Developing, optimising and evaluating a conversion of standard smoking cessation support in pregnancy into a digital support package (eSupport)

Prenatal smoking is a key public health priority and major driver of health inequalities. Routine NHS support consists of interpersonal counselling with Nicotine Replacement Therapy (NRT). This is effective, but few pregnant people engage with this. An alternative is digital support - text messages, web and smartphone apps – which can help smokers quit.

Pregnant people require pregnancy-orientated support.

Pregnancy-specific digital support to stop smoking is effective and of high interest among pregnant people, who perceive it as more accessible than interpersonal support. However, none is routinely available.

Our Programme Development Grant qualitative work with experts and women with lived experience of prenatal smoking found strong support for pregnancy-specific digital cessation support.

Experts felt nearly all elements of interpersonal support could be translated into a digital intervention, including NRT provision, and potentially vapes.

The women felt digital approaches would overcome key barriers to interpersonal support, by being non-judgemental, more convenient, and providing greater privacy and autonomy. However, both groups identified important reach and engagement challenges.

We propose a four-workstream PGfAR, guided by PPIE and advisory panels, and relevant frameworks, to develop and evaluate a pregnancy-specific digital smoking cessation support (eSupport), as a stand-alone or adjunct intervention.

Objectives and methods: Workstream 1 (months 1-18): Identify key delivery modalities, content and behaviour change techniques to promote engagement and smoking cessation Two systematic reviews examining: 1) effectiveness of pregnancy-specific digital cessation support, including for different delivery modes and behaviour change techniques; 2) effectiveness of strategies and behaviour change techniques for promoting reach and engagement of digital cessation interventions.

Reviews, prior studies and advisory groups will inform an eSupport programme theory.

Workstream 2 (months 8-34): Co-develop eSupport, including NRT provision, and potentially vapes Optimise eSupport Identify key eSupport implementation barriers and enablers Collaboratively develop a prototype eSupport intervention, with commercial collaborators, advisory groups, and through a series of co-design workshops, and identify implementation barriers and enablers.

The prototype will be iteratively tested and optimised using four testing cohorts.

Workstream 3 (months 23-72): Assess (cost)-effectiveness of eSupport Identify eSupport user experiences, potential mechanisms of effect and perceived barriers and enablers for implementation Randomised controlled trial, with internal pilot demonstrating recruitment feasibility, evaluating effectiveness and cost-effectiveness of eSupport versus usual care.

Qualitative process evaluation will investigate participant experiences of the trial and eSupport, and implementation views.

Workstream 4 (months 39-70): Develop implementation strategies for promoting eSupport Evaluate reach, engagement, implementation cost effectiveness and sustained promotion of eSupport using implementation strategies in clinical and online settings Development of eSupport implementation strategies, informed by workstreams, advisory input and frameworks, and evaluation of effectiveness and cost-effectiveness in a maternity clinic setting and via electronic patient record communications.

Our PPIE and advisory group-guided dissemination will use multiple channels to reach the public, particularly pregnant people, academic, policy, practice and education communities, with maximal reach to diverse groups. We anticipate producing effective eSupport and implementation strategies.

Our commercial development partner will facilitate rapid deployment to help more pregnant people stop smoking and, consequently, reduce infant morbidity and mortality.