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)
TERMINATED
NA
7412 participants
Postoperative day 7
2026-02-19
Participant Flow
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
| 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 7Postoperative 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
| 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 1Adherence 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
| 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 1Avoiding 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
| 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 1Age-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
| 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
Standard of Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place