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Quitlink: Peer worker facilitated Quitline support for smokers receiving mental health services

Quitlink: A randomised controlled trial of peer worker facilitated Quitline support for smokers receiving mental health services

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000244101
Enrollment
111
Registered
2019-02-19
Start date
2019-03-20
Completion date
2021-04-29
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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. In addition to recruitment across participating mental health services in Victoria, recruitment will occur via community recruitment online across broader 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.

Interventions

Intervention (Quitlink) Intervention participants will receive standard smoking care as in the control condition plus additional support. As in the control condition, the standard care is delivered by a peer worker (either verbally by the peer worker for face-to-face or telephone assessments; or via a video for online participants). 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 o

Intervention (Quitlink) Intervention participants will receive standard smoking care as in the control condition plus additional support. As in the control condition, the standard care is delivered by a peer worker (either verbally by the peer worker for face-to-face or telephone assessments; or via a video for online participants). 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. For participants recruited online, the Quitline referral will be made automatically by RedCap. • 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.

Sponsors

The University of Newcastle
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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. In addition to the site based recruitment above, community based online recruitment was added for people meeting the age, location and smoking requirements above but rather than accessing treatment or support from participating site based services, potential participants could be accessing any treatment, support or care service for a mental health or drug and alcohol condition.

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).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 21, 2026