Clinical trial NCT05999903: Driving Rehabilitation and Innovation for Evaluating Risk in Post-Intensive Care Unit Survivors
Official title: Driving Rehabilitation and Innovation for Evaluating Risk in Post-Intensive Care Unit Survivors
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: University of Wisconsin, Madison
name: University of Texas at Austin
name: Vanderbilt University
name: National Institute on Aging (NIA)
First posted: 2023-08-21
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU survivors

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Total Driving Time
timeFrame: 0-6 months after hospital discharge
Secondary outcomes:
measure: Depression
timeFrame: Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
measure: Executive Function
timeFrame: 3 months after hospital discharge, 6 months after hospital discharge
measure: Attention
timeFrame: 3 months after hospital discharge, 6 months after hospital discharge
measure: Working Memory
timeFrame: 3 months after hospital discharge, 6 months after hospital discharge
measure: Processing Speed
timeFrame: 3 months after hospital discharge, 6 months after hospital discharge
measure: Health-Related Quality of Life
timeFrame: Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
measure: Anxiety
timeFrame: Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
measure: Employment
timeFrame: Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
measure: Driving Trips
timeFrame: 0-6 months after hospital discharge
measure: Driving Behaviors
timeFrame: 0-6 months after hospital discharge
Other outcomes:
Locations:
city: Temple
country: United States
facility: Baylor Scott and White Health Medical Center At Temple
state: Texas
Study officials:
affiliation: Baylor Scott and White Research Institute
name: Valerie Danesh, PhD
role: PRINCIPAL_INVESTIGATOR
References: