search
Back to results

On the Road to Recovery After Critical Illness (ORRCI)

Primary Purpose

Post Intensive Care Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Driving Assessment
Sponsored by
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post Intensive Care Syndrome focused on measuring Driving

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guys and St Thomas NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional

Arm Description

Driving Assessment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient-reported driving status
Patients will be asked at the recovery clinic appointments if they have returned to driving
To evaluate acceptability of the driving assessment
Acceptability will be determined by a non-validated questionnaire formulated for the study.
To evaluate feasibility of the driving assessment
Feasibilty will be determined by a non-validated questionnaire formulated for the study
Enablers of driving resumption
Determined by questionnaire and focus group. Number and type of enablers will be recorded.
Barriers to driving resumption
Determined by questionnaire and focus group. Number and type of barriers will be recorded.

Full Information

First Posted
February 4, 2020
Last Updated
June 3, 2021
Sponsor
Guy's and St Thomas' NHS Foundation Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT04272684
Brief Title
On the Road to Recovery After Critical Illness
Acronym
ORRCI
Official Title
Feasibility of a Comprehensive Driving Assessment to Inform Driving Resumption Following Critical Illness: an Interventional Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 26, 2020 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Intensive Care Syndrome
Keywords
Driving

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Experimental
Arm Description
Driving Assessment
Intervention Type
Other
Intervention Name(s)
Driving Assessment
Intervention Description
Participants will undergo a driving assessment approximately two months after returning home from hospital
Primary Outcome Measure Information:
Title
Incidence of new driving impairments as determined by a DVLA approved driving assessment
Description
DVLA approved driving assessment will be completed 2 months after discharge from hospital.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Patient-reported driving status
Description
Patients will be asked at the recovery clinic appointments if they have returned to driving
Time Frame
3, 6 and 12 month time-ponts
Title
To evaluate acceptability of the driving assessment
Description
Acceptability will be determined by a non-validated questionnaire formulated for the study.
Time Frame
2, 3, 6 and 12 month time-points
Title
To evaluate feasibility of the driving assessment
Description
Feasibilty will be determined by a non-validated questionnaire formulated for the study
Time Frame
2, 3, 6 and 12 month time-points
Title
Enablers of driving resumption
Description
Determined by questionnaire and focus group. Number and type of enablers will be recorded.
Time Frame
2, 3, 6 and 12 month time-points
Title
Barriers to driving resumption
Description
Determined by questionnaire and focus group. Number and type of barriers will be recorded.
Time Frame
2, 3, 6 and 12 month time-points

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chloe Apps, MSc
Phone
02071888070
Email
chloe.apps@gstt.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Meyer, MD
Organizational Affiliation
Guy's and St Thomas' NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guys and St Thomas NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chloe Apps
Phone
02071887188
Email
chloe.apps@gstt.nhs.uk
First Name & Middle Initial & Last Name & Degree
Joel Meyer
Phone
02081887188
Email
joel.meyer@gstt.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

On the Road to Recovery After Critical Illness

We'll reach out to this number within 24 hrs