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Terminated
Study enrollment closed due to low enrollment.

Mitigation of Postoperative Delirium in High-Risk Patients

ClinicalTrials.gov ID NCT05777187
Sponsor Icahn School of Medicine at Mount Sinai
Information provided by Ira Hofer, Icahn School of Medicine at Mount Sinai (Responsible Party)
Last Update Posted 2024-09-19
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Study Overview

Brief Summary
Among patients with cognitive impairment (CI) that undergo surgery, the risk for developing postoperative delirium (POD) is high (50%) and associated with further morbidity and mortality. Yet, 30-40% of POD cases are preventable with perioperative management. This randomized pragmatic clinical trial aims to assess incidence of POD in adult surgical patients with CI, as well as provider adherence to a set of 12 perioperative best practice recommendations for perioperative management. Electronic health record (EHR) data will be used to identify patients as high risk for developing POD and clinical decision support (CDS) prompts within the EHR will display best practices. Cases will be randomized to either the control group, usual care or the intervention which includes the high-risk alert and best practice prompts.
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Official Title
Integration of Machine Learning and Clinical Decision Support to Prevent Postoperative Delirium in Patients with Cognitive Impairment
Conditions
Post-operative Delirium
Decision Support Systems, Clinical
Cognitive Impairment
Intervention / Treatment
  • Other: Clinical Decision Support
  • Other: Clinical Decision Support
Other Study ID Numbers
Study Start (Actual)
2023-06-20
Primary Completion (Actual)
2024-08-31
Study Completion (Actual)
2024-08-31
Enrollment (Actual)
24426
Study Type
Interventional
Phase
Not Applicable

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

This study has 1 location
United States
New York Locations
New York, New York, United States, 10029

Mount Sinai Health System
Click to view interactive map

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

Inclusion Criteria:

  • Adult patients with a history of cognitive impairment (CI) undergoing surgery at the Mount Sinai Health System.
  • Attending physicians, resident physicians, and nurse anesthetists at the Mount Sinai Health System receiving CDS alerts during EHR system implementation.

Exclusion Criteria:

  • Patients will be excluded if this not their first surgery since study start, if they do not have cognitive impairment based on EHR data, or if the surgery is for organ donation.
  • There will be no exclusion criteria for providers or historical controls.
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Ages Eligible for Study
18 Years to 120 Years (AdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Primary Purpose : Prevention
Allocation : Randomized
Interventional Model : Parallel Assignment
Masking : None (Open Label)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Experimental: Clinical Decision Support
Clinical decision support alerts in the electronic health record directed towards anesthesiologists caring for patients with preexisting cognitive impairment.
Intervention/Treatment Other: Clinical Decision Support
  • The intervention will consist of clinical decision support alerts in the electronic health record directed towards anesthesiologists caring for patients with preexisting cognitive impairment. This intervention will alert towards delirium risk informed by history of cognitive impairment and promote 12 evidence based best practices during care for perioperative patients.

Participant Group/Arm No Intervention: Standard of Care
No clinical decision support will appear, and standard of care procedures will take place.
Intervention/Treatment
Primary Outcome Measures
Outcome Measure Measure Description Time Frame
4AT Delirium Score

Incidence of Postoperative Delirium measured using the 4AT delirium assessment documentation

Scoring:

4 or above: possible delirium +/- cognitive impairment 1-3: possible cognitive impairment 0: delirium or severe cognitive impairment unlikely (but delirium still possible if [4] information incomplete)

Postoperative days 0-7
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
Perioperative Best Practices proportion

For each of the 12 practices, adherence will be measured as a binary variable; overall protocol adherence will be defined as the proportion of the 12 practices performed by the anesthesia team.

The 12 perioperative best practices are grouped in 5 intervention domains including, avoid potential inappropriate medication, perioperative glycemic control, avoid hypotension, maintain normothermia, and titrate anesthetic depth. Within avoid potential inappropriate medication is avoid diphenhydramine, scopolamine, and midazolam. Within perioperative glycemic control is check pre-op glucose, check glucose every 2 hours, maintain glucose <200 mg/dL, and check post-anesthesia care unit glucose. Within avoid hypotension is Mean Arterial Pressure >65 mmHg. Within maintain normothermia is use temperature probe and maintain temperature >36 degrees Celsius. Within titrate anesthetic depth is age adjusted MAC<1 and monitor anesthesia depth.

Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
  • University of California, Los Angeles
  • National Institute on Aging (NIA)
Investigators
  • Principal Investigator:Ira Hofer, MD,Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2023-03-08
First Submitted that Met QC Criteria
2023-03-08
First Posted
2023-03-21
Study Record Updates
Last Update Submitted that met QC Criteria
2024-09-05
Last Update Posted
2024-09-19
Last Verified
2024-09

More Information

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Additional Relevant MeSH Terms

Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
The research team will be collecting the data in a data warehouse, but it will be extracted by an honest broker de-identified. No participant level data will be shared outside Sinai or the study team.