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Mitigation of Postoperative Delirium in High-Risk Patients

Primary Purpose

Post-operative Delirium, Decision Support Systems, Clinical, Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical Decision Support
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-operative Delirium

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mount Sinai Health SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Clinical Decision Support

Standard of Care

Arm Description

Clinical decision support alerts in the electronic health record directed towards anesthesiologists caring for patients with preexisting cognitive impairment.

No clinical decision support will appear, and standard of care procedures will take place.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

Full Information

First Posted
March 8, 2023
Last Updated
September 29, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
University of California, Los Angeles, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05777187
Brief Title
Mitigation of Postoperative Delirium in High-Risk Patients
Official Title
Integration of Machine Learning and Clinical Decision Support to Prevent Postoperative Delirium in Patients With Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
University of California, Los Angeles, National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Delirium, Decision Support Systems, Clinical, Cognitive Impairment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24426 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clinical Decision Support
Arm Type
Experimental
Arm Description
Clinical decision support alerts in the electronic health record directed towards anesthesiologists caring for patients with preexisting cognitive impairment.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
No clinical decision support will appear, and standard of care procedures will take place.
Intervention Type
Other
Intervention Name(s)
Clinical Decision Support
Intervention Description
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.
Primary Outcome Measure Information:
Title
4AT Delirium Score
Description
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)
Time Frame
Postoperative days 0-7
Secondary Outcome Measure Information:
Title
Perioperative Best Practices proportion
Description
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.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kerry R Meyers, MPH
Phone
646-901-9237
Email
kerry.meyers@mssm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rachelle Weisman, MPH
Phone
(332) 237-8978
Email
rachelle.weisman@mssm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ira Hofer, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Health System
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry R Meyers, MPH
Phone
646-901-9237
Email
kerry.meyers@mssm.edu
First Name & Middle Initial & Last Name & Degree
Rachelle Weisman, MPH
Phone
(332) 237-8978
Email
rachelle.weisman@mssm.edu
First Name & Middle Initial & Last Name & Degree
Ira Hofer

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Mitigation of Postoperative Delirium in High-Risk Patients

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