A block randomised controlled trial will be conducted. At baseline, clients attending one community social service will be asked to complete a touch screen computer survey asking them about health issues and their smoking status. Clients identified as smokers will be asked to participate in a smoking cessation trial. Allocation to the intervention or control groups will be determined by time periods with clients randomised in one-week blocks to reduce selection bias and contamination between groups. The trial has been carefully designed to conform to the CONSORT statement which has recently been updated for psychosocial and behavioural interventions [27
The trial is funded by the National Health and Medical Research Council (NHMRC) of Australia (Ref no. 631055) and approved by the University of Newcastle Human Research Ethics Committee (Ref no. H-2010-1002).
The study will be conducted in a non-government organisation, Community Care Centre (referred to here as the Centre) which is a community social service located in NSW, Australia providing financial counselling, relationship counselling, Life Skills courses, emergency relief and a communal use room/waiting area. The Centre operates 7 days a week, providing counselling services 4 days a week and predominantly assists those on government income assistance (95% of clients).
Clients eligible for the trial will be those aged over 18 years, attending the Centre for their first visit, and who are self-reported smokers. Clients who have attended the Centre at another time in the past and are returning to start a new program will be eligible to participate. English-speaking clients who are unable to read at this level will be offered assistance from the research assistant (RA) to complete study consent forms and surveys. Ineligible clients will be those who are non-English speaking, presentation with uncontrolled mental illness (as identified by the RA and confirmed by the caseworker), and whose partner is already enrolled in the study.
A sample of 200 participants per group at 12 months will allow detection of a difference in smoking cessation rates of 8% between groups at 12 months (slightly smaller difference of 7% can be detected at 1 month), based on 5% smoking cessation in the usual care group and 13% in the intervention group, at 5% significance level and 80% power. This effect size is achievable and important from a population-effect perspective. Non-randomised and observational studies using less intensive smoking cessation interventions within disadvantaged groups have demonstrated high cessation rates [25
]. Estimating that 30% of the sample are lost to follow-up (10% at each of one, six and 12 months), 290 patients per group will be recruited at baseline. The Centre receives approximately 50 new clients a week and 50% of those are for ongoing counselling care. All new clients will be eligible to complete the baseline touch screen computer survey. Over a 12-month recruitment period, 1,300 new clients will attend for counselling services. Staff estimate that 60%-90% of clients are current smokers. Assuming a median value of 75%, there will be approximately 975 eligible clients during the study period. Assuming a consent rate of 60% [28
], 585 individuals will consent to participate in the study.
Recruitment and randomisation
A trained RA will be situated in the Centre communal waiting room during recruitment. The RA will approach all clients entering the Centre, ascertain eligibility, and seek written consent. A two-stage consent process will be used. First, the RA will inform clients that the study aims to expand the services provided by the Centre and involves completing a health survey on a touch screen computer and that their case-worker may discuss health issues with them. When they complete the survey, if they reported to smoke, they will be informed, on-screen, that a study for smokers is being conducted and that the RA will seek their consent to participate in the smoking study. They will be told that participation in the smoking study will involve their counsellor or case worker possibly discussing quitting with them, and that they will be asked to return to the Centre in one, six and 12 months time to complete the survey and conduct a breath test for carbon monoxide (CO) measurement. Consenting clients will be assisted in the use of the touch screen survey. The RA will review the clients' smoking status on a touch screen survey print-out and randomly allocate participants who are current smokers to the control or intervention group depending on whether it is an intervention or control week. Intervention or control times will be randomly allocated in blocks of four by a computer generated randomisation procedure. Clients who are not smokers will not participate further in the study.
Touch screen computer baseline survey and print-outs
Studies indicate that touch screen computers are a confidential, acceptable, feasible, user-preferred, and cost-effective mechanism for collecting health information in vulnerable populations [32
]. The computer will be placed in a private location ensuring confidentiality. The RA will be present at all times when the computer is in use. An additional advantage of the computerised data collection is that it can provide 'real time' results, immediately available to users and staff [33
]. The computer will provide intervention participants with two print-outs of their results with a checklist that will outline components of the intervention their case worker should address. One copy will go to the case worker and one will be retained by the client. Clients and staff will be asked to keep checklists and mark off the components of the intervention 1) offered, 2) accepted or refused by the client, and 3) provided. These print-outs will form one component of the intervention as well as process measures.
Definition of current smoker
The survey will assess demographic characteristics, client smoking status as well as a number of screening tools (such as nicotine dependence, partner's smoking status, depression, financial stress). Self-reported smoking will be determined using the following questions "Which of the following best describes your smoking status?" and respond by selecting from "I'm a smoker, I smoke daily", "I'm a smoker, I smoke occasionally", "I'm an ex-smoker, I never smoke now" or "I'm a non-smoker, I have never smoked." Clients who smoke daily or occasionally will be asked if they have smoked in the past 7 days and those who have will meet the definition of current smokers for the purpose of this trial.
The use of these items to elicit smoking history has demonstrated accuracy in past research [38
The minimal ethical care (control) group
Consenting, smoking clients who complete the survey during control weeks will receive on-screen information at completion of the survey including advice to quit and the telephone smoking cessation assistance Quitline number.
The smoking cessation (intervention) group
will receive an intensive client-centred smoking cessation intervention offered by the caseworker over one to two face-to-face and two telephone contacts.
The theoretical framework for the intervention is based on the PRIME theory of motivation [39
]. A number of factors are likely to influence an individual's motivation to smoke and quit [7
]. The theory suggests that in order to motivate change, an intervention must minimise the strength and frequency of the need to smoke, maximise the countervailing desire to remain abstinent, optimise use of medication and maximise the capacity to exercise self control. The intervention aims to: use motivational interviewing [40
] to encourage repeated quit attempts among all smokers, maximise use of effective quitting assistance strategies [18
] and provide support for life 'stresses' believed to contribute to the high rates of relapse in disadvantaged populations [9
Tailoring will be used as cessation research with disadvantaged groups suggests that in order for the client group to benefit, the intervention must fit their level of need, their unique circumstances and be accessible [22
]. Data from the baseline screening survey regarding nicotine dependence, previous quit attempts, depression, partner smoking status, and financial stress will be used to produce an individualised checklist of the types of assistance each client may need.
Other behavioural elements of the intervention program will include use of motivational interviewing, behavioural contracting, provision of pharmacotherapy subsidies, allocation of a support person and support pack, referral to specialist quit services as well as Centre-run Life Skills courses, and follow-up using unscheduled drop-in or phone-in sessions.
The Case Worker Sessions
The intervention will be implemented over one or two face-to-face visits (each two weeks apart) which will commence immediately following baseline survey completion, followed by at least two phone contacts (one week apart). This intervention will constitute an add-on to clients' usual regular counselling visits, reducing additional costs to the Centre and to clients. If a client requires further contact, staff will provide further quitting assistance and record what they delivered on their checklist. Clients who do not return within the two week timeframe will be contacted by the caseworker by telephone. Appendix 1 provides a session by session description of the intervention.
Staff training and resources
Centre staff will be provided with training in the smoking cessation strategies. Local training will be provided during a one day course. Similar courses are regularly provided for various health professionals. The course will be tailored to the needs of community service staff and clients.
Primary outcome measure - client validated self-reported smoking cessation
There will be two primary outcome measures obtained at one, six and 12 month follow-up: 1) 24-hour CO validated self-reported smoking cessation and 2) 7-day self-reported smoking cessation. These follow-up time periods and measures of smoking cessation have been recommended by the Society for Research on Nicotine and Tobacco (SRNT) workgroup [42
] for measuring smoking cessation. Seven-day smoking cessation will be defined as abstinent for the past seven days at one, six and 12 months respectively. Seven-day point prevalence abstinence is a common and recommended cessation outcome and has the highest concurrent validity of a range of cessation measures [43
]. Biochemical verification of self-report:
General population reports and some clinical trial based studies show that misreporting tends to be low, around 5% [38
]. Little is known regarding the misreporting rate of smoking status in this population. Thus, this study will use biochemical validation methods to ensure self-report estimates are validated. Verification will be conducted using measures of CO in expired air as recommended by the SRNT Biochemical Verification workgroup [44
]. Although cotinine measures provide the gold standard tool for assessing smoking status self-report, the collection of blood, urine or saliva samples with clients in a non-health setting is invasive and impractical. To assess 24-hour smoking cessation, clients will be asked how long ago they last smoked a cigarette, cigar or pipe? (and respond by indicating, last four hours, between 4-8 hours ago, between 8-24 hours ago, more than 24 hours ago). Twenty four-hours is the recommended biochemically verifiable window for CO in expired air [44
]. The Jarvis protocol will be used to record expired air CO. A cut-off point of 8 ppm will be used to define a smoker [44
]. Measuring CO in expired air has demonstrated high sensitivity and specificity of around 90% for both [44
Secondary outcome measure
In addition to the point prevalence measures, six and 12 month continuous abstinence will be assessed at six and 12 month follow up as recommended by the SRNT [42
These items will be collected at baseline, used as part of the intervention print-out, and included in multivariate analysis. Sociodemographic characteristics
will include age, gender, marital status, housing status, income, education, postcode. Nicotine dependence
will be measured by the Heaviness of Smoking Index (HSI), a two-item short form of the Fagerstrom Tolerance Questionnaire [45
]. The HSI scores range from 0-6 and are calculated by summing the points for 1) time to first cigarette smoked after waking (in minutes) and 2) number of cigarettes smoked per day. Higher HSI scores indicate more dependence on nicotine. Quit attempts
. A commonly used [16
] item which asks "How many serious attempts to stop smoking have you made in the last 12 months? By serious attempt I mean you decided that you would try to make sure you never smoked again. Please include any attempt that you are currently making and please include any successful attempt made within the last year". Use of cessation aids
. Clients who have made a serious quit attempt will be asked about treatments they had used in their most recent quit attempt. A single item developed by Shiffman et al [16
] will list various pharmacological, behavioural and alternative smoking cessation aids. Partner smoking behaviour
. One item [46
] will assess partner smoking behaviour: "Does your partner smoke?" (response options: yes, yes but stopping with me, no ex-smoker, no never smoked, N/A). Depression
. A recent meta-analysis indicates that the Patient Health Questionnaire (PHQ) has sensitivity of 80% and specificity of 92% in diagnosing major depression [47
]. The two-item PHQ2 is recommended by the US Preventive Services Taskforce for depression screening and will ask "Over the last 2 weeks have you felt down, depressed or hopeless?" and ".. have you felt little interest or pleasure in doing things?". Financial stress
will be measured using a scale developed by Siahpush et al [9
] and previously used as a predictor of smoking behaviour. It includes items asking "In the last six months, did any of the following happen to you because of a shortage of money?" followed by six options.
Process measures. Acceptability of intervention
At six-month follow-up staff and clients will also be asked to rate the acceptability, usefulness and perceived effectiveness of the smoking cessation intervention. Staff and client intervention checklists. Completed staff and client printed checklists of intervention strategies offered, accepted, refused, and provided will be compared at the conclusion of the trial to measure exposure and adherence to the intervention. Costs. Relevant costs of delivery of the intervention and estimates of costs to the community service sector including staff time will be identified, collected and valued to allow a cost-benefit analysis from the service provider perspective. Savings in terms of cessation rates and savings in health care costs will be analysed.
Data will be stored in Access databases and exported for analysis to SAS. The distribution of all variables will be checked for normality, with non-parametric statistics used when appropriate. Characteristics of study participants will be compared between intervention groups using the chi-square test for categorical variables and the t-test or a non-parametric equivalent for continuous variables.
Efficacy of intervention
To assess the efficacy of the intervention at smoking cessation (validated by expired air CO), the intervention and control groups will be compared on each of the primary outcomes using chi-square analysis: 1) proportion abstinent last 24 hours (validated) at one, six and 12 months; and 2) proportion abstinent for seven days at one, six and 12 months. Univariate analyses will be undertaken to examine factors associated with each of the two outcomes, using the chi-square test for categorical variables and the t-test or a non-parametric equivalent for continuous variables. In addition to the primary analysis, intention-to-treat analysis will also be undertaken whereby clients who fail to complete follow-up in the study will be considered to be continuing smokers. Multiple logistic regression analyses will be used to compare outcomes between the two intervention groups while adjusting for prognostic variables and potential confounders (sociodemographic, financial stress, depression, and other variables collected).
The proportion of participants reporting that the intervention was acceptable, useful, and effective will be determined with 95% confidence intervals.