Mitigation of Postoperative Delirium in High-Risk Patients

NCT05777187 | Terminated Results DMC

• 3 other identifiers: STUDY-22-0092022-009205U54AG063546
• Study Type: interventional
• Target: 7,412
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 4AT Delirium Score

  Postoperative Delirium measured using the 4 A's Test (4AT) delirium assessment documentation. The 4AT is a commonly used tool that identifies the presence/absence of Postoperative Delirium (POD). It consists of 4 sections; alertness, AMT4: Abbreviated Mental Test -4, attention, and acute change of fluctuating course. The 4AT is scored from 0-12, with higher score indicating poorer health outcomes. 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 day 7

Secondary Outcomes (3)

• Number of Participants Where Perioperative Best Practices for Intervention Was Performed

  Day 1

• Mean Arterial Pressure >65 mmHg

  Day 1

• Age Adjusted Minimum Alveolar Concentration (MAC)

  Day 1

Study Arms (2)

Clinical Decision Support

EXPERIMENTAL

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

Other: Clinical Decision Support

Standard of Care

NO INTERVENTION

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

Interventions

Clinical Decision Support OTHER

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.

Clinical Decision Support

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• Icahn School of Medicine at Mount Sinai: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

Mount Sinai Health System

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Emergence Delirium; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Results Point of Contact

• Title: Dr. Ira Hofer
• Organization: Icahn School of Medicine at Mount Sinai

ira.hofer@moungsinai.org

212-241-7473

Study Officials

• Ira Hofer, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 21, 2023
• Study Start: June 20, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: February 19, 2026
• Results First Posted: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)