Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000159550
Ethics application status
Approved
Date submitted
24/01/2024
Date registered
20/02/2024
Date last updated
16/06/2024
Date data sharing statement initially provided
20/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
QuitPick: Best practice smoking cessation care for individuals receiving mental health services
Scientific title
QuitPick: A pilot intervention of direct-to-consumer best practice smoking cessation care for individuals accessing mental health services
Secondary ID [1] 310482 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco smoking 331272 0
Severe mental illness 331273 0
Condition category
Condition code
Public Health 328026 328026 0 0
Other public health
Mental Health 328027 328027 0 0
Depression
Mental Health 328028 328028 0 0
Psychosis and personality disorders
Mental Health 328029 328029 0 0
Schizophrenia
Mental Health 328030 328030 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
QuitPick intervention:
- Quit pack of written resources from Quitline Victoria will be mailed to participants.
Extended and tailored Quitline counselling with a dedicated counsellor: Proactive referral (opt-out; where Quitline contacts the participant) made by the research team (with consent via REDCap) to tailored counselling for people with SMI. Following the Quitpick treatment protocol (i.e., different from standard Quitline practice) including offer of weekly calls within the 12-week period; structured monitoring of mental health symptoms, nicotine withdrawal symptoms and medication side effects (the latter may increase due to medication interactions with smoking cessation); and the use of mood management strategies that dually act to aid mood and cessation (e.g., exercise, scheduling pleasant activities). A dedicated counsellor will manage counselling for each participant. Counsellors will monitor and encourage correct use of nicotine replacement therapy and nicotine vaping products and will address barriers to use. Quitline has established protocols to support people using nicotine vaping products for smoking cessation and also offers support to people wanting to reduce or cease vaping, with a focus on preventing smoking relapse or increases in smoking.

- Peer support forum: Access to study website with peer worker videos sharing lived experienced of mental health conditions / smoking and recovery (including recommendation and encouragement with engage with Quitline) and online forum where participants can ask questions, share experiences and support each other. This messaging style forum will be monitored by peer workers (supervised by the chief investigator) and enhance engagement with the intervention by providing lived experienced expertise, encouragement, and resources to tackle smoking and other areas of physical health.

The online forum will be hosted on Facebook. Participants will be offered the opportunity to join the study’s Facebook support group page. The group will be set up using the ‘secret’ group setting from Facebook; a secret group that involves only those an administrator allows to participate. Participants are not required to post to the Facebook group page. Upon enrolment, we will advise participants that if we become concerned about any one individual’s need for additional counselling, we will refer him or her to appropriate services. We have successfully used this method in previous studies (ACTRN12621001315808).
Approximately bi-weekly (depending on participant recruitment rate) material on tackling smoking, stories of lived experience and encouragement for quitting will be posted on the Facebook group. Peer workers will monitor postings weekly and respond when appropriate (clarifying, answering questions, offering encouragement, or asking additional facilitating questions).
Use and acceptability of the forum will be assessed using self-report items within the follow up assessments.
- Pharmacotherapy (12 weeks choice of state-of-the-art nicotine vaping products or combined nicotine replacement therapy and GP support:
o Week 1 trial pack: The study GP will review participants’ baseline assessments for relevant information (e.g., nicotine dependence, current medications likely to be affected by smoking cessation and take action/make appropriate referrals). An initial assessment via telehealth will be conducted with the trial GP to address health and safety issues and any concerns and to help the participant for when they make an informed choice to proceed with either nicotine vaping products or combination nicotine replacement therapy for the remainder of the intervention period. An e-script will be sent to our partnering Australian pharmacy and a 1-week supply of nicotine vaping products and combination nicotine replacement therapy (patches plus lozenges as per best practice) with written resource guides for use will be sent to the participant to trial, matched to nicotine dependence. Allo vapes are a quality, nicotine delivery system that has been selected for their simplicity and ease of use. Participants’ nominated GP will be advised what treatments have been prescribed.

o Week 2: Participants will be sent their choice of either a remaining 11 week supply of nicotine replacement therapy or nicotine vaping products.
Use of nicotine replacement therapy and nicotine vaping products will be assessed within follow up assessments using participant self-report items.
The study links together three existing supports already available to participants in the community/through their mental health service – Quitline counselling, peer workers and nicotine replacement therapy. Following the 12-week intervention period, participants can continue to access these resources.
- Engagement with GP and mental health providers: Participants will be asked to provide the details of their current GP and/or psychiatrist. A letter will be sent by the research team to these health professionals with information about their client’s trial participation and a link to Australia’s smoking cessation guidelines for health professionals (includes a list of medications affected by smoking) and peer-reviewed articles that provide practical advice to assist doctors in helping people with SMI to quit smoking. Participants will receive a Quitting Mood and Experiences diary which they will be encouraged to use and discuss with the study GP, Quitline counsellor and other health professionals as relevant. Quitline will provide written feedback to treatment providers at the end of the telephone counselling program. They 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.

- Quitline engagement of support network: A Quitline brochure for carers which offers Quitline as a resource for supporters of people with SMI to address any queries/concerns about quitting.
Intervention code [1] 326872 0
Treatment: Drugs
Intervention code [2] 326873 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335904 0
Feasibility of the QuitPick intervention is a primary composite outcome. This outcome will be determined using multiple measures including recruitment rate (determined by proportion of participants from number of site clients from study records), participant retention (determined study records of participants engaged in study treatment components), lost to follow-up rates (determined by study records), and proportion of successfully collected biochemically verified abstinence using piCO Smokerlyzer for those that report abstinence at 6 months (study records).
Timepoint [1] 335904 0
Recruitment rate will be assessed at study completion, retention will be assessed at 3 months post-baseline, lost to follow-up will be assessed at 3 and 6 mths post-baseline, proportion of successfully collected abstinence will be assessed at 6 mths post-baseline.
Primary outcome [2] 335905 0
Acceptability of the QuitPick intervention is a primary composite outcome. It will be determined using multiple measures including self-report acceptability items in follow up assessments and participant feedback in qualitative interviews.
Timepoint [2] 335905 0
Self-report acceptability items will be assessed at 3 months post-baseline and participant feedback in qualitative interviews will be conducted at 3 mths post-baseline.
Primary outcome [3] 335906 0
Preliminary effectiveness of the QuitPick intervention as measured by continued abstinence from smoking since the end of the treatment period, i.e., 3 months sustained abstinence, with no relapse (defined as 7+ days of continuous smoking, and no reported smoking in the last week), at 8-month follow-up. Sustained abstinence will be assessed via the following question: “When did you last smoke a cigarette, even a puff?”.
Timepoint [3] 335906 0
6-months post-baseline
Secondary outcome [1] 426076 0
Reported cigarettes smoked per day (for daily smokers) or cigarettes per week (for non-daily smokers) by self-report in follow-up assessments.
Timepoint [1] 426076 0
Baseline, 3-, and 6-months post-baseline
Secondary outcome [2] 426077 0
7-day point prevalence abstinence, based on “Have you smoked at least part of a cigarette in the last seven days?” by self-report in follow-up assessments.
Timepoint [2] 426077 0
3- and 6-months post-baseline
Secondary outcome [3] 426078 0
Number of quit attempts of 24 hours or more, 1 week or more, and 1 month or more since last assessed. Assessed by questionnaire item designed for this study "since you joined the study - have you made a quit attempt?".
Timepoint [3] 426078 0
3-and 6-months post-baseline
Secondary outcome [4] 426079 0
Psychological distress as 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 [4] 426079 0
Baseline and 6-months post-baseline
Secondary outcome [5] 426080 0
Recovering Quality of Life as measured by The Recovering Quality of Life – Utility Index (ReQoL-UI). The ReQoL-UI is a recovery-focused generic preference based data analysis tool for extracting valuable health economics data from the existing Recovering Quality of Life (ReQoL) Patient Reported Outcome Measure. The ReQoL is a 20-item tool used to assess the quality of life for people with different mental health conditions.
Timepoint [5] 426080 0
Baseline and 6-months post-baseline
Secondary outcome [6] 426081 0
Self-reported chronic obstructive pulmonary disease (COPD) symptoms assessed by questionnaire items designed for this study.
Timepoint [6] 426081 0
Baseline and 6-months post-baseline
Secondary outcome [7] 426082 0
Physical activity as measured by the Simple Physical Activity Questionnaire (SIMPAQ). The SIMPAQ is a clinical physical activity measurement tool designed to be used
as a structured interview, which assesses combined physical activity across all domains including leisure time, domestic, work and transport-related activities.
Timepoint [7] 426082 0
Baseline and 6-months post-baseline
Secondary outcome [8] 426083 0
Self-rated health, as measured by the EuroQol-Visual Analogue Scales (EQ-VAS). The EQ-VAS is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
Timepoint [8] 426083 0
Baseline and 6-months post-baseline
Secondary outcome [9] 426084 0
Treatment received - use of NRT and/or NVPs assessed by questionnaire items designed for this study.
Timepoint [9] 426084 0
Baseline, 3-, and 6-months post-baseline
Secondary outcome [10] 426085 0
Self-reported service use: participants’ use 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 [10] 426085 0
Baseline and 6-months post-baseline
Secondary outcome [11] 426086 0
Quitline use - objective data on service use (number and length of calls) will be extracted from the Quitline database for all participants.
Timepoint [11] 426086 0
3-months post-baseline
Secondary outcome [12] 426087 0
Satisfaction with Quitline assessed by questionnaire items designed for this study.
Timepoint [12] 426087 0
3-months post-baseline
Secondary outcome [13] 426088 0
Barriers and enablers to making and sustaining quit attempts so as to better understand why cessation rates among people with mental illness remain low. Assessed via one-on-one qualitative interviews with 20 participants (first 20 to agree) from the QuitPick intervention.
Timepoint [13] 426088 0
3-months post-baseline
Secondary outcome [14] 431495 0
Service satisfaction: participants’ 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 [14] 431495 0
Baseline and 6-months post-baseline.

Eligibility
Key inclusion criteria
To be eligible, participants must:
(i) be aged at least 18 years;
(ii) have a self-reported diagnosis or receipt of SMI (including major depressive disorder, psychosis, schizophrenia, schizophrenia spectrum or bipolar disorder) and/or receiving treatment or support from Mind services;
(iii) be residing in Victoria; and
(iv) be a current tobacco smoker (smoke at least 10 cigarettes per day and currently smokes cigarettes).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they:
(i) are currently smoking less than 10 cigarettes per day;
(ii) are currently engaged in Quitline’s callback service;
(iii) have no ready access to a phone;
(iv) are unable to complete informed consent and/or the screening survey;
(v) show signs of acute suicidality; and
(vi) are pregnant, breastfeeding or planning pregnancy in the next 12 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics on the number of eligible participants, recruitment and retention rate, reasons for dropout, protocol completion, and acceptability items will be provided. Descriptive analysis of baseline demographics and clinical characteristics will be presented. Paired t-tests will compare scores from baseline to 6 months for changes in cigarette consumptions, estimated expenditure on cigarettes, mental health, recovering quality of life and physical health measures.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/02/2024
Actual
22/03/2024
Date of last participant enrolment
Anticipated
31/08/2024
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
30
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314687 0
University
Name [1] 314687 0
The University of Newcastle
Country [1] 314687 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 316657 0
None
Name [1] 316657 0
Address [1] 316657 0
Country [1] 316657 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313703 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 313703 0
Research Governance Unit Level 5, Building E (Aikenhead Building) 27 Victoria Parade Fitzroy VIC 3065
Ethics committee country [1] 313703 0
Australia
Date submitted for ethics approval [1] 313703 0
31/07/2023
Approval date [1] 313703 0
04/10/2023
Ethics approval number [1] 313703 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. This pilot feasibility study will assess the acceptability of the QuitPick intervention for smoking cessation among individuals living with severe mental illness.

30 participants who are accessing any treatment, support or care service for a mental health condition from Mind Australia Limited in Victoria will be recruited. All participants will receive the QuitPick intervention. Participants will be contacted by Quitline and offered a targeted smoking cessation counselling intervention with a choice of pharmacotherapy (NRT or NVP) and peer support over a 12-week period. Assessments will be conducted at baseline, 3 months (end of treatment), and 6 months (3 months post-treatment). After completing the QuitPick intervention, one-on-one semi-structured interviews will be conducted with 20 participants to investigate the experience of participants and understand acceptability of the intervention, with a focus on further enhancing engagement with the intervention.
Trial website
Trial related presentations / publications
Public notes
Participants can continue to access nicotine replacement therapy over the counter from pharmacies, can continue to access nicotine vapes through the prescriber scheme. In their telehealth appointment with their study doctor, participants will be provided information about how to access nicotine replacement therapy or vapes beyond the study period (this is an existing component of the study doctor’s routine care provision for those that they provide nicotine prescriptions to). The participants existing GP will also be notified of the participant’s trial participation via letter and will be encouraged to support their ongoing efforts to quit smoking. Quitline will also send a letter to the participant’s GP advising of the participant’s engagement with Quitline and smoking status. At the end of the trial, participants will be sent a letter outlining how they can continue to access support.

Contacts
Principal investigator
Name 129070 0
Dr Kristen McCarter
Address 129070 0
University of Newcastle PO Box 833 Newcastle NSW 2300
Country 129070 0
Australia
Phone 129070 0
+61 2 4055 3219
Fax 129070 0
Email 129070 0
kristen.mccarter@newcastle.edu.au
Contact person for public queries
Name 129071 0
Dr Kristen McCarter
Address 129071 0
University of Newcastle PO Box 833 Newcastle NSW 2300
Country 129071 0
Australia
Phone 129071 0
+61 2 4055 3219
Fax 129071 0
Email 129071 0
kristen.mccarter@newcastle.edu.au
Contact person for scientific queries
Name 129072 0
Dr Kristen McCarter
Address 129072 0
University of Newcastle PO Box 833 Newcastle NSW 2300
Country 129072 0
Australia
Phone 129072 0
+61 2 4055 3219
Fax 129072 0
Email 129072 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20153Study protocol  kristen.mccarter@newcastle.edu.au



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.