The assessment of emergence from a disorder of consciousness version 1
Research type
Research Study
Full title
Identifying appropriate assessment methods for determining the return of functional communication in patients emerging from a Prolonged Disorder of Consciousness (PDOC)
IRAS ID
275560
Contact name
Amy Pundole
Contact email
Sponsor organisation
The Royal Hospital for Neuro-disability
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
The purpose of this project is to improve the assessment of the return of functional communication in patients emerging from a Prolonged Disorder of Consciousness (PDOC).Following a severe brain injury some patients are left in a PDOC, with little or no awareness of themselves or their surroundings. The current criteria to determine emergence from this state are narrow and a range of tasks and stimuli are used. Patients may find these tasks difficult due to motor, cognitive and language impairments. It is unclear which tasks are easiest for patients to respond to and clinicians in the UK lack confidence in choosing appropriate stimuli (Pundole et al. 2019 Submitted for publication).
Patients are at risk of being misdiagnosed as still being in PDOC when they are not. Accurate diagnosis is vital when making complex decisions in a patient’s ‘best interests’ such as whether to continue with Clinically Assisted Nutrition and Hydration (CANH).
This study will involve 30 patients emerging from PDOC in a specialist post-acute setting over a three year period. It will investigate which tasks and stimuli are easiest for emerging patients to respond accurately to, and compare their responses when a family member* versus a therapist presents the tasks. Responses to yes/no questions and making choices from two items will be investigated, using objects and colours. Tasks will be presented on five occasions by a therapist and five occasions by a family member within a three-week period.
Results will indicate which tasks, stimuli and methods of presentation promote accurate responses in patients emerging from PDOC. This will improve assessment and support clinical practice.
‘Family member’ will be used throughout this application as outlined in the RCP National Clinical Guidelines on PDOC (2013), to include any person who is close to the patient and actively involved in their recovery.
REC name
London - Harrow Research Ethics Committee
REC reference
20/LO/0241
Date of REC Opinion
17 May 2020
REC opinion
Further Information Favourable Opinion