Driving Rehabilitation and Innovation for Evaluating Risk in Post-Intensive Care Unit Survivors

NCT ID: NCT05999903

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-13
• Study Completion Date: 2025-07-14

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.

Conditions

Delirium; Critical Illness; Drive

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Observational Kinematic Driving Data

Longitudinal kinematic driving data paired with neurocognitive assessments at 3- and 6-months

No interventions assigned to this group

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valerie Danesh, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor Scott and White Research Institute

Locations

Baylor Scott and White Health Medical Center At Temple

Temple, Texas, United States

Countries

United States

Other Identifiers

1R21AG080339-01

Identifier Type: NIH

Identifier Source: secondary_id

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1R21AG080339-01

Identifier Type: NIH

Identifier Source: org_study_id

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