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BACKGROUND: National Health Service Stop Smoking Services (SSSs) offer help to smokers motivated to quit; however, attendance rates are low and recent figures show a downward trend. We aimed to assess the effectiveness of a two-component personalised intervention on attendance at SSSs. METHODS: We did this randomised controlled trial in 18 SSSs in England. Current smokers (aged ≥16 years) were identified from medical records in 99 general practices and invited to participate by their general practitioner. Individuals who gave consent, were motivated to quit, and had not attended the SSS within the past 12 months, were randomly assigned (3:2), via computer-generated randomisation with permuted blocks (block size of five), to receive either an individually tailored risk letter and invitation to attend a no-commitment introductory session run by the local SSS (intervention group) or a standard generic letter advertising the local SSS (control group). Randomisation was stratified by sex. Masking of participants to receipt of a personal letter and invitation to a taster session was not possible. The personal letter was generated by a research assistant, but the remainder of the research team were masked to group allocation. General practitioners, practice staff, and SSS advisers were unaware of their patients' allocation. The primary outcome was attendance at the first session of an SSS course within 6 months from randomisation. We did analysis by intention to treat. This trial is registered with Current Controlled Trials, number ISRCTN 76561916. FINDINGS: Recruitment, collection of baseline data, delivery of the intervention, and follow up of participants took place between Jan 31, 2011, and July 12, 2014. We randomly assigned 4384 smokers to the intervention group (n=2636) or the control group (n=1748); 4383 participants comprised the intention-to-treat population. Attendance at the first session of an SSS course was significantly higher in the intervention group than in the control group (458 [17·4%] vs 158 [9·0%] participants; unadjusted odds ratio 2·12 [95% CI 1·75-2·57]; p<0·0001). INTERPRETATION: Delivery of personalised risk information alongside an invitation to an introductory session more than doubled the odds of attending the SSS compared with a standard generic invitation to contact the service. This result suggests that a more proactive approach, combined with an opportunity to experience local services, can reduce patient barriers to receiving treatment and has high potential to increase uptake. FUNDING: National Institutes of Health Research Health Technology Assessment.
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Medição de Risco , Abandono do Hábito de Fumar/métodos , Prevenção do Hábito de Fumar/métodos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Aconselhamento , Inglaterra , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Motivação , Aceitação pelo Paciente de Cuidados de Saúde , Adulto JovemRESUMO
INTRODUCTION: Smoking remains a significant public health problem and is a leading cause of preventable morbidity and mortality around the world. By combining the behavioral intervention principles used in specialist services with the high reach rates of public health interventions, personal tailored self-help cessation intervention provides a potential economical method for improving reach and effectiveness. METHODS: Cost-effectiveness analysis is performed alongside a randomized controlled trial to compare the computer-tailored self-help intervention with a generic self-help intervention in smoking cessation. A Markov model was developed to extrapolate lifetime cost-effectiveness by combining trial data with estimates from the literature. FINDINGS: In the short term, smokers in the intervention group gained 0.0006 (95% CI = -0.0024 to 0.0036) quality-adjusted life years (QALYs) more than those in the control group at an increased cost of about £9 per person (95% CI = £5-£12). This yielded an incremental cost-effectiveness ratio (ICER) of £14,432/QALY. Precision of the ICER estimates was assessed by 5,000 bootstrapping replications. The probability that the intervention was cost effective was 54% (58%) at a cost-effectiveness threshold of £20,000(£30,000) per QALY. The Markov model showed that simulating lifetime outcomes improved the cost-effectiveness ratio (£9,700/QALY) in favor of the tailored intervention. The intervention would have a 55%-57% chance of being more cost effective than nontailored intervention at the willingness-to-pay threshold of £20,000-30,000/QALY. CONCLUSIONS: The computer-tailored intervention appears slightly more likely to be cost effective than the generic self-help intervention in smoking cessation, in both the short term and the long term, but caution is required given the considerable uncertainty surrounding the estimates.
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Abandono do Hábito de Fumar/economia , Abandono do Hábito de Fumar/métodos , Adolescente , Adulto , Idoso , Computadores , Análise Custo-Benefício , Humanos , Pessoa de Meia-Idade , Atenção Primária à Saúde , Anos de Vida Ajustados por Qualidade de Vida , Adulto JovemRESUMO
BACKGROUND: Primary care is an important setting for smoking cessation interventions. There is evidence for the effectiveness of tailored interventions for smoking cessation, and text messaging interventions for smoking cessation show promise. The intervention to be evaluated in this trial consists of two components: (1) a web-based program designed to be used by a practice nurse or other smoking cessation advisor (SCA); the program generates a cessation advice report that is highly tailored to relevant characteristics of the smoker; and (2) a three-month programme of automated tailored text messages sent to the smoker's mobile phone. The objectives of the trial are to assess the acceptability and feasibility of the intervention and to estimate the short-term effectiveness of the intervention in increasing the quit rate compared with usual care alone. METHODS/DESIGN: The design is a two parallel group randomised controlled trial (RCT). 600 smokers who want to quit will be recruited in up to 30 general practices in the East of England. During a consultation with an SCA, they will be individually randomised by computer program to usual care (Control) or to usual care plus the iQuit system (Intervention). At the four-week follow-up appointment, the SCA will record smoking status and measure carbon monoxide level. There will be two further follow-ups, at eight weeks and six months from randomisation date, by postal questionnaire sent from and returned to the study centre or by telephone interview conducted by a research interviewer. The primary outcome will be self-reported abstinence for at least two weeks at eight weeks. A sample size of 300 per group would give 80% power to detect an increase in quit rate from 20% to 30% (alpha = 0.05, 2-sided test). The main analyses of quit rates will be conducted on an intention-to-treat basis, making the usual assumption that participants lost to follow up are smoking. DISCUSSION: This trial will focus on acceptability, feasibility and short-term effectiveness. The findings will be used to refine the intervention and to inform the decision to proceed to a pragmatic trial to estimate longer-term effectiveness and cost-effectiveness. TRIAL REGISTRATION: ISRCTN56702353.
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Atenção Primária à Saúde/métodos , Abandono do Hábito de Fumar/métodos , Adolescente , Adulto , Idoso , Protocolos Clínicos , Inglaterra , Estudos de Viabilidade , Feminino , Seguimentos , Humanos , Internet , Masculino , Pessoa de Meia-Idade , Aceitação pelo Paciente de Cuidados de Saúde , Inquéritos e Questionários , Envio de Mensagens de Texto , Resultado do Tratamento , Adulto JovemRESUMO
INTRODUCTION: Study aims were to assess the feasibility and acceptability of a tailored self-help smoking cessation intervention for pregnant smokers (MiQuit). Secondary aims were to assess whether MiQuit affected cognitive determinants of quitting and to provide a range of potential effect sizes of the intervention effect on smoking abstinence. METHODS: A randomized controlled trial was undertaken in which pregnant smokers were allocated to either receive MiQuit, a tailored self-help leaflet followed by an 11-week program of tailored text messages, or to a control group, receiving a nontailored self-help leaflet. Participants were 207 pregnant smokers identified by community midwives across 7 NHS Trusts (United Kingdom). At 3-month follow-up, intervention acceptability, cognitive determinants of quitting, and smoking outcomes (self-reported and cotinine-validated 7-day point prevalence abstinence) were assessed. RESULTS: Feasibility: 94% (95% CI 89%-99%) of MiQuit participants reported receiving both intervention components. Acceptability: 9% (95% CI 4%-15%) of MiQuit participants opted to discontinue the text messages. Mechanism: compared with controls, MiQuit participants were more likely to set a quit date (p = .049) and reported higher levels of self-efficacy (p = .024), harm beliefs (p = .052), and determination to quit (p = .019). Potential efficacy: self-reported abstinence-MiQuit 22.9%, control 19.6%; odds ratio (OR) = 1.22, 95% CI 0.62-2.41; cotinine-validated abstinence-MiQuit 12.5%, control 7.8%; OR = 1.68, 95% CI 0.66-4.31. CONCLUSIONS: Delivering tailored smoking cessation support to pregnant smokers via leaflet and text message is feasible and acceptable. The positive effects of MiQuit on cognitive determinants and the likelihood of setting a quit date are encouraging. A larger efficacy trial is warranted.
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Complicações na Gravidez , Abandono do Hábito de Fumar , Fumar/epidemiologia , Envio de Mensagens de Texto , Estudos de Viabilidade , Feminino , Humanos , Avaliação de Processos e Resultados em Cuidados de Saúde , Gravidez , Prevalência , Reino Unido/epidemiologiaRESUMO
BACKGROUND: Recruiting smokers to smoking cessation trials is challenging and participation rates are often low. Consequently, the interventions evaluated may fail to reach a broad spectrum of the target population, thus compromising the generalizability of the findings. Brief interventions, using proactive recruitment, are likely to attract a broader and more representative proportion of the population. OBJECTIVE: We explored the factors that influenced recruitment into a trial evaluating computer-tailored feedback reports that aimed to help smokers to quit [the ESCAPE (Effectiveness of computer-tailored Smoking Cessation Advice in Primary Care) study] in order to investigate the possibilities for increasing recruitment into smoking cessation trials. METHODS: Current cigarette smokers, identified from GP records, were invited to participate in the study. The main outcome measure was the recruitment rate, i.e. the proportion of participants who responded and were randomized to one of the intervention groups. Predictor variables included geographical region, level of deprivation, practice characteristics and the number and timing of mailings of questionnaires. RESULTS: The recruitment rate varied by practice (2.5-19.8%) and differed significantly between regions (from 16.3% in Scotland to 8.4% in London, P < 0.001). Recruitment decreased significantly by 1.1% between the lowest and highest quintiles of deprivation (P = 0.012), measured by Index of Multiple Deprivation scores, and decreased by 1.33% for every extra 10% smokers identified within a practice population (P = 0.010). Sending reminders increased recruitment by 7.5% (P < 0.001). Multivariable analysis showed region and length of time between mailings were the main predictors of recruitment. CONCLUSIONS: Proactive recruitment methods can increase participation in smoking cessation trials and weighting the target sample in favour of more deprived areas will recruit a more representative sample. The number and timing of mailings to potential participants can also increase recruitment.
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Seleção de Pacientes , Atenção Primária à Saúde , Abandono do Hábito de Fumar , Promoção da Saúde , Humanos , Programas Nacionais de Saúde , Reino Unido , Interface Usuário-ComputadorRESUMO
BACKGROUND AND AIMS: Clinicians could promote e-cigarettes for harm reduction to people who smoke but cannot stop, but many clinicians feel uneasy doing so. In a randomized controlled trial (RCT), primary care clinicians offered free e-cigarettes and encouraged people with chronic diseases who were unwilling to stop smoking to switch to vaping. We interviewed clinicians and patients to understand how to adopt harm reduction in routine practice. DESIGN: Qualitative analysis nested within an RCT, comprising thematic analysis of semi-structured interviews with primary care clinicians who delivered the trial intervention, and patients who took part. SETTING: Primary care clinics in England. PARTICIPANTS/CASES: Twenty-one patients and 11 clinicians, purposively sampled from an RCT. MEASUREMENTS: We qualitatively explored patients' and clinicians' experiences of: being offered/offering an e-cigarette, past and current perceptions about e-cigarettes and applying a harm reduction approach. FINDINGS: Four themes captured clinicians' and patients' reported perspectives. These were: (1) concepts of safety/risk, with clinicians concerned about recommending a product with unknown long-term risks and patients preferring the known risks of cigarettes; (2) clinicians felt they were going out on a limb by offering these as though they were prescribing them, whereas patients did not share this view; (3) equating quitting with success, as both patients and clinicians conceptualized e-cigarettes as quitting aids; and (4) unchanged views, as clinicians reported that training did not change their existing views about e-cigarettes. These themes were united by the higher-order concept: 'The old and familiar meets the new and unknown', as a contradiction between this new approach and long-established methods underpinned these concerns. CONCLUSIONS: A qualitative analysis found barriers obstructing clinicians and patients from easily accepting e-cigarettes for harm reduction, rather than as aids to support smoking cessation: clinicians had difficulty reconciling harm reduction with their existing ethical models of practice, even following targeted training, and patients saw e-cigarettes as quitting aids.
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Sistemas Eletrônicos de Liberação de Nicotina , Medicina Geral , Redução do Consumo de Tabaco , Vaping , Inglaterra , Humanos , Pesquisa QualitativaRESUMO
INTRODUCTION: This systematic review and meta-analysis assessed the effectiveness of smoking cessation interventions among women smokers in low socio-economic status (SES) groups or women living in disadvantaged areas who are historically underserved by smoking cessation services. METHODS: A systematic literature search was conducted using MEDLINE (OVID), EMBASE, Cochrane, CINAHL, PsychINFO and Web of Science databases. Eligibility criteria included randomised controlled trials of any smoking cessation intervention among women in low SES groups or living in socio-economically disadvantaged areas. A random effects meta-analysis assessed effectiveness of interventions on smoking cessation. Risk of bias was assessed with the Cochrane Risk of Bias tool. The GRADE approach established certainty of evidence. RESULTS: A total of 396 studies were screened for eligibility and 11 (6153 female participants) were included. Seven studies targeted women-only. 5/11 tested a form of face-to-face support. A pooled effect size was estimated in 10/11 studies. At end of treatment, two-thirds more low SES women who received a smoking cessation intervention were more likely to stop smoking than women in control groups (risk ratio (RR) 1.68, 95% CI 1.36-2.08, I2= 34%). The effect was reduced but remained significant when longest available follow-up periods were pooled (RR 1.23, 95% CI 1.04-1.48, I2 = 0%). There was moderate-to-high risk of bias in most studies. Certainty of evidence was low. CONCLUSIONS: Behavioural and behavioural + pharmacotherapy interventions for smoking cessation targeting women in low SES groups or women living in areas of disadvantage were effective in the short term. However, longer follow-up periods indicated reduced effectiveness. Future studies to explore ways to prevent smoking relapse in this population are needed. SYSTEMATIC REVIEW REGISTRATION: PROSPERO: CRD42019130160.
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Abandono do Hábito de Fumar , Terapia Comportamental , Feminino , Humanos , Fumar , Fumar Tabaco , Populações VulneráveisRESUMO
INTRODUCTION: Despite the availability of effective stop smoking assistance, most smokers do not utilise formal cessation programmes such as the English Stop Smoking Services (SSS). We modified the Treatment Barriers Questionnaire (TBQ), developed in the USA, and distributed it to a sample of English smokers to explore the most important barriers to the use of the SSS. METHODS: Participants of Start2quit, a randomised controlled trial aiming to increase attendance at the SSS using tailored risk information and 'taster' sessions, who reported at follow-up that they had not attended the SSS, were asked to complete the TBQ; 672 (76.9% response rate) were retained for analysis. Principal Component Analysis (PCA) was conducted to examine the structure of the data. Multiple linear regressions were used to determine whether any participant characteristics were associated with particular barriers. RESULTS: The most commonly endorsed items related to a lack of information on and a lack of confidence in the efficacy of the SSS. PCA yielded seven factors: Work and time constraints (Factor1); Smokers should quit on their own (Factor2); Nothing can help in quitting smoking(Factor3); Disinterest in quitting (Factor4); Lack of social support to attend (Factor5); Lack of privacy at programmes (Factor6); Lack of information and perceived availability (Factor7). Age was associated with Factors 1, 3 and 4, motivation to quit with Factors 2 and 4, and confidence in quitting with Factors 1, 2, and 3. CONCLUSIONS: The findings suggest that many barriers exist, and they vary according to smoker demographics and characteristics, pointing to the need for tailored recruitment strategies. TRIAL REGISTRATION: ISRCTN76561916.
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BACKGROUND: Despite the clear harm associated with smoking tobacco, many people with smoking-related chronic diseases or serious mental illnesses (SMI) are unwilling or unable to stop smoking. In many cases, these smokers have tried and exhausted all methods to stop smoking and yet clinicians are repeatedly mandated to offer them during routine consultations. Providing nicotine through electronic cigarettes (e-cigarettes) may reduce the adverse health consequences associated with tobacco smoking, but these are not currently offered. The aim of this study is to examine the feasibility, acceptability and effectiveness of general practitioners (GPs) and nurses delivering a brief advice intervention on e-cigarettes and offering an e-cigarette starter pack and patient support resources compared with standard care in smokers with smoking-related chronic diseases or SMI who are unwilling to stop smoking. METHODS/DESIGN: This is an individually randomised, blinded, two-arm trial. Smokers with a smoking-related chronic condition or SMI with no intention of stopping smoking will be recruited through primary care registers. Eligible participants will be randomised to one of two groups if they decline standard care for stopping smoking: a control group who will receive no additional support beyond standard care; or an intervention group who will receive GP or nurse-led brief advice about e-cigarettes, an e-cigarette starter pack with accompanying practical support booklet, and telephone support from experienced vapers and online video tutorials. The primary outcome measures will be smoking reduction, measured through changes in cigarettes per day and 7-day point-prevalence abstinence at 2 months. Secondary outcomes include smoking reduction, 7-day point-prevalence abstinence and prolonged abstinence at 8 months. Other outcomes include patient recruitment and follow-up, patient uptake and use of e-cigarettes, nicotine intake, contamination of randomisation and practitioner adherence to the delivery of the intervention. Qualitative interviews will be conducted in a subsample of practitioners, patients and the vape team to garner their reactions to the programme. DISCUSSION: This is the first randomised controlled trial to investigate whether e-cigarette provision alongside a brief intervention delivered by practitioners leads to reduced smoking and abstinence among smokers with smoking-related chronic diseases or SMI. TRIAL REGISTRATION: ISRCTN registry, ISRCTN59404712. Registered 28/11/17.
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Sistemas Eletrônicos de Liberação de Nicotina , Clínicos Gerais , Enfermeiras e Enfermeiros , Ensaios Clínicos Controlados Aleatórios como Assunto , Prevenção do Hábito de Fumar/métodos , Redução do Consumo de Tabaco/métodos , Doença Crônica , Humanos , Avaliação de Resultados em Cuidados de Saúde , Garantia da Qualidade dos Cuidados de Saúde , Fumar/efeitos adversosRESUMO
BACKGROUND: The introduction of electronic cigarettes (e-cigarettes) has provided smokers with an alternative source of nicotine. Interest and use of the device has increased exponentially in the last decade with an estimated 2.9 m adult users in Great Britain. Research so far on the attitudes and perceptions of smokers to this new product has largely focussed on the views of current e-cigarette users, smokers attempting to quit and former cigarette smokers. AIM: This study aimed to explore the views of current tobacco smokers who were not using e-cigarettes and not looking for a cessation method, their understanding and knowledge of e-cigarettes, and their views of e-cigarettes as a smoking cessation aid provided by the National Health Service (NHS). METHODS: Semi-structured in-depth interviews were conducted with 14 patients from a general practice in North London, who smoked conventional tobacco cigarettes on a daily or weekly basis, over 18 years old. An iterative approach allowed for constant data analysis using a thematic approach throughout the data collection stage, and generated four recurring themes. FINDINGS: E-cigarettes were primarily seen as a smoking cessation device, with the supply of nicotine viewed as a benefit helping to reduce withdrawal symptoms, although for some participants this supply could also be a hindrance to dealing with their addiction. Despite uncertainty about the components, e-cigarettes were mostly viewed as healthier due to their lack of carcinogens, tar and smoke inhalation. The lack of reliable information and strong evidence for both the effectiveness and the safety of e-cigarettes led participants to be apprehensive about their provision by the NHS, and acted as a barrier to their use as an aid to quitting. The recurring appeal for more information regarding e-cigarettes make it clear that further high-quality research is urgently needed in this field to provide reliable and accurate information to smokers.
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AIMS: To assess the cost-effectiveness of a two-component intervention designed to increase attendance at the NHS Stop Smoking Services (SSSs) in England. DESIGN: Cost-effectiveness analysis alongside a randomized controlled trial (Start2quit). SETTING: NHS SSS and general practices in England. PARTICIPANTS: The study comprised 4384 smokers aged 16 years or more identified from medical records in 99 participating practices, who were motivated to quit and had not attended the SSS in the previous 12 months. INTERVENTION AND COMPARATOR: Intervention was a personalized and tailored letter sent from the general practitioner (GP) and a personal invitation and appointment to attend a taster session providing information about SSS. Control was a standard generic letter from the GP advertising SSS and asking smokers to contact the service to make an appointment. MEASUREMENTS: Costs measured from an NHS/personal social services perspective, estimated health gains in quality-adjusted life-years (QALYs) measured with EQ-5D and incremental cost per QALY gained during both 6 months and a life-time horizon. FINDINGS: During the trial period, the adjusted mean difference in costs was £92 [95% confidence interval (CI) = -£32 to -£216) and the adjusted mean difference in QALY gains was 0.002 (95% CI = -0.001 to 0.004). This generates an incremental cost per QALY gained of £59 401. The probability that the tailored letter and taster session is more cost-effective than the generic letter at 6 months is never above 50%. In contrast, the discounted life-time health-care cost was lower in the intervention group, while the life-time QALY gains were significantly higher. The probability that the intervention is more cost-effective is more than 83% using a £20 000-30 000 per QALY-gained decision-making threshold. CONCLUSIONS: An intervention designed to increase attendance at the NHS Stop Smoking Services (tailored letter and taster session in the services) appears less likely to be cost-effective than a generic letter in the short term, but is likely to become more cost-effective than the generic letter during the long term.
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Educação de Pacientes como Assunto/métodos , Seleção de Pacientes , Abandono do Hábito de Fumar , Fumar/terapia , Análise Custo-Benefício , Inglaterra , Clínicos Gerais , Humanos , Educação de Pacientes como Assunto/economia , Anos de Vida Ajustados por Qualidade de Vida , Risco , Medicina Estatal , Reino UnidoRESUMO
BACKGROUND: People with severe mental illnesses, including psychosis, have an increased risk of cardiovascular disease. We aimed to evaluate the effects of a primary care intervention on decreasing total cholesterol concentrations and cardiovascular disease risk in people with severe mental illnesses. METHODS: We did this cluster randomised trial in general practices across England, with general practices as the cluster unit. We randomly assigned general practices (1:1) with 40 or more patients with severe mental illnesses using a computer-generated random sequence with a block size of four. Researchers were masked to allocation, but patients and general practice staff were not. We included participants aged 30-75 years with severe mental illnesses (schizophrenia, bipolar disorder, or psychosis), who had raised cholesterol concentrations (5·0 mmol/L) or a total:HDL cholesterol ratio of 4·0 mmol/L or more and one or more modifiable cardiovascular disease risk factors. Eligible participants were recruited within each practice before randomisation. The Primrose intervention consisted of appointments (≤12) with a trained primary care professional involving manualised interventions for cardiovascular disease prevention (ie, adhering to statins, improving diet or physical activity levels, reducing alcohol, or quitting smoking). Treatment as usual involved feedback of screening results only. The primary outcome was total cholesterol at 12 months and the primary economic analysis outcome was health-care costs. We used intention-to-treat analysis. The trial is registered with Current Controlled Trials, number ISRCTN13762819. FINDINGS: Between Dec 10, 2013, and Sept 30, 2015, we recruited general practices and between May 9, 2014, and Feb 10, 2016, we recruited participants and randomly assigned 76 general practices with 327 participants to the Primrose intervention (n=38 with 155 patients) or treatment as usual (n=38 with 172 patients). Total cholesterol concentration data were available at 12 months for 137 (88%) participants in the Primrose intervention group and 152 (88%) participants in the treatment-as-usual group. The mean total cholesterol concentration did not differ at 12 months between the two groups (5·4 mmol/L [SD 1·1] for Primrose vs 5·5 mmol/L [1·1] for treatment as usual; mean difference estimate 0·03, 95% CI -0·22 to 0·29; p=0·788). This result was unchanged by pre-agreed supportive analyses. Mean cholesterol decreased over 12 months (-0·22 mmol/L [1·1] for Primrose vs -0·36 mmol/L [1·1] for treatment as usual). Total health-care costs (£1286 [SE 178] in the Primrose intervention group vs £2182 [328] in the treatment-as-usual group; mean difference -£895, 95% CI -1631 to -160; p=0·012) and psychiatric inpatient costs (£157 [135] vs £956 [313]; -£799, -1480 to -117; p=0·018) were lower in the Primrose intervention group than the treatment-as-usual group. Six serious adverse events of hospital admission and one death occurred in the Primrose group (n=7) and 23, including three deaths, occurred in the treatment-as-usual group (n=18). INTERPRETATION: Total cholesterol concentration at 12 months did not differ between the Primrose and treatment-as-usual groups, possibly because of the cluster design, good care in the treatment-as-usual group, short duration of the intervention, or suboptimal focus on statin prescribing. The association between the Primrose intervention and fewer psychiatric admissions, with potential cost-effectiveness, might be important. FUNDING: National Institute of Health Research Programme Grants for Applied Research.
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Transtorno Bipolar , Doenças Cardiovasculares/prevenção & controle , Colesterol/análise , Análise Custo-Benefício , Transtornos Psicóticos , Esquizofrenia , Adulto , Idoso , Terapia Comportamental , Transtorno Bipolar/complicações , Transtorno Bipolar/psicologia , Transtorno Bipolar/terapia , Inglaterra , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Transtornos Psicóticos/complicações , Transtornos Psicóticos/psicologia , Transtornos Psicóticos/terapia , Fatores de Risco , Esquizofrenia/complicações , Esquizofrenia/terapia , Resultado do TratamentoRESUMO
OBJECTIVE: To evaluate the effectiveness of individually tailored smoking cessation advice letters as an adjunct to telephone counselling and generic self-help materials. DESIGN: Randomized controlled trial. SETTING: The UK Quitline. PARTICIPANTS: A total of 1508 current smokers and recent ex-smokers. INTERVENTIONS: The control group received usual care (telephone counselling and an information pack sent through the post). The intervention group received in addition a computer-generated individually tailored advice letter. MAIN OUTCOME MEASURES: All outcomes were assessed at 6-month follow-up. The primary outcome measure was self-reported prolonged abstinence for at least 3 months. Secondary outcomes were self-reported prolonged abstinence for at least 1 month and 7-day and 24-hour point-prevalence abstinence. RESULTS: For the sample as a whole, quit rates did not differ significantly between the two conditions. However, among the majority (n = 1164) who were smokers at baseline, quit rates were consistently higher in the intervention group: prolonged abstinence for 3 months, 12.2% versus 9.0% [odds ratio (OR) = 1.40, 95% confidence interval (CI) = 0.96-2.04, P = 0.080); prolonged abstinence for 1 month, 16.4% versus 11.3% (OR = 1.53, 95% CI = 1.09-2.15, P = 0.013); 7-day point-prevalence abstinence, 18.9% versus 12.7% (OR = 1.59, 95% CI = 1.15-2.19, P = 0.004); 24-hour point-prevalence abstinence, 20.9% versus 15.4% (OR = 1.45, 95% CI = 1.07-1.96, P = 0.015). CONCLUSIONS: The results for the smokers are encouraging in showing a small but useful effect of the tailored letter on quit rate. Versions of the tailoring program could be used on the web and in general practices, pharmacies and primary care trusts.
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Aconselhamento/métodos , Promoção da Saúde/métodos , Abandono do Hábito de Fumar/métodos , Prevenção do Hábito de Fumar , Adulto , Estudos de Casos e Controles , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Educação de Pacientes como Assunto , Resultado do TratamentoRESUMO
BACKGROUND: The NHS Stop Smoking Services (SSSs) offer help to smokers who want to quit. However, the proportion of smokers attending the SSSs is low and current figures show a continuing downward trend. This research addressed the problem of how to motivate more smokers to accept help to quit. OBJECTIVES: To assess the relative effectiveness, and cost-effectiveness, of an intervention consisting of proactive recruitment by a brief computer-tailored personal risk letter and an invitation to a 'Come and Try it' taster session to provide information about the SSSs, compared with a standard generic letter advertising the service, in terms of attendance at the SSSs of at least one session and validated 7-day point prevalent abstinence at the 6-month follow-up. DESIGN: Randomised controlled trial of a complex intervention with follow-up 6 months after the date of randomisation. SETTING: SSSs and general practices in England. PARTICIPANTS: All smokers aged ≥ 16 years identified from medical records in participating practices who were motivated to quit and who had not attended the SSS in the previous 12 months. Participants were randomised in the ratio 3 : 2 (intervention to control) by a computer program. INTERVENTIONS: Intervention - brief personalised and tailored letter sent from the general practitioner using information obtained from the screening questionnaire and from medical records, and an invitation to attend a taster session, run by the local SSS. Control - standard generic letter from the general practice advertising the local SSS and the therapies available, and asking the smoker to contact the service to make an appointment. MAIN OUTCOME MEASURES: (1) Proportion of people attending the first session of a 6-week course over a period of 6 months from the receipt of the invitation letter, measured by records of attendance at the SSSs; (2) 7-day point prevalent abstinence at the 6-month follow-up, validated by salivary cotinine analysis; and (3) cost-effectiveness of the intervention. RESULTS: Eighteen SSSs and 99 practices within the SSS areas participated; 4384 participants were randomised to the intervention (n = 2636) or control (n = 1748). One participant withdrew and 4383 were analysed. The proportion of people attending the first session of a SSS course was significantly higher in the intervention group than in the control group [17.4% vs. 9.0%; unadjusted odds ratio (OR) 2.12, 95% confidence interval (CI) 1.75 to 2.57; p < 0.001]. The validated 7-day point prevalent abstinence at the 6-month follow-up was significantly higher in the intervention group than in the control group (9.0% vs. 5.6%; unadjusted OR 1.68, 95% CI 1.32 to 2.15; p < 0.001), as was the validated 3-month prolonged abstinence and all other periods of abstinence measured by self-report. Using the National Institute for Health and Care Excellence decision-making threshold range of £20,000-30,000 per quality-adjusted life-year gained, the probability that the intervention was more cost-effective than the control was up to 27% at 6 months and > 86% over a lifetime horizon. LIMITATIONS: Participating SSSs may not be representative of all SSSs in England. Recruitment was low, at 4%. CONCLUSIONS: The Start2quit trial added to evidence that a proactive approach with an intensive intervention to deliver personalised risk information and offer a no-commitment introductory session can be successful in reaching more smokers and increasing the uptake of the SSS and quit rates. The intervention appears less likely to be cost-effective in the short term, but is highly likely to be cost-effective over a lifetime horizon. FUTURE WORK: Further research could assess the separate effects of these components. TRIAL REGISTRATION: Current Controlled Trials ISRCTN76561916. FUNDING DETAILS: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 3. See the NIHR Journals Library website for further project information.
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Aceitação pelo Paciente de Cuidados de Saúde , Abandono do Hábito de Fumar/economia , Abandono do Hábito de Fumar/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Análise Custo-Benefício , Cotinina/análise , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Motivação , Anos de Vida Ajustados por Qualidade de Vida , Saliva/química , Método Simples-Cego , Fatores Socioeconômicos , Medicina Estatal/organização & administração , Reino UnidoRESUMO
AIM: To evaluate the effectiveness of repeated-contact proactive telephone counselling for smoking cessation in a UK setting. DESIGN: Randomized controlled trial. SETTING: The Quitline, an established national telephone counselling service available throughout the UK. PARTICIPANTS AND INTERVENTION: A total of 1,457 callers to the Quitline in 2000 and 2001 were allocated randomly to a Control group to receive usual care or to a Repeated Contact group to be offered five proactive calls in addition to usual care. MEASUREMENTS Prolonged abstinence and 24-hour point-prevalent abstinence 6 and 12 months after recruitment, quit attempts and 24-hour periods of abstinence in non-quitters. FINDINGS: No significant differences were found between the Repeated Contact and Control groups on prolonged or point-prevalent abstinence. On an intention-to-treat basis, 9.5% of the Control group were abstinent for longer than 6 months at the 12-month follow-up, compared with 9.3% of the Repeated Contact group; 18.9% and 20.2%, respectively, were point-prevalent abstinent at the 6-month follow-up. Significantly more non-quitters in the Control group made a quit attempt in the first 6 months following recruitment than in the Repeated Contact group (62.6%/56.1%, P < 0.05). CONCLUSIONS Proactive telephone counselling did not significantly increase abstinence rates, and appeared to decrease quit attempts, in callers to the Quitline. A non-structured, client-led counselling protocol and insufficient pre-quit motivational counselling could account for the lack of effect.
Assuntos
Aconselhamento/métodos , Linhas Diretas , Abandono do Hábito de Fumar/métodos , Adulto , Feminino , Humanos , Masculino , Rememoração Mental , Pessoa de Meia-Idade , Satisfação do Paciente , Telefone , Resultado do TratamentoRESUMO
BACKGROUND: Implementation fidelity refers to the extent to which a proposed intervention is enacted as designed and is necessary to determine how much the intervention in question is the primary mechanism in any changes observed. Start2quit was a randomised controlled trial that aimed to improve attendance at the English Stop Smoking Service (SSS). The complex intervention combining computer-tailored personal risk letters and no-commitment ("taster") sessions aimed at encouraging attendance at the SSS doubled attendance at the SSS and significantly increased abstinence rates, although attendance and abstinence varied between participating SSSs. Assessment of the fidelity of the delivery of the taster sessions to the protocol was embedded into the trial and is the focus of this study. METHODS: Eighteen SSSs participated in the study. Taster sessions were delivered by SSS advisors in the area. Of the 131 sessions delivered, 93 (71 %) were recorded and 41 (31.3 %) were selected for transcription and analysis. The taster session protocol contained 73 specified behaviours, which were independently classified into component behaviour change techniques (BCTs) using an established taxonomy for smoking cessation. All transcripts were coded by two authors with 25 % additionally coded by a third. The fidelity of each taster session was expressed as the percentage of overall protocol-specified behaviours that were delivered. Adherence to each BCT was measured as the number of behaviours applied by the advisors within each BCT divided by the total number classified within each. RESULTS: Adherence of protocol-specified behaviours was relatively high (median 71.23 %), though there was considerable variation (28.76 to 95.89 %) in individual sessions. Median fidelity to specific BCTs across sessions also varied from 50 to 100 %. Shorter sessions, sessions run jointly by two advisors, by female advisors, or by advisors aged 45 to 54 were associated with higher levels of adherence. There was no association between adherence and subsequent attendance at the SSS. CONCLUSIONS: These results suggest that the delivery of the intervention of this study is not likely to have been impacted by issues of fidelity. As such, we can have greater confidence that variability in the main outcome is not due to variability in SSS advisor adherence to the protocol of the taster sessions. TRIAL REGISTRATION: Current Controlled Trials ISRCTN76561916.
Assuntos
Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Abandono do Hábito de Fumar/métodos , Tabagismo/terapia , Inglaterra , Feminino , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
BACKGROUND: People with severe mental illnesses die up to 20 years earlier than the general population, with cardiovascular disease being the leading cause of death. National guidelines recommend that the physical care of people with severe mental illnesses should be the responsibility of primary care; however, little is known about effective interventions to lower cardiovascular disease risk in this population and setting. Following extensive peer review, funding was secured from the United Kingdom National Institute for Health Research (NIHR) to deliver the proposed study. The aim of the trial is to test the effectiveness of a behavioural intervention to lower cardiovascular disease risk in people with severe mental illnesses in United Kingdom General Practices. METHODS/DESIGN: The study is a cluster randomised controlled trial in 70 GP practices for people with severe mental illnesses, aged 30 to 75 years old, with elevated cardiovascular disease risk factors. The trial will compare the effectiveness of a behavioural intervention designed to lower cardiovascular disease risk and delivered by a practice nurse or healthcare assistant, with standard care offered in General Practice. A total of 350 people will be recruited and followed up at 6 and 12 months. The primary outcome is total cholesterol level at the 12-month follow-up and secondary outcomes include blood pressure, body mass index, waist circumference, smoking status, quality of life, adherence to treatments and services and behavioural measures for diet, physical activity and alcohol use. An economic evaluation will be carried out to determine the cost effectiveness of the intervention compared with standard care. DISCUSSION: The results of this pragmatic trial will provide evidence on the clinical and cost effectiveness of the intervention on lowering total cholesterol and addressing multiple cardiovascular disease risk factors in people with severe mental illnesses in GP Practices. TRIAL REGISTRATION: Current Controlled Trials ISRCTN13762819. Date of Registration: 25 February 2013. Date and Version Number: 27 August 2014 Version 5.
Assuntos
Terapia Comportamental , Doenças Cardiovasculares/prevenção & controle , Transtornos Mentais/terapia , Adulto , Idoso , Análise Custo-Benefício , Interpretação Estatística de Dados , Humanos , Transtornos Mentais/complicações , Transtornos Mentais/psicologia , Pessoa de Meia-Idade , Seleção de Pacientes , Atenção Primária à Saúde , Qualidade de Vida , Fatores de RiscoRESUMO
OBJECTIVE: To explore perceptions of computer-tailored advice reports for smoking cessation matched to the recipient's reading level. METHODS: Current cigarette smokers in the UK aged 18-65 who completed a Smoking Behavior Questionnaire (n=6911) were randomized to receive standard generic materials or standard materials plus computer-tailored reports adapted to the recipient's reading level. Smoking status and perception of the reports was assessed at a 6-month follow-up. 4677 participants were included in the analysis. RESULTS: 53.3% were categorized into the easy reading group (ERG). The relative benefit of the intervention for prolonged 3-month abstinence was more marked in the ERG (2.6%/1.9%, OR=1.50) than in the standard reading group (SRG) (4.0%/3.8%, OR=1.05), although the interaction was not statistically significant. Participants in the Intervention group perceived the standard materials more positively than did those in the Control group, and participants in the ERG perceived both the generic material and the tailored report more positively. CONCLUSIONS: The easy reading version of this brief self-help intervention was better perceived than the standard version, and appeared to have a small, but promising effect in smokers with a lower literacy level. PRACTICE IMPLICATIONS: An association between reading level and deprivation emphasizes the need to adapt smoking cessation materials to address the needs of smokers with lower literacy.