Post Intensive Care SyndromeORRCINCT04272684
On the Road to Recovery After Critical Illness
A study testing Driving Assessment in people with Post Intensive Care Syndrome, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Intensive Care Syndrome
- What is being tested?
- Driving Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Feb 2020to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guys and St Thomas NHS Foundation Trust
London, London, SE1 9RT
About this study
Official title: Feasibility of a Comprehensive Driving Assessment to Inform Driving Resumption Following Critical Illness: an Interventional Cohort Study
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.
Read the 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.
- Conditions
- Post Intensive Care Syndrome
- Being tested
- Driving Assessment
- Keywords
- Driving
- Medical subject headings
- postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Driving AssessmentOther
Participants will undergo a driving assessment approximately two months after returning home from hospital
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Driving Assessment Receives: Other: Driving Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (5)
Patient-reported driving status
Patients will be asked at the recovery clinic appointments if they have returned to driving
Measured: 3, 6 and 12 month time-ponts
To evaluate acceptability of the driving assessment
Acceptability will be determined by a non-validated questionnaire formulated for the study.
Measured: 2, 3, 6 and 12 month time-points
To evaluate feasibility of the driving assessment
Feasibilty will be determined by a non-validated questionnaire formulated for the study
Measured: 2, 3, 6 and 12 month time-points
Enablers of driving resumption
Determined by questionnaire and focus group. Number and type of enablers will be recorded.
Measured: 2, 3, 6 and 12 month time-points
Barriers to driving resumption
Determined by questionnaire and focus group. Number and type of barriers will be recorded.
Measured: 2, 3, 6 and 12 month time-points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start26 Feb 2020
- Primary completion30 Sep 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Intensive Care SyndromeStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joel Meyer, MD, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272684
- Sponsor's protocol ID
- 262986
- Acronym
- ORRCI
- Status last verified
- May 2026
- First submitted
- 4 Feb 2020
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Apps C, Brooks K, Rose L, Meyer J, Pattison N. "Back on the road": Exploring experiences of driving resumption in patients recovering from critical illness. Aust Crit Care. 2025 Nov;38(6):101442. doi: 10.1016/j.aucc.2025.101442. Epub 2025 Oct 24.
PubMed 41138521
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Comprehensive Driving Assessment to Inform Driving Resumption Following Critical Illness: an Interventional Cohort Study
- ClinicalTrials.gov ID
- NCT04272684
- Acronym / sponsor ID
- ORRCI / 262986
- Conditions
- Post Intensive Care Syndrome
- Keywords
- Driving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Other: Driving AssessmentDriving Assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Driving AssessmentParticipants will undergo a driving assessment approximately two months after returning home from hospital | Other | Interventional |
Primary outcome
Incidence of new driving impairments as determined by a DVLA approved driving assessment
Time frame: 2 months
DVLA approved driving assessment will be completed 2 months after discharge from hospital.
5 secondary outcomes
Patient-reported driving status
Time frame: 3, 6 and 12 month time-ponts
To evaluate acceptability of the driving assessment
Time frame: 2, 3, 6 and 12 month time-points
To evaluate feasibility of the driving assessment
Time frame: 2, 3, 6 and 12 month time-points
Enablers of driving resumption
Time frame: 2, 3, 6 and 12 month time-points
Barriers to driving resumption
Time frame: 2, 3, 6 and 12 month time-points
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Derived from this study: PubMed 41138521Apps C, Brooks K, Rose L, Meyer J, Pattison N. "Back on the road": Exploring experiences of driving resumption in patients recovering from critical illness. Aust Crit Care. 2025 Nov;38(6):101442. doi: 10.1016/j.aucc.2025.101442. Epub 2025 Oct 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Meyer, MD principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Driving Assessment in people with Post Intensive Care Syndrome, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of new driving impairments as determined by a DVLA approved driving assessment (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04272684, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.