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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

Other trials in United States

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.

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 groups in NCT05999903
Study groupRoleWhat they receive
Observational Kinematic Driving DataLongitudinal 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.

  1. Total Driving Time

    Total driving time in minutes.

    Measured: 0-6 months after hospital discharge

Secondary outcomes (10)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

  1. First posted21 Aug 2023
  2. Study start13 Sep 2023
  3. Primary completion9 Dec 2024
  4. Study completion14 Jul 2025 (estimated)

Resources

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)
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.

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.

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