DeliriumDRIVE-PICSNCT05999903
Driving Rehabilitation and Innovation for Evaluating Risk in Post-Intensive Care Unit Survivors
An observational study of Delirium and Critical Illness, run by Baylor Research Institute at 1 site in United States.
Trial summary
Older adults are at risk for ICU-acquired cognitive decline discernible from clinical, biological, and imaging- related changes in the brain following delirium and critical illness. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Delirium, Critical Illness, Drive
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2023to 14 Jul 2025
- Phase
- Observational
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU survivors
Who may be able to join
- Age 40 and older.
- Must have had an ICU stay with delirium.
- Expected to survive hospital discharge.
- English proficiency
- Active driver within 4 weeks prior to index hospitalization
- Regular use of vehicle that is model year 1996 or newer
Who cannot join
- Communication challenges due to severe pre-existing dementia, hearing, or vision impairment.
- No access to driving.
- Loss or suspension of driver's license
- Current Incarceration
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Scott and White Health Medical Center At Temple
Temple, Texas, 76508
About this study
Older adults are at risk for ICU-acquired cognitive decline discernible from clinical, biological, and imaging- related changes in the brain following delirium and critical illness. Our Driving Rehabilitation and Innovation for Evaluating Risk in Post Intensive Care Unit Survivors (DRIVE-PICS) application seeks to implement in-vehicle kinematic driving data with neurocognitive assessments for essential formative work to develop data-based insights into driving behaviors. DRIVE-PICS is designed to contribute to a critical gap in health promotion to develop an evidence-based, in-vehicle driving assessment system to provide actionable driving safety data and rehabilitation strategies tailored to older ICU survivors, the participants' care partners, and clinicians.
Read the detailed description
There are more than 50 million older adults licensed to drive in the United States. Driving is a complex task requiring cognitive and sensorimotor skills. Survivors of critical illness experience cognitive, psychological and physical impairments, known as Post-Intensive Care Syndrome (PICS), that can last months to years following critical illness. Across the lifespan, ICU recovery has far-reaching implications for independent functioning, employment, and healthcare utilization, costing billions annually. Older adults are at risk for ICU- acquired cognitive decline discernible from clinical, biological, and imaging-related changes in the brain following delirium and critical illness. Similar to other forms of dementia, the combination of normal aging paired with cognitive deficits associated with critical illness survivorship places these older adults at high risk of automobile crashes. To address ICU-acquired cognitive decline, driving assessments to characterize risky driving behaviors are promising to guide driving rehabilitation and intervention development. Rigorous and reproducible driving safety assessment programs have demonstrated success in post-stroke and dementia contexts, established via in-vehicle and virtual modes. The investigators hypothesize that in-vehicle driving assessment and monitoring is a feasible and acceptable approach to assess and address ICU survivor driving safety. The investigators seek to implement novel in-vehicle cloud-data collection technology developed by the investigators' team. The investigators propose to pair neurocognitive assessments with in-vehicle kinematic driving data to conduct essential formative work to develop data-based insights into driving behaviors of older adults with ICU-acquired cognitive declines. The investigators aim to determine protocol feasibility and acceptability of neurocognitive assessments and in-vehicle sensor deployment (Aim 1). The investigators will enroll a cohort of older ICU survivors (n=24) with risk factors for ICU-acquired cognitive impairment to complete neurocognitive measures and participate in driving data collection via in-vehicle sensors over a 6-month post-hospital discharge period. Next, the investigators will evaluate the relationship between neurocognitive assessments and driving behavior and safety in older ICU survivors (Aim 2). Lastly, the investigators will conduct stakeholder advisory panels on the priorities and data presentation needs of driving assessments for older ICU survivors (Aim 3). The stakeholder advisory panel insights will provide scientific justification and protocol feasibility to evaluate recruitment, acceptability and attrition for future full-scale implementation. As the population of older drivers grows, almost doubling in size from 2012 to 2040 there is an immediate and critical need to address this impactful issue. This work is designed in response to the NIA Strategic Plan (Goal C-1-9 Safety of Older Drivers) to contribute to a critical gap in health promotion to develop an evidence-based, in- vehicle driving assessment system to provide actionable driving safety data and rehabilitation strategies tailored to ICU survivors, the participants' care partners and clinicians.
- Conditions
- Delirium, Critical Illness, Drive
- Keywords
- Adult, Human, Vehicle Driving, Functional Outcomes, Post-Intensive Care Syndrome (PICS), Neuro-Psychological, Cognitive, Neuro Cognitive, Intensive Care Unit (ICU), Longitudinal
- Medical subject headings
- Delirium, Critical Illness, postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational Kinematic Driving Data | Longitudinal kinematic driving data paired with neurocognitive assessments at 3- and 6-months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Driving Time
Total driving time in minutes.
Measured: 0-6 months after hospital discharge
Secondary outcomes (10)
Depression
Depression will be measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report of depression symptoms. Participants rate each item from 0 (not at all) to 3 (very often) to indicate the degree to which they have experienced the symptom in the past 7 days. Higher scores indicate greater depression.
Measured: Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
Executive Function
Executive Function will be measured using the Dimensional Change Card Sort. The participant will be required to sort first according to one dimension (e.g., color) and then according to another dimension (e.g., shape).
Measured: 3 months after hospital discharge, 6 months after hospital discharge
Attention
Attention will be measured using the Flanker Inhibitory Control and Attention Test. The participants will be required to focus on a given stimulus while inhibiting attention to stimuli. Sometimes the middle stimulus points in the same direction as the "flankers" (congruent) and sometimes in the opposite direction (incongruent). if a participant scores ≥ 90%, 20 additional trials with arrows are presented.
Measured: 3 months after hospital discharge, 6 months after hospital discharge
Working Memory
Working memory will be measured using the List Sorting Test. Participants will be provided pictures of different foods and animals accompanied with an audio recording as well as written text. The participant will be asked to recall the items back in size order from smallest to largest, first within a single dimension (either animals or foods, called 1-List) and then on two dimensions (foods, then animals, called 2-List).
Measured: 3 months after hospital discharge, 6 months after hospital discharge
Processing Speed
Processing Speed will be measured using the Pattern Comparison Processing Speed Test. Participants are asked to quickly determine whether two stimuli are the same or not the same. The participants' score will be based on how many items they answer correctly out of a possible 130 items, completed in 90 seconds.
Measured: 3 months after hospital discharge, 6 months after hospital discharge
Health-Related Quality of Life
Health-Related Quality of Life will be measured using the EuroQol- 5 Dimension Test (EQ-5D). The participant will be required to answer one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Within the questionnaire, the participants will also be asked to rate their perception of how their health is on a scale of 0 (worst possible health status) to 100 (best possible health status). Questions are scored as a 1 (full health) and 0 (poorest health). With 0 being the worst health status.
Measured: Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
Anxiety
Anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report of depression symptoms. Participants rate each item from 0 (not at all) to 3 (very often) to indicate the degree to which they have experienced the symptom in the past 7 days. Higher scores indicate greater depression.
Measured: Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
Employment
Employment will be measured through the Johns Hopkins OACIS Employment Questionnaire. It is not a scored questionnaire.
Measured: Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
Driving Trips
Driving trips will be measured using the number of trips the participant takes from the beginning of ignition to the end when the vehicle is turned off.
Measured: 0-6 months after hospital discharge
Driving Behaviors
Driving behaviors will be measured using near-crash events that are detected with validated accelerometer thresholds.
Measured: 0-6 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start13 Sep 2023
- Primary completion9 Dec 2024
- Study completion14 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of Wisconsin, Madison, University of Texas at Austin, Vanderbilt University, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Valerie Danesh, PhD, Principal investigator, Baylor Scott & White The Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999903
- Sponsor's protocol ID
- 1R21AG080339-01
- Other IDs
- 1R21AG080339-01
- Acronym
- DRIVE-PICS
- Status last verified
- Aug 2024
- First submitted
- 31 Jul 2023
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No study documents available.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Driving Rehabilitation and Innovation for Evaluating Risk in Post-Intensive Care Unit Survivors
- ClinicalTrials.gov ID
- NCT05999903
- Acronym / sponsor ID
- DRIVE-PICS / 1R21AG080339-01
- Conditions
- Delirium, Critical Illness, Drive
- Keywords
- Adult, Human, Vehicle Driving, Functional Outcomes, Post-Intensive Care Syndrome (PICS), Neuro-Psychological, Cognitive, Neuro Cognitive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of Wisconsin, Madison, University of Texas at Austin, Vanderbilt University, National Institute on Aging (NIA)
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 14 Jul 2025 (estimated)
- First posted
- 21 Aug 2023 (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.
Older adults are at risk for ICU-acquired cognitive decline discernible from clinical, biological, and imaging- related changes in the brain following delirium and critical illness. Our Driving Rehabilitation and Innovation for Evaluating Risk in Post Intensive Care Unit Survivors (DRIVE-PICS) application seeks to implement in-vehicle kinematic driving data with neurocognitive assessments for essential formative work to develop data-based insights into driving behaviors. DRIVE-PICS is designed to contribute to a critical gap in health promotion to develop an evidence-based, in-vehicle driving assessment system to provide actionable driving safety data and rehabilitation strategies tailored to older ICU survivors, the participants' care partners, and clinicians.
Detailed description
There are more than 50 million older adults licensed to drive in the United States. Driving is a complex task requiring cognitive and sensorimotor skills. Survivors of critical illness experience cognitive, psychological and physical impairments, known as Post-Intensive Care Syndrome (PICS), that can last months to years following critical illness. Across the lifespan, ICU recovery has far-reaching implications for independent functioning, employment, and healthcare utilization, costing billions annually. Older adults are at risk for ICU- acquired cognitive decline discernible from clinical, biological, and imaging-related changes in the brain following delirium and critical illness. Similar to other forms of dementia, the combination of normal aging paired with cognitive deficits associated with critical illness survivorship places these older adults at high risk of automobile crashes. To address ICU-acquired cognitive decline, driving assessments to characterize risky driving behaviors are promising to guide driving rehabilitation and intervention development. Rigorous and reproducible driving safety assessment programs have demonstrated success in post-stroke and dementia contexts, established via in-vehicle and virtual modes. The investigators hypothesize that in-vehicle driving assessment and monitoring is a feasible and acceptable approach to assess and address ICU survivor driving safety. The investigators seek to implement novel in-vehicle cloud-data collection technology developed by the investigators' team. The investigators propose to pair neurocognitive assessments with in-vehicle kinematic driving data to conduct essential formative work to develop data-based insights into driving behaviors of older adults with ICU-acquired cognitive declines. The investigators aim to determine protocol feasibility and acceptability of neurocognitive assessments and in-vehicle sensor deployment (Aim 1). The investigators will enroll a cohort of older ICU survivors (n=24) with risk factors for ICU-acquired cognitive impairment to complete neurocognitive measures and participate in driving data collection via in-vehicle sensors over a 6-month post-hospital discharge period. Next, the investigators will evaluate the relationship between neurocognitive assessments and driving behavior and safety in older ICU survivors (Aim 2). Lastly, the investigators will conduct stakeholder advisory panels on the priorities and data presentation needs of driving assessments for older ICU survivors (Aim 3). The stakeholder advisory panel insights will provide scientific justification and protocol feasibility to evaluate recruitment, acceptability and attrition for future full-scale implementation. As the population of older drivers grows, almost doubling in size from 2012 to 2040 there is an immediate and critical need to address this impactful issue. This work is designed in response to the NIA Strategic Plan (Goal C-1-9 Safety of Older Drivers) to contribute to a critical gap in health promotion to develop an evidence-based, in- vehicle driving assessment system to provide actionable driving safety data and rehabilitation strategies tailored to ICU survivors, the participants' care partners and clinicians.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Kinematic Driving Data | – | –Longitudinal kinematic driving data paired with neurocognitive assessments at 3- and 6-months |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU survivors
Key inclusion criteria (6 listed)
- Age 40 and older.
- Must have had an ICU stay with delirium.
- Expected to survive hospital discharge.
- English proficiency
- Active driver within 4 weeks prior to index hospitalization
Key exclusion criteria (4 listed)
- Communication challenges due to severe pre-existing dementia, hearing, or vision impairment.
- No access to driving.
- Loss or suspension of driver's license
- Current Incarceration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total Driving Time
Time frame: 0-6 months after hospital discharge
Total driving time in minutes.
10 secondary outcomes
Depression
Time frame: Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
Executive Function
Time frame: 3 months after hospital discharge, 6 months after hospital discharge
Attention
Time frame: 3 months after hospital discharge, 6 months after hospital discharge
Working Memory
Time frame: 3 months after hospital discharge, 6 months after hospital discharge
Processing Speed
Time frame: 3 months after hospital discharge, 6 months after hospital discharge
Health-Related Quality of Life
Time frame: Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
Anxiety
Time frame: Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
Employment
Time frame: Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
Driving Trips
Time frame: 0-6 months after hospital discharge
Driving Behaviors
Time frame: 0-6 months after hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: Undecided. No study documents available.
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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.
Valerie Danesh, PhD principal investigator
Baylor Scott & White The Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Critical Illness, run by Baylor Research Institute at 1 site in United States.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Feb 2025. 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 States. 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?
Results are not available in the source record.
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?
Total Driving Time (time frame: 0-6 months after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.