icuRESOLVE-D (Intensive Care Unit REcovery Solutions cO-Led through surVivor Engagement-Digital): Protocol for a multicentre randomised controlled trial of digital peer support for adult survivors of critical illness.

BACKGROUND: Peer support is a candidate intervention to improve health-related quality of life in survivors of critical illness. This trial will evaluate the effect of a codesigned digital peer support intervention (expert-facilitated, web-based peer support) compared to usual care. DESIGN: This study is planned as a randomised, multicentre, two-arm, parallel-group (1:1) hybrid effectiveness implementation trial of a digital peer support model versus usual care. This trial will include an embedded process evaluation and health economic analysis. PARTICIPANTS: A total of 212 adult intensive care unit (ICU) survivors, recruited by telephone from 28 days after hospital discharge. STUDY SETTING: Six health services in Victoria and the Australian Capital Territory, Australia-including five metropolitan and one regional hospital. MAIN OUTCOME MEASURES: The primary outcome is the self-reported health status at 90-days post hospital discharge using the EuroQol Visual Analogue Scale. Secondary outcomes will be measured at baseline 28 days after hospital discharge and at 90 days and 180 days after hospital discharge. Secondary outcomes include EuroQol five-dimensional five-level (EQ-5D-5L), Assessment of Quality of Life 6D, Impact of Events Scale-Revised, University of California Los Angeles three-item Loneliness Scale, Patient Health Questionnaire for Depression and Anxiety (PHQ-4), Connor-Davidson Resilience Scale, Patient Activation Measure, and healthcare costs. INTERVENTION: The codesigned digital peer support intervention is a rolling program consisting of four 1-h peer support sessions, occurring fortnightly, delivered via Zoom and facilitated by an expert clinical social worker or psychologist. The sessions include a formal (standardised education focused on ICU recovery) and an informal component (peer-to-peer discussion and peer support). DISCUSSION: This is a trial of a novel, codesigned, digital intervention aimed at improving recovery following critical illness. Through this randomised, parallel-group, two-arm, hybrid type 1 effectiveness implementation trial, we will examine the effectiveness and cost-effectiveness of a digital health peer support model and identify implementation factors necessary for scaling (if effective). Due to the digital health design, this trial has the potential to enhance equity of access to post-ICU services. TRIAL REGISTRATION: This study was registered to the Australian New Zealand Clinical Trials Registry (ACTRN12624000267550). This trial will be conducted in compliance with all stipulation of this protocol, the conditions of the ethics committee approval, the National Health and Medical Research Council, National Statement on ethical Conduct in Human Research (2007 and updates), and the Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2) (2016). The protocol is reported according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist.

Duke Scholars

Author Christopher Ethan Cox Medicine, Pulmonary, Allergy, and Critical Care Medicine