Hazel Gilbert

Randomized Controlled Trial Evaluation of a Tailored Leaflet and SMS Text Message Self-help Intervention for Pregnant Smokers (MiQuit)

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.

Randomized controlled trial to assess the short-term effectiveness of tailored web- and text-based facilitation of smoking cessation in primary care (iQuit in practice).

Aims To estimate the short-term effectiveness, feasibility and acceptability of a smoking cessation intervention (the iQuit system) that consists of tailored printed and Short Message Service (SMS) text message self-help delivered as an adjunct to cessation support in primary care to inform the design of a definitive trial. Design A stratified two parallel-group randomized controlled trial comparing usual care (control) with usual care plus the iQuit system (intervention), delivered by primary care nurses/healthcare assistants who were blinded to the allocation sequence. Setting Thirty-two general practice (GP) surgeries in England, UK. Participants A total of 602 smokers initiating smoking cessation support from their local GP surgery were randomized (control n = 303, intervention n = 299). Measurements Primary outcome was self-reported 2-week point prevalence abstinence at 8 weeks follow-up. Secondary smoking outcomes and feasibility and acceptability measures were collected at 4 weeks after quit date, 8 weeks and 6 months follow-up. Findings There were no significant between-group differences in the primary outcome [control 40.3%, iQuit 45.2%; odds ratio (OR) = 1.22, 95% confidence interval (CI) = 0.88–1.69] or in secondary short-term smoking outcomes. Six-month prolonged abstinence was significantly higher in the iQuit arm (control 8.9%, iQuit 15.1%; OR = 1.81, 95% CI = 1.09–3.01). iQuit support took on average 7.7 minutes (standard deviation = 4.0) to deliver and 18.9% (95% CI = 14.8–23.7%) of intervention participants discontinued the text message support during the programme. Conclusions Tailored printed and text message self-help delivered alongside routine smoking cessation support in primary care does not significantly increase short-term abstinence, but may increase long-term abstinence and demonstrated feasibility and acceptability compared with routine cessation support alone.

Effectiveness of web-based tailored smoking cessation advice reports (iQuit): a randomized trial.

AIMS To determine whether web-based tailored cessation advice, based on social cognitive theory and the perspectives on change model, was more effective in aiding a quit attempt than broadly similar web-based advice that was not tailored. DESIGN Participants were allocated randomly to one of two groups, to receive either a cessation advice report and progress report that were tailored to individual-level characteristics or a cessation advice report that presented standardized (non-tailored) content. Tailoring was based on smoking-related beliefs, personal characteristics and smoking patterns, self-efficacy and outcome expectations. SETTING Participant enrolment and baseline assessments were conducted remotely online via the study website, with the advice reports presented by the same website. PARTICIPANTS Participants (n = 1758) were visitors to the QUIT website who were based in the United Kingdom, aged 18 years or over and who smoked cigarettes or hand-rolled tobacco. MEASUREMENTS Follow-up assessments were made at 6 months by telephone interview. The primary outcome measure was self-reported 3 months prolonged abstinence, and secondary outcomes were 1 month prolonged abstinence, 7-day and 24-hour point prevalence abstinence. FINDINGS The intervention group did not differ from the control group on the primary outcome (9.1% versus 9.3%; odds ratio = 1.02 95% confidence interval 0.73-1.42) or on any of the secondary outcomes. Intervention participants gave more positive evaluations of the materials than control participants. CONCLUSIONS A web-based intervention that tailored content according to smoking-related beliefs, personal characteristics and smoking patterns, self-efficacy and outcome expectations, was not more effective than web-based materials presenting broadly similar non-tailored information.

Effectiveness of computer-tailored Smoking Cessation Advice in Primary Care (ESCAPE): a Randomised Trial

BackgroundSmoking remains a major public health problem; developing effective interventions to encourage more quit attempts, and to improve the success rate of self-quit attempts, is essential to reduce the numbers of people who smoke. Interventions for smoking cessation can be characterised in two extremes: the intensive face-to face therapy of the clinical approach, and large-scale, public health interventions and policy initiatives. Computer-based systems offer a method for generating highly tailored behavioural feedback letters, and can bridge the gap between these two extremes. Proactive mailing and recruitment can also serve as a prompt to motivate smokers to make quit attempts or to seek more intensive help. The aim of this study is to evaluate the effect of personally tailored feedback reports, sent to smokers identified from general practitioners lists on quit rates and quitting activity. The trial uses a modified version of a computer-based system developed by two of the authors to generate individually tailored feedback reports.MethodA random sample of cigarette smokers, aged between 18 and 65, identified from GP records at a representative selection of practices registered with the GPRF are sent a questionnaire. Smokers returning the questionnaire are randomly allocated to a control group to receive usual care and standard information, or to an intervention group to receive usual care and standard information plus tailored feedback reports. Smoking status and cognitive change will be assessed by postal questionnaire at 6-months.DiscussionComputer tailored personal feedback, adapted to reading levels and motivation to quit, is a simple and inexpensive intervention which could be widely replicated and delivered cost effectively to a large proportion of the smoking population. Given its recruitment potential, a modest success rate could have a large effect on public health. The intervention also fits into the broader scope of tobacco control, by prompting more quit attempts, and increasing referrals to specialised services. The provision of this option to smokers in primary care can complement existing services, and work synergistically with other measures to produce more quitters and reduce the prevalence of smoking in the UK.Trial registrationCurrent Controlled Trials ISRCTN05385712

Factors predicting recruitment to a UK wide primary care smoking cessation study (the ESCAPE trial)

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.

Study protocol for iQuit in Practice: a randomised controlled trial to assess the feasibility, acceptability and effectiveness of tailored web- and text-based facilitation of smoking cessation in primary care

BackgroundPrimary 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/designThe 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.DiscussionThis 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 registrationISRCTN56702353

Are predictors of making a quit attempt the same as predictors of 3‐month abstinence from smoking? Findings from a sample of smokers recruited for a study of computer‐tailored smoking cessation advice in primary care

AIMS To identify predictors of quit attempts and of 3-month abstinence from cigarette smoking. DESIGN Secondary analysis of data gathered for a two-armed randomized controlled trial with 6-month follow-up. SETTING A total of 123 general practices across the United Kingdom. PARTICIPANTS A total of 4397 participants who completed the 6-month follow-up. Participants were categorized on self-reported smoking behaviour at 6-month follow-up as non-attempters (n = 2664), attempted quitters (n = 1548) and successful quitters (n = 185). MEASURES Demographic characteristics, smoking history and nicotine dependence, cognitive and social-environmental factors measured at baseline were examined as potential predictors of quit attempts and 3-month abstinence. FINDINGS Univariate predictors of quit attempts included commitment [odds ratio (OR) = 11.64, 95% confidence interval (CI) = 8.30-16.32], motivation (OR = 2.10, 95% CI = 1.98-2.22) and determination to quit (OR = 1.94, 95% CI = 1.83-2.05). Successful quitting was associated with being married (OR = 1.51, 95% CI = 1.11-2.05), lower social deprivation (OR = 0.47, 95% CI = 0.30-0.74), higher reading level (OR = 1.62, 95% CI = 1.19-2.21) and lower nicotine dependence (OR = 0.42, 95% CI = 0.29-0.62). Health problems related to smoking and previous quit attempts for 3 months or longer predicted both. In the multivariate analysis, the significant predictors of making a quit attempt were; later stage of readiness to quit (OR = 5.38, 95% CI = 3.67-7.89), motivation (OR = 1.48, 95% CI = 1.34-1.62) and determination to quit (OR = 1.16, 95% CI = 1.05-1.29) and health problems related to smoking (OR = 1.44, 95% CI = 1.18-1.75). For 3-month abstinence, the only significant predictor was not having health problems related to smoking (OR = 0.50, 95% CI = 0.29-0.83). CONCLUSIONS While high motivation and determination to quit is necessary to prompt an attempt to quit smoking, demographic factors and level of nicotine dependence are more important for maintaining abstinence.

ESCAPE: a randomised controlled trial of computer-tailored smoking cessation advice in primary care.

AIMS To evaluate the effectiveness of tailored cessation advice reports, including levels of reading ability, compared with a generic self-help booklet. DESIGN Participants were randomised to receive standard non-tailored information or to receive standard information plus a cessation advice report and a progress report, both tailored to individual characteristics. SETTING One hundred and twenty-three general practices located throughout the UK. PARTICIPANTS Questionnaires were mailed to 58 660 current cigarette smokers aged 18-65 years, identified from general practitioner records. Of the 6911 (11.8%) who completed the questionnaire, provided consent and were enrolled into the study, 6697 (11.4%) were included in the analysis. MEASUREMENTS Follow-up was by postal questionnaire sent six months after randomisation, or by telephone interview for participants failing to return the questionnaire. The primary outcome was self-reported prolonged abstinence for at least three months at the six-month follow-up. FINDINGS Quit rates on the primary outcome were not significantly different (3.2% versus 2.7%) (OR = 1.20, 95% CI [0.94, 1.54], P = 0.15). A significantly higher proportion of intervention group participants made a quit attempt during the follow-up period (32.3% versus 29.6%; OR = 1.13, 95% CI [1.01, 1.26], P = 0.026). CONCLUSION ESCAPE, a brief tailored smoking cessation intervention delivered by post and designed to reach a wide population of smokers, appears to increase the rate at which smokers try to stop, but if there is an effect on prolonged abstinence it is small.

Characteristics of a population-wide sample of smokers recruited proactively for the ESCAPE trial.

OBJECTIVES To describe the characteristics of a sample of smokers recruited proactively into a smoking cessation trial, and to compare these characteristics with the wider population using data from the General Household Survey (GHS) and National Statistics Omnibus Survey. STUDY DESIGN Sample recruited for a randomized controlled trial. METHODS Between August 2007 and October 2008, 123 general practices mailed questionnaires to smokers in the U.K. identified from computer records. Smokers willing to participate in a trial of personalized computer-tailored feedback returned the questionnaires to the research team. The characteristics of the sample were compared with the wider population using data from the GHS and National Statistics Omnibus Survey, and Index of Material Deprivation scores. RESULTS A response rate of 11.4% (n = 6697) was achieved. The sample was demographically similar to the population sample, with an even distribution of participants from areas of both high and low deprivation. The sample was more dependent than the GHS sample, but less dependent than clinic samples. Distribution by motivation and readiness to quit was similar to population estimates. CONCLUSIONS Public health strategies targeting the entire population of smokers are needed to counter the low recruitment rates resulting from the traditional reactive methods of recruitment to smoking cessation studies. Using computerized records to identify and contact patients who are smokers is a simple method of recruiting a larger, more representative sample of smokers.

Lowering Cardiovascular Disease Risk for People with Severe Mental Illnesses in Primary Care: A Focus Group Study.

Background People with severe mental illnesses die early from cardiovascular disease. Evidence is lacking regarding effective primary care based interventions to tackle this problem. Aim To identify current procedures for, barriers to, and facilitators of the delivery of primary care based interventions for lowering cardiovascular risk for people with severe mental illnesses. Method 75 GPs, practice nurses, service users, community mental health staff and carers in UK GP practice or community mental health settings were interviewed in 14 focus groups which were audio-recorded, transcribed and analysed using Framework Analysis. Results Five barriers to delivering primary care based interventions for lowering cardiovascular risk in people with severe mental illnesses were identified by the groups: negative perceptions of people with severe mental illnesses amongst some health professionals, difficulties accessing GP and community-based services, difficulties in managing a healthy lifestyle, not attending appointments, and a lack of awareness of increased cardiovascular risk in people with severe mental illnesses by some health professionals. Identified facilitators included involving supportive others, improving patient engagement with services, continuity of care, providing positive feedback in consultations and goal setting. Conclusion We identified a range of factors which can be incorporated in to the design, delivery and evaluation of services to reduce cardiovascular risk for people with severe mental illnesses in primary care. The next step is determining the clinical and cost effectiveness of primary care based interventions for lowering cardiovascular risk in people with severe mental illnesses, and evaluating the most important components of such interventions.