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

Critical Illness Clinical Trial

— DRIVE-PICS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05999903
• Other study ID #: 1R21AG080339-01
• Secondary ID: 1R21AG080339-01
• Status: Recruiting
• Start date: September 13, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Baylor Research Institute
• Contact: Valerie Danesh, PhD
• Phone: 2547714853
• Email: CAHRcriticalcare[@]bswhealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Delirium
• Drive

Locations

Country	Name	City	State
United States	Baylor Scott and White Health Medical Center At Temple	Temple	Texas

Sponsors (6)

Lead Sponsor	Collaborator
Baylor Research Institute	National Institute on Aging (NIA), National Institutes of Health (NIH), University of Texas at Austin, University of Wisconsin, Madison, Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Driving Time	Total driving time in minutes.	0-6 months after hospital discharge
Secondary	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.	Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
Secondary	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).	3 months after hospital discharge, 6 months after hospital discharge
Secondary	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.	3 months after hospital discharge, 6 months after hospital discharge
Secondary	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).	3 months after hospital discharge, 6 months after hospital discharge
Secondary	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.	3 months after hospital discharge, 6 months after hospital discharge
Secondary	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.	Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
Secondary	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.	Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
Secondary	Employment	Employment will be measured through the Johns Hopkins OACIS Employment Questionnaire. It is not a scored questionnaire.	Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
Secondary	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.	0-6 months after hospital discharge
Secondary	Driving Behaviors	Driving behaviors will be measured using near-crash events that are detected with validated accelerometer thresholds.	0-6 months after hospital discharge