Mitigation of Postoperative Delirium in High-Risk Patients

Cognitive Impairment Clinical Trial

Official title:

Integration of Machine Learning and Clinical Decision Support to Prevent Postoperative Delirium in Patients With Cognitive Impairment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05777187
• Other study ID #: GCO 22-0012
• Secondary ID: 22-009205U54AG06
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2023
• Est. completion date: September 2024

Study information

• Verified date: September 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Kerry R Meyers, MPH
• Phone: 646-901-9237
• Email: kerry.meyers[@]mssm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24426
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Decision Support Systems, Clinical
• Delirium
• Emergence Delirium
• Post-operative Delirium

Intervention

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.

Locations

Country	Name	City	State
United States	Mount Sinai Health System	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute on Aging (NIA), University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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