Title: Evaluating ICON
Funder: Department of Health and Social Care

Abstract: Research questions In infants, has implementation of the ICON programme, compared to standard newborn advice, resulted in a reduction in abusive head trauma? Amongst families and healthcare professionals, what factors determine the reach of the ICON programme, and what are the key enablers and obstacles for its adoption, implementation, and maintenance? Is the ICON programme cost-effective compared to normal care? Background Abusive head trauma (AHT) is the most common severe injury in infants aged under 1 year, with accompanying high rates of mortality and life-long adversity. It is associated with intrinsic and extrinsic stressors, including the peak of normal infant crying, and societal influences such as economic recession. Evidence suggests that this catastrophic injury may be preventable by modifying adult responses to normal crying. This may be achieved through the delivery of clear education and support messages to families, especially if reinforced several times during early infant life. The ICON programme is an evidence-based intervention which provides such a function, with four clear messages planned to be given at five key touchpoints. This has been implemented in a number of UK regions since 2018, but its impact has not yet been widely assessed. Evaluations of similar programmes in other settings have varied in their findings. Aims and objectives The primary aim is to determine whether implementation of the ICON programme has resulted in a reduction in the incidence of AHT. The secondary aims are to identify factors which affect the impact of the ICON programme, especially those which influence its reach. Our key objective is to inform policy makers and stakeholders on potential benefits, and guidance on adoption, implementation, and maintenance processes by which to optimise the programme s effects. Methods In this mixed methods study we will perform quantitative and qualitative analyses, and an economic evaluation. All elements will be underpinned by the RE-AIM framework to determine factors which modify the Reach, Effectiveness, Adoption, Implementation, and Maintenance of this family education and support tool. Timelines for delivery Phase 1 (development of the evaluation plan, and of a theory of change model) will take place over three months between January 2021-March 2021. Phase 2 (delivery of the evaluation) will take place over 18 months between May 2021-October 2022 Anticipated impact and dissemination The results of this evaluation study will inform policy makers at local and national levels on the effectiveness and cost-effectiveness of the ICON programme in reducing the incidence of AHT in young infants. This will be coupled with the results of qualitative evaluation and health economic analyses to make recommendations on future implementation. The results of this evaluation will provide guidance on the optimisation of its delivery to families &ndash; ensuring that all key demographics are reached, including socioeconomically deprived populations, and male partners. Results will inform how to optimise strategies for engagement of clinical services, ensuring that clear plans for reach, adoption, implementation and maintenance are provided

Lay abstract: What is the background to this research? The commonest severe injury in infants is brain trauma, caused by being struck or shaken. This is called abusive head trauma (AHT). Although infrequent, it is a devastating injury, with high rates of death or lifelong disability. AHT is most common around the age when babies cry the most, a period known to be stressful for carers. Whilst it is not always possible to reduce how much a baby cries, it is possible to help parents cope. Research suggests that AHT may be preventable with clear education and support messages for families about normal crying, especially if given on several occasions. Using this evidence, a programme called ICON was developed, and has been growing in use. It comprises four simple messages, given to families by healthcare professionals on five occasions in the baby s early life. What is the research question? Does AHT occur less often in areas offering the ICON programme than areas that do not, and what factors influence its impact? How will this research be done? To answer these questions, we will count the number of cases of AHT before and after the introduction of the ICON programme using a range of different health record systems. We will contact families and healthcare professionals to ask what they know about ICON, and their views on it, including how to make it available and understood by as many families as possible. By doing this we will find out what helps, or prevents, its rollout to new areas. How will this research make a difference? Using this research, we will make recommendations to policy makers and commissioners on whether ICON is beneficial for families, and if it is, recommend the best way to implement it. By engaging with a wide range of people, including healthcare professionals, policy makers, and the owners of the ICON programme, we will get the best effects. How are families, the public, and other stakeholders involved in this research? During early planning for this research, families shared their views on this research, and their stories as new parents. This helped us understand the details of how we can complete this evaluation. This included the &ldquo;how and when&rdquo; to contact and speak with parents of young babies, and they all supported using existing information to measure whether AHT was less common. During the first three months of this research, we will expand this engagement work with families and healthcare professionals, to create the best plan to engage with the broadest possible range of people and settings.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: INJURIES AND ACCIDENTS