Post-operative DeliriumNCT05777187
Mitigation of Postoperative Delirium in High-Risk Patients
A study testing Clinical Decision Support in people with Post-operative Delirium and Decision Support Systems, Clinical, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Post-operative Delirium, Decision Support Systems, Clinical, Cognitive Impairment
- What is being tested?
- Clinical Decision Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,412 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2023to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Integration of Machine Learning and Clinical Decision Support to Prevent Postoperative Delirium in Patients With Cognitive Impairment
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.
- Being tested
- Clinical Decision Support
- Medical subject headings
- Emergence Delirium, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision SupportOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Decision Support | Experimental | Clinical decision support alerts in the electronic health record directed towards anesthesiologists caring for patients with preexisting cognitive impairment. Receives: Other: Clinical Decision Support |
| Standard of Care | No intervention | No clinical decision support will appear, and standard of care procedures will take place. |
What is being measured
The primary outcome is the main question the study is designed to answer.
4AT Delirium Score
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)
Measured: Postoperative day 7
Secondary outcomes (3)
Number of Participants Where Perioperative Best Practices for Intervention Was Performed
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.
Measured: Day 1
Mean Arterial Pressure >65 mmHg
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.
Measured: Day 1
Age Adjusted Minimum Alveolar Concentration (MAC)
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start20 Jun 2023
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Why it stopped: Study enrollment closed due to low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-operative DeliriumStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Ira Hofer, Icahn School of Medicine at Mount Sinai
- Investigators
- Ira Hofer, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777187
- Sponsor's protocol ID
- STUDY-22-00920
- Other IDs
- 22-00920, 5U54AG063546
- Status last verified
- Feb 2026
- First submitted
- 8 Mar 2023
- Last updated
- 19 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research team will be collecting the data in a data warehouse, but it will be extracted by an honest broker de-identified. No participant level data will be shared outside Sinai or the study team.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Machine Learning and Clinical Decision Support to Prevent Postoperative Delirium in Patients With Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05777187
- Acronym / sponsor ID
- STUDY-22-00920
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study enrollment closed due to low enrollment.
- Enrolment
- 7,412 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, National Institute on Aging (NIA)
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 21 Mar 2023 (actual)
- Results
- Posted 19 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Decision Support | Experimental | Other: Clinical Decision SupportClinical decision support alerts in the electronic health record directed towards anesthesiologists caring for patients with preexisting cognitive impairment. |
| Standard of Care | No intervention | –No clinical decision support will appear, and standard of care procedures will take place. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Decision SupportThe 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. | Other | Clinical Decision Support |
Primary outcome
4AT Delirium Score
Time frame: 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)
3 secondary outcomes
Number of Participants Where Perioperative Best Practices for Intervention Was Performed
Time frame: Day 1
Mean Arterial Pressure >65 mmHg
Time frame: Day 1
Age Adjusted Minimum Alveolar Concentration (MAC)
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The research team will be collecting the data in a data warehouse, but it will be extracted by an honest broker de-identified. No participant level data will be shared outside Sinai or the study team.
Related trials for Post-operative Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ira Hofer, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Decision Support in people with Post-operative Delirium and Decision Support Systems, Clinical, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4AT Delirium Score (time frame: Postoperative day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.