Identifying determinants of varenicline adherence using the Theoretical Domains framework: a rapid review.

BACKGROUND: Adhering to varenicline has been shown to significantly improve the chances of successfully quitting smoking, with studies indicating a twofold increase in 6-month quit rates. However, despite its potential benefits, many individuals struggle with maintaining good adherence to varenicline; thus there is a need to develop scalable strategies to help people adhere. As a first step to inform the development of an intervention to improve adherence to varenicline, we conducted a rapid literature review to identify: 1) modifiable barriers and facilitators to varenicline adherence, and 2) behaviour change techniques associated with increased adherence to varenicline. METHODS: We searched MEDLINE, Embase, APA PsycINFO, CINAHL, and the Cochrane Central Register of Controlled Trials for relevant studies published between 2006 and 2022. Search terms included "varenicline," "smoking cessation," and "adherence," and their respective subject headings and synonyms. We screened and included studies reporting modifiable determinants of adherence to varenicline and then assessed quality, extracted modifiable determinants and mapped them to the Theoretical Domains Framework version 2 and the Behaviour Change Technique Taxonomy version 1. RESULTS: A total of 1,221 titles were identified through the database searches; 61 met the eligibility criteria. Most of the studies were randomized controlled trials and predominantly focused on barriers to varenicline. Only nine studies explicitly mentioned behaviour change techniques used to help varenicline adherence. Eight domains were identified as barriers to varenicline adherence (behavioural regulation, memory, goals, intentions, beliefs about capabilities, beliefs about consequences, optimism/pessimism, and environmental context) and five as facilitators (knowledge, behavioural regulation, beliefs about capabilities, social influences, and environmental context). CONCLUSIONS: This study identifies barriers and facilitators that should be addressed when developing a complex adherence intervention tailored to patients' needs based on modifiable determinants of medication adherence, some of which are under- used by existing adherence interventions. The findings from this review will inform the design of a theory-based healthbot planned to improve varenicline adherence in people undergoing smoking cessation treatment. SYSTEMATIC REVIEW REGISTRATION: This study was registered with PROSPERO (# CRD42022321838).

Effects of COVID-19-Related Disruptions on Service Use in a Large Smoking Cessation Program.

INTRODUCTION: The COVID-19 pandemic caused a rapid shift to virtual care, with largely unknown consequences for accessibility. The purpose of this study is to examine pandemic-related changes in use of care for smoking cessation. AIMS AND METHODS: We conducted a secondary analysis 65 565 enrollments in a large smoking cessation program in Ontario, Canada. We used piecewise mixed-effects regression to examine how weeks nicotine replacement therapy (NRT) received, as well as counseling provided and visits attended, varied with date of enrollment over three time periods: more than 6 months before the pandemic began; the 6 months before the pandemic; and the pandemic period itself. We then examined changes in the associations between use of care and participant characteristics by fitting a model including a set of interactions between time and other variables. Based on an omnibus test of these interactions, we then tested individual terms, using the Holm method to control the family-wise error rate. RESULTS: From the start of the pandemic in March 2020, the total weeks of NRT provided rose significantly and then declined, while the amount of counseling fell. Associations between NRT use and participant characteristics changed significantly after the pandemic onset. Individual models showed that people with lower income, living in areas of higher marginalization, unable to work, and reporting higher levels of depressive symptoms all received NRT for a longer time during the pandemic period. CONCLUSIONS: The pandemic led to small but significant changes in the amount of services used per enrollment. The transition to remote care appears to have reduced the effects of socioeconomic and health barriers. IMPLICATIONS: The amount of care used by participants in tobacco cessation treatment is known to be associated with health and sociodemographic characteristics. Most of these associations did not change markedly following the pandemic-related switch to virtual care in 2020; however, the effects of some economic and health barriers seem to have lessened, perhaps because of a likely reduction in transport and time requirements of treatment.

The Impact of a Clinical Decision Support System for Addressing Physical Activity and Healthy Eating During Smoking Cessation Treatment: Hybrid Type I Randomized Controlled Trial.

BACKGROUND: People who smoke have other risk factors for chronic diseases, such as low levels of physical activity and poor diet. Clinical decision support systems (CDSSs) might help health care practitioners integrate interventions for diet and physical activity into their smoking cessation programming but could worsen quit rates. OBJECTIVE: The aims of this study are to assess the effects of the addition of a CDSS for physical activity and diet on smoking cessation outcomes and to assess the implementation of the study. METHODS: We conducted a pragmatic hybrid type I effectiveness-implementation trial with 232 team-based primary care practices in Ontario, Canada, from November 2019 to May 2021. We used a 2-arm randomized controlled trial comparing a CDSS addressing physical activity and diet to treatment as usual and used the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework to measure implementation outcomes. The primary outcome was self-reported 7-day tobacco abstinence at 6 months. RESULTS: We enrolled 5331 participants in the study. Of these, 2732 (51.2%) were randomized to the intervention group and 2599 (48.8%) to the control group. At the 6-month follow-up, 29.7% (634/2137) of respondents in the intervention arm and 27.3% (552/2020) in the control arm reported abstinence from tobacco. After multiple imputation, the absolute group difference was 2.1% (95% CI -0.5 to 4.6; F1,1000.42=2.43; P=.12). Mean exercise minutes changed from 32 (SD 44.7) to 110 (SD 196.1) in the intervention arm and from 32 (SD 45.1) to 113 (SD 195.1) in the control arm (group effect: B=-3.7 minutes; 95% CI -17.8 to 10.4; P=.61). Servings of fruit and vegetables changed from 2.64 servings to 2.42 servings in the intervention group and from 2.52 servings to 2.45 servings in the control group (incidence rate ratio for intervention group=0.98; 95% CI 0.93-1.02; P=.35). CONCLUSIONS: A CDSS for physical activity and diet may be added to a smoking cessation program without affecting the outcomes. Further research is needed to improve the impact of integrated health promotion interventions in primary care smoking cessation programs. TRIAL REGISTRATION: ClinicalTrials.gov NCT04223336 https://www.clinicaltrials.gov/ct2/show/NCT04223336. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/19157.

A Comparison of Quit Outcomes for Men and Women in a Smoking Cessation Program Offering Personalized Nicotine Replacement Therapy and Counseling in Primary Care Clinics.

INTRODUCTION: Women may have greater difficulty achieving long-term abstinence following a quit attempt compared to men. We sought to determine whether there were differences in treatment characteristics or outcome between female and male primary care patients enrolled in a smoking cessation program providing personalized nicotine replacement therapy (NRT) with counseling support. AIMS AND METHODS: The sample included 27 601 Ontarians (53% female, 47% male) who enrolled in the Smoking Treatment for Ontario Patients program between 2016 and 2018. Dose, type, and duration of NRT supplied were personalized to need. Thirty-day point prevalence tobacco smoking abstinence was self-reported via online or telephone survey at 6 months after enrollment. RESULTS: Both female and male participants received a median of 8 weeks of NRT. Types of NRT received were similar, with 80% of both female and male participants receiving patch and short-acting NRT. The total cumulative dose was somewhat higher for men (1373 mg vs. 1265 mg, p < .001); but when calculated as dose per day, per cigarette smoked at baseline, the dose was slightly higher among women (1.6 mg vs. 1.5 mg, p < .001). Quit rates at 6 months were lower for women versus men (24% vs. 27%; adjusted OR = 0.84 [95% CI = 0.78 to 0.90], p < .001). There were no significant interactions between gender and dose, type, or duration of NRT supplied. CONCLUSIONS: Women were slightly less likely to quit than men, despite receiving similar treatment. There was no evidence that women benefitted more or less from variations in dose, type, or duration of NRT supplied. IMPLICATIONS: Women who received personalized NRT with counseling support in a primary care setting had lower quit success than men. Although the absolute difference in quit outcome was small, the public health impact may be large given the burden of disease associated with continued smoking. NRT supplied was similar for women and men, and there was no evidence upon which to suggest tailoring the dose, duration, or type, based on gender alone. Further research to identify the underlying biological and social factors responsible for reduced quit success will help identify ways to optimize treatment for women.

Identifying contexts and mechanisms in multiple behavior change interventions affecting smoking cessation success: a rapid realist review.

BACKGROUND: Smoking continues to be a leading cause of preventable chronic disease-related morbidity and mortality, excess healthcare expenditure, and lost work productivity. Tobacco users are disproportionately more likely to be engaging in other modifiable risk behaviours such as excess alcohol consumption, physical inactivity, and poor diet. While hundreds of interventions addressing the clustering of smoking and other modifiable risk behaviours have been conducted worldwide, there is insufficient information available about the context and mechanisms in these interventions that promote successful smoking cessation. The aim of this rapid realist review was to identify possible contexts and mechanisms used in multiple health behaviour change interventions (targeting tobacco and two or more additional risk behaviours) that are associated with improving smoking cessation outcome. METHODS: This realist review method incorporated the following steps: (1) clarifying the scope, (2) searching for relevant evidence, (3) relevance confirmation, data extraction, and quality assessment, (4) data analysis and synthesis. RESULTS: Of the 20,423 articles screened, 138 articles were included in this realist review. Following Michie et al.'s behavior change model (the COM-B model), capability, opportunity, and motivation were used to identify the mechanisms of behaviour change. Universally, increasing opportunities (i.e. factors that lie outside the individual that prompt the behaviour or make it possible) for participants to engage in healthy behaviours was associated with smoking cessation success. However, increasing participant's capability or motivation to make a behaviour change was only successful within certain contexts. CONCLUSION: In order to address multiple health behaviours and assist individuals in quitting smoking, public health promotion interventions need to shift away from 'individualistic epidemiology' and invest resources into modifying factors that are external from the individual (i.e. creating a supportive environment). TRIAL REGISTRATION: PROSPERO registration number: CRD42017064430.

Woman focused smoking cessation programming: a qualitative study.

BACKGROUND: Several studies of smoking cessation programs in clinical settings have revealed poorer outcomes for women compared to men, including counselling alone or in combination with pharmacotherapy. The objective of the current study was to explore treatment and program structure needs and preferences among female clients in a specialized smoking cessation clinic in an academic mental health and addiction health science centre in order to inform program design so that it meets the needs of female clients. METHODS: Four focus groups were conducted with current and former female clients (n = 23, mode age range = 50-59 years old, 56.5% were still smoking and 43.5% had quit) who had registered for outpatient smoking cessation treatment. Questions were designed to examine what aspects of the services were helpful and what changes they would like to see to better assist them and other women with quitting smoking. A thematic analysis of the raw data (audio recordings and notes taken during the focus groups) was conducted using a phenomenological theoretical framework. RESULTS: Themes that emerged indicated that females trying to quit smoking are best supported if they have choice from a variety of services so that treatment can be individualized to meet their specific needs; psychosocial support is provided both one-one-one with health care professionals and by peers in support groups; free pharmacotherapy is available to eliminate financial barriers to use; women-specific educational topics and support groups are offered; the clinic is accessible with evening/weekend hours, options to attend a local clinic, and childcare availability; and communication about clinic services and operation are clear, readily available, and regularly updated. CONCLUSIONS: An ideal smoking cessation program for women includes a women's centred approach with sufficient variety and choice, free pharmacotherapy, non-judgmental support, accessible services and clear communication of program options and changes. Findings may suggest an actionable list of adaptations that can be adopted by other clinics providing smoking cessation services to women.

The effects of alcohol use on smoking cessation treatment with nicotine replacement therapy: An observational study.

INTRODUCTION: Concurrent users of tobacco and alcohol are at greater risk of harm than use of either substance alone. It remains unclear how concurrent tobacco and alcohol use affects smoking cessation across levels of alcohol use and related problems. This study assessed the relationship between smoking cessation and levels of alcohol use problems. METHODS: 59,018 participants received nicotine replacement therapy through a smoking cessation program. Alcohol use and related symptoms were assessed using the Alcohol Use Disorders Identification Test (AUDIT-10) and the AUDIT-Concise (AUDIT-C). The primary outcome was 7-day point prevalence cigarette abstinence (PPA) at 6-month follow-up. We evaluated the association between alcohol use (and related problems) and smoking cessation using descriptive methods and mixed-effects logistic regression. RESULTS: 7-day PPA at 6-months was lower in groups meeting hazardous alcohol consumption criteria, with the lowest probability of smoking abstinence observed in the highest risk group. The probability of successful tobacco cessation fell with increasing levels of alcohol use and related problems. Adjusted predicted probabilities were 30.3 (95 % CI = 29.4, 31.1) for non-users, 30.2 (95 % CI = 29.4, 31.0) for low-risk users, 29.0 (95 % CI = 28.1, 29.9) for those scoring below 8 on the AUDIT-10, 27.3 (95 % CI = 26.0, 28.6) for those scoring 8-14, and 24.4 (95 % CI = 22.3, 26.5) for those scoring 15 or higher. CONCLUSION: Heavy, hazardous alcohol use is associated with lower odds of successfully quitting smoking compared to low or non-use of alcohol. Targeting alcohol treatment to this group may improve tobacco cessation outcomes.

Healthcare providers' perspectives on implementing a brief physical activity and diet intervention within a primary care smoking cessation program: a qualitative study.

BACKGROUND: Post-smoking-cessation weight gain can be a major barrier to quitting smoking; however, adding behavior change interventions for physical activity (PA) and diet may adversely affect smoking cessation outcomes. The "Picking up the PACE (Promoting and Accelerating Change through Empowerment)" study assessed change in PA, fruit/vegetable consumption, and smoking cessation by providing a clinical decision support system for healthcare providers to utilize at the intake appointment, and found no significant change in PA, fruits/vegetable consumption, or smoking cessation. The objective of this qualitative study was to explore the factors affecting the implementation of the intervention and contextualize the quantitative results. METHODS: Twenty-five semi-structured interviews were conducted with healthcare providers, using questions based on the National Implementation Research Network's Hexagon Tool. The data were analyzed using the framework's standard analysis approach. RESULTS: Most healthcare providers reported a need to address PA and fruit/vegetable consumption in patients trying to quit smoking, and several acknowledged that the intervention was a good fit since exercise and diet could improve smoking cessation outcomes. However, many healthcare providers mentioned the need to explain the fit to the patients. Social determinants of health (e.g., low income, food insecurity) were brought up as barriers to the implementation of the intervention by a majority of healthcare providers. Most healthcare providers recognized training as a facilitator to the implementation, but time was mentioned as a barrier by many of healthcare providers. Majority of healthcare providers mentioned allied health professionals (e.g., dieticians, physiotherapists) supported the implementation of the PACE intervention. However, most healthcare providers reported a need for individualized approach and adaptation of the intervention based on the patients' needs when implementing the intervention. The COVID-19 pandemic was found to impact the implementation of the PACE intervention based on the Hexagon Tool indicators. CONCLUSION: There appears to be a need to utilize a flexible approach when addressing PA and fruit/vegetable consumption within a smoking cessation program, based on the context of clinic, the patients' it is serving, and their life circumstances. Healthcare providers need support and external resources to implement this particular intervention. NAME OF THE REGISTRY: Clinicaltrials.gov. TRIAL REGISTRATION NUMBER: NCT04223336. DATE OF REGISTRATION: 7 January 2020 Retrospectively registered. URL OF TRIAL REGISTRY RECORD: https://classic. CLINICALTRIALS: gov/ct2/show/NCT04223336 .

Prototyping the implementation of a suicide prevention protocol in primary care settings using PDSA cycles: a mixed method study.

Introduction: In Canada, approximately 4,500 individuals die by suicide annually. Approximately 45% of suicide decedents had contact with their primary care provider within the month prior to their death. Current versus never smokers have an 81% increased risk of death by suicide. Those who smoke have additional risks for suicide such as depression, chronic pain, alcohol, and other substance use. They are more likely to experience adverse social determinants of health. Taken together, this suggests that smoking cessation programs in primary care could be facilitators of suicide prevention, but this has not been studied. Study objectives: The objectives of the study are to understand barriers/facilitators to implementing a suicide prevention protocol within a smoking cessation program (STOP program), which is deployed by an academic mental health and addiction treatment hospital in primary care clinics and to develop and test implementation strategies to facilitate the uptake of suicide screening and assessment in primary care clinics across Ontario. Methods: The study employed a three-phase sequential mixed-method design. Phase 1: Conducted interviews guided by the Consolidated Framework for Implementation Research exploring barriers to implementing a suicide prevention protocol. Phase 2: Performed consensus discussions to map barriers to implementation strategies using the Expert Recommendations for Implementing Change tool and rank barriers by relevance. Phase 3: Evaluated the feasibility and acceptability of implementation strategies using Plan Do Study Act cycles. Results: Eleven healthcare providers and four research assistants identified lack of training and the need of better educational materials as implementation barriers. Participants endorsed and tested the top three ranked implementation strategies, namely, a webinar, adding a preamble before depression survey questions, and an infographic. After participating in the webinar and reviewing the educational materials, all participants endorsed the three strategies as acceptable/very acceptable and feasible/very feasible. Conclusion: Although there are barriers to implementing a suicide prevention protocol within primary care, it is possible to overcome them with strategies deemed both acceptable and feasible. These results offer promising practice solutions to implement a suicide prevention protocol in smoking cessation programs delivered in primary care settings. Future efforts should track implementation of these strategies and measure outcomes, including provider confidence, self-efficacy, and knowledge, and patient outcomes.

Cocreation of a conversational agent to help patients adhere to their varenicline treatment: A study protocol.

Objective: Varenicline is the most efficacious approved smoking cessation medication, making it one of the most cost-effective clinical interventions for reducing tobacco-related morbidity and mortality. Adhering to varenicline is strongly associated with smoking cessation. Healthbots have the potential to help people adhere to their medications by scaling up evidence-based behavioral interventions. In this protocol, we outline how we will follow the UK's Medical Research Council's guidance to codesign a theory-informed, evidence-based, and patient-centered healthbot to help people adhere to varenicline. Methods: The study will utilize the Discover, Design and Build, and Test framework and will include three phases: (a) a rapid review and interviews with 20 patients and 20 healthcare providers to understand barriers and facilitators to varenicline adherence (Discover phase); (b) Wizard of Oz test to design the healthbot and get a sense of the questions that chatbot has to be able to answer (Design phase); and (c) building, training, and beta-testing the healthbot (Building and Testing phases) where the Nonadoption, Abandonment, Scale-up, Spread, and Sustainability framework will be used to develop the healthbot using the simplest sensible solution, and 20 participants will beta test the healthbot. We will use the Capability, Opportunity, Motivation-Behavior (COM-B) model of behavior change and its associated framework, the Theoretical Domains Framework, to organize the findings. Conclusions: The present approach will enable us to systematically identify the most appropriate features for the healthbot based on a well-established behavioral theory, the latest scientific evidence, and end users' and healthcare providers' knowledge.

Primary healthcare provider experience of knowledge brokering interventions for mood management.

Background: Knowledge brokering is a knowledge translation strategy used in healthcare settings to facilitate the implementation of evidence into practice. How healthcare providers perceive and respond to various knowledge translation approaches is not well understood. This qualitative study used the Theoretical Domains Framework to examine healthcare providers' experiences with receiving one of two knowledge translation strategies: a remote knowledge broker (rKB); or monthly emails, for encouraging delivery of mood management interventions to patients enrolled in a smoking cessation program. Methods: Semi-structured interviews were conducted with 21 healthcare providers recruited from primary care teams. We used stratified purposeful sampling to recruit participants who were allocated to receive either the rKB, or a monthly email-based knowledge translation strategy as part of a cluster randomized controlled trial. Interviews were structured around domains of the Theoretical Domains Framework (TDF) to explore determinants influencing practice change. Data were coded into relevant domains. Results: Both knowledge translation strategies were considered helpful prompts to remind participants to deliver mood interventions to patients presenting depressive symptoms. Neither strategy appeared to have influenced the health care providers on the domains we probed. The domains pertaining to knowledge and professional identity were perceived as facilitators to implementation, while domains related to beliefs about consequences, emotion, and environmental context acted as barriers and/or facilitators to healthcare providers implementing mood management interventions. Conclusion: Both strategies served as reminders and reinforced providers' knowledge regarding the connection between smoking and depressed mood. The TDF can help researchers better understand the influence of specific knowledge translation strategies on healthcare provider behavior change, as well as potential barriers and facilitators to implementation of evidence-informed interventions. Environmental context should be considered to address challenges and facilitate the movement of knowledge into clinical practice.

Coordinating smoking cessation treatment with menstrual cycle phase to improve quit outcomes (MC-NRT): study protocol for a randomized controlled trial.

BACKGROUND: Women experience greater difficulty achieving smoking abstinence compared to men. Recent evidence suggests that hormonal fluctuations during different phases of the menstrual cycle can contribute to lower smoking abstinence rates following a quit attempt among women. However, these findings are limited by small sample sizes and variability among targeted smoking quit dates. This clinical trial aims to clarify whether targeting the quit date to the follicular or luteal phase of the menstrual cycle can improve smoking abstinence. METHODS: Participants will enroll in an online smoking cessation program providing nicotine replacement therapy (NRT) and behavioral support. We will randomize 1200 eligible individuals to set a target quit date: (1) during the mid-luteal phase, (2) during the mid-follicular phase, or (3) 15-30 days after enrollment with no regard to the menstrual cycle phase (usual practice). Participants will receive a 6-week supply of combination NRT consisting of a nicotine patch plus their choice of nicotine gum or lozenge. Participants will be instructed to start using NRT on their target quit date. Optional behavioral support will consist of a free downloadable app and brief videos focusing on building a quit plan, coping with cravings, and relapse prevention, delivered via e-mail. Smoking status will be assessed via dried blood spot analysis of cotinine concentration at 7 days, 6 weeks, and 6 months post-target quit date. DISCUSSION: We aim to overcome the limitations of previous studies by recruiting a large sample of participants and assigning target quit dates to the middle of both the follicular and luteal phases. The results of the trial can further elucidate the effects of the menstrual cycle on smoking cessation outcomes and whether it is beneficial to combine menstrual cycle phase timing strategies with accessible and low-cost NRT. TRIAL REGISTRATION: ClinicalTrials.gov NCT05515354. Registered on August 23, 2022.

AI Conversational Agent to Improve Varenicline Adherence: Protocol for a Mixed Methods Feasibility Study.

BACKGROUND: Varenicline is a pharmacological intervention for tobacco dependence that is safe and effective in facilitating smoking cessation. Enhanced adherence to varenicline augments the probability of prolonged smoking abstinence. However, research has shown that one-third of people who use varenicline are nonadherent by the second week. There is evidence showing that behavioral support helps with medication adherence. We have designed an artificial intelligence (AI) conversational agent or health bot, called "ChatV," based on evidence of what works as well as what varenicline is, that can provide these supports. ChatV is an evidence-based, patient- and health care provider-informed health bot to improve adherence to varenicline. ChatV has been programmed to provide medication reminders, answer questions about varenicline and smoking cessation, and track medication intake and the number of cigarettes. OBJECTIVE: This study aims to explore the feasibility of the ChatV health bot, to examine if it is used as intended, and to determine the appropriateness of proceeding with a randomized controlled trial. METHODS: We will conduct a mixed methods feasibility study where we will pilot-test ChatV with 40 participants. Participants will be provided with a standard 12-week varenicline regimen and access to ChatV. Passive data collection will include adoption measures (how often participants use the chatbot, what features they used, when did they use it, etc). In addition, participants will complete questionnaires (at 1, 4, 8, and 12 weeks) assessing self-reported smoking status and varenicline adherence, as well as questions regarding the acceptability, appropriateness, and usability of the chatbot, and participate in an interview assessing acceptability, appropriateness, fidelity, and adoption. We will use "stop, amend, and go" progression criteria for pilot studies to decide if a randomized controlled trial is a reasonable next step and what modifications are required. A health equity lens will be adopted during participant recruitment and data analysis to understand and address the differences in uptake and use of this digital health solution among diverse sociodemographic groups. The taxonomy of implementation outcomes will be used to assess feasibility, that is, acceptability, appropriateness, fidelity, adoption, and usability. In addition, medication adherence and smoking cessation will be measured to assess the preliminary treatment effect. Interview data will be analyzed using the framework analysis method. RESULTS: Participant enrollment for the study will begin in January 2024. CONCLUSIONS: By using predetermined progression criteria, the results of this preliminary study will inform the determination of whether to advance toward a larger randomized controlled trial to test the effectiveness of the health bot. Additionally, this study will explore the acceptability, appropriateness, fidelity, adoption, and usability of the health bot. These insights will be instrumental in refining the intervention and the health bot. TRIAL REGISTRATION: ClinicalTrials.gov NCT05997901; https://classic.clinicaltrials.gov/ct2/show/NCT05997901. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/53556.

A Motivational Interviewing Chatbot With Generative Reflections for Increasing Readiness to Quit Smoking: Iterative Development Study.

BACKGROUND: The motivational interviewing (MI) approach has been shown to help move ambivalent smokers toward the decision to quit smoking. There have been several attempts to broaden access to MI through text-based chatbots. These typically use scripted responses to client statements, but such nonspecific responses have been shown to reduce effectiveness. Recent advances in natural language processing provide a new way to create responses that are specific to a client's statements, using a generative language model. OBJECTIVE: This study aimed to design, evolve, and measure the effectiveness of a chatbot system that can guide ambivalent people who smoke toward the decision to quit smoking with MI-style generative reflections. METHODS: Over time, 4 different MI chatbot versions were evolved, and each version was tested with a separate group of ambivalent smokers. A total of 349 smokers were recruited through a web-based recruitment platform. The first chatbot version only asked questions without reflections on the answers. The second version asked the questions and provided reflections with an initial version of the reflection generator. The third version used an improved reflection generator, and the fourth version added extended interaction on some of the questions. Participants' readiness to quit was measured before the conversation and 1 week later using an 11-point scale that measured 3 attributes related to smoking cessation: readiness, confidence, and importance. The number of quit attempts made in the week before the conversation and the week after was surveyed; in addition, participants rated the perceived empathy of the chatbot. The main body of the conversation consists of 5 scripted questions, responses from participants, and (for 3 of the 4 versions) generated reflections. A pretrained transformer-based neural network was fine-tuned on examples of high-quality reflections to generate MI reflections. RESULTS: The increase in average confidence using the nongenerative version was 1.0 (SD 2.0; P=.001), whereas for the 3 generative versions, the increases ranged from 1.2 to 1.3 (SD 2.0-2.3; P<.001). The extended conversation with improved generative reflections was the only version associated with a significant increase in average importance (0.7, SD 2.0; P<.001) and readiness (0.4, SD 1.7; P=.01). The enhanced reflection and extended conversations exhibited significantly better perceived empathy than the nongenerative conversation (P=.02 and P=.004, respectively). The number of quit attempts did not significantly change between the week before the conversation and the week after across all 4 conversations. CONCLUSIONS: The results suggest that generative reflections increase the impact of a conversation on readiness to quit smoking 1 week later, although a significant portion of the impact seen so far can be achieved by only asking questions without the reflections. These results support further evolution of the chatbot conversation and can serve as a basis for comparison against more advanced versions.

An e-Mental Health Resource for COVID-19-Associated Stress Reduction: Mixed Methods Study of Reach, Usability, and User Perceptions.

BACKGROUND: COVID-19 and its public health response are having a profound effect on people's mental health. To provide support during these times, Canada's largest mental health and addiction teaching hospital (Centre for Addiction and Mental Health [CAMH]) launched the Mental Health and COVID-19 Pandemic website on March 18, 2020. This website was designed to be a nonstigmatizing psychoeducational resource for people experiencing mild to moderate distress due to COVID-19 and the public health response to the pandemic. OBJECTIVE: The aim of this study was to examine the reach, usability, and user perceptions of the CAMH Mental Health and COVID-19 Pandemic website. METHODS: This study used a mixed methods sequential explanatory design approach, which consisted of the following 2 distinct phases: (1) quantitative data collection and analysis and (2) qualitative semistructured interviews. In phase 1, we analyzed Google Analytics data to understand how many people visited the website and which were the most visited pages. We conducted a survey to identify users' sociodemographic backgrounds, and assess the usability of the website using the System Usability Scale and users' subjective stress levels using the Perceived Stress Scale (PSS-10). For phase 2, we conducted semistructured interviews to explore user experiences; user motivation, engagement, satisfaction, and perception of the stress reduction strategies; reflections of the website's functionality, ease of use, navigation, and design; and recommendations for improvement. RESULTS: Google Analytics results showed 146,978 unique users from June 2020 to March 2021. Most users were from Canada (130,066, 88.5%). Between February 20, 2021, and June 4, 2021, 152 users completed the survey. Most users identified as white, female, and having at least a college degree. Based on the PSS-10 scores, most participants were experiencing moderate to high stress when they visited the website. Users rated the usability of the website as acceptable. Ten users completed in-depth interviews between May 2021 and June 2021. Positive feedback related to the content was that the website was a trustworthy source of mental health information with helpful evidence-based stress reduction strategies. Areas for improvement included the text heavy design of the website, wider dissemination/marketing, and greater accessibility of the website to meet the needs of diverse populations. CONCLUSIONS: Adding stress reduction resources to a website from a well-respected institution may be a practical method to increase awareness and access to evidence-based stress reduction resources during times of crisis, where there is severe disruption to usual health care contacts. Efforts to ensure that these resources are more widely accessed, especially by diverse populations, are needed.

Video Game to Attenuate Pandemic-Related Stress From an Equity Lens: Development and Usability Study.

BACKGROUND: The emergence of the novel coronavirus (COVID-19) has introduced additional pressures on an already fragile mental health care system due to a significant rise in depression, anxiety, and stress among Canadians. Although cognitive behavioral therapy (CBT) is known to be an efficacious treatment to reduce such mental health issues, few people have access to CBT in an engaging and sustainable manner. To address this gap, a collaboration between the Centre for Addiction and Mental Health (CAMH) and the National Research Council of Canada (NRC) developed CBT-based self-led, online, clinician-tested modules in the form of a video game, named Legend of Evelys, and evaluated its usability in the attenuation of a COVID-19-related increase in stress. OBJECTIVE: We here present the conceptualization and design of new self-care modules in the form of a video game, its implementation in a technological infrastructure, and inclusivity and privacy considerations that informed the development. A usability study of the modules was performed to assess the video game's usability, user engagement, and user perceptions. METHODS: The development of the video game involved establishment of a technology infrastructure for secure implementation of the software for the modules and a clinician-led assessment of the clinical utility of these modules through two "whiteboard" sessions. The usability study was informed by a mixed methods sequential explanatory design to evaluate the intervention of the mobile app through two distinct phases: quantitative data collection using in-app analytics data and two surveys, followed by qualitative data collection by semistructured interviews. RESULTS: A total of 32 participants trialed the app for 2 weeks. They used the video game an average of six times and rated the game as "good" based on the Systems Usability Scale score. In terms of stress reduction, the study demonstrated a significant difference in the participants' Perceived Stress Scale score at baseline (mean 22.14, SD 6.187) compared with that at the 2-week follow-up (mean 18.04, SD 6.083; t27=3.628, P=.001). Qualitative interviews helped participants identify numerous functionality issues and provided specific recommendations, most of which were successfully integrated into the video game for future release. CONCLUSIONS: Through this collaboration, we have established that it is possible to incorporate CBT exercises into a video game and have these exercises adopted to address stress. While video games are a promising strategy to help people with their stress and anxiety, there is a further need to examine the real-world effectiveness of the Legend of Evelys in reducing anxiety.

Co-designing Behavior Change Resources With Treatment-Seeking Smokers: Engagement Events' Findings.

Background: Primary care organizations are well-suited to help patients change their unhealthy behaviors. Evidence shows that risk communication and self-monitoring of behavior are is an effective strategy practitioners can use to promote health behavior change with their patients. In order for this evidence to be actionable, it is important to understand how patients would like this information to be communicated and to operationalize the self-monitoring resources. The objective of this study was to co-create resources that encourage behavior change based on the scientific evidence and from patients with lived experiences. Materials and Methods: Twenty-seven individuals who participated in a smoking cessation program and engaged in at least one other unhealthy behavior joined one of two engagement events. Each event was 3 h in duration and consisted of two exercises that provided support to participants in reaching a consensus about the types of messages they would like to receive from their practitioner as well as self-monitoring resources they would prefer to use. The first exercise followed an adapted version of the Consensus Methodology developed by the Institute of Cultural Affairs Canada, while the second exercise was in accordance to the Nominal Group Technique. Results: Participants' preference was to have practitioners convey messages to promote health behavior change that include positive affirmation and to monitor all their health behaviors using a single self-reported tracking sheet. Conclusions: This paper features the use of engagement events to reflect upon and identify potential resources that treatment seeking smokers prefer to receive while attempting to modify unhealthy behaviors. These resources can be used by health care providers in primary care settings to support health promotion interventions and assist their patients to increase their likelihood of adopting positive changes to risk behaviors.

Changes in the reach of a smoking cessation program in Ontario, Canada, during the COVID-19 pandemic: a cross-sectional study.

BACKGROUND: Given the harms associated with tobacco use, continuing the provision of smoking cessation treatment during the COVID-19 pandemic is critical. The aim of this study was to examine pandemic-related changes in enrolment, total treatment use and participant characteristics in a large, publicly funded smoking cessation program in Ontario, Canada. METHODS: We conducted a secondary data analysis of patients who enrolled in the program between Jan. 1, 2018, and Dec. 7, 2020. We used descriptive statistics to examine changes in treatment use. To test for differences in sociodemographic and health variables, we used segmented mixed-effects regression with a break point on Mar. 17, 2020, when Ontario declared a state of emergency. We tested 25 variables, using Holm's correction for multiplicity. RESULTS: We analyzed 60 373 enrolments. In the month after the break point, enrolments fell 69% and total visits fell 42% relative to previous years. After Mar. 17, 2020, those who enrolled were less likely to report employment in the previous week (absolute expected difference -12.4%, 95% confidence interval [CI] -15.0% to -9.8%); were more likely to be occasional (1.3%, 95% CI 0.6% to 1.9%) or noncurrent smokers (1.7%, 95% CI 0.8% to 2.6%); were less likely to have set a target quit date (-4.8%, 95% CI -7.0% to -2.6%); and were more likely to have a physical health (6.6%, 95% CI 4.0% to 9.2%), mental health (4.6%, 95% CI 1.9% to 7.2%) or substance use diagnosis (3.5%, 95% CI 1.3% to 5.6%). INTERPRETATION: Sharp decreases in new enrolments and subsequent visits to smoking cessation programs were seen when pandemic restrictions were implemented in Ontario, but the characteristics of the people who accessed the programs did not change markedly. Incorporating an equity perspective is essential when new models of care for smoking cessation are developed.

Integrating a brief alcohol intervention with tobacco addiction treatment in primary care: qualitative study of health care practitioner perceptions.

BACKGROUND: Randomized trials of complex interventions are increasingly including qualitative components to further understand factors that contribute to their success. In this paper, we explore the experiences of health care practitioners in a province wide smoking cessation program (the Smoking Treatment for Ontario Patients program) who participated in the COMBAT trial. This trial examined if the addition of an electronic prompt embedded in a Clinical Decision Support System (CDSS)-designed to prompt practitioners to Screen, provide a Brief intervention and Referral to Treatment (SBIRT) to patients who drank alcohol above the amounts recommended by the Canadian Cancer Society guidelines-influenced the proportion of practitioners delivering a brief intervention to their eligible patients. We wanted to understand the factors influencing implementation and acceptability of delivering a brief alcohol intervention for treatment-seeking smokers for health care providers who had access to the CDSS (intervention arm) and those who did not (control arm). METHODS: Twenty-three health care practitioners were selected for a qualitative interview using stratified purposeful sampling (12 from the control arm and 11 from the intervention arm). Interviews were 45 to 90 min in length and conducted by phone using an interview guide that was informed by the National Implementation Research Network's Hexagon tool. Interview recordings were transcribed and coded iteratively between three researchers to achieve consensus on emerging themes. The preliminary coding structure was developed using the National Implementation Research Network's Hexagon Tool framework and data was analyzed using the framework analysis approach. RESULTS: Seventy eight percent (18/23) of the health care practitioners interviewed recognized the need to simultaneously address alcohol and tobacco use. Seventy four percent (17/23), were knowledgeable about the evidence of health risks associated with dual alcohol and tobacco use but 57% (13/23) expressed concerns with using the Canadian Cancer Society guidelines to screen for alcohol use. Practitioners acknowledged the value of adding a validated screening tool to the STOP program's baseline questionnaire (19/23); however, following through with a brief intervention and referral to treatment proved challenging due to lack of training, limited time, and fear of stigmatizing patients. Practitioners in the intervention arm (5/11; 45%) might not follow the recommendations from CDSS if these recommendations are not perceived as beneficial to the patients. CONCLUSIONS: The results of the study show that practitioners' beliefs were reflective of the current social norms around alcohol use and this influenced their decision to offer a brief alcohol intervention. Future interventions need to emphasize both organizational and sociocultural factors as part of the design. The results of this study point to the need to change social norms regarding alcohol in order to effectively implement interventions that target both alcohol and tobacco use in primary care clinics. Trial registration ClinicalTrials.gov NCT03108144. Retrospectively registered 11 April 2017, https://www.clinicaltrials.gov/ct2/show/NCT03108144.

The effectiveness of generic emails versus a remote knowledge broker to integrate mood management into a smoking cessation programme in team-based primary care: a cluster randomised trial.

BACKGROUND: Knowledge brokering is a knowledge translation approach that has been gaining popularity in Canada although the effectiveness is unknown. This study evaluated the effectiveness of generalised, exclusively email-based prompts versus a personalised remote knowledge broker for delivering evidence-based mood management interventions within an existing smoking cessation programme in primary care settings. METHODS: The study design is a cluster randomised controlled trial of 123 Ontario Family Health Teams participating in the Smoking Treatment for Ontario Patients programme. They were randomly allocated 1:1 for healthcare providers to receive either: a remote knowledge broker offering tailored support via phone and email (group A), or a generalised monthly email focused on tobacco and depression treatment (group B), to encourage the implementation of an evidence-based mood management intervention to smokers presenting depressive symptoms. The primary outcome was participants' acceptance of a self-help mood management resource. The secondary outcome was smoking abstinence at 6-month follow-up, measured by self-report of smoking abstinence for at least 7 previous days. The tertiary outcome was the costs of delivering each intervention arm, which, together with the effectiveness outcomes, were used to undertake a cost minimisation analysis. RESULTS: Between February 2018 and January 2019, 7175 smokers were screened for depression and 2765 (39%) reported current/past depression. Among those who reported current/past depression, 29% (437/1486) and 27% (345/1277) of patients accepted the mood management resource in group A and group B, respectively. The adjusted generalised estimating equations showed that there was no significant difference between the two treatment groups in patients' odds of accepting the mood management resource or in the patients' odds of smoking abstinence at follow-up. The cost minimisation analysis showed that the email strategy was the least costly option. CONCLUSIONS: Most participants did not accept the resource regardless of remote knowledge broker strategy. In contexts with an existing KT infrastructure, decision-makers should consider an email strategy when making changes to a programme given its lower cost compared with other strategies. More research is required to improve remote knowledge broker strategies. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03130998 . Registered April 18, 2017, (Archived on WebCite at www.webcitation.org/6ylyS6RTe ).