Mitigation of Postoperative Delirium in High-Risk Patients

NCT ID: NCT05777187

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

24426 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-20

Study Completion Date

2024-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Post-operative Delirium Decision Support Systems, Clinical Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Clinical Decision Support

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

Group Type EXPERIMENTAL

Clinical Decision Support

Intervention Type 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.

Standard of Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Ira Hofer

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ira Hofer, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Mount Sinai Health System

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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22-00920

Identifier Type: OTHER

Identifier Source: secondary_id

5U54AG063546

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY-22-00920

Identifier Type: -

Identifier Source: org_study_id

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