Using EMR Data and AI to Develop a Passive Digital Marker to Predict Postoperative Delirium (NCT06216483) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Using EMR Data and AI to Develop a Passive Digital Marker to Predict Postoperative Delirium
United States60 participantsStarted 2024-07-23
Plain-language summary
This study will be a pilot randomized controlled trial that will determine the effect of an indicator of delirium risk, which will be delivered either via a paper form or via the electronic medical record, on (1)postoperative delirium incidence; and (2)the development of long term cognitive decline and dementia.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
65 years old Planned inpatient major surgery requiring inpatient stay ≥ 1 day
Exclusion Criteria:
* Baseline cognitive impairment or a diagnosis of Alzheimer's Disease/Alzheimer's Disease and Related Dementias (AD/ADRD)
* Alcohol or drug withdrawal
* Prisoner status
* Unable to communicate with research staff due to sensory impairments
* Not fluent in English
* Currently has a personal safety attendant
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Delirium incidence as measured by the 3D-CAM
Timeframe: Daily during post-operative inpatient hospitalization through post-operative day 7
2
Delirium incidence as measured by the CAM ICU
Timeframe: Daily during post-operative inpatient hospitalization through post-operative day 7
3
Delirium severity as measured by the CAM ICU
Timeframe: Daily during post-operative inpatient hospitalization through post-operative day 7