Title: Informing a research programme to develop, optimise and evaluate a Digital and Remote Support package for Smoking in Pregnancy (DrSSIP)
Funder: Department of Health and Social Care

Abstract: Background: Reducing smoking in pregnancy is a public health priority. The NHS offers effective interpersonal behavioural counselling and nicotine replacement therapy (NRT) to pregnant women; this support is known as the Standard Treatment Programme for Pregnant Women . However, over the last 10 years the numbers of pregnant women engaging with such support have halved. Initially, during this time rates of smoking in pregnancy fell but, these have been static since 2015. Offering additional modes for receiving cessation support could help increase numbers of women engaging with this, ultimately helping more to permanently stop smoking. Digital media can cheaply deliver cessation support to pregnant women but, there are no evidence-based digital cessation interventions for use by pregnant women in the UK. In a future programme grant (PGfAR), we propose translating the Standard Treatment Programme for pregnant smokers, including the provision of NRT, into a digital and remote support package and testing this in an RCT. In this project (PDG), we will complete preparatory work to define PGfAR objectives and hence, optimal research team expertise needed to successfully achieve these. PDG research questions: How do policy and practice experts and, pregnant women who smoke, think NHS smoking cessation care can best be translated into a Digital and remote Support package for Smoking in Pregnancy (DrSSIP) and, how should this influence PGfAR aims? How can we best rationalise a text message cessation support programme, creating space for new NRT-focussed content? Objectives and development work plan: Investigate views of ~40 policy, practice and academic experts on translating the Standard Treatment Programme for pregnant smokers into a DrSSIP, how DrSSIP could successfully support NRT use, and on future implementation pathways. Methods: Qualitative interview and focus group study Investigate pregnant women s views on translation of usual care into a DrSSIP. Methods: Qualitative interview study with ~30 pregnant women recruited online Identify whether or not an existing theory-guided text message cessation support platform: Is effective for those with high nicotine dependence and Whether selected core messages change determinants of smoking behaviour and, whether such changes in determinants mediate intervention effects Methods: Secondary analysis of data from two completed RCTs combined (N=1,409). Findings will help inform scope and breadth of PGfAR objectives and, the resources required in a PGfAR to adapt an existing text support system, retaining effective content and, incorporating new content addressing nicotine dependence An intervention scoping search will identify interventions potentially suitable as DrSSIP components and, potential PGfAR co-applicants. Timelines: Study 1: months 1-10; study 2: months 6-16; study 3: months 1-11; intervention scoping search: months 10-12. Three members of the public will form the PPI panel and will be involved regularly throughout. We aim to submit the stage 1 PGfAR proposal by month 14. Anticipated impact and dissemination: We will gain key understandings to plan a PGfAR for translating the Standard Treatment Programme into a DrSSIP, including the identification of appropriate additional and existing intervention components. Findings will be disseminated to clinical, academic, policy and public groups.

Lay abstract: Background: Smoking during pregnancy causes many health problems for babies before and after they are born which stopping smoking prevents. NHS care for helping pregnant women stop smoking includes specialist counselling and Nicotine Replacement Therapy. This is known as the Standard Treatment Programme . However, few pregnant women have ever used this support and, over the last 10 years the number doing so has reduced a lot. If support for stopping smoking could be offered remotely and, through digital devices like smartphones, more women would probably use it and so, the NHS would be able to help more women to stop. Currently, the NHS doesn t help pregnant women to stop smoking in this way so, we plan to convert the Standard Treatment Programme so that this is delivered remotely and digitally and, we will test if this helps pregnant women stop smoking. This is a big undertaking and, before we can start, we need to do some developmental study to successfully plan for the larger work programme. Development work aims: To speak to experts and pregnant women to understand their views about converting the Standard Treatment Programme into a remote and digital support package. We also plan to see how helpful different types of stop smoking support can be when delivered by SMS text messages to pregnant women. This work will help us decide what should be included in a digital and remote package and who we need in the team to help achieve this. Development work plan Study 1: Speak to approximately 40 experts on smoking in pregnancy to understand their views and expertise on converting the Standard Treatment Programme into a digital and remote stop smoking support package. Study 2: Speak to approximately 30 pregnant women with experience of receiving support to stop smoking in pregnancy to understand their views and preferences for a digital and remote support package. Study 3: Analyse data we already have from a text message support programme. We will investigate how useful the programme is for pregnant women who are more heavily addicted and, which types of messages most effectively help women to change their smoking behaviour. We will also look for existing support that might be suitable to include in the support package. Patient and Public Involvement: Three members of the public with experience of smoking, including during pregnancy, are helping to plan and deliver the development work and plan future work. Dissemination and anticipated outcomes: After finishing this work, we will be able to effectively deliver a bigger project to develop and test a digital and remote stop smoking support package for pregnant women. We will communicate findings to different audiences including NHS practitioners, researchers, policy makers and members of the public.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: CARDIOVASCULAR;STROKE;CANCER AND NEOPLASMS;RESPIRATORY;REPRODUCTIVE HEALTH AND CHILDBIRTH