Title: A multi-centre longitudinal mixed methods study to explore the Outcomes of ChildrEn and fAmilies iN the first year after paediatric Intensive Care discharge: The OCEANIC study
Funder: Health Education England

Abstract: Background Due to medical advances, there has been a decline in Paediatric Intensive Care Unit (PICU) mortality, but the consequence is a rise in morbidity. Children who survive critical illness today may survive with increased medical complexity, chronicity of disease, and dependence on technology because of these advances. Furthermore, there is growing evidence that PICU survivors often become physically deconditioned, cognitively impaired, and emotionally distraught. The emotional and social health of the PICU survivor's parents and siblings may also be affected. However, deficits remain within the literature that inhibit a contemporary and comprehensive understanding of the outcomes and their trajectories of children and their families that survive a critical illness or injury. Investigating outcomes of children, their parents and siblings following PICU discharge has been identified as a research priority by patients, the public, and health professionals. Research question What are the longitudinal physical, cognitive, emotional, social health outcomes, and the support needs of children and their family members in the first-year after a PICU discharge? Methods/Design A multi-centre longitudinal mixed-methods study of children's and their families' outcomes and support needs in the first-year post-PICU discharge. A consecutive sampling strategy will be employed to recruit 300 PICU survivors (aged 1 month to 17 years) and their parents and siblings from five PICUs in England. Quantitative study: Data will be collected from children, parents and siblings (if applicable) via face-to-face, telephone, website, or postal mail at six time-points over 1 year (pre-PICU discharge; at PICU discharge; and post-PICU discharge at 1 month; 3 months; 6 months and 12 months). Demographic data and characteristics of PICU admission will be collected in conjunction with a number of validated and reliable, self/parent reported outcome measures assessing physical, cognitive, emotional, and social health outcomes. Data will be analysed using descriptive and inferential statistics to assess the outcomes over time and whether pertinent outcomes differ between the published data and subgroups, whilst considering potential confounders or effect modifiers. Qualitative study: A stratified purposeful sample of 24 children and their families will be recruited to participate in qualitative semi-structured interviews at 3 and 9 months post-PICU discharge. Interviews will explore care and support needs and data will be analysed using framework analysis.Potential impactThis research will provide, for the first time in the UK, a comprehensive understanding of the outcomes and their trajectories of children, their parents, and siblings, over the first year post-PICU discharge. This will improve knowledge of those at risk of morbidity and any factors that could be modified to improve health outcomes. This study has scope to inform and impact on the delivery and configuration of current PICU or other health services and the development of targeted interventions to optimise the outcomes and lives of children and their families after a PICU admission.

Lay abstract: What is the problem?Each year 20,000 children become very ill or injured and need specialist care within a Paediatric Intensive Care Unit (PICU). Most children survive. However, these children and their families (parents and siblings) may experience problems after they have left the PICU. These can include physical (breathing, eating and drinking), functional (moving and concentration), and/or emotional problems (stress and fears) to themselves and their families (parents and siblings). These have the potential to affect health, place burdens on parents/carers, impact on education and social development. However, we currently do not know which children and families experience problems, when the problems occur, and what causes them. Without this information, we are unsure how to help and support children and their families after PICU. What have we done so far? We have talked to children and their families that have been on PICU, health professionals, and researchers in the field who identify that this topic is a priority for clinical practice and research. Children and their families have said that they would like follow-up and support. Professionals and researchers have identified that there is a lack of research that clearly identifies what needs children and their families have, and when these should be addressed in their recovery pathway. We have also undertaken a national questionnaire of all PICUs to understand what support they currently offer to children and families after they leave PICU. And the result was that only two out of 22 PICUs provide follow-up to children and families after a PICU admission.What are we going to do?We want to understand the physical, functional, emotional and social consequences of being on PICU to children (aged 1 month-17 years), their parents and siblings, in the first-year after a PICU admission. We will conduct a study that will collect information from children, their parents and siblings, who have been admitted to PICU over a year to see if there are any changes over time. In addition, some families will take part in interviews in order to explore their care and support needs.How are we going to do it?We want to follow up 300 children, their parents, and their siblings over the first-year after they have left the PICU. We will collect information just before and then after the child leaves the PICU. Information will also be collected over the telephone or via the internet at 1 month, 3 months, 6 months, and 12 months after leaving PICU. We will collect information about physical, functional, emotional and social health with methods that have been used successfully before in other research. In addition, at 3 and 9 months, we will invite 12 families to take part in face-to-face or telephone interviews to talk about their care needs. Data will be analysed to look at any trends or changes in this information over time. What will we do with the results? At the end of this project we hope to have a better understanding of the health consequences of children, their parents and siblings in the first-year following PICU and their experiences of care and support needs. This will provide information about anything that can be changed to improve negative consequences of being on a PICU. We will share our results with children and their families, national organisations, healthcare commissioners, policy makers and the international paediatric intensive care community to ensure that our results can be used to improve care for children and their families, leading to better health and well-being.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: GENERIC HEALTH RELEVANCE