Dataset Information

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

ABSTRACT: 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.

SUBMITTER: Sweeney R

PROVIDER: S-EPMC6735263 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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

Sweeney Rohan R Moodie Marj M Baker Amanda L AL Borland Ron R Castle David D Segan Catherine C Turner Alyna A Attia John J Kelly Peter J PJ Brophy Lisa L Bonevski Billie B Williams Jill M JM Baird Donita D White Sarah L SL McCarter Kristen K

Frontiers in psychiatry 20190903

<b>Introduction:</b> 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 effectivenes ...[more]

PMID: 31551827

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Project description:BackgroundPeople with a serious mental illness are more likely to smoke more and to be more dependent smokers than the general population. This may be due to a wide range of factors that could include a common aetiology to both smoking and the illness, self medication, smoking to alleviate adverse effects of medications, boredom in the existing environment, or a combination of these factors. It is important to undertake this review to facilitate improvements in both the health and safety of people with serious mental illness who smoke, and to reduce the overall burden of costs (both financial and health) to the smoker and, eventually, to the taxpayer.ObjectivesTo review the effects of smoking cessation advice for people with serious mental illness.Search methodsWe searched the Cochrane Schizophrenia Group Specialized Trials Register up to 2 April 2015, which is based on regular searches of CENTRAL, BIOSIS, PubMed, MEDLINE, EMBASE, CINAHL, PsycINFO, and trial registries. We also undertook unsystematic searches of a sample of the component databases (BNI, CINHAL, EMBASE, MEDLINE, and PsycINFO), up to 2 April 2015, and searched references of all identified studiesSelection criteriaWe planned to include all randomised controlled trials (RCTs) that focussed on smoking cessation advice versus standard care or comparing smoking cessation advice with other more focussed methods of delivering care or information.Data collection and analysisThe review authors (PK, AC, and DB) independently screened search results but did not identify any trials that fulfilled the inclusion criteria of this review.Main resultsWe did not identify any RCTs that evaluated advice regarding smoking cessation for people with serious mental illness. The excluded studies illustrate that randomisation of packages of care relevant to smokers with serious mental illness is possible.Authors' conclusionsPeople with serious mental illness are more likely to smoke than the general population. Yet we could not find any high quality evidence to guide the smoking cessation advice healthcare professionals pass onto service users. This is an area where trials are possible and needed.

Project description:ObjectivesTo investigate delivery of smoking cessation interventions, recorded quit attempts and successful quitting rates within primary care in smokers with depression or severe mental illness (SMI) compared with those without.DesignLongitudinal cohort study using primary healthcare records.SettingEnglish primary care.Participants882 849 patients registered with participating practices recorded as current smokers during 2007-2014, including three groups: (1) 13 078 with SMI, (2) 55 630 with no SMI but recent depression and (3) 814 141 with no SMI nor recent depression.OutcomesRecorded advice to quit smoking, referrals to smoking cessation services, prescriptions for smoking cessation medication, recorded quit attempts and changes of smoking status.ResultsThe majority (>70%) of smokers had recorded smoking cessation advice. This was consistently higher in those with SMI than the other cohorts of patients, although the gap greatly reduced in more recent years. Increases in smoking cessation advice over time were not accompanied by increases in recorded attempts to quit or changes of smoking status. Overall nicotine replacement therapy prescribing by general practitioners (GPs) was higher in those with SMI (10.1%) and depression (8.7%) than those without (5.9%), but a downward time trend was observed in all groups. Bupropion and varenicline prescribing was very low and lower for those with SMI. Few smokers (<5%) had referrals to stop smoking services, though this increased over time, but no significant differences were observed between those with and without mental health problems.ConclusionsThere was no evidence of consistent inequalities in access to GP-delivered smoking cessation interventions for people with mental health conditions. Smoking cessation advice was widely reported as taking place in all groups. In order to address the widening gap in smoking prevalence in those with poor mental health compared with those without, the emphasis should be on addressing the quality of advice and support given.

Project description:IntroductionPeople 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.MethodsQualitative 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.ResultsWe 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.DiscussionThe 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 registrationThe 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.

Project description:Interventions: We are assessing the impact of the National Bowel Cancer Screening Program (NBCSP) by comparing participation rates of people with and without Severe Mental Illness (SMI) and looking at health outcomes. We will be using data collected from Aug 2006 - latest available. We are linking data using Commonwealth data (NBCSP, Medicare Benefits Schedule, Pharmaceutical Benefits Scheme, Australian Cancer Database & the National Death Index) to compare bowel cancer screening participation in people with SMI to those from the general population. We will additionally link these to the NSW cancer registry and hospital data to examine care pathways from diagnosis through treatment and end-of-life care. We will also conduct a consultation with people with experience of SMI and Colorectal cancer and people with SMI in peer support roles who can provide their perspective on the barriers faced by people with SMI to gaining timely screening, diagnosis and optimal care. These participants will be recruited from New South Wales consumer organisations and organisations with a strong focus on provision of peer support and advocacy. We will use a semi structured group interview schedule to facilitate discussion of a single focus group of 15 people. The group will consist of both people with lived experience who have direct experience of bowel cancer (n=10), as well as other people with lived experience who have supported people in this situation – as peer support workers or in other consumer advocacy/support roles (n=5). We will use this qualitative arm of the study to further develop our understanding of the quantitative findings. The consultation will also develop ideas on how to improve access to care. Primary outcome(s): Participation rates in the National Bowel Cancer Screening Program assessed using data from the NBCSP.[Person-years will be calculated from entry into the study (2006) (the date of commencement of the NBCSP) or from the year that people become eligible for screening (i.e. age 50), whichever occurs later.. This is a retrospective cohort study, so all of the outcomes have already occurred and were recorded in the administrative data. This will be assessed when we receive the data.];Colonoscopy rates assessed using data from the NBCSP [Person-years will be calculated from entry into the study (2006 the date of commencement of the NBCSP), or from the year that people become eligible for screening (i.e. age 50), whichever occurs later, until colonoscopy. This is a retrospective cohort study, so all of the outcomes have already occurred and have been recorded in the administrative data.];Cancer diagnosis using data from the Australian Cancer Database[Person-years will be calculated from entry into the study (2006 the date of commencement of the NBCSP), or from the year that people become eligible for screening (i.e. age 50), whichever occurs later, until cancer diagnosis. This is a retrospective cohort study, so all of the outcomes have already occurred and have been recorded in the administrative data.] Study Design: Purpose: Screening;Duration: Longitudinal;Selection: Case control;Timing: Both

Project description:BACKGROUND:An advance directive is a document specifying a person's preferences for treatment, should he or she lose capacity to make such decisions in the future. They have been used in end-of-life settings to direct care but should be well suited to the mental health setting. OBJECTIVES:To examine the effects of advance treatment directives for people with severe mental illness. SEARCH STRATEGY:We searched the Cochrane Schizophrenia Group's Register (February 2008), the Cochrane Library (Issue 1 2008), BIOSIS (1985 to February 2008), CINAHL (1982 to February 2008), EMBASE (1980 to February 2008), MEDLINE (1966 to February 2008), PsycINFO (1872 to February 2008), as well as SCISEARCH and Google - Internet search engine (February 2008). We inspected relevant references and contacted first authors of included studies. SELECTION CRITERIA:We included all randomised controlled trials (RCTs), involving adults with severe mental illness, comparing any form of advance directive with standard care for health service and clinical outcomes. DATA COLLECTION AND ANALYSIS:We extracted data independently. For homogenous dichotomous data we calculated fixed-effect relative risk (RR) and 95% confidence intervals (CI) on an intention-to-treat basis. For continuous data, we calculated weighted mean differences (WMD) and their 95% confidence interval again using a fixed-effect model. MAIN RESULTS:We were able to include two trials involving 321 people with severe mental illnesses. There was no significant difference in hospital admission (n=160, 1 RCT, RR 0.69 0.5 to 1.0), or number of psychiatric outpatient attendances between participants given advanced treatment directives or usual care. Similarly, no significant differences were found for compliance with treatment, self harm or number of arrests. Participants given advanced treatment directives needed less use of social workers time (n=160, 1 RCT, WMD -106.00 CI -156.2 to -55.8) than the usual care group, and violent acts were also lower in the advanced directives group (n=160, 1 RCT, RR 0.27 CI 0.1 to 0.9, NNT 8 CI 6 to 92). The number of people leaving the study early were not different between groups (n=321, 2 RCTs, RR 0.92 CI 0.6 to 1.6). AUTHORS' CONCLUSIONS:There are too few data available to make definitive recommendations. More intensive forms of advance directive appear to show promise, but currently practice must be guided by evidence other than that derived from randomised trials. More trials are indicated to determine whether higher intensity interventions, such as joint crisis planning, have an effect on outcomes of clinical relevance.

Project description:BackgroundSmoking rates in the United States have been reduced in the past decades to 15% of the general population. However, up to 88% of people with psychiatric symptoms still smoke, leading to high rates of disease and mortality. Therefore, there is a great need to develop smoking cessation interventions that have adequate levels of usability and can reach this population.ObjectiveThe objective of this study was to report the rationale, ideation, design, user research, and final specifications of a novel smoking cessation app for people with serious mental illness (SMI) that will be tested in a feasibility trial.MethodsWe used a variety of user-centered design methods and materials to develop the tailored smoking cessation app. This included expert panel guidance, a set of design principles and theory-based smoking cessation content, development of personas and paper prototyping, usability testing of the app prototype, establishment of app's core vision and design specification, and collaboration with a software development company.ResultsWe developed Learn to Quit, a smoking cessation app designed and tailored to individuals with SMI that incorporates the following: (1) evidence-based smoking cessation content from Acceptance and Commitment Therapy and US Clinical Practice Guidelines for smoking cessation aimed at providing skills for quitting while addressing mental health symptoms, (2) a set of behavioral principles to increase retention and comprehension of smoking cessation content, (3) a gamification component to encourage and sustain app engagement during a 14-day period, (4) an app structure and layout designed to minimize usability errors in people with SMI, and (5) a set of stories and visuals that communicate smoking cessation concepts and skills in simple terms.ConclusionsDespite its increasing importance, the design and development of mHealth technology is typically underreported, hampering scientific innovation. This report describes the systematic development of the first smoking cessation app tailored to people with SMI, a population with very high rates of nicotine addiction, and offers new design strategies to engage this population. mHealth developers in smoking cessation and related fields could benefit from a design strategy that capitalizes on the role visual engagement, storytelling, and the systematic application of behavior analytic principles to deliver evidence-based content.

Dataset Information

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

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

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