Cognitive Impairment, Decision Support Systems, Clinical, Post-operative Delirium
Conditions
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.
Interventions
OTHERClinical 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.
Sponsors
Icahn School of Medicine at Mount Sinai
University of California, Los Angeles
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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.
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 4AT Delirium Score | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Where Perioperative Best Practices for Intervention Was Performed | 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. |
| Mean Arterial Pressure >65 mmHg | 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. |
| Age Adjusted Minimum Alveolar Concentration (MAC) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORIra Hofer, MD
Icahn School of Medicine at Mount Sinai
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 64.4 years STANDARD_DEVIATION 14.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1032 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2303 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 343 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 260 Participants |
| Race (NIH/OMB) Black or African American | 831 Participants |
| Race (NIH/OMB) More than one race | 2485 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 9 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 122 Participants |
| Race (NIH/OMB) White | 2347 Participants |
| Sex: Female, Male Female | 1959 Participants |
| Sex: Female, Male Male | 1675 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3,634 | 0 / 3,678 |
| other Total, other adverse events | 0 / 3,634 | 0 / 3,678 |
| serious Total, serious adverse events | 0 / 3,634 | 0 / 3,678 |
Outcome results
None listed