensive group and 46% among those in the minimal group (odds ratio [OR] 2.0, 95% confidence interval [CI] 1.2–3.1). Abstinence was confirmed for 54% of patients in the intensive group and 35% in the minimal group (OR 2.0, 95% CI 1.3–3.6). Abstinence was significantly lower among those who used pharmacotherapy than among those who did not (p < 0.001). Continuous 12-month abstinence was 57% in the intensive group and 39% in the minimal group (p < 0.01). It was significantly higher among patients admitted for CABG than among those admitted because of acute MI (p < 0.05).
Providing intensive programs for smoking cessation for patients admitted for CABG or because of acute MI could have a major impact on health and health care costs.
Australian Aboriginal peoples and Torres Strait Islanders (Indigenous Australians) smoke at much higher rates than non-Indigenous people and smoking is an important contributor to increased disease, hospital admissions and deaths in Indigenous Australian populations. Smoking cessation programs in Australia have not had the same impact on Indigenous smokers as on non-Indigenous smokers. This paper describes the protocol for a study that aims to test the efficacy of a locally-tailored, intensive, multidimensional smoking cessation program.
This study is a parallel, randomised, controlled trial. Participants are Aboriginal and Torres Strait Islander smokers aged 16 years and over, who are randomly allocated to a 'control' or 'intervention' group in a 2:1 ratio. Those assigned to the 'intervention' group receive smoking cessation counselling at face-to-face visits, weekly for the first four weeks, monthly to six months and two monthly to 12 months. They are also encouraged to attend a monthly smoking cessation support group. The 'control' group receive 'usual care' (i.e. they do not receive the smoking cessation program). Aboriginal researchers deliver the intervention, the goal of which is to help Aboriginal peoples and Torres Strait Islanders quit smoking. Data collection occurs at baseline (when they enrol) and at six and 12 months after enrolling. The primary outcome is self-reported smoking cessation with urinary cotinine confirmation at 12 months.
Stopping smoking has been described as the single most important individual change Aboriginal and Torres Strait Islander smokers could make to improve their health. Smoking cessation programs are a major priority in Aboriginal and Torres Strait Islander health and evidence for effective approaches is essential for policy development and resourcing. A range of strategies have been used to encourage Aboriginal peoples and Torres Strait Islanders to quit smoking however there have been few good quality studies that show what approaches work best. More evidence of strategies that could work more widely in Indigenous primary health care settings is needed if effective policy is to be developed and implemented. Our project will make an important contribution in this area.
Australian New Zealand Clinical Trials Registry (ACTRN12608000604303)
Indigenous; Aboriginal; Torres Strait Islander; Randomised controlled trial; Smoking cessation; Study protocol; Be Our Ally Beat Smoking (BOABS) Study
Many smoking-cessation programs and pharmaceutical aids demonstrate substantial health gains for a relatively low allocation of resources. Genetic information represents a type of individualized or personal feedback regarding the risk of developing lung cancer, and hence the potential benefits from stopping smoking, may motivate the person to remain smoke-free. The purpose of this study was to explore what the impact of a genetic test needs to have within a typical smoking-cessation program aimed at heavy smokers in order to be cost-effective.
Two strategies were modelled for a hypothetical cohort of heavy smokers aged 50 years; individuals either received or did not receive a genetic test within the course of a usual smoking-cessation intervention comprising nicotine replacement therapy (NRT) and counselling. A Markov model was constructed using evidence from published randomized controlled trials and meta-analyses for estimates on 12-month quit rates and long-term relapse rates. Epidemiological data were used for estimates on lung cancer risk stratified by time since quitting and smoking patterns. Extensive sensitivity analyses were used to explore parameter uncertainty.
The discounted incremental cost per QALY was AU$34,687 (95% CI $12,483, $87,734) over 35 years. At a willingness-to-pay of AU$20,000 per QALY gained, the genetic testing strategy needs to produce a 12-month quit rate of at least 12.4% or a relapse rate 12% lower than NRT and counselling alone for it to be equally cost-effective. The likelihood that adding a genetic test to the usual smoking-cessation intervention is cost-effective was 20.6% however cost-effectiveness ratios were favourable in certain situations (e.g., applied to men only, a 60 year old cohort).
The findings were sensitive to small changes in critical variables such as the 12-month quit rates and relapse rates. As such, the cost-effectiveness of the genetic testing smoking cessation program is uncertain. Further clinical research on smoking-cessation quit and relapse rates following genetic testing is needed to inform its cost-effectiveness.
Hospitalization may be a particularly important time to promote smoking cessation, especially in the immediate post-discharge period. However, there are few studies to date that shed light on the most effective or cost-effective methods to provide post-discharge cessation treatment, especially among low-income populations and those with a heavy burden of mental illness and substance use disorders.
This randomized trial will compare the effectiveness and cost-effectiveness of two approaches to smoking cessation treatment among patients discharged from two urban public hospitals in New York City. During hospitalization, staff will be prompted to ask about smoking and to offer nicotine replacement therapy (NRT) on admission and at discharge. Subjects will be randomized on discharge to one of two arms: one arm will be proactive multi-session telephone counseling with motivational enhancement delivered by study staff, and the other will be a faxed or online referral to the New York State Quitline. The primary outcome is 30-day point-prevalence abstinence from smoking at 6-month follow-up post-discharge. We will also examine cost-effectiveness from a societal and a payer perspective, as well as explore subgroup analyses related to patient location of hospitalization, race/ethnicity, immigrant status, and inpatient diagnosis.
This study will explore issues of implementation feasibility in a post-hospitalization patient population, as well as add information about the effectiveness and cost-effectiveness of different strategies for designing smoking cessation programs for hospitalized patients.
Clinicaltrials.gov ID# NCT01363245
Hospital; Randomized trial; Smoking cessation; Telephone counseling; Underserved population
Pharmacotherapies for smoking cessation have not been adequately tested in pregnancy and women are reluctant to use them. Behavioural support alone has a modest effect on cessation rates; therefore, more effective interventions are needed. Even moderate intensity physical activity (e.g. brisk walk) reduces urges to smoke and there is some evidence it increases cessation rates in non-pregnant smokers. Two pilot studies assessed i) the feasibility of recruiting pregnant women to a trial of physical activity for smoking cessation, ii) adherence to physical activity and iii) womens' perceptions of the intervention.
Pregnant smokers volunteered for an intervention combining smoking cessation support, physical activity counselling and supervised exercise (e.g. treadmill walking). The first study provided six weekly treatment sessions. The second study provided 15 sessions over eight weeks. Physical activity levels and continuous smoking abstinence (verified by expired carbon monoxide) were monitored up to eight months gestation.
Overall, 11.6% (32/277) of women recorded as smokers at their first antenatal booking visit were recruited. At eight months gestation 25% (8/32) of the women achieved continuous smoking abstinence. Abstinent women attended at least 85% of treatment sessions and 75% (6/8) achieved the target level of 110 minutes/week of physical activity at end-of-treatment. Increased physical activity was maintained at eight months gestation only in the second study. Women reported that the intervention helped weight management, reduced cigarette cravings and increased confidence for quitting.
It is feasible to recruit pregnant smokers to a trial of physical activity for smoking cessation and this is likely to be popular. A large randomised controlled trial is needed to examine the efficacy of this intervention.
Tobacco control in hospital settings is characterised by a focus on protection strategies and an increasing expectation that health practitioners provide cessation support to patients. While practitioners claim to have positive attitudes toward supporting patient cessation efforts, missed opportunities are the practice norm.
To study hospital workplace culture relevant to tobacco use and control as part of a mixed‐methods research project that investigated hospital‐based registered nurses' integration of cessation interventions.
The study was conducted at two hospitals situated in British Columbia, Canada. Data collection included 135 hours of field work including observations of ward activities and designated smoking areas, 85 unstructured conversations with nurses, and the collection of patient‐care documents on 16 adult in‐patient wards.
The findings demonstrate that protection strategies (for example, smoking restrictions) were relatively well integrated into organisational culture and practice activities but the same was not true for cessation strategies. An analysis of resources and documentation relevant to tobacco revealed an absence of support for addressing tobacco use and cessation. Nurses framed patients' tobacco use as a relational issue, a risk to patient safety, and a burden. Furthermore, conversations revealed that nurses tended to possess only a vague awareness of nicotine dependence.
Overcoming challenges to extending tobacco control within hospitals could be enhanced by emphasising the value of addressing patients' tobacco use, raising awareness of nicotine dependence, and improving the availability of resources to address addiction issues.
tobacco control; cessation strategies; hospitals; nursing; ethnography
A hospital admission offers smokers an opportunity to quit. Smoking cessation counseling provided in the hospital is effective, but only if it continues for more than one month after discharge. Providing smoking cessation medication at discharge may add benefit to counseling. A major barrier to translating this research into clinical practice is sustaining treatment during the transition to outpatient care. An evidence-based, practical, cost-effective model that facilitates the continuation of tobacco treatment after discharge is needed. This paper describes the design of a comparative effectiveness trial testing a hospital-initiated intervention against standard care.
A two-arm randomized controlled trial compares the effectiveness of standard post-discharge care with a multi-component smoking cessation intervention provided for three months after discharge. Current smokers admitted to Massachusetts General Hospital who receive bedside smoking cessation counseling, intend to quit after discharge and are willing to consider smoking cessation medication are eligible. Study participants are recruited following the hospital counseling visit and randomly assigned to receive Standard Care or Extended Care after hospital discharge. Standard Care includes a recommendation for a smoking cessation medication and information about community resources. Extended Care includes up to three months of free FDA-approved smoking cessation medication and five proactive computerized telephone calls that use interactive voice response technology to provide tailored motivational messages, offer additional live telephone counseling calls from a smoking cessation counselor, and facilitate medication refills. Outcomes are assessed at one, three, and six months after hospital discharge. The primary outcomes are self-reported and validated seven-day point prevalence tobacco abstinence at six months. Other outcomes include short-term and sustained smoking cessation, post-discharge utilization of smoking cessation treatment, hospital readmissions and emergency room visits, and program cost per quit.
This study tests a disseminable smoking intervention model for hospitalized smokers. If effective and widely adopted, it could help to reduce population smoking rates and thereby reduce tobacco-related mortality, morbidity, and health care costs.
United States Clinical Trials Registry NCT01177176.
Smoking cessation; Hospitalization; Pharmacotherapy; Counseling; Randomized clinical trial; Interactive voice response
To estimate the incremental cost‐effectiveness of the first‐line pharmacotherapies (nicotine gum, patch, spray, inhaler, and bupropion) for smoking cessation across six Western countries—Canada, France, Spain, Switzerland, the United States, and the United Kingdom.
Design and study population
A Markov‐chain cohort model to simulate two cohorts of smokers: (1) a reference cohort given brief cessation counselling by a general practitioner (GP); (2) a treatment cohort given counselling plus pharmacotherapy. Effectiveness expressed as odds ratios for quitting associated with pharmacotherapies. Costs based on the additional physician time required and retail prices of the medications.
Addition of each first‐line pharmacotherapy to GP cessation counselling.
Main outcome measures
Cost per life‐year saved associated with pharmacotherapies.
The cost per life‐year saved for counselling only ranged from US$190 in Spain to $773 in the UK for men, and from $288 in Spain to $1168 in the UK for women. The incremental cost per life‐year saved for gum ranged from $2230 for men in Spain to $7643 for women in the US; for patch from $1758 for men in Spain to $5131 for women in the UK; for spray from $1935 for men in Spain to $7969 for women in the US; for inhaler from $3480 for men in Switzerland to $8700 for women in France; and for bupropion from $792 for men in Canada to $2922 for women in the US. In sensitivity analysis, changes in discount rate, treatment effectiveness, and natural quit rate had the strongest influences on cost‐effectiveness.
The cost‐effectiveness of the pharmacotherapies varied significantly across the six study countries, however, in each case, the results would be considered favourable as compared to other common preventive pharmacotherapies.
smoking cessation; nicotine replacement therapy; cost‐effectiveness analysis; Markov model; countries
Mental health inpatients smoke at higher rates than the general population and are disproportionately affected by tobacco dependence. Despite the advent of smoke free policies within mental health hospitals, limited systems are in place to support a cessation attempt post hospitalisation, and international evidence suggests that most smokers return to pre-admission smoking levels following discharge. This protocol describes a randomised controlled trial that will test the feasibility, acceptability and efficacy of linking inpatient smoking care with ongoing community cessation support for smokers with a mental illness.
This study will be conducted as a randomised controlled trial. 200 smokers with an acute mental illness will be recruited from a large inpatient mental health facility. Participants will complete a baseline survey and will be randomised to either a multimodal smoking cessation intervention or provided with hospital smoking care only. Randomisation will be stratified by diagnosis (psychotic, non-psychotic). Intervention participants will be provided with a brief motivational interview in the inpatient setting and options of ongoing smoking cessation support post discharge: nicotine replacement therapy (NRT); referral to Quitline; smoking cessation groups; and fortnightly telephone support. Outcome data, including cigarettes smoked per day, quit attempts, and self-reported 7-day point prevalence abstinence (validated by exhaled carbon monoxide), will be collected via blind interview at one week, two months, four months and six months post discharge. Process information will also be collected, including the use of cessation supports and cost of the intervention.
This study will provide comprehensive data on the potential of an integrated, multimodal smoking cessation intervention for persons with an acute mental illness, linking inpatient with community cessation support.
Australian and New Zealand Clinical Trials Registry ANZTCN: ACTRN12609000465257
Particularly in groups of adolescents with lower educational level the smoking prevalence is still high and constitutes a serious public health problem. There is limited evidence of effective smoking cessation interventions in this group. Individualised text messaging (SMS) based interventions are promising to support smoking cessation and could be provided to adolescents irrespective of their motivation to quit. The aim of the current paper is to outline the study protocol of a trial testing the efficacy of an SMS based intervention for smoking cessation in apprentices.
A two-arm cluster-randomised controlled trial will be conducted to test the efficacy of an SMS intervention for smoking cessation in adolescents and young adults compared to an assessment only control group. A total of 910 daily or occasional (≥ 4 cigarettes in the preceding month and ≥ 1 cigarette in the preceding week) smoking apprentices will be proactively recruited in vocational school classes and, using school class as a randomisation unit, randomly assigned to an intervention group (n = 455) receiving the SMS based intervention or an assessment only control group (n = 455). Individualised text messages taking into account demographic data and the individuals' smoking behaviours will be sent to the participants of the intervention group over a period of 3 months. Participants will receive two text messages promoting smoking cessation per week. Program participants who intend to quit smoking have the opportunity to use a more intensive SMS program to prepare for their quit day and to prevent a subsequent relapse. The primary outcome measure will be the proportion of participants with 7-day point prevalence smoking abstinence assessed at 6-months follow-up. The research assistants conducting the baseline and the follow-up assessments will be blinded regarding group assignment.
It is expected that the program offers an effective and inexpensive way to promote smoking cessation among adolescents and young adults including those with lower educational level and independent of their motivation to quit.
Trial registration number
Well-documented challenges have hampered both intervention development and research in teen smoking cessation. Addressing these challenges, the Hutchinson Study of High School Smoking (HS Study), the largest group-randomized trial in adolescent smoking cessation to date, incorporates several design innovations to investigate the effect of a counselor-initiated, individually tailored telephone counseling smoking cessation intervention for older adolescents. This paper presents and discusses these innovative design features, and baseline findings on the resulting study population.
The trial used a population-based survey to proactively identify and recruit all high school juniors who had smoked in the past month—potentially expanding intervention reach to all smokers, even those who smoked less than daily and those not motivated to quit. For ethical and intervention reasons, some nonsmokers were enrolled in the intervention, also. Other important design features included the random allocation of schools into experimental conditions (intervention vs. no-intervention control) and a multi-wave design.
Results & Conclusion
The design innovations address problems and challenges identified in adolescent smoking cessation literature. The heterogeneous baseline characteristics of the study population, well-balanced between the two arms, have three significant implications: They (1) demonstrate the effectiveness of the trial’s design features, (2) highlight several intervention-related issues, and (3) provide assurance that the trial’s evaluation of intervention effectiveness will be unbiased.
adolescent; smoking cessation; randomized trial; group-randomized; cessation intervention; proactive intervention; telephone counseling; youth
We describe practical, effective, office-based methods for physicians to use to assist patients to stop smoking that do not require special training or support personnel. Brief counseling achieves smoking cessation in a small percent of well patients but is more effective in patients with smoking-related illnesses or abnormal laboratory test results. Routine prescribing of nicotine gum without participation by the patient in a smoking-cessation program does not increase smoking cessation, and we do not recommend it. The prevention of smoking relapse can probably be enhanced by scheduling follow-up office visits after the patient has quit. Failure to quit on initial attempts should not discourage physicians and patients, since most successful abstainers usually must make several attempts to quit. We outline for physicians two approaches, one brief and one more intensive, to help patients stop smoking.
BACKGROUND: Brief advice to stop smoking from general practitioners (GPs) has been repeatedly shown to increase smoking cessation by a small, but measurable amount. Some studies have suggested that adding more intensive interventions to brief advice may increase its effectiveness, but it is unclear whether this is true in general practice. AIMS: To determine whether brief advice from a doctor together with counselling and follow-up from a trained practice nurse is more effective than brief advice alone in helping people to stop smoking. METHODS: The design was a randomized controlled trial. Four hundred and ninety-seven general practice patients aged older than 18 years and smoking at least one cigarette per day in six general practices in Oxfordshire, Berkshire, and Buckinghamshire were randomized to one of two interventions: brief verbal or written advice from a GP plus extended counselling and follow-up from a trained practice nurse; brief advice from a GP alone. The primary outcome was sustained abstinence from smoking at three and 12 months. A secondary outcome was forward movement in the stages of change cycle. RESULTS: The proportion showing sustained abstinence was 3.6% in the extended counselling group, and 4.4% in the brief advice group (difference = -0.8%; 95% confidence interval = -4.3% to 2.6%). Seventy-four (30%) of those randomized to extended counselling actually took up this offer. No significant progression in stages of change was detected between the two groups. CONCLUSIONS: In unselected general practice patients who smoke, brief advice from a GP combined with intensive intervention and follow-up by a practice nurse is no more effective than brief advice alone.
Tobacco use is the cause of immense burden on our nation in terms of mortality and morbidity, being the single leading cause of preventable illnesses and death. Smoking cessation interventions in our country will be the most cost effective of all interventions considering that the cost incurred on the three main tobacco related illnesses (COPD, CAD, and Cancer) being around Rs 27,761 crore in the year 1999.
Matrials and Methods
A double blind placebo controlled trial was conducted to see the efficacy of Bupropion in smoking cessation. Smokers with current depression were excluded. The subjects (n = 30) were randomly assigned to receive Bupropion SR 300 mg/day or placebo for seven weeks. Target quit date was preferentially 8th day of starting the treatment. Intensive counseling was provided by the physician at the baseline and brief counseling at every visit weekly during the treatment phase and at weeks 12 and 16. Self reported abstinence was confirmed by a carbon monoxide concentration in expired air of less than 10 ppm.
The seven-day point prevalence abstinence rate at the end of week 2 and week 16 in the drug group was 46.67% and 53.33 % respectively and in the placebo group was 13.33% and 20% respectively with the ‘P’ value of 0.04 and 0.05 respectively. Rates of continuous abstinence at weeks 4, 7 and 16 were 46.67%, 40% and 33.33% in the drug group and 13.33%, 13.33% and 13.33% in the placebo group respectively. The rates were significantly higher in the drug group till week 4 starting from week 2 of the treatment phase. The mean weight gain in drug group was found to be significant less as compared to the placebo at week 16 (P = 0.025) The mean change of depression scores from the baseline was not significantly different between the two groups at any point of time. The withdrawal symptom score increase from the baseline was not significantly higher at any point of time in the drug group but in the placebo group the increase was significantly higher for seven days after target quit date and at weeks 3 and 4 (P < 0.05). The most common adverse events in the drug group were insomnia, which was seen in 6 (40%) patients and dry mouth and/or altered taste in 4 (26.67%) patients, which was significantly higher as compared to placebo.
Predictors of Outcome:
The univariate predictors of a successful outcome were the point prevalence abstinence at week 16 were older age (>40 years), (P = 0.044) and quitter status at week 2 (P = 0.001). Multivariate predictors in order of importance were Quit status at 2nd week (P = 0.002) and Age >40 years (P = 0.031). The combined predictive value of these two variables was found to be 86.3%.
Bupropion helps in smoking cessation. This has been proved by three large multicenter randomized controlled trials. This study has also reflected the same result in the form of significantly high seven-day point prevalence abstinence at week 16 in the Bupropion group as compared to placebo. Bupropion has a beneficial effect on weight gain and withdrawal symptoms and the benign adverse effects of insomnia and dry mouth or altered taste make it a very effective and cheap treatment for nicotine addiction in smokers.
Smoking cessation; Bupropion quit rate; nicotine addiction
To consider the problem of the calculation of number needed to treat (NNT) derived from risk difference, odds ratio, and raw pooled events shown to give different results using data from a review of nursing interventions for smoking cessation.
A review of nursing interventions for smoking cessation from the Cochrane Library provided different values for NNT depending on how NNTs were calculated. The Cochrane review was evaluated for clinical heterogeneity using L'Abbé plot and subsequent analysis by secondary and primary care settings.
Three studies in primary care had low (4%) baseline quit rates, and nursing interventions were without effect. Seven trials in hospital settings with patients after cardiac surgery, or heart attack, or even with cancer, had high baseline quit rates (25%). Nursing intervention to stop smoking in the hospital setting was effective, with an NNT of 14 (95% confidence interval 9 to 26). The assumptions involved in using risk difference and odds ratio scales for calculating NNTs are discussed.
Clinical common sense and concentration on raw data helps to detect clinical heterogeneity. Once robust statistical tests have told us that an intervention works, we then need to know how well it works. The number needed to treat or harm is just one way of showing that, and when used sensibly can be a useful tool.
A potential new treatment in smoking cessation and relapse prevention is nicotine vaccination which is based on active immunization against the nicotine molecule. This immunization will elicit the immune system to produce nicotine-specific antibodies that sequester nicotine in the blood stream, after inhaling tobacco products. The resulting antibody-antigen is too large to cross the blood–brain barrier and is therefore postulated to attenuate the rewarding effect of nicotine by preventing the latter from reaching its receptors in the brain and causing the release of dopamine. The aim of this paper is to describe the design of a phase IIb, multi-center, double blind, randomized, placebo controlled trial to assess the efficacy of the nicotine vaccine NicVAX® co-administered with varenicline (Champix®) and intensive counseling as an aid in smoking cessation and relapse prevention.
Two centers will include a total of 600 smokers who are motivated to quit smoking. At week −2 these smokers will be randomized, in a 1:1 ratio, to either 6 injections of NicVAX® or placebo, both co-administered with 12-weeks of varenicline treatment, starting at week 0. The target quit day will be set after 7 days of varenicline treatment at week 1. Smokers will be followed up for 54 weeks. The primary outcome is defined as biochemically validated prolonged smoking abstinence from week 9 to 52. Secondary outcomes include safety, immunogenicity, smoking abstinence from week 37 to 52, abstinence from week 9 to 24, abstinence in the subset of subjects with the highest antibody response, and lapse/relapse rate.
This is the first study to assess the efficacy of a nicotine conjugate vaccine in combination with an evidence-based smoking cessation pharmacotherapy (varenicline) to quit smoking. Although NicVAX® is primarily designed as an aid to smoking cessation, our study is designed to explore its potential to maintain abstinence and prevent relapse. The results of this trial will give a unique insight in the potential of nicotine vaccination for relapse prevention.
Nicotine vaccination; NicVAX; Varenicline; Combination therapy; Efficacy; Safety; Immunogenicity; Randomized controlled trial
Maternal smoking is the most significant cause of preventable complications during pregnancy, with smoking cessation during pregnancy shown to increase birth weight and reduce preterm birth among pregnant women who quit smoking. Taking into account the fact that the number of women who smoke in Greece has increased steadily throughout the previous decade and that the prevalence of smoking among Greek females is one of the highest in the world, smoking cessation should be a top priority among Greek health care professionals.
The Maternal Smoking Cessation during Pregnancy Study (M-SCOPE), is a Randomized Control Trial (RCT) that aims to test whether offering Greek pregnant smokers a high intensity intervention increases smoking cessation during the third trimester of pregnancy, when compared to a low intensity intervention. Prospective participants will be pregnant smokers of more than 5 cigarettes per week, recruited up to the second trimester of pregnancy. Urine samples for biomarker analysis of cotinine will be collected at three time points: at baseline, at around the 32nd week of gestation and at six months post partum. The control group/low intensity intervention will include: brief advice for 5 minutes and a short leaflet, while the experimental group/intensive intervention will include: 30 minutes of individualized cognitive-behavioural intervention provided by a trained health professional and a self-help manual especially tailored for smoking cessation during pregnancy, while counselling will be based on the ''5 As.'' After childbirth, the infants' birth weight, gestational age and any other health related complications during pregnancy will be recorded. A six months post-partum a follow up will be performed in order to re-assess the quitters smoking status.
If offering pregnant smokers a high intensity intervention for smoking cessation increases the rate of smoking cessation in comparison to a usual care low intensity intervention in Greek pregnant smokers, such a scheme if beneficial could be implemented successfully within clinical practice in Greece.
ClinicalTrials.gov Identifier NCT01210118
The purpose of this study was to investigate the efficacy of an intensive tobacco cessation intervention for alcohol-dependent smokers in early recovery.
A total of 162 alcohol-dependent smokers were randomized to either intensive intervention for smoking cessation or usual care. The intensive intervention consisted of 16 sessions of individual cognitive behavior therapy (CBT) and combination nicotine replacement therapy that lasted 26 weeks. Usual care involved referral to a free-standing smoking cessation program that provided smoking cessation counseling of varying duration and guideline-concordant medications. The primary cessation outcome was verified 7-day point prevalence abstinence (PPA) at 12, 26, 38, and 52 weeks.
At 12 and 26 weeks, the verified 7-day point-prevalence quit rate was significantly higher for the intensive intervention group than for the usual care group (both p = .03). However, the quit rates for the two treatment groups were not significantly different at 38 or 52 weeks. Verified 30-day alcohol abstinence rates were not significantly different for the two treatment groups at any of the follow-up assessments.
The intensive smoking cessation intervention yielded a higher short-term smoking quit rate without jeopardizing sobriety. A chronic care model might facilitate maintenance of smoking cessation during the first year of alcohol treatment and perhaps for longer periods of time. It is hoped that studies such as this will inform the development of more effective interventions for concurrent alcohol and tobacco use disorders.
Smoking cessation; tobacco use; alcohol dependence; concurrent intervention; early recover