The effect of the ABCDEF bundle on delirium, functional outcomes and quality of life in critically ill patients - a randomised controlled trial with embedded process evaluation

The intervention group will receive the protocolised ABCDEF bundle of cares which is outlined below: A: - Assess, prevent and manage pain: Pain will be assessed every 2 hours and when necessary using the Numeric Rating Scale (NRS) if the patient is conscious or the Critical Care Observation Tool (CCOT) if unconscious. Significant pain will be assumed if the NRS is greater than 4 or the CCOT is greater than 3. Pre-procedural analgesia will be administered as per medical officer's prescription. “Treat pain first, then sedate” will be emphasised. B: - Both Spontaneous awakening trial (SAT) and spontaneous breathing trial (SBT) This component relates to mechanically ventilated patients. Sedative medications will be ceased daily, the patient will be orientated to time and day, and an SBT will be conducted to liberate the patient from the ventilator. A safety screen within the CIS will be completed by the RN every morning to determine whether it is safe to interrupt sedation and commence a SAT. The Consultant must agree to both the SAT and SBT before progressing. C: - Choice of analgesia and sedation. Level of alertness will be monitored every 4 hours with the Richmond Agitation and Sedation Scale (RASS). ICU nursing and medical staff will optimise sedation by keeping the RASS between light sedation (-2) to restless (+1) for mechanically ventilated patients unless it is deemed not appropriate by the treating consultant. D: - Delirium: assess, prevent and manage. The CAM-ICU will be performed every 12 hours (8am and 8pm) on patients with a RASS score of -2 or higher to determine if the patient is delirious. Reorientation and cognitive stimulation activities will be performed by the occupational therapist and nursing staff. Patients will be provided their glasses and hearing aids throughout the day. Shower and bed bath will be considered once the patient is conscious and haemodynamically stable. The use of physical restraints will be avoided. Patients will be taken outside to the courtyard each day- weather permitting. Patients will receive a sleep hygiene program that will occur from 11 pm to 5 am and will include the use of earplugs, reduction in light and noise, and organisation of care activities to provide maximum uninterrupted sleep. E: - Early mobility and exercise. The physiotherapist and nursing staff will ensure the early mobility and exercise program is incorporated into patient care. The completion of a screen within the Clinical Information System (CIS) will ensure the patient meets safety criteria. The patient will progress through four levels of progressive activity, receiving the highest level they can manage. Level 1: If the patient does not pass the safety screen, they will receive passive range of motion exercise and sitting position three times a day in bed. Level 2: If the patient can lift their arm on request, they will receive active resistance exercises, will sit in bed at a sitting position three times per day, and will sit on the edge of the bed daily. Level 3: If able to lift their leg on request, the patient will receive level 2 exercises and will also trial a stand once per day. Level 4: If the patient can lift their leg and managed level 3 the previous day, they will receive level 3 exercises and will be encouraged to ambulate- march in place, or take a few steps, or walk with assistance. F: - Family engagement and empowerment. The F component of the bundle focuses on strategies that are respectful of and responsive to patient and family needs and values, enhance family satisfaction with patient care, enhance decision-making, and acknowledge that delirious patients often feel greater trust toward family members versus staff. Families within the intervention group will be offered the following: face to face meeting with a member of the medical team (Monday - Sunday) or with the social worker (Monday – Friday). At this meeting, the family will be provided an update on the patient's status. The family will be given the opportunity to have questions answered and concerns addressed. Family members will receive an information brochure related to delirium on admission to the ward (Delirium in the Intensive Care Unit - A guide for Families and Patients developed by Critical Illness, Brain Dysfuction, and Survivorship (CIBS) Center, Nashville USA.) Family members will be encouraged to be actively involved in delirium management and exercise components of the protocol under supervision of the treating team. This involvement may include bringing in photos and personal items from home, ensuring hearing aids and glasses are used, re-orientating the patient, reading to and talking to the patient, bringing in favorite music, spreading out visits throughout the day, assisting the patient with Level 1 and 2 exercise as described in component E. Data related to adherence to each component of the ABCDEF protocol will be collected. The bed-side Registered Nurse will record each component of the ABCDEF bundle as it is delivered within the ICU clinical information system. The Principal Investigator will retrospectively record this data on a case report form. Reasons for not completing components of the ABCDEF bundle will be recorded by the bedside nurse. The intervention will continue until the patient is considered suitable to transfer to a ward.