On the Road to Recovery After Critical Illness (ORRCI)

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • London
      • London, London, United Kingdom, SE1 9RT
        • Guys and St Thomas NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional
Driving Assessment
Participants will undergo a driving assessment approximately two months after returning home from hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported driving status
Time Frame: 3, 6 and 12 month time-ponts
Patients will be asked at the recovery clinic appointments if they have returned to driving
3, 6 and 12 month time-ponts
To evaluate acceptability of the driving assessment
Time Frame: 2, 3, 6 and 12 month time-points
Acceptability will be determined by a non-validated questionnaire formulated for the study.
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
Feasibilty will be determined by a non-validated questionnaire formulated for the study
2, 3, 6 and 12 month time-points
Enablers of driving resumption
Time Frame: 2, 3, 6 and 12 month time-points
Determined by questionnaire and focus group. Number and type of enablers will be recorded.
2, 3, 6 and 12 month time-points
Barriers to driving resumption
Time Frame: 2, 3, 6 and 12 month time-points
Determined by questionnaire and focus group. Number and type of barriers will be recorded.
2, 3, 6 and 12 month time-points

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Joel Meyer, MD, Guy's and St Thomas' NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2020

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

October 1, 2024

Study Registration Dates

First Submitted

February 4, 2020

First Submitted That Met QC Criteria

February 13, 2020

First Posted (Actual)

February 17, 2020

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 262986

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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