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| ID | Type | Description | Link |
|---|---|---|---|
| 22-00920 | Other Identifier | Advarra/CIRBI | |
| 5U54AG063546 | U.S. NIH Grant/Contract | View source |
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Study enrollment closed due to low enrollment.
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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical Decision Support | Experimental | Clinical 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Decision Support | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Postoperative day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ira Hofer, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Health System | New York | New York | 10029 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Standard of Care | No clinical decision support will appear, and standard of care procedures will take place. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No baseline characteristics data on individual providers will be collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | Standard Deviation | score on a scale | Postoperative day 7 |
|
7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ira Hofer | Icahn School of Medicine at Mount Sinai | 212-241-7473 | ira.hofer@moungsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 14, 2023 | Jul 24, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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|
| 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. | 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. | Day 1 |
| BG001 | Standard of Care | No clinical decision support will appear, and standard of care procedures will take place. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Standard of Care | No clinical decision support will appear, and standard of care procedures will take place. |
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mmHg | Day 1 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | % MAC | Day 1 |
|
|
|
| 0 |
| 3,634 |
| 0 |
| 3,634 |
| 0 |
| 3,634 |
| EG001 | Standard of Care | No clinical decision support will appear, and standard of care procedures will take place. | 0 | 3,678 | 0 | 3,678 | 0 | 3,678 |
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| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| maintain normothermia |
|