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Clinical Decision Support for Delirium
N/A
Recruiting
Led By Ira Hofer, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postoperative days 0-7
Awards & highlights
Study Summary
This trial will assess if a set of best practices can reduce cases of POD in people with cognitive impairment who undergo surgery. EHR data & CDS will be used.
Who is the study for?
This trial is for adult patients with cognitive impairment who are undergoing surgery at Mount Sinai Health System. It's also for the healthcare providers there receiving alerts during electronic health record system use. Patients can't join if it's not their first surgery since the study started, they lack documented cognitive impairment, or if the surgery is for organ donation.Check my eligibility
What is being tested?
The trial tests whether clinical decision support (CDS) prompts in electronic health records can reduce postoperative delirium (POD) in high-risk patients with cognitive issues. Half of these patients will receive usual care; the other half will get special alerts and best practice recommendations.See study design
What are the potential side effects?
Since this intervention involves information prompts rather than medications, traditional side effects aren't expected. However, there may be indirect effects on patient care based on how healthcare providers respond to these new CDS prompts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ postoperative days 0-7
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postoperative days 0-7
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
4AT Delirium Score
Secondary outcome measures
Perioperative Best Practices proportion
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Clinical Decision SupportExperimental Treatment1 Intervention
Clinical decision support alerts in the electronic health record directed towards anesthesiologists caring for patients with preexisting cognitive impairment.
Group II: Standard of CareActive Control1 Intervention
No clinical decision support will appear, and standard of care procedures will take place.
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
871 Previous Clinical Trials
502,837 Total Patients Enrolled
University of California, Los AngelesOTHER
1,538 Previous Clinical Trials
10,242,604 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,699 Previous Clinical Trials
28,008,350 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- This criterion means that doctors, resident doctors, and nurse anesthetists at Mount Sinai Health System who are getting computerized alerts during the installation of a new electronic health record system.This is my first surgery since the study began.I am not having surgery to donate an organ.I am an adult with a history of cognitive issues and am having surgery at Mount Sinai.
Research Study Groups:
This trial has the following groups:- Group 1: Clinical Decision Support
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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