“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

Effect of a family-centered, secondhand smoke intervention to reduce respiratory illness in indigenous infants in Australia and New Zealand: a randomized controlled trial

Introduction: Secondhand smoke (SHS) is a significant cause of acute respiratory illness (ARI) and 5 times more common in indigenous children. A single-blind randomized trial was undertaken to determine the efficacy of a family centered SHS intervention to reduce ARI in indigenous infants in Australia and New Zealand. Methods: Indigenous mothers/infants from homes with ≥1 smoker were randomized to a SHS intervention involving 3 home visits in the first 3 months of the infants\u27 lives (plus usual care) or usual care. The primary outcome was number of ARI-related visits to a health provider in the first year of life. Secondary outcomes, assessed at 4 and 12 months of age, included ARI hospitalization rates and mothers\u27 report of infants\u27 SHS exposure (validated by urinary cotinine/creatinine ratios [CCRs]), smoking restrictions, and smoking cessation. Results: Two hundred and ninety-three mother/infant dyads were randomized and followed up. Three quarters of mothers smoked during pregnancy and two thirds were smoking at baseline (as were their partners), with no change for more than 12 months. Reported infant exposure to SHS was low (≥95% had smoke-free homes/cars). Infant CCRs were higher if one or both parents were smokers and if mothers breast fed their infants. There was no effect of the intervention on ARI events [471 intervention vs. 438 usual care (reference); incidence rate ratio = 1.10, 95% confidence intervals (CI) = 0.88-1.37, p = .40]. Conclusions: Despite reporting smoke-free homes/cars, mothers and their partners continue to smoke in the first year of infants\u27 lives, exposing them to SHS. Emphasis needs to be placed on supporting parents to stop smoking preconception, during pregnancy, and postnatal

The study protocol for a randomized controlled trial of a family-centred tobacco control program about environmental tobacco smoke (ETS) to reduce respiratory illness in Indigenous infants

Background: Acute respiratory illness (ARI) is the most common cause of acute presentations and hospitalisations of young Indigenous children in Australia and New Zealand (NZ). Environmental tobacco smoke (ETS) from household smoking is a significant and preventable contributor to childhood ARI. This paper describes the protocol for a study which aims to test the efficacy of a family-centred tobacco control program about ETS to improve the respiratory health of Indigenous infants in Australia and New Zealand. For the purpose of this paper 'Indigenous' refers to Australia's Aboriginal and Torres Strait Islander peoples when referring to Australian Indigenous populations. In New Zealand, the term 'Indigenous' refers to Maori

Systematic review of factors influencing smoking following release from smoke-free prisons

Given the current proliferation of prison smoke-free policies internationally, and the multiple benefits of continued smoking abstinence for correctional populations, improved understanding of factors influencing post-release smoking abstinence is required to inform support strategies aimed at individuals exiting smoke-free prisons.We systematically searched health, social science, and criminal justice databases for studies relating to smoking behaviours among people released from smoke-free prisons. Studies were included if: they were published between 1 January 2000 and 26 July 2017; they were published in English; the population was people who were incarcerated or formerly incarcerated in prisons with total smoke-free policies; and the reported outcomes included measures of: i) pre-release intention to smoke or remain abstinent from smoking following release, ii) smoking relapse or abstinence following release, or iii) quit attempts following post-release smoking relapse. Both authors independently screened returned citations to assess eligibility and reviewed studies for methodological quality using the Effective Public Health Practice Project's Quality Assessment Tool for Quantitative Studies.Fifteen of 121 publications were included. The evidence base in this area is small, almost exclusively US-based, and is mostly methodologically weak. Interventions delivered both pre- and post-release, that strengthen intention to quit, integrate with other substance use treatment, and facilitate social support for quitting may help maintain post-release smoking abstinence.There is an urgent need for high-quality research to inform interventions to reduce high smoking relapse rates upon release from smoke-free prisons, to extend the multiple benefits of continued smoking abstinence into the community.Interventions designed to help people remain abstinent from tobacco following release from smoke-free prisons are an important opportunity to improve the health, finances and well-being of this vulnerable population

The effectiveness of callback counselling for smoking cessation: a randomized trial

Aims. The development of acceptable, widely available and effective smoking cessation methods is central to public health strategy for tobacco control. We examined the effectiveness of a telephone callback counselling intervention, compared to the provision of self-help resources alone. Methods. Participants were 998 smokers calling a state-wide &quot;Quitline&quot; service randomly allocated to either callback counselling or ordinary care. The callback condition consisted of a series of brief counselling calls at strategic times in addition to ordinary care. The number of calls varied according to caller needs, and most occurred generally just before the person\u27s quit day and in the week or two after it. The service was delivered by trained telephone counsellors. Results. At the 3-month follow-up, significantly more participants in the callback group (24%) reported that they were quit, compared to those in the usual care comparison group (13%). The difference in point prevalence of smoking declined to 6% by the 12-month follow-up. Using sustained abstinence there was a significant benefit of callback counselling at 12-month follow-up. Treating dropouts as smokers reduced the overall magnitude of the effects somewhat. The benefit of callbacks was to marginally increase quit attempts and to significantly reduce relapse. Conclusion. Our findings are consistent with those of other studies demonstrating benefits of callback telephone counselling to facilitate cessation. Such counselling provides a flexible, relatively inexpensive and widely available form of cessation service. It appears to encourage a greater proportion of quit attempts and to reduce the rate of relapse among those quitting. Further research is required to determine ways to enhance effectiveness, particularly studies of how to reduce relapse. <br /

Nicotine withdrawal, relapse of mental illness, or medication side-effect? Implementing a monitoring tool for people with mental illness into quitline counseling

BACKGROUND: Smokers with mental illness and their health care providers are often concerned that smoking cessation will worsen mental health. Smokers with mental illness tend to be more nicotine-dependent and experience more severe symptoms of nicotine withdrawal, some of which are difficult to distinguish from psychiatric symptoms. In addition, smoking cessation can increase the blood levels and hence side effects of some psychotropic medications. Improved monitoring of nicotine withdrawal and medication side effects may help distinguish temporary withdrawal symptoms from psychiatric symptoms and facilitate targeted treatment to help smokers with mental illness manage the acute phase of nicotine withdrawal. OBJECTIVE: The aim of this research was to examine the acceptability and feasibility to quitline counselors of implementing structured assessments of nicotine withdrawal and common medication side effects in people with mental illness who are quitting smoking using a telephone smoking cessation service. METHODS: Monitoring involves administering (once pre-cessation and at each contact post-cessation) (1) the Minnesota Nicotine Withdrawal Scale, assessing eight symptoms: anger, anxiety, depression, cravings, difficulty concentrating, increased appetite, insomnia, and restlessness and (2) an adverse side effects checklist of 5 to 10 symptoms, for example, dry mouth and increased thirst. Following a 1-day update training in mental health, quitline counselors were asked to offer these assessments to callers disclosing mental illness in addition to usual counseling. Group interviews with counselors were conducted 2&nbsp;months later to examine implementation barriers and benefits. RESULTS: Barriers included awkwardness in integrating a new structured practice into counseling, difficulty in limiting some callers to only the content of new items, and initial anxieties about how to respond to changes in some symptoms. Benefits included the ability to provide objective feedback on changes in symptoms, as this identified early benefits of quitting, provided reassurance for clients, and provided an opportunity for early intervention where symptoms worsened. CONCLUSIONS: Structured monitoring of withdrawal symptoms and medication side effects was able to be integrated into the quitline\u27s counseling and was valued by counselors and clients. Given evidence of its benefits in this limited pilot study, we recommend it be considered for larger-scale adoption by quitlines

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\u27s 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