Table S6. Leadership and management responsible for implementation of the intervention. (DOCX 23 kb)

Table S5. Key themes and their relation to Normalization Process Theory concepts. (DOCX 23 kb)

Smoking in pregnancy causes harm to mother and baby. Despite evidence from trials of what helps women quit, implementation in the real world has been hard to achieve. An evidence-based intervention, babyClear©, involving staff training, universal carbon monoxide monitoring, opt-out referral to smoking cessation services, enhanced follow-up protocols and a risk perception tool was introduced across North East England. This paper presents the results of the qualitative analyses, reporting acceptability of the system changes to staff, as well as aids and hindrances to implementation and normalization of this complex intervention. Process evaluation was used to complement an effectiveness study. Interviews with maternity and smoking cessation services staff and observations of training were undertaken. Normalization Process Theory (NPT) was used to frame the interview guides and analysis. NPT is an empirically-derived theory, developed by sociologists, that uses four concepts to understand the process of routinising new practices. Staff interviews took place across eight National Health Service trusts at a time of widespread restructuring in smoking cessation services. Principally interviewees worked in maternity (n = 63) and smoking cessation services (n = 35). Five main themes, identified inductively, influenced the implementation: 1) initial preparedness of the organisations; 2) staff training; 3) managing partnership working; 4) resources; 5) review and planning for sustainability. NPT was used to show that the babyClear© package was acceptable to staff in a range of organisations. Illustrated in Themes 1, 2 & 3, staff welcomed ways to approach pregnant women about their smoking, without damaging their professional relationship with them. Predicated on producing individual behaviour change in women, the intervention does this largely through reorganising and standardising healthcare systems that are required to implement best practice guidelines. Changing organisational systems requires belief and commitment from staff, so that they set up and maintain practical adjustments to their practice and are reflective about adapting themselves and the work context as new challenges are encountered. The ongoing challenge is to identify and maintain the elements of the intervention package which are essential for its effectiveness and how to tailor them to local circumstances and resources without compromising its core ingredients.

Background and challenges to implementation An intervention to encourage and support pregnant women to stop smoking by implementing National Institute of Health and Clinical Excellence guidance (2010) was introduced across north east England, a region with almost 30 000 births per year. Intervention or response Comprised provision of equipment for universal, routine carbon monoxide (CO) monitoring, opt-out referral and enhanced follow-up. Positive impact was reported in Bell et al (2017). The current paper reports findings from qualitative interviews with pregnant smokers which aimed to ascertain the acceptability of the intervention. Women from the four areas where full implementation had taken place were interviewed individually face-to-face, initially at around 16 weeks of pregnancy (n=17) and again 4-10 weeks later (n=8) or postpartum (n=3). Interviews were recorded, transcribed then analysed thematically. Results and lessons learnt Universal CO monitoring and opt-out referral appeared acceptable and the former motivated women to quit. When linked to a professional discourse of caring and concern, the intervention prompted women to take action. Where women continued to smoke or failed to attend smoking cessation services (SCS) appointments, they received a risk perception intervention (RPI), visually demonstrating the immediate, negative effects of CO on the foetus. Most women accepted the need for this hard-hitting approach, and although distressing, they expressed gratitude for it. Having this risk message personalised raised awareness and sometimes led to setting a quit date; however some resented the approach. Women generally found the RPI and enhanced follow up supportive and also benefited from greater family inclusion. Where maternity services were either less focused on prioritising the smoking cessation message, or less well integrated with SCS or where maternity staff were not as adept at delivering the RPI women found the intervention less acceptable. Conclusions and key recommendations The intervention proved to be acceptable to pregnant women smokers interviewed during and shortly after pregnancy. Wider application is recommended.

Background and challenges to implementation In 2011/12, more pregnant women smoked at delivery in North East England (population 2.6 million) than the national average (21% vs 13%). Work with midwives across the region identified barriers to implementing national guidance for universal carbon monoxide (CO) screening and referral for smoking cessation (SC) support. These included lack of equipment, and midwives' concerns that quit advice was not worthwhile and might undermine relationships with women. Intervention or response A system wide approach, babyClear©, was commissioned across 12 local government areas involving eight NHS hospital maternity services and associated smoking cessation services. The intervention provided equipment and training for universal CO monitoring, opt-out referral to SC services and enhanced support to quit. Independent evaluation assessed effectiveness and implementation. Service data for more than 37,000 deliveries in 2013-14, including 10,500 smokers, was analysed for impact on quit rates. Interviews with more than 90 healthcare staff were conducted. Routine smoking at delivery data for local commissioning areas was monitored 2012-2017. Results and lessons learnt Quit rates nearly doubled (aOR 1.8, 95% CI 1.5-2.2) and referrals for SC support increased by 2.5 fold (95% CI 2.2-2.8) after initial implementation (Bell et al, 2017). There was variation in effectiveness between maternity services. Process evaluation indicated that effective SC advice was deliverable within routine maternity care and acceptable to women and maternity staff. Diversity of SC service delivery models, variable resourcing and organisational stability influenced implementation. Regional smoking at delivery rates declined steadily from 21% to 16% 2012-2017, but some localities experienced recent increases, suggesting variable sustainability. Conclusions and key recommendations The intervention improved quit rates through system wide training and action to improve identification and referral of pregnant smokers. Local contexts have a critical role to play in both implementing and sustaining such initiatives into practice. Identifying core intervention ingredients and potential for flexibility and tailoring is recommended.

Objectives To evaluate the effectiveness of a complex intervention to improve referral and treatment of pregnant smokers in routine practice, and to assess the incremental costs to the National Health Service (NHS) per additional woman quitting smoking. Design Interrupted time series analysis of routine data before and after introducing the intervention, within-study economic evaluation. Setting Eight acute NHS hospital trusts and 12 local authority areas in North East England. Participants 37 726 records of singleton delivery including 10 594 to mothers classified as smoking during pregnancy. Interventions A package of measures implemented in trusts and smoking cessation services, aimed at increasing the proportion of pregnant smokers quitting during pregnancy, comprising skills training for healthcare and smoking cessation staff; universal carbon monoxide monitoring with routine opt-out referral for smoking cessation support; provision of carbon monoxide monitors and supporting materials; and an explicit referral pathway and follow-up protocol. Main outcome measures Referrals to smoking cessation services; probability of quitting smoking during pregnancy; additional costs to health services; incremental cost per additional woman quitting. Results After introduction of the intervention, the referral rate increased more than twofold (incidence rate ratio=2.47, 95% CI 2.16 to 2.81) and the probability of quitting by delivery increased (adjusted OR=1.81, 95% CI 1.54 to 2.12). The additional cost per delivery was £31 and the incremental cost per additional quit was £952; 31 pregnant women needed to be treated for each additional quitter. Conclusions The implementation of a system-wide complex healthcare intervention was associated with significant increase in rates of quitting by delivery.

Background Rates of smoking at delivery are higher in the North East than in the rest of England (21% vs 13% in 2011/12). The babyClear© approach was commissioned in 2012/13 to support the full implementation of NICE guidance, and rolled out to all localities in the North East. The intervention package included training for staff in maternity and stop smoking services (SSS) and a new referral pathway for pregnant smokers. Systematic identification of smokers and opt-out referral to SSS, with intensive follow up, was emphasised. We aimed to evaluate its impact on referral rates, quit rates and birthweight, and estimate its cost-effectiveness. Methods Data from all maternity units in the north east of England for deliveries between Jan 2013 and Sept 2014 were linked with SSS referral data. We used a mixed-effects modelling approach to analyse the effect of the intervention on referral to SSS and on the probability of quitting smoking before delivery, using a before and after design. We used a linear mixed-effects model to investigate the impact of quitting during pregnancy on birthweight. Costs of delivering the intervention over five years were estimated. Results 37,726 singleton deliveries, including 10,594 smokers, were analysed. Referrals to SSS increased by 2.5 fold (95% CI 2.2–2.8) by month four after implementation. The odds of quitting during pregnancy nearly doubled (adjusted OR 1.8, 95% CI 1.5–2.2). Quit rates were higher in women who were referred to SSS (aOR 3.2, 95% CI 3.0–3.7) or who set a quit date (aOR 4.2, 95% CI 3.5–4.9). Quit rates were lower among women living in deprived areas (aOR 0.5, 95% CI 0.4–0.6). Birthweight was 6.5% (95% CI 5.8%–7.2%) higher among babies of women who quit during pregnancy compared with those who continued smoking, equivalent to 200 g increase for a reference term birth. Quitters’ babies were slightly lighter than babies of non smokers (1.4%, 95% CI 0.1–1.9%; 46 g lower for reference birth). 30 pregnant women (9 pregnant smokers) needed to be treated for each additional quit, at an estimated additional cost of £57 to £938 per quit. Conclusion Implementation of a system wide intervention to promote smoking cessation in pregnancy, focussed on systematic identification of pregnant smokers and opt-out referral to SSS, substantially increased quit rates, improved birth weight among pregnant quitters and was highly cost effective.