Trial Outcomes & Findings for Mitigation of Postoperative Delirium in High-Risk Patients (NCT NCT05777187)

NCT ID: NCT05777187

Last Updated: 2026-02-19

Results Overview

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)

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

7412 participants

Primary outcome timeframe

Postoperative day 7

Results posted on

2026-02-19

Participant Flow

Participant milestones

Participant milestones
Measure
Clinical Decision Support
Clinical decision support alerts in the electronic health record directed towards anesthesiologists caring for patients with preexisting cognitive impairment. 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.
Standard of Care
No clinical decision support will appear, and standard of care procedures will take place.
Providers
Providers receiving the Clinical Decision Support (CDS) prompts. No identifiers on individual providers will be collected and there will be no analysis at the provider level.
Overall Study
STARTED
3634
3678
100
Overall Study
Screened for Delirium
644
617
0
Overall Study
COMPLETED
3634
3678
100
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mitigation of Postoperative Delirium in High-Risk Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Clinical Decision Support
n=3634 Participants
Clinical decision support alerts in the electronic health record directed towards anesthesiologists caring for patients with preexisting cognitive impairment. 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.
Standard of Care
n=3678 Participants
No clinical decision support will appear, and standard of care procedures will take place.
Providers
Providers receiving the Clinical Decision Support (CDS) prompts. No identifiers on individual providers will be collected and there will be no analysis at the provider level.
Total
n=7312 Participants
Total of all reporting groups
Age, Continuous
64.4 years
STANDARD_DEVIATION 14.6 • n=4 Participants
64.0 years
STANDARD_DEVIATION 14.5
64.2 years
STANDARD_DEVIATION 14.5 • n=30 Participants
Sex: Female, Male
Female
1959 Participants
n=4 Participants
1957 Participants
3916 Participants
n=30 Participants
Sex: Female, Male
Male
1675 Participants
n=4 Participants
1721 Participants
3396 Participants
n=30 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1020 Participants
n=4 Participants
1032 Participants
2052 Participants
n=30 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
2259 Participants
n=4 Participants
2303 Participants
4562 Participants
n=30 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
355 Participants
n=4 Participants
343 Participants
698 Participants
n=30 Participants
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants
n=4 Participants
9 Participants
12 Participants
n=30 Participants
Race (NIH/OMB)
Asian
276 Participants
n=4 Participants
260 Participants
536 Participants
n=30 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
6 Participants
n=4 Participants
3 Participants
9 Participants
n=30 Participants
Race (NIH/OMB)
Black or African American
834 Participants
n=4 Participants
831 Participants
1665 Participants
n=30 Participants
Race (NIH/OMB)
White
1116 Participants
n=4 Participants
1231 Participants
2347 Participants
n=30 Participants
Race (NIH/OMB)
More than one race
1263 Participants
n=4 Participants
1222 Participants
2485 Participants
n=30 Participants
Race (NIH/OMB)
Unknown or Not Reported
136 Participants
n=4 Participants
122 Participants
258 Participants
n=30 Participants

PRIMARY outcome

Timeframe: Postoperative day 7

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)

Outcome measures

Outcome measures
Measure
Clinical Decision Support
n=644 Participants
Clinical decision support alerts in the electronic health record directed towards anesthesiologists caring for patients with preexisting cognitive impairment. 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.
Standard of Care
n=617 Participants
No clinical decision support will appear, and standard of care procedures will take place.
4AT Delirium Score
2.95 score on a scale
Standard Deviation 3.84
2.76 score on a scale
Standard Deviation 3.77

SECONDARY outcome

Timeframe: Day 1

Adherence will be measured as a binary variable; overall protocol adherence will be defined as the number of participants where best practices was 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. Three of 5 intervention domains measured by number of participants where the following conditions met: 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 maintain normothermia is use temperature probe and maintain temperature \>36 degrees Celsius.

Outcome measures

Outcome measures
Measure
Clinical Decision Support
n=3634 Participants
Clinical decision support alerts in the electronic health record directed towards anesthesiologists caring for patients with preexisting cognitive impairment. 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.
Standard of Care
n=3678 Participants
No clinical decision support will appear, and standard of care procedures will take place.
Number of Participants Where Perioperative Best Practices for Intervention Was Performed
avoid potential inappropriate medication
1894 Participants
1907 Participants
Number of Participants Where Perioperative Best Practices for Intervention Was Performed
perioperative glycemic control
3405 Participants
3473 Participants
Number of Participants Where Perioperative Best Practices for Intervention Was Performed
maintain normothermia
3080 Participants
3045 Participants

SECONDARY outcome

Timeframe: Day 1

Avoiding hypotension is one of 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 hypotension is Mean Arterial Pressure (MAP) \>65 mmHg. MAP assess blood flow throughout the body.

Outcome measures

Outcome measures
Measure
Clinical Decision Support
n=3634 Participants
Clinical decision support alerts in the electronic health record directed towards anesthesiologists caring for patients with preexisting cognitive impairment. 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.
Standard of Care
n=3678 Participants
No clinical decision support will appear, and standard of care procedures will take place.
Mean Arterial Pressure >65 mmHg
0.0472 mmHg
Standard Deviation 0.0886
0.0483 mmHg
Standard Deviation 0.0872

SECONDARY outcome

Timeframe: Day 1

Age-adjusted Minimum Alveolar Concentration (MAC) represents the concentration of anesthetic gas required to prevent movement in response to surgical stimuli, adjusted for a patient's age. For every case, age-adjusted MAC values were calculated for each minute during anesthetic administration using standard formulas. The calculation was performed as follows: For every case and for every minute that anesthetic gas was administered to a person, the age-adjusted MAC was calculated using the formula. For each minute, compute the sum of all age adjusted MAC values for all gases administered Next, % MAC was calculated for every case as TOTAL # of mins where MAC\>1 /# of minutes X 100 MAC\>1 indicates that it is more anesthetic than is typical for a patient with given demographics is being administered.

Outcome measures

Outcome measures
Measure
Clinical Decision Support
n=1894 Participants
Clinical decision support alerts in the electronic health record directed towards anesthesiologists caring for patients with preexisting cognitive impairment. 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.
Standard of Care
n=1907 Participants
No clinical decision support will appear, and standard of care procedures will take place.
Age Adjusted Minimum Alveolar Concentration (MAC)
16.5 % MAC
Standard Deviation 24.3
17.0 % MAC
Standard Deviation 24.1

Adverse Events

Clinical Decision Support

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ira Hofer

Icahn School of Medicine at Mount Sinai

Phone: 212-241-7473

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place