Mitigation of Postoperative Delirium in High-Risk Patients

Mount Sinai Health System

Status: Terminated

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

Treatments: Other: Clinical Decision Support

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05777187

5U54AG063546 (U.S. NIH Grant/Contract)

STUDY-22-00920

22-00920 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 24,426 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24,426 participants in 2 patient groups

Clinical Decision Support

Experimental group

Description:

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

Treatment:

Other: Clinical Decision Support

Standard of Care

No Intervention group

Description:

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