Survivorship of Patients After Long Intensive Care Stay With Exploration and Experience in a New Zealand Cohort (SPLIT ENZ): Protocol for a Mixed Methods Study

Abstract

Background Post Intensive Care Syndrome (PICS) was defined by the Society of Critical Care Medicine in 2012 with subsequent international research highlighting poor long-term outcomes; reduced quality of life; and impairments, for survivors of critical illness. To date, there has been no published research on the long-term outcomes of survivors of critical illness in New Zealand. Objective The aim of this study is to explore long-term outcomes after critical illness in New Zealand. The primary objectives are to describe and quantify symptoms and disability, explore possible risk factors, and to identify unmet needs in survivors of critical illness. Methods This will be a mixed methods study with 2 components. First, a prospective cohort study of approximately 100 participants with critical illness will be followed up at 1, 6, and 12 months after hospital discharge. The primary outcome will be disability assessed using the World Health Organization Disability Assessment Scale 2.0. Secondary outcomes will focus on mental health using the Hospital Anxiety and Depression Scale and the Impact of Events Scale-revised, cognitive function using the Montreal Cognitive Assessment (Montreal Cognitive Assessment–BLIND), and health-related quality of life using the European Quality of Life-Five Dimension-Five Level. The second element of the study will use qualitative grounded theory methods to explore participants experiences of recovery and highlight unmet needs. Results This study was approved by the New Zealand Northern A Health and Disability Ethics Committee on August 16, 2021 (21/NTA/107), and has been registered with the Australian New Zealand Clinical Trials Registry on October 5, 2021. SPLIT ENZ is due to start recruitment in early 2022, aiming to enroll 125 patients over 2 years. Data collection is estimated to be completed by 2024-2025 and will be published once all data are available for reporting. Conclusions Although international research has identified the prevalence of PICS and the extent of disability in survivors of critical illness, there is no published research in New Zealand. Research in this field is particularly pressing in the context of COVID-19, an illness that may include PICS in its sequelae. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN1262100133588; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382566&showOriginal=true&isReview=true International Registered Report Identifier (IRRID) PRR1-10.2196/35936