On the Road to Recovery After Critical Illness

Post Intensive Care Syndrome Clinical Trial

— ORRCI  

Official title:

Feasibility of a Comprehensive Driving Assessment to Inform Driving Resumption Following Critical Illness: an Interventional Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04272684
• Other study ID #: 262986
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2020
• Est. completion date: February 2023

Study information

• Verified date: June 2021
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Chloe Apps, MSc
• Phone: 02071888070
• Email: chloe.apps[@]gstt.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Post Intensive Care Syndrome

Intervention

Other:
• Driving Assessment
Participants will undergo a driving assessment approximately two months after returning home from hospital

Locations

Country	Name	City	State
United Kingdom	Guys and St Thomas NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of new driving impairments as determined by a DVLA approved driving assessment	DVLA approved driving assessment will be completed 2 months after discharge from hospital.	2 months
Secondary	Patient-reported driving status	Patients will be asked at the recovery clinic appointments if they have returned to driving	3, 6 and 12 month time-ponts
Secondary	To evaluate acceptability of the driving assessment	Acceptability will be determined by a non-validated questionnaire formulated for the study.	2, 3, 6 and 12 month time-points
Secondary	To evaluate feasibility of the driving assessment	Feasibilty will be determined by a non-validated questionnaire formulated for the study	2, 3, 6 and 12 month time-points
Secondary	Enablers of driving resumption	Determined by questionnaire and focus group. Number and type of enablers will be recorded.	2, 3, 6 and 12 month time-points
Secondary	Barriers to driving resumption	Determined by questionnaire and focus group. Number and type of barriers will be recorded.	2, 3, 6 and 12 month time-points