A protocol for a pilot randomised controlled trial of an Early Psychiatric Assessment, Referral, and Intervention Study (EPARIS) for intensive care patients

Background: Up to 80% of Intensive Care Unit patients experience physical, cognitive, and/or psychological complications post-discharge, known as ‘Post Intensive Care Syndrome’ (PICS). Early diagnosis and intervention are a priority, but while current post-intensive care follow-up processes endorse a multidisciplinary model, incorporating a psychiatric consultation has not been studied. Methods: A pilot, open-label randomised controlled trial was developed by a multidisciplinary team to evaluate the feasibility and acceptability of incorporating a psychiatric review into an existing post-ICU clinic. The study will run for 12 months and aim to recruit 30 participants. Inclusion criteria for participants: a) ICU admission greater than 48 hours, b) no cognitive impairment that prevents participation, c) ≥ 18 years old, d) residing in Australia, e) fluent in English, f) able to provide GP information, and g) likely to be contactable in 6 months. Patient recruitment will be at Redcliffe Hospital, Queensland, Australia, and will involve patients attending the Redcliffe post intensive care clinic. Participants will be allocated to intervention or control using block randomisation and allocation concealment. Participants allocated to the control arm will receive the standard cares provided by the clinic, which involves an unstructured interview about their ICU experience and a battery of surveys about their psychological, cognitive, and physical function. Those allocated to the intervention arm will receive these same cares as well as an appointment with a psychiatrist for a single session intervention. The psychiatric intervention will involve a comprehensive review, including comorbid disorders, substance use, suicidal ideation, psychosocial stressors, social/emotional supports. Psychoeducation and initial treatment will be provided as indicated and recommendations given to the patient and their GP about how to access ongoing care. In addition to surveys conducted as part of standard clinic cares, all participants will complete additional questionnaires about their history, hospital experience, mental and physical health as well as employment circumstances. All participants will be followed up 6 months after their appointment and will be invited to complete follow-up questionnaires about their mental and physical health, as well as health service use and employment circumstances. The trial has been registered with ANZCTR (ACTRN12622000894796). Results: To evaluate the feasibility and acceptability of the intervention to the patient population. Differences between groups will be assessed using an independent samples t-test. Resource requirements to administer the intervention will be evaluated by reporting the mean duration of the EPARIS assessment and approximate cost per patient to provide this service. To estimate the effect size of any treatment effects, changes in secondary outcome measures between baseline and 6 months will be compared between intervention and control groups using Analysis of Covariance regression. As this is a pilot, we will not use p-values or test a null hypothesis, but will give confidence intervals. Conclusions: This protocol provides a pragmatic evaluation of the acceptability of introducing early psychiatric assessment into an existing post-ICU follow-up process, and if considered acceptable will inform future research into the efficacy and generalisability of the intervention. The strengths of EPARIS are the prospective, longitudinal design with a control population, and its use of validated post-ICU outcome measures.