Mitigation of Postoperative Delirium in High-Risk Patients

Not Applicable

Recruiting

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

• Registration Number: NCT05777187
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-03-08
• Study First Posted: 2023-03-21
• Study Start: 2023-06-20
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-29
• Last Update Posted: 2023-10-03
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24426

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
4AT Delirium Score	Postoperative days 0-7	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

Name	Time	Method
Perioperative Best Practices proportion	Day 1	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.

Trial Locations

Locations (1)

Mount Sinai Health System; 🇺🇸 New York, New York, United States