'Quitlink': Outcomes of a randomised controlled trial of peer researcher facilitated referral to a tailored quitline tobacco treatment for people receiving mental health services.

OBJECTIVE: The aim of this study was to test the effectiveness of a tailored quitline tobacco treatment ('Quitlink') among people receiving support for mental health conditions. METHODS: We employed a prospective, cluster-randomised, open, blinded endpoint design to compare a control condition to our 'Quitlink' intervention. Both conditions received a brief intervention delivered by a peer researcher. Control participants received no further intervention. Quitlink participants were referred to a tailored 8-week quitline intervention delivered by dedicated Quitline counsellors plus combination nicotine replacement therapy. The primary outcome was self-reported 6 months continuous abstinence from end of treatment (8 months from baseline). Secondary outcomes included additional smoking outcomes, mental health symptoms, substance use and quality of life. A within-trial economic evaluation was conducted. RESULTS: In total, 110 participants were recruited over 26 months and 91 had confirmed outcomes at 8 months post baseline. There was a difference in self-reported prolonged abstinence at 8-month follow-up between Quitlink (16%, n = 6) and control (2%, n = 1) conditions, which was not statistically significant (OR = 8.33 [0.52, 132.09] p = 0.131 available case). There was a significant difference in favour of the Quitlink condition on 7-day point prevalence at 2 months (OR = 8.06 [1.27, 51.00] p = 0.027 available case). Quitlink costs AU$9231 per additional quit achieved. CONCLUSION: The Quitlink intervention did not result in significantly higher rates of prolonged abstinence at 8 months post baseline. However, engagement rates and satisfaction with the 'Quitlink' intervention were high. While underpowered, the Quitlink intervention shows promise. A powered trial to determine its effectiveness for improving long-term cessation is warranted.

The value of compassionate support to address smoking: A qualitative study with people who experience severe mental illness.

Introduction: People experiencing severe mental illness (SMI) smoke at much higher rates than the general population and require additional support. Engagement with existing evidence-based interventions such as quitlines and nicotine replacement therapy (NRT) may be improved by mental health peer worker involvement and tailored support. This paper reports on a qualitative study nested within a peer researcher-facilitated tobacco treatment trial that included brief advice plus, for those in the intervention group, tailored quitline callback counseling and combination NRT. It contextualizes participant life experience and reflection on trial participation and offers insights for future interventions. Methods: Qualitative semi-structured interviews were conducted with 29 participants in a randomized controlled trial (intervention group n = 15, control group n = 14) following their 2-month (post-recruitment) follow-up assessments, which marked the end of the "Quitlink" intervention for those in the intervention group. Interviews explored the experience of getting help to address smoking (before and during the trial), perceptions of main trial components including assistance from peer researchers and tailored quitline counseling, the role of NRT, and other support received. A general inductive approach to analysis was applied. Results: We identified four main themes: (1) the long and complex journey of quitting smoking in the context of disrupted lives; (2) factors affecting quitting (desire to quit, psychological and social barriers, and facilitators and reasons for quitting); (3) the perceived benefits of a tailored approach for people with mental ill-health including the invitation to quit and practical resources; and (4) the importance of compassionate delivery of support, beginning with the peer researchers and extended by quitline counselors for intervention participants. Subthemes were identified within each of these overarching main themes. Discussion: The findings underscore the enormity of the challenges that our targeted population face and the considerations needed for providing tobacco treatment to people who experience SMI. The data suggest that a tailored tobacco treatment intervention has the potential to assist people on a journey to quitting, and that compassionate support encapsulating a recovery-oriented approach is highly valued. Clinical trial registration: The Quitlink trial was registered with ANZCTR (www.anzctr.org.au): ACTRN12619000244101 prior to the accrual of the first participant and updated regularly as per registry guidelines.

Adapting Peer Researcher Facilitated Strategies to Recruit People Receiving Mental Health Services to a Tobacco Treatment Trial.

Introduction: One of the most challenging aspects of conducting intervention trials among people who experience severe mental illness (SMI) and who smoke tobacco, is recruitment. In our parent "QuitLink" randomized controlled trial (RCT), slower than expected peer researcher facilitated recruitment, along with the impact of COVID-19 pandemic restrictions, necessitated an adaptive recruitment response. The objectives of the present study were to: (i) describe adaptive peer researcher facilitated recruitment strategies; (ii) explore the effectiveness of these strategies; (iii) investigate whether recruitment strategies reached different subgroups of participants; and (iv) examine the costs and resources required for implementing these strategies. Finally, we offer experience-based lessons in a Peer Researcher Commentary. Methods: People were included in the RCT if they smoked at least 10 cigarettes a day and were accessing mental health support from the project's two partnering mental health organizations in Victoria, Australia. The majority of people accessing these services will have been diagnosed with SMI. Recruitment occurred over 2 years. We began with peer facilitated recruitment strategies delivered face-to-face, then replaced this with direct mail postcards followed by telephone contact. In the final 4 months of the study, we began online recruitment, broadening it to people who smoked and were accessing support or treatment (including from general practitioners) for mental health and/or alcohol or other drug problems, anywhere in the state of Victoria. Differences between recruitment strategies on key participant variables were assessed. We calculated the average cost per enrolee of the different recruitment approaches. Results: Only 109 people were recruited from a target of 382: 29 via face-to-face (March 2019 to April 2020), 66 from postcards (May 2020 to November 2020), and 14 from online (November to December 2020 and January to March 2021) strategies. Reflecting our initial focus on recruiting from supported independent living accommodation facilities, participants recruited face-to-face were significantly more likely to be living in partially or fully supported independent living (n = 29, <0.001), but the samples were otherwise similar. After the initial investment in training and equipping peer researchers, the average cost of recruitment was AU$1,182 per participant-~US$850. Face-to-face recruitment was the most expensive approach and postcard recruitment the least (AU$1,648 and AU$928 per participant). Discussion: Peer researcher facilitated recruitment into a tobacco treatment trial was difficult and expensive. Widely dispersed services and COVID-19 restrictions necessitated non-face-to-face recruitment strategies, such as direct mail postcards, which improved recruitment and may be worthy of further research. Clinical Trial Registration: The trial is registered with ANZCTR (www.anzctr.org.au): ACTRN12619000244101 prior to the accrual of the first participant and updated regularly as per registry guidelines. The trial sponsor was the University of Newcastle, NSW, Australia.

Protocol for an Economic Evaluation of the Quitlink Randomized Controlled Trial for Accessible Smoking Cessation Support for People With Severe Mental Illness.

Introduction: Smoking is a major cause of disease burden and reduced quality of life for people with severe mental illness (SMI). It places significant resource pressure on health systems and financial stress on smokers with SMI (SSMI). Telephone-based smoking cessation interventions have been shown to be cost effective in general populations. However, evidence suggests that SSMI are less likely to be referred to quitlines, and little is known about the effectiveness and cost effectiveness of such interventions that specifically target SSMI. The Quitlink randomized controlled trial for accessible smoking cessation support for SSMI aims to bridge this gap. This paper describes the protocol for evaluating the cost effectiveness of Quitlink. Methods: Quitlink will be implemented in the Australian setting, utilizing the existing mental health peer workforce to link SSMI to a tailored quitline service. The effectiveness of Quitlink will be evaluated in a clustered randomized controlled trial. A cost-effectiveness evaluation will be conducted alongside the Quitlink clustered randomized controlled trial (RCT) with incremental cost-effectiveness ratios (ICERs) calculated for the cost (AUD) per successful quit and quality adjusted life year (QALY) gained at 8 months compared with usual care from both health care system and limited societal perspectives. Financial implications for study participants will also be investigated. A modeled cost-effectiveness analysis will also be conducted to estimate future costs and benefits associated with any treatment effect observed during the trial. Results will be extrapolated to estimate the cost effectiveness of rolling out Quitlink nationally. Sensitivity analyses will be undertaken to assess the impact on results from plausible variations in all modeled variables. Discussion: SSMI require additional support to quit. Quitlink utilizes existing peer worker and quitline workforces and tailors quitline support specifically to provide that increased cessation support. Given Quitlink engages these existing skilled workforces, it is hypothesized that, if found to be effective, it will also be found to be both cost effective and scalable. This protocol describes the economic evaluation of Quitlink that will assess these hypotheses. Ethics and dissemination: Full ethics clearances have been received for the methods described below from the University of Newcastle (Australia) Human Research Ethics Committee (H-2018-0192) and St Vincent's Hospital, Melbourne (HREC/18/SVHM/154). The trial has been registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12619000244101). Participant consent is sought both to participate in the study and to have the study data linked to routine health administrative data on publicly subsidized health service and pharmaceutical use, specifically the Medicare Benefits and Pharmaceutical Benefits Schemes (MBS/PBS). Trial findings (including economic evaluation) will be published in peer reviewed journals and presented at international conferences. Collected data and analyses will be made available in accordance with journal policies and study ethics approvals. Results will be presented to relevant government authorities with an interest in cost effectiveness of these types of interventions.

Staying Quit After Release (SQuARe) trial protocol: a randomised controlled trial of a multicomponent intervention to maintain smoking abstinence after release from smoke-free prisons in Victoria, Australia.

INTRODUCTION: Smoke-free policies have been introduced in prisons internationally. However, high rates of relapse to smoking after release from prison indicate that these policies typically result in short-term smoking cessation only. These high rates of relapse, combined with a lack of investment in relapse prevention, highlight a missed opportunity to improve the health of a population who smoke tobacco at two to six times the rate of the general population. This paper describes the rationale and design of a randomised controlled trial, testing the effectiveness of a caseworker-delivered intervention promoting smoking cessation among former smokers released from smoke-free prisons in Victoria, Australia. METHODS AND ANALYSIS: The multicomponent, brief intervention consists of behavioural counselling, provision of nicotine spray and referral to Quitline and primary care to promote use of government-subsidised smoking cessation pharmacotherapy. The intervention is embedded in routine service delivery and is administered at three time points: one prerelease and two postrelease from prison. Control group participants will receive usual care. Smoking abstinence will be assessed at 1 and 3 months postrelease, and confirmed with carbon monoxide breath testing. Linkage of participant records to survey and routinely collected administrative data will provide further information on postrelease use of health services and prescribed medication. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Corrections Victoria Research Committee, the Victorian Department of Justice Human Research Ethics Committee, the Department of Human Services External Request Evaluation Committee and the University of Melbourne Human Research Ethics Committee. Results will be submitted to major international health-focused journals. In case of success, findings will assist policymakers to implement urgently needed interventions promoting the maintenance of prison-initiated smoking abstinence after release, to reduce the health disparities experienced by this marginalised population. TRIAL REGISTRATION NUMBER: ACTRN12618000072213; Pre-results.

"Quitlink"-A Randomized Controlled Trial of Peer Worker Facilitated Quitline Support for Smokers Receiving Mental Health Services: Study Protocol.

Introduction: Although smokers with severe mental illnesses (SSMI) make quit attempts at comparable levels to other smokers, fewer are successful in achieving smoking cessation. Specialized smoking cessation treatments targeting their needs can be effective but have not been widely disseminated. Telephone delivered interventions, including by quitlines, show promise. However, few SSMI contact quitlines and few are referred to them by health professionals. Mental health peer workers can potentially play an important role in supporting smoking cessation. This study will apply a pragmatic model using peer workers to engage SSMI with a customized quitline service, forming the "Quitlink" intervention. Methods: A multi-center prospective, cluster-randomized, open, blinded endpoint (PROBE) trial. Over 3 years, 382 smokers will be recruited from mental health services in Victoria, Australia. Following completion of baseline assessment, a brief intervention will be delivered by a peer worker. Participants will then be randomly allocated either to no further intervention, or to be referred and contacted by the Victorian Quitline and offered a targeted 8-week cognitive behavioral intervention along with nicotine replacement therapy (NRT). Follow-up measures will be administered at 2-, 5-, and 8-months post-baseline. The primary outcome is 6 months continuous abstinence from end of treatment with biochemical verification. Secondary outcomes include 7-day point prevalence abstinence from smoking, increased quit attempts, and reductions in cigarettes per day, cravings and withdrawal, mental health symptoms, and other substance use, and improvements in quality of life. We will use a generalized linear mixed model (linear regression for continuous outcomes and logistic regression for dichotomous outcomes) to handle clustering and the repeated measures at baseline, 2-, 5-, and 8-months; individuals will be modeled as random effects, cluster as a random effect, and group assignment as a fixed effect. Discussion: This is the first rigorously designed RCT to evaluate a specialized quitline intervention accompanied by NRT among SSMI. The study will apply a pragmatic model to link SSMI to the Quitline, using peer workers, with the potential for wide dissemination. Clinical Trial Registration: Trial Registry: The trial is registered with ANZCTR (www.anzctr.org.au): ACTRN12619000244101 prior to the accrual of the first participant and updated regularly as per registry guidelines. Trial Sponsor: University of Newcastle, NSW, Australia.