Assessment of the Effectiveness and Cost-Effectiveness of Tailored Web- and Text-Based Smoking Cessation Support in Primary Care (iQuit in Practice II): Protocol for a Randomized Controlled Trial.

BACKGROUND: The prevalence of smoking is declining; however, it continues to be a major public health burden. In England, primary care is the health setting that provides smoking cessation support to most smokers. However, this setting has one of the lowest success rates. The iQuit in practice intervention (iQuit) is a tailored web-based and text message intervention developed for use in primary care consultations as an adjunct to routine smoking cessation support with the aim of increasing success rates. iQuit has demonstrated feasibility, acceptability, and potential effectiveness. OBJECTIVE: This definitive trial aims to determine the effectiveness and cost-effectiveness of iQuit when used as an adjunct to the usual support provided to patients who wish to quit smoking, compared with usual care alone. METHODS: The iQuit in Practice II trial is a two-arm, parallel-group, randomized controlled trial (RCT) with a 1:1 individual allocation comparing usual care (ie, pharmacotherapy combined with multisession behavioral support)-the control-with usual care plus iQuit-the intervention. Participants were recruited through primary care clinics and talked to a smoking cessation advisor. Participants were randomized during the initial consultation, and those allocated to the intervention group received a tailored advice report and 90 days of text messaging in addition to the standard support provided to all patients. RESULTS: The primary outcome is self-reported prolonged abstinence biochemically verified using saliva cotinine at 6 months after the quit date. A sample size of 1700 participants, with 850 per arm, would yield 90% power to detect a 4.3% difference in validated quit rates between the groups at the two-sided 5% level of significance. The Cambridge East Research Ethics Committee approved the study in February 2016, and funding for the study was granted from May 2016. In total, 1671 participants were recruited between August 2016 and July 2019. Follow-up for all participants was completed in January 2020. Data analysis will begin in the summer of 2020. CONCLUSIONS: iQuit in Practice II is a definitive, pragmatic RCT assessing whether a digital intervention can augment the impact of routine smoking cessation support in primary care. Previous research has found good acceptability and feasibility for delivering iQuit among smoking cessation advisors working in primary care. If demonstrated to be cost-effective, iQuit could be delivered across primary care and other settings, such as community pharmacies. The potential benefit would likely be highest where less behavioral support is delivered. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 44559004; http://www.isrctn.com /ISRCTN44559004. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17160.

Barriers and facilitators to smoking cessation in pregnancy and in the post-partum period: The health care professionals' perspective.

OBJECTIVES: Health care professionals and the health care environment play a central role in protecting pregnant and post-partum women and their infants from smoking-related harms. This study aimed to better understand the health professional's perspective on how interactions between women, health care professionals, and the environment influence how smoking is managed. DESIGN: Semi-structured interviews and focus groups. METHODS: Data were from 48 health care staff involved in antenatal or post-partum care at two UK sites, including midwives, obstetricians, health visitors, GPs, pharmacists, service commissioners, and Stop Smoking Service (SSS) advisors and managers. Thematic analysis was guided by a social-ecological framework (SEF). RESULTS: Themes were divided across three SEF levels and represented factors connected to the management of smoking in the health care context and the beliefs and behaviour of pregnant or post-partum smokers. Organizational level: Service reconfigurations, 'last resort' nicotine replacement therapy prescribing policies, and non-mandatory training were largely negative factors. There were mixed views on opt-out referral pathways and positive views on carbon monoxide monitoring. Interpersonal level: Protection of client-professional relationships often inhibited frank discussions about smoking, and weak interservice relationships affected SSS referral motivation and quality. Individual level: Professionals felt community midwives had primary responsibility for managing smoking, although midwives felt underskilled doing this. Midwives' perceived priority for addressing smoking was influenced by the demands from unrelated organizational initiatives. CONCLUSIONS: Opportunities to improve clinical support for pregnant smokers exist at organizational, interservice, and health care professional levels. Interactions between levels reflect the importance of simultaneously addressing different level-specific barriers to smoking cessation in pregnancy. Statement of contribution What is already known on this subject? Few health care professionals discuss smoking cessation support with pregnant or post-partum women. Identified health care professional-related barriers to supporting pregnant and post-partum women to stop smoking include deficits in knowledge and confidence, perceived lack of time, and concerns about damaging client relationships. There is currently a gap in understanding regarding the barriers and facilitators to supporting this group and how interactions between the health care environment and health care professionals influence the way smoking is addressed. What does this study add? This study identifies modifiable factors that can influence cessation support delivery to pregnant and post-partum women. These factors are mapped across organizational, interpersonal, and individual health care professional levels. Service structure, communication pathways, and policies appear to influence what cessation support is offered. Interpersonal and individual factors influence how this support is delivered.

Barriers to and facilitators of smoking cessation in pregnancy and following childbirth: literature review and qualitative study.

BACKGROUND: Although many women stop smoking in pregnancy, others continue, causing harm to maternal and child health. Smoking behaviour is influenced by many factors, including the role of women's significant others (SOs) and support from health-care professionals (HPs). OBJECTIVES: To enhance understanding of the barriers to, and facilitators of, smoking cessation and the feasibility and acceptability of interventions to reach and support pregnant women to stop smoking. DESIGN: Four parts: (1) a description of interventions in the UK for smoking cessation in pregnancy; (2) three systematic reviews (syntheses) of qualitative research of women's, SOs' and HPs' views of smoking in pregnancy using meta-ethnography (interpretative approach for combining findings); (3) semistructured interviews with pregnant women, SOs and HPs, guided by the social-ecological framework (conceptualises behaviour as an outcome of individuals' interactions with environment); and (4) identification of new/improved interventions for future testing. SETTING: Studies in reviews conducted in high-income countries. Qualitative research was conducted from October 2013 to December 2014 in two mixed urban/rural study sites: area A (Scotland) and area B (England). PARTICIPANTS: Thirty-eight studies (1100 pregnant women) in 42 papers, nine studies (150 partners) in 14 papers and eight studies described in nine papers (190 HPs) included in reviews. Forty-one interviews with pregnant women, 32 interviews with pregnant women's SOs and 28 individual/group interviews with 48 HPs were conducted. MAIN OUTCOME MEASURES: The perceived barriers to, and facilitators of, smoking cessation in pregnancy and the identification of potential new/modified interventions. RESULTS: Syntheses identified smoking-related perceptions and experiences for pregnant women and SOs that were fluid and context dependent with the capacity to help or hinder smoking cessation. Themes were analysed in accordance with the social-ecological framework levels. From the analysis of the interviews, the themes that were central to cessation in pregnancy at an individual level, and that reflected the findings from the reviews, were perception of risk to baby, self-efficacy, influence of close relationships and smoking as a way of coping with stress. Overall, pregnant smokers were faced with more barriers than facilitators. At an interpersonal level, partners' emotional and practical support, willingness to change smoking behaviour and role of smoking within relationships were important. Across the review and interviews of HPs, education to enhance knowledge and confidence in delivering information about smoking in pregnancy and the centrality of the client relationship, protection of which could be a factor in downplaying risks, were important. HPs acknowledged that they could best assist by providing support and understanding, and access to effective interventions, including an opt-out referral pathway to Stop Smoking Services, routine carbon monoxide screening, behavioural support and access to pharmacotherapy. Additional themes at community, organisational and societal levels were also identified. LIMITATIONS: Limitations include a design grounded in qualitative studies, difficulties recruiting SOs, and local service configurations and recruitment processes that potentially skewed the sample. CONCLUSIONS: Perceptions and experiences of barriers to and facilitators of smoking cessation in pregnancy are fluid and context dependent. Effective interventions for smoking cessation in pregnancy should take account of the interplay between the individual, interpersonal and environmental aspects of women's lives. FUTURE WORK: Research focus: removing barriers to support, improving HPs' capacity to offer accurate advice, and exploration of weight concerns and relapse prevention. Interventions focus: financial incentives, self-help and social network interventions. STUDY REGISTRATION: This study is registered as PROSPERO CRD42013004170. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Smoking Cessation Support by Text Message During Pregnancy: A Qualitative Study of Views and Experiences of the MiQuit Intervention.

INTRODUCTION: SMS text messaging is increasingly used for delivering smoking cessation support and pilot studies suggest this may also be useful in pregnancy. This study explores the views of women who received a tailored text messaging cessation intervention (MiQuit) during pregnancy, focusing on acceptability, perceived impact, and suggestions for improvements. METHODS: Semi-structured interviews were undertaken with 15 purposively sampled women who had received the MiQuit intervention during pregnancy as part of a randomized controlled trial. Data were analyzed thematically. RESULTS: Three main themes were identified: "impact", "approach," and "optimization." Participants described an immediate, yet often short-lived, impact from the texts that distracted and delayed them from smoking and they perceived that texts focusing on the development of and risk to the baby generated more enduring emotional impacts. Most women found receiving support by text preferable to face-to-face cessation support, with participants citing the greater regularity, convenience, and non-judgmental style as particular advantages. Participants would have preferred a longer support program with increased tailoring, greater customization of text timings and consideration of cutting down as an alternative/precursor to quitting. CONCLUSION: Pregnancy-specific cessation support by text message was well received and participants considered the support increased their motivation to stop smoking. The focus on the developing baby, the regularity of contact and the provision of gentle, encouraging messages were highlighted as particularly important elements of the program. IMPLICATIONS: This study adds further evidence to the acceptability and perceived positive impact of text-messaging programs in aiding smoking cessation in pregnancy. The findings indicate that for some women, this type of support is preferable to face-to-face methods and could be utilized by health professionals, either in addition to current methods or as an alternative. This study is also relevant to researchers developing health-related text programs to consider participants' desire for greater tailoring. Further research is required into adapting and continuing text support for women postpartum.

A Context-Sensing Mobile Phone App (Q Sense) for Smoking Cessation: A Mixed-Methods Study.

BACKGROUND: A major cause of lapse and relapse to smoking during a quit attempt is craving triggered by cues from a smoker's immediate environment. To help smokers address these cue-induced cravings when attempting to quit, we have developed a context-aware smoking cessation app, Q Sense, which uses a smoking episode-reporting system combined with location sensing and geofencing to tailor support content and trigger support delivery in real time. OBJECTIVE: We sought to (1) assess smokers' compliance with reporting their smoking in real time and identify reasons for noncompliance, (2) assess the app's accuracy in identifying user-specific high-risk locations for smoking, (3) explore the feasibility and user perspective of geofence-triggered support, and (4) identify any technological issues or privacy concerns. METHODS: An explanatory sequential mixed-methods design was used, where data collected by the app informed semistructured interviews. Participants were smokers who owned an Android mobile phone and were willing to set a quit date within one month (N=15). App data included smoking reports with context information and geolocation, end-of-day (EoD) surveys of smoking beliefs and behavior, support message ratings, and app interaction data. Interviews were undertaken and analyzed thematically (N=13). Quantitative and qualitative data were analyzed separately and findings presented sequentially. RESULTS: Out of 15 participants, 3 (20%) discontinued use of the app prematurely. Pre-quit date, the mean number of smoking reports received was 37.8 (SD 21.2) per participant, or 2.0 (SD 2.2) per day per participant. EoD surveys indicated that participants underreported smoking on at least 56.2% of days. Geolocation was collected in 97.0% of smoking reports with a mean accuracy of 31.6 (SD 16.8) meters. A total of 5 out of 9 (56%) eligible participants received geofence-triggered support. Interaction data indicated that 50.0% (137/274) of geofence-triggered message notifications were tapped within 30 minutes of being generated, resulting in delivery of a support message, and 78.2% (158/202) of delivered messages were rated by participants. Qualitative findings identified multiple reasons for noncompliance in reporting smoking, most notably due to environmental constraints and forgetting. Participants verified the app's identification of their smoking locations, were largely positive about the value of geofence-triggered support, and had no privacy concerns about the data collected by the app. CONCLUSIONS: User-initiated self-report is feasible for training a cessation app about an individual's smoking behavior, although underreporting is likely. Geofencing was a reliable and accurate method of identifying smoking locations, and geofence-triggered support was regarded positively by participants.