Clinical trial NCT04272684: On the Road to Recovery After Critical Illness
Official title: Feasibility of a Comprehensive Driving Assessment to Inform Driving Resumption Following Critical Illness: an Interventional Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Intensive Care Syndrome
Keywords: Driving
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Spending time on intensive care can affect people in many different ways. Ability to move, walk, concentrate and remember events can all be affected. People may find their mood is altered and anxiety, stress and reduced confidence are common. These symptoms are frequently grouped together in a term called 'post intensive care syndrome'. Recovery often takes time and can be challenging.

Returning to driving is an important milestone and can enable individuals to return to important activities such as work and hobbies. As a complex task, driving requires individuals to do many things at once which initially can be demanding. Currently there is limited guidance about driving after a period of time on intensive care.

This study is being carried out to increase understanding of driving difficulties after a stay on intensive care and how successful and safe return to driving can be ensured. It is known that a stay on intensive care can have many effects on the body but currently the best advice to give to patients about returning to drive is unknown. The investigators would like to gather information on how many people do and do not return to driving and the reasons for this so people can be provided with more accurate information in the future. Additionally, it is important to find out if the driving assessment is practical and achievable for individuals who have had a stay on intensive care.

Detailed description: Recovery from critical illness is often prolonged and challenging due to a combination of acquired physical, psychological and cognitive impairments, which have been termed Post Intensive care syndrome (PICS). These impairments are common, slow to recover and have cumulative effects on patients' personal, social and financial wellbeing. An increasing awareness and recognition of PICS has prompted commitments to enhance multidisciplinary aftercare with the overall goal of improving patient-centred outcomes and health-related quality of life.

For many adult ICU survivors, resumption of driving is perceived as an important milestone in their recovery pathway. Driving is an advanced task reliant on complex physical and mental functioning. It also necessitates independence, self-confidence and motivation. As such clinicians may view the return to driving as an objective marker of recovery.

Furthermore, returning to drive accelerates resumption of "normal life", enablement of social interactions, hobbies, leisure activities, and most vitally, returning to work. This is not only because of its enabling effect on commuting to place of work. Approximately one million people in the UK are employed primarily as drivers, or are required to drive or operate motorised vehicles as part of their job. Thus driving after ICU is important for the UK economy as well as for patients' wellbeing and that of their loved ones. Reducing avoidable delay to driving ought therefore to be viewed as a low-cost high-impact intervention to enhance health-related quality of life.

Eligibility criteria: Inclusion Criteria:

* Adult \>18 years
* Severe critical illness and high risk PICS as defined by 72 hours or more of invasive mechanical ventilation in ICU
* Previously driving car in the 12 months prior to admission and currently holds UK category B driving licence (i.e.: car category)
* Able and willing to travel to Carshalton, Surrey and undergo full driving ability assessment and study follow up for a duration of 12 months
* Intention to resume driving, or has already resumed driving

Exclusion Criteria:

* DVLA-confirmed long term driving ineligibility (as per existing DVLA medical guidance)
* Invalid, revoked or expired driving licence
* Deemed unlikely to return to independent living status due to e.g.: severe neurological injury, advanced cancer, progressive/degenerative condition, or other
* High risk of illness recurrence or readmission to hospital
* Social or neuropsychiatric circumstances deemed likely to adversely study participation

Primary outcomes:
measure: Incidence of new driving impairments as determined by a DVLA approved driving assessment
timeFrame: 2 months
Secondary outcomes:
measure: Patient-reported driving status
timeFrame: 3, 6 and 12 month time-ponts
measure: To evaluate acceptability of the driving assessment
timeFrame: 2, 3, 6 and 12 month time-points
measure: To evaluate feasibility of the driving assessment
timeFrame: 2, 3, 6 and 12 month time-points
measure: Enablers of driving resumption
timeFrame: 2, 3, 6 and 12 month time-points
measure: Barriers to driving resumption
timeFrame: 2, 3, 6 and 12 month time-points
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Joel Meyer, MD
role: PRINCIPAL_INVESTIGATOR
References: