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Trial registered on ANZCTR


Registration number
ACTRN12619000244101
Ethics application status
Approved
Date submitted
12/02/2019
Date registered
19/02/2019
Date last updated
3/02/2020
Date data sharing statement initially provided
19/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Quitlink: Peer worker facilitated Quitline support for smokers receiving mental health services
Scientific title
Quitlink: A randomised controlled trial of peer worker facilitated Quitline support for smokers receiving mental health services
Secondary ID [1] 295555 0
Nil known
Universal Trial Number (UTN)
U1111-1209-3796
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco smoking

308824 0
Severe mental illness 308825 0
Condition category
Condition code
Public Health 307754 307754 0 0
Other public health
Mental Health 307755 307755 0 0
Schizophrenia
Mental Health 309572 309572 0 0
Psychosis and personality disorders
Mental Health 309573 309573 0 0
Depression
Mental Health 309574 309574 0 0
Other mental health disorders
Mental Health 310207 310207 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention (Quitlink)
Intervention participants will receive standard smoking care as in the control condition plus additional support. The standard care is delivered by a peer worker and includes advice to quit, encouragement to use NRT, and a Quit Victoria pack of written materials to motivate a quit attempt (e.g. costs of smoking and benefits of quitting) and resources to support self-management (e.g. Quitline phone number, ‘4Ds’ strategy: Delay, Deep-breathe, Drink water, Do something else’ to manage cravings; using NRT products). With consent, a letter will be sent by the research team to nominated health professionals (GP/psychiatrist) with information about their client’s trial participation and a link to Australia’s smoking cessation guidelines for health professionals, which includes a list of medications affected by smoking.
Additionally, the intervention group will receive:
• Referral to Quitline: immediately following the brief intervention, the peer worker will make a proactive referral to Quitline
• Manual guided Quitline counselling: Quitline will then call the participant to offer the Quitlink service. This service includes up to seven scheduled calls with additional calls allowed to deal with relapse crises within an eight-week period. Calls are scheduled approximately weekly or according to caller preference for pre-quit calls and post-quitting calls follow a relapse-sensitive schedule. It includes structured monitoring of mental health symptoms, nicotine withdrawal symptoms and medication side-effects; and a focus on psychoeducation including the relationship between smoking and mood; goal setting; identification of triggers to smoke; and facilitating problem solving and skills building, including the use of mood management strategies that also act to aid cessation (e.g., exercise, scheduling pleasant activities). A dedicated Quitline counsellor will manage the quitting process for each participant.
• As in the control condition, with consent, a letter will be sent to the person’s general practitioner and/or psychiatrist. Additionally for the intervention condition, peer reviewed articles that provide practical advice to assist doctors in helping people with mental illness to quit smoking will be included (Mendelsohn and Montebello, 2013; Mendelsohn et al., 2015). Additionally, participants will receive a Quit Victoria brochure for carers and a Quit Victoria stop smoking moods and experiences diary.
• Quitline engagement with mental health services: Quitline will provide written feedback to treatment providers at the end of the telephone counselling program. Providers will be encouraged to monitor and support cessation efforts whenever appropriate. In addition, Quitline will contact the mental health treatment provider, if concerns arise about mental health issues.
• NRT: Participants will initially be provided with a four week supply (enough for daily use) of patches plus their choice of oral-form NRT (gum, lozenge, inhalator, spray). These products include:
* Patch (Transdermal; 21mg)
* Gum (Oromucosal; 2 mg)
* Lozenge (Oromucosal; 2 mg)
*Inhalator (Oromucosal; 15mg per cartridge)
* Spray (Oromucosal; 1mg 150 sprays)
The research team will post NRT to participants with an information pack that includes printed instructions on how to use NRT correctly, for how long, potential side effects (and when to notify a health care provider), and safe storage and handling. Quitline counsellors will monitor and encourage correct use of NRT and address barriers to use. Intervention participants that decide to use the supplied NRT will receive a final 4-week supply of NRT as per the initial supply. Quitline counsellors will ask participant preferences for oral dose forms during the Week 2 call (for those participants that do not engage with Quitline, the peer worker will contact participants to determine participant preferences for NRT) in order for NRT to be delivered to the participant by Week 4. Participants who desire to shift to use of a prescription-based stop smoking medication (e.g., varenicline) will be supported to do so, but the study will not fund the purchase (which is low for those with health care cards as it is heavily government subsidized).
The Quitlink intervention is similar to the Quitline’s routine care for clients disclosing mental health issues. Components unique to this trial include the peer worker referring to Quitline, a dedicated counsellor for each participant and provision of NRT.
Intervention code [1] 301853 0
Behaviour
Intervention code [2] 301854 0
Treatment: Drugs
Comparator / control treatment
Control
Participants will receive standard smoking care. The standard care is delivered by a peer worker and includes advice to quit, encouragement to use NRT, and a Quit Victoria pack of written materials to motivate a quit attempt (e.g. costs of smoking and benefits of quitting) and resources to support self-management (e.g. Quitline phone number, ‘4Ds’ strategy: Delay, Deep-breathe, Drink water, Do something else’ to manage cravings; using NRT products). With consent, a letter will be sent by the research team to nominated health professionals (GP/psychiatrist) with information about their client’s trial participation and a link to Australia’s smoking cessation guidelines for health professionals, which includes a list of medications affected by smoking.
Control group
Active

Outcomes
Primary outcome [1] 306741 0
Continued abstinence
The primary outcome is defined as continued abstinence from smoking since the end of the treatment period, i.e., 6 months sustained abstinence, with no relapse (defined as 7+ days of continuous smoking, and no reported smoking in the last week), with biochemical
verification at 8-month follow-up. Sustained abstinence will be assessed via the following question: “When did you last smoke a cigarette, even a puff?” If a participant reports
prolonged abstinence at the 8 month follow up, and no smoking in the last week, they will be asked to attend a face to face visit to complete CO testing for objective validation using a Micro+ Smokelyzer, with a reading of 8ppm or higher defined as indicative of recent smoking.
Timepoint [1] 306741 0
8 months post baseline (allowing participants up to 2 months to stop).
Secondary outcome [1] 349721 0
7-day point prevalence abstinence, based on “Have you smoked at least part of a cigarette in the last seven days?”
Timepoint [1] 349721 0
2, 5 and 8 months post baseline.
Secondary outcome [2] 365262 0
Reported cigarettes smoked per day (for daily smokers) or cigarettes per week (for non-daily smokers).

Timepoint [2] 365262 0
Baseline, 2-, 5- and 8-months post baseline.
Secondary outcome [3] 365263 0
Expenditure on cigarettes measured by self-reported cigarette consumption (cigarettes per day/week x current market average price) x (no. of smoking days/weeks over the outcome time period assessed)
Timepoint [3] 365263 0
Baseline, 2-, 5- and 8-months post baseline.
Secondary outcome [4] 365264 0
Number of quit attempts of 24 hours or more, 1 week or more, and 1 month or more in the previous 3 months or since last assessed. Assessed by questionnaire item designed for this study 'since you joined the study - have you made a quit attempt?'
Timepoint [4] 365264 0
2-, 5- and 8-months post baseline.
Secondary outcome [5] 365265 0
Time to relapse. In those who do relapse will be assessed by questionnaire item designed for this study ' How long ago did you relapse back to smoking?'
Timepoint [5] 365265 0
2-, 5- and 8-months post baseline.
Secondary outcome [6] 365266 0
Number of subsequent quit attempts among those who relapsed. Assessed by questionnaire item designed for this study ' How long ago did you relapse back to smoking?'
Timepoint [6] 365266 0
2-, 5- and 8-months post baseline.
Secondary outcome [7] 365267 0
Hospitalizations and other intensive health service use. Assessed by questionnaire items designed for this study.
Timepoint [7] 365267 0
2- and 8-months post baseline.
Secondary outcome [8] 365268 0
Financial stress (questions adapted from Siahpush and Carlin, 2006).
Timepoint [8] 365268 0
Baseline, 2-, 5- and 8-months post baseline.
Secondary outcome [9] 365269 0
Productivity impacts (time off work or other duties). Assessed by questionnaire items designed for this study.

Timepoint [9] 365269 0
2-, 5- and 8-months post baseline.
Secondary outcome [10] 365270 0
Nicotine dependence measured by the Heaviness of Smoking Index (HSI). Nicotine dependence is assessed using this two item Index to create a total score (Heatherton et al., 1989; Kozlowski et al., 1994). It uses a six-point scale calculated from the number of cigarettes smoked per day (1-10, 11-20, 21-30, 31+) and the time to first cigarette after waking (less than/equal to 5, 6-30, 31-60, and 61+ minutes). The HSI has been found to have good reliability and reasonable predictive validity (Borland et al., 2010).
Timepoint [10] 365270 0
Baseline, 2-, 5- and 8-months post baseline.
Secondary outcome [11] 365271 0
Cravings are assessed by one item taken from the International Tobacco Control (ITC) Four Country Survey (Herd and Borland, 2009; Herd et al., 2009), “Currently, how often do you get strong cravings to smoke tobacco?” with the response options of: 1) Hourly or more often; 2) Several times per day; 3) At least once a day; and 4) Less than daily.
Timepoint [11] 365271 0
Baseline, 2-, 5- and 8-months post baseline.
Secondary outcome [12] 365272 0
Withdrawal symptoms are assessed by the Minnesota Nicotine Withdrawal Scale (MNWS; Hughes and Hatsukami, 1986), an eight item ordinal scale rating withdrawal symptoms from 0 (not present) to 3 (severe). At baseline the MNWS is administered, with two symptoms (concentration and appetite) assessed at follow-up. The MNWS has been shown to have good reliability and predictive validity (Toll et al., 2007).
Timepoint [12] 365272 0
Baseline, 2-, 5- and 8-months post baseline.
Secondary outcome [13] 365273 0
Difficulty in coping with situations in which smoking is not allowed is also assessed, on a 4-point Likert Scale from ‘very’, ‘moderately’, ‘mildly’ to ‘not at all difficult’.
Timepoint [13] 365273 0
2-, 5- and 8-months post baseline.
Secondary outcome [14] 365274 0
Psychological distress is measured by the Kessler Psychological Distress Scale (Kessler-10; Kessler et al., 2003) a 10-item scale of non specific psychological distress with a total score. It has shown consistent psychometric properties across major sociodemographic subsamples (Kessler et al., 2002).
Timepoint [14] 365274 0
Baseline, 2-, 5- and 8-months post baseline.
Secondary outcome [15] 365275 0
Alcohol use is assessed by the Alcohol Use Disorders Identification Test – Brief (AUDIT-C; Bush et al., 1998) a three item screening tool used to identify hazardous alcohol use or active alcohol use disorders. It is scored on a scale of 0-12 to create a total score. For men, it has been shown to have a sensitivity of .90 and specificity of .45; for women the sensitivity is .80 and specificity is .87.
Timepoint [15] 365275 0
Baseline, 2-, 5- and 8-months post baseline.
Secondary outcome [16] 365276 0
Cannabis use is assessed by the Cannabis Use Disorders Identification Test – Revised (CUDIT-1 R; Adamson et al., 2010) is a briefer (8-item) and more refined version of the CUDIT (Adamson and Sellman, 2003), a simple modification of the AUDIT. Items cover the domains of consumption, cannabis problems, dependence and psychological features. The CUDIT-R was found to comprise a single factor, with high test-retest reliability (r=0.871), high internal consistency (a=0.914) and discriminant validity (area under the curve = 0.960). Only question 1, “How often do you use cannabis? (over the last 2 months)” is included in the present study (never, monthly or less, 2 to 4 times a month, 2 to 3 times a week, 4 or more times a week). In addition, participants who use cannabis are asked “Do you ever mix tobacco with your cannabis?” with response options of “Yes, always or nearly always”, “Yes, sometimes” or “No, never or very rarely.”
Timepoint [16] 365276 0
Baseline, 2-, 5- and 8-months post baseline.
Secondary outcome [17] 365277 0
Quality of life is assessed by the Assessment of Quality of Life 8 Dimension (AQoL-8D; Richardson et al., 2014) instrument which is comprised of 35 items from which eight dimensions (independent living, pain, senses, mental health, happiness, coping, relationships and self-worth) and two ‘super dimensions’ (physical and psychosocial) are derived. It has demonstrated strong content validity and has been found to perform relatively well in populations with SMI (Mihalopoulos et al., 2014). The 35 items may be reduced to a single utility score. Use of the instrument enables calculation of quality adjusted life years (QALYs) experienced across the two study arms, which will be reported in the cost-effectiveness analysis.
Timepoint [17] 365277 0
Baseline, 2-, 5- and 8-months post baseline.
Secondary outcome [18] 365278 0
Covariate or process measure at follow up
Motivation to quit: assessed by a single question adapted from Crittenden et al. (1994), “Are you trying to quit smoking altogether or are you planning to keep smoking at this level?”
Timepoint [18] 365278 0
Baseline, 2-, 5- and 8-months post baseline.
Secondary outcome [19] 365279 0
Covariate or process measure at follow up
Self-efficacy in quitting is measured by the following question adapted from Perkins et al. (2012): “How confident are you that you will not smoke at all tomorrow?” (not at all, somewhat, moderately, very, extremely). For those who quit at follow-up, “How confident are you that you will be able to stay quit long-term and become a permanent ex-smoker?” (not at all, somewhat, moderately, very, extremely).
Timepoint [19] 365279 0
Baseline, 2-, 5- and 8-months post baseline.
Secondary outcome [20] 365280 0
Covariate or process measure at follow up
Medications: Changes in use of prescribed psychotropic medication assessed by questionnaire item designed for this study.
Timepoint [20] 365280 0
2-months post baseline.
Secondary outcome [21] 365281 0
Covariate or process measure at follow up
Treatment received (use of NRT and Quitline – number and length of calls) assessed by questionnaire items designed for this study.

Timepoint [21] 365281 0
2-, 5- and 8-months post baseline.
Secondary outcome [22] 365282 0
Covariate or process measure at follow up
Quitline use - objective data on service use (number and length of calls) will be extracted from the Quitline database for all participants (as some control participants may have self-referred).

Timepoint [22] 365282 0
8-months post baseline.
Secondary outcome [23] 365283 0
Covariate or process measure at follow up
Therapeutic alliance with Quitline counsellor : the 3-item Working Alliance Inventory for Tobacco (Warlick et al., 2018), measuring goal, task and bond on a 5 item Likert Scale (seldom, sometimes, fairly often, very often, always) will be administered. The 3-item measure has been found to have acceptable-good internal consistency and construct validity.
Timepoint [23] 365283 0
2-months post baseline.
Secondary outcome [24] 365284 0
Covariate or process measure at follow up
Self-reported service use and satisfaction: participants’ use and assessment of level of support they have received for quitting from their mental health service, doctors and other health professionals assessed by questionnaire items designed for this study.
Timepoint [24] 365284 0
2-months post baseline.
Secondary outcome [25] 365285 0
Covariate or process measure at follow up
Linked data on service and prescription medication use from the Australian Government subsidised Medicare and Pharmaceutical Benefits Schemes.
Timepoint [25] 365285 0
8-months post baseline.

Eligibility
Key inclusion criteria
Participant inclusion criteria are: aged at least 18 years; residing in Victoria; smoking at least 10 cigarettes per day; and accessing treatment or support from participating mental health
agencies.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are: current engagement in Victorian Quitline’s callback service; no ready access to a telephone; inability to complete informed consent and/or the screening survey; acute suicidality; myocardial infarction or unstable arrhythmia or angina within the previous two weeks (NRT contraindications); and pregnancy (as smokers who are pregnant already receive a different extended Quitline callback service).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The computer program used to complete the baseline will randomize to condition using 1:1 randomisation. Participants will be randomly allocated to either no further intervention, or to be contacted by Quitline who will offer a targeted callback counselling intervention with NRT provided, over an eight-week period. Randomisation will be independently managed by the trial epidemiologist and uploaded to a web-based data capture tool (Research Electronic Data Capture; REDCap) that will also have case report forms (eCRF) created for the project using REDCap.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Due to the nature of the intervention under investigation (i.e., linking smokers to existing smoking cessation care options readily available in the community, quitline and NRT) there is a high risk of contamination among residential services where participants may compare treatment received. Therefore, we will use a partial clustering design where cluster randomisation will be used in situations where risk of contamination is particularly high (e.g. in residential services) stratified by short- or long-term residence, with 1:1 allocation. Individual randomisation will be used in services where contamination risk is lower, via permutated block sizes of 4 and 6 to avoid incomplete blocks, stratified for site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size determination
We anticipate that for the primary outcome of prolonged abstinence at 8 months, success will occur in 1% of the control arm vs 8% in the intervention arm. To detect this effect with 80% power at p=0.05, we need 134 per arm. We expect ~30% attrition, inflating the sample size to 191/arm or 382 overall. We will recruit 382 smokers over 36 months (12/month with additional time for periods of slowed recruitment; with treatment finishing after 38 months) and follow them up at 2-, 5- and 8-months post-baseline, completing the study over a 4.5-year period.

Statistical analyses
Independent and blinded statisticians from the CReDITSS Unit at the Hunter Medical Research Institute, Australia, will conduct analyses of the primary and secondary outcomes. Analyses will be carried out using a cluster randomised trial framework where the individuals (n=150) are treated as clusters that contribute only 1 person, the short-term residential programs are clusters that contribute an average of 15 people each (10 programs x 15 people/program = 150 total) and the long-term programs are clusters that contribute 10 people each (6 programs x 10 people/program = 60). We will use a generalised linear mixed model (linear regression for continuous outcomes and logistic regression for dichotomous outcomes) to handle the clustering and the repeated measures at baseline, 2-, 5- and 8- months; individuals will be modelled as random effects, cluster as a random effect, and group assignment as a fixed effect. Mixed models allow for missing data for the primary intention to treat analysis, but a sensitivity analysis using a worst case scenario (baseline value for continuous outcomes or relapse for dichotomous outcomes in case of missing value) will also be carried out. Intervention participants who do not complete the intervention, and participants who miss an assessment follow-up time point, will be kept in the study and contacted for later assessments (unless they choose to withdraw from the follow-up assessments).

Exploratory analyses
We plan to examine whether the amount of intervention (Quitline counselling, NRT) received by participants is related to outcomes. We will also explore different imputation strategies for missing data related to outcomes.

Economic evaluation
A cost-effectiveness analysis of Quitlink will be conducted alongside the trial described here, using data 8 months post randomisation. A modelled analysis will estimate future costs and benenfits of smoking cessation beyond the trial period, over the life course. In brief, incremental cost-effectiveness ratios (ICER) will be calculated for the cost ($AUD) per successful quit and quality adjusted life year (QALY) gained (ie.cost-utility) as a result of Quitlink when compared with usual care. Healthcare system and limited societal perspectives will be taken.

Qualitative evaluation
A nested qualitative study will be conducted. All interviews (participants and workers) will
be audio recorded, transcribed and a general inductive approach will be taken to the analysis (Thomas, 2006).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 300132 0
Government body
Name [1] 300132 0
National Health and Medical Research Council (NHMRC)
Address [1] 300132 0
16 Marcus Clarke Street
Canberra City ACT 2600
Country [1] 300132 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 299601 0
None
Name [1] 299601 0
Address [1] 299601 0
Country [1] 299601 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300969 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 300969 0
Research Governance Unit
Level 5, Building E (Aikenhead Building)
27 Victoria Parade
Fitzroy VIC 3065

Ethics committee country [1] 300969 0
Australia
Date submitted for ethics approval [1] 300969 0
17/04/2018
Approval date [1] 300969 0
18/07/2018
Ethics approval number [1] 300969 0
HREC 097/18
Ethics committee name [2] 302260 0
University of Newcastle HREC
Ethics committee address [2] 302260 0
University Drive
Callaghan NSW
2308
Ethics committee country [2] 302260 0
Australia
Date submitted for ethics approval [2] 302260 0
19/04/2018
Approval date [2] 302260 0
28/08/2018
Ethics approval number [2] 302260 0
Ethics committee name [3] 302261 0
Cancer Council Victoria HREC
Ethics committee address [3] 302261 0
615 St Kilda Rd
Melbourne Victoria
3004 VIC
Ethics committee country [3] 302261 0
Australia
Date submitted for ethics approval [3] 302261 0
23/08/2018
Approval date [3] 302261 0
21/12/2018
Ethics approval number [3] 302261 0

Summary
Brief summary
Smoking is the leading cause of preventable death in people with severe mental illness (SMI). Although smokers with SMI want to quit, tailored interventions are rarely delivered in practice. Quitlines are well placed but underutilised by this group. “Quitlink” will utilise peer workers within mental health services to engage smokers with SMI in a tailored Quitline intervention.
382 participants will be recruited across participating mental health services in Victoria. All participants will receive a brief smoking cessation intervention. Participants will be randomly allocated to either no further intervention, or to the Quitlink intervention (proactively contacted by Quitline and offered a targeted smoking cessation counselling intervention with nicotine replacement therapy (NRT) provided over an 8 week period). All participants will be followed up at 2 months, 5 months and 8 months. We will also qualitatively examine facilitators and barriers to cessation in order to improve future interventions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85458 0
Prof Amanda Baker
Address 85458 0
University of Newcastle
PO Box 833
Newcastle NSW 2300
Country 85458 0
Australia
Phone 85458 0
+61 412267164
Fax 85458 0
Email 85458 0
Amanda.Baker@newcastle.edu.au
Contact person for public queries
Name 85459 0
Prof Amanda Baker
Address 85459 0
University of Newcastle
PO Box 833
Newcastle NSW 2300
Country 85459 0
Australia
Phone 85459 0
+61 412267164
Fax 85459 0
Email 85459 0
Amanda.Baker@newcastle.edu.au
Contact person for scientific queries
Name 85460 0
Dr Kristen McCarter
Address 85460 0
University of Newcastle
PO Box 833
Newcastle NSW 2300
Country 85460 0
Australia
Phone 85460 0
+61 2 4033 5721
Fax 85460 0
Email 85460 0
Kristen.McCarter@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 1360 0
Study protocol
Citation [1] 1360 0
Link [1] 1360 0
Email [1] 1360 0
Other [1] 1360 0
Submitted to Journal - Frontiers in Psychiatry 30 August 2018. DOI will be made available when published.
Baker, A.L., Borland, R., Bonevski, B., Segan, C., Turner, A., Brophy, L., McCarter, K., Kelly, P.J., Williams, J.M., Baird, D., Attia, J., Sweeney, R., White, S.L., Filia, S., Castle, D..
‘Quitlink’ - A Randomised Controlled Trial of Peer Worker Facilitated Quitline Support for Smokers Receiving Mental Health Services: Study Protocol.
Attachment [1] 1360 0
Summary results
No Results