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The objectives of this study are to determine whether identifying patients with baseline cognitive deficits or frailty predict postoperative delirium.
This project is designed as a prospective, single-center observational study. The cohort will consist of 229 consenting subjects ≥ 70 years of age who present to the Brigham and Women's Hospital Weiner Center for Preoperative Evaluation (CPE) prior to elective spine surgery. These ages are chosen as significant clinical data demonstrate increased cognitive impairment in community dwelling elders. Eligibility criteria include: patients ≥ 70 years of age with an American Society of Anesthesiologists (ASA) physical status classification of I-III presenting for elective spine surgery. Exclusion criteria will include planned Intensive Care Unit (ICU) admission postoperatively, history of stroke or brain tumor, uncorrected vision or hearing impairment (unable to see pictures or read or hear instructions); limited use of the dominant hand (limited ability to draw); and or inability to speak, read, or understand English.
Patients will be introduced to the study through a flyer provided to them in their surgeon's office. A study team member will speak with those favorably predisposed to participate to determine if they satisfy eligibility criteria. After obtaining consent, study staff will gain information about the patient's age and years of education. Study staff will administer Health and functional status activities of daily living (ADLs) and instrumental activities of daily living (IADLs), respectively, and the World Health Organization Disability Assessment Scale [WHODAS]) will be administered to all surgical patients. The World Health Organization Disability Assessment Schedule 2.0 is an alternative to the 36-Item Rand Health Survey Short-Form (SF36) to measure physical health and disability. In addition, all patients will be asked if they've had a fall within the last 6 months, whether they've been evaluated for a change in memory or thinking, who accompanied them to their appointment, their employment status and their living situation (alone, institutionalized, living with family members) in a patient survey. The study staff will administer the MiniCog, a simple cognitive screening tool that takes just 2-4 min to complete and has little or no education, language, or race bias. In addition, the Animal Fluency test will be administered, which is a short cognitive screen that takes one minute to complete. Frailty will be measured using the Frail Scale. Other measures of cognitive impairment will be obtained by study staff through: documentation on the patient's standard preoperative form, patient or informant report of diagnosis or evaluation for cognitive impairment or memory concerns, and systematic medical record review. Each enrolled patient will receive a business card listing the investigators' contact information and be advised to expect a follow up telephone up to 6 and 12 months after surgery to verify data elements and reassess functional outcome.
Delirium will be assessed prospectively once per day on postoperative days 1, 2, and 3 if the patient remains hospitalized, by a trained study team member using the Confusion Assessment Method [CAM]. For patients that are in the Intensive Care Unit (ICU) postoperatively, the Confusion Assessment Method for the ICU (CAM-ICU) will be administered prospectively twice per day on postoperative days 1, 2, and 3 if the patient remains hospitalized by a trained study team member (Attachment-CAM-ICU). Delirium is most common on postoperative days 1-3 and the CAM is a well-validated measure of delirium in surgical patients. For functional status, the WHODAS will be administered 6-12 months postoperatively either by personnel in the surgeon's office as part of routine follow up or by study staff or by telephone. We will also collect information on secondary outcomes including discharge to place other than home (rehabilitation, skilled nursing facility), hospital length of stay (LOS), 30-day reoperation or readmission rate, and 30-day mortality. These outcomes are recorded in the medical record, the BWH Balanced Scorecard, an electronic database of all hospitalized patients that tabulates 31 elements of the hospital event, or the Brigham and Women's Hospital BWH Research Patient Database Enhanced Query. Data will also be confirmed by a follow up telephone interview.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| older surgical patients | Older surgical patients presenting for elective spine surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mini Cog | Other | short cognitive screen, short Frailty screen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Delirium by Age | The median ages of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method. The Confusion Assessment Method (CAM) is a short diagnostic interview for CAM-defined delirium. Delirium is defined as the sudden change in someone's thinking ability that can have devastating consequences and can be very easily missed due to its frequent subtlety. The 4 CAM features assessed by the CAM include: acute onset or fluctuation, inattention, disorganized thinking, or altered level of consciousness. | up to 3 days post-op |
| Number of Participants With or Without Delirium by Sex | Sex of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method. | up to 3 days post-op |
| Delirium by Body Mass Index | Median body mass index of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method. | up to 3 days post-op |
| Number of Participants With or Without Delirium by College Degree | Counts of patients with a college degree who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method. | up to 3 days post-op |
| Participants With an ASA Physical Status Score and the Development of Postoperative Delirium | The ASA Physical Status Classification System assesses and communicates a patient's pre-anesthesia medical co-morbidities and is on a scale of I-VI. This study recruited patients with an ASA physical status of I-III. ASA I is defined as a normal healthy patient, ASA II is defined as a patient with a mild systemic disease, ASA III is defined as a patient with severe systemic disease. ASA physical status of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With In-hospital Complications Were Observed During Their Length of Stay in the Hospital With Death Postoperative Death Monitored up to Day 30. | In hospital complications after the surgical procedure including: Myocardial Infarction, congestive heart failure (CHF), Cardiac Arrest, Arrythmia, Pneumonia, pulmonary embolism (PE), Reintubation, Stroke, Delirium, Coma>24h, deep wound infection,Superficial wound infection, Sepsis, Renal Failure, urinary tract infection (UTI), Reoperation, deep vein thrombosis (DVT), intensive care unit (ICU) admission, |
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Inclusion Criteria:
Exclusion Criteria:
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229 consenting subjects ≥ 70 years of age who present to the BWH Weiner Center for Preoperative Evaluation (CPE) prior to elective spine surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Culley, M.D. | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weiner Center for Preoperative Evaluation | Boston | Massachusetts | 02115 | United States |
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Older patients ≥ 70 years of age presenting for elective spine surgery.
Between April 17, 2017 and October 9, 2018, study staff members recruited patients ≥ 70 yr of age scheduled for elective spine surgery at the Brigham and Women's Hospital and were expected to have an inpatient admission after their procedure. We selected this patient population because spine surgery is the third most common surgical procedure in older persons18 and our previous work showed that nearly 20% of this surgical demographic develops delirium postoperatively.
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| ID | Title | Description |
|---|---|---|
| FG000 | Older Surgical Patients Having Spine Surgery | Older surgical patients (≥ 70 years of age) presenting for elective spine surgery. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients ≥ 70 yr of age who were scheduled for elective spine surgery expected to have an inpatient admission after their procedure. Patients were identified in the preoperative evaluation schedule in the electronic medical record. 5 of these patients withdrew from the study and 5 did not have their surgical procedure thus 219 patients were analyzed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Older Surgical Patients | Older surgical patients presenting for elective spine surgery by neurosurgeons Dr. Groff, Dr. Lu and Dr. Chi Mini Cog: short cognitive screen, short Frailty screen |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 5 patients withdrew from the study, 5 patients did not have their surgery |
| 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 | Delirium by Age | The median ages of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method. The Confusion Assessment Method (CAM) is a short diagnostic interview for CAM-defined delirium. Delirium is defined as the sudden change in someone's thinking ability that can have devastating consequences and can be very easily missed due to its frequent subtlety. The 4 CAM features assessed by the CAM include: acute onset or fluctuation, inattention, disorganized thinking, or altered level of consciousness. | Patients over the age of 70 undergoing spinal surgeries | Posted | Median | Inter-Quartile Range | years | up to 3 days post-op |
|
The patients were observed for postoperative complications during their hospital length of stay and death monitored up to postoperative day 30
This was an observational study that only followed patients through their length of stay in the hospital with the exception of 30 day mortality. No patients were identified with 30 day mortality
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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 | Postoperative Outcomes in Older Patients After Spine Surgery | Older surgical patients that had elective spine surgery and developed an in-hospital cardiopulmonary, infectious, renal or cerebrovascular complication. |
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Thirty percent of eligible patients declined participation in this study leading to potential selection bias based on the type of person who chooses to participate in such a study. There is also the possibility that we underestimated the prevalence of post-operative delirium because we only assessed patients for delirium once a day for 3 days post-op and by systematic chart review.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gregory Crosby | BWH | 617-732-7330 | gcrosby@bwh.harvard.edu |
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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 | Jan 28, 2021 | Mar 30, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 27, 2019 | Mar 30, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003221 | Confusion |
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| ID | Term |
|---|---|
| D000073216 | Mental Status and Dementia Tests |
| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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Plasma
| up to 3 days post-op |
| Number of Participants With or Without Delirium by Metabolic Equivalent of Task Score < 4 | Patients with a metabolic equivalent of task (METS) score < 4 who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method. The METS score is a ratio of the working metabolic rate relative to the resting metabolic rate and is one way to describe the intensity of an exercise or activity. This was assessed by the preoperative or surgical study staff. A score of < 3 is for light intesity activities, 3-6 for moderate intensity activities, and ≥ 6 for vigorous intensity activities. | up to 3 days post-op |
| Delirium by Total Number of Medications Taken at Baseline | Median total number of medications of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method. | up to 3 days post-op |
| Number of Participants With or Without Delirium by Opioid Use | Patients with chronic use of opioids who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method. | up to 3 days post-op |
| Number of Participants With or Without Delirium by Alcohol Consumption | Patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method based on alcohol consumption. | up to 3 days post-op |
| Number of Participants With or Without Delirium by Presence of Depression | Patients with depression who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method. | up to 3 days post-op |
| Number of Participants With or Without Delirium by Psychiatric History | Patients with a history of psychiatric disorders who did or did not develop post-operative delirium as assessed by the confusion assessment method. | up to 3 days post-op |
| Delirium by Mini-cog Score | Median mini-cog score of patients who did or did not develop post-operative delirium as assessed by the confusion assessment method. The Mini-Cog is a brief cognitive screening test for visuospatial representation, recall, and executive function. The test involves that includes recalling three words (banana, sunrise, and chair) and a clock drawing. The Mini-Cog has a scale from 0 to 5, a with higher scores suggesting better cognitive performance. One point is designated for each of 3 words recalled and up to two points for the clock drawing component. | up to 3 days post-op |
| Number of Participants With or Without Delirium by FRAIL Score | Robust, pre-frail, and frail patients who did or did not develop post-operative delirium as assessed by the confusion assessment method. | up to 3 days post-op |
| Number of Participants With or Without Delirium by Surgical Invasivness | Surgical invasiveness for patients who did or did not develop post-operative delirium as assessed by the confusion assessment method. The levels of invasiveness were categorized clinically as the following: Tier 1 for microdiscectomy, Tier 2 for lumbar laminectomy, anterior cervical, minimally invasive, foraminotomy, facetectomy, Tier 3 for lumbar fusion, trauma, and post-cervical, and Tier 4 for tumor, infection, deformity, and anterior and posterior cervical. Higher tiers indicate greater levels of invasiveness. Since there were very few patients with an invasiveness of 1 or 4 they were placed into two groups, with invasiveness levels I and 2 or 3 and 4. | up to 3 days post-op |
| duration of hospital stay, up to 30 days |
| Participants' Discharge Location (Home vs. Other Than Home) | Location where patients were discharged (Home vs other than home) on the day of patients discharge from the hospital. | up to 30 days after the surgical procedure |
| Count of Participants |
| Participants |
|
| Age, Continuous | collected from the medical record | 5 Patients withdrew from the study, 5 patients did not have surgery | Median | Inter-Quartile Range | Year |
|
| Sex: Female, Male | binary sex, male or female | 5 patients withdrew from the study and 5 patients did not have surgery | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Frail Scale | 5 point scale with score of 0 meaning robust, 1-2 pre-frail, and scores of 3-5 frail. | 5 patients withdrew from the study, 5 patients did not have their surgery and 1 patient left before completing the frail scale. | Count of Participants | Participants |
|
| Mini-Cog | The Mini-Cog is a brief cognitive screening test for visuospatial representation, recall, and executive function. The test involves that includes recalling three words (banana, sunrise, and chair) and a clock drawing. The Mini-Cog has a scale from 0 to 5, and a score of ≥ 3 indicates better cognitive outcomes. One point is designated for each of 3 words recalled and up to two points for the clock drawing component. | 5 patients withdrew from the study and 5 patients did not have surgery | Median | Inter-Quartile Range | units on a scale |
|
| Animal Verbal Fluency | Number of unique animals the patient can say in 1 minute. Higher number of animals named in 1 minute reflects better cognitive performance | 5 patients withdrew from the study and 5 patients did not have surgery | Mean | Standard Deviation | animals |
|
| Surgical Invasiveness | Surgical invasiveness on a 4 point scale. The stages were categorized clinically as the following: Tier 1 for microdiscectomy, Tier 2 for lumbar laminectomy, anterior cervical, minimally invasive, foraminotomy, facetectomy, Tier 3 for lumbar fusion, trauma, and post-cervical, and Tier 4 for tumor, infection, deformity, and anterior and posterior cervical. Higher tiers indicate greater levels of invasiveness. Since there were very few patients with an invasiveness of 1 or 4 they were placed into two groups, with invasiveness levels I and 2 or 3 and 4. | 5 patients withdrew from the study and 5 patients did not have their surgery | Count of Participants | Participants |
|
| Body Mass Index | 5 of these patients withdrew from the study and 5 did not have their surgical procedure and 2 patients did not have their BMI recorded in the medical record | Median | Inter-Quartile Range | kg/m^2 |
|
| Level of education | Patients were divided into those that had less than a bachelors degree, and those that had a bachelors degree or higher | 5 of these patients withdrew from the study and 5 did not have their surgical procedure. An additional 7 did not provide information on their level of education. | Count of Participants | Participants |
|
| ASA Physical Status | Scaled score with lower scores having a better functional status than a higher score. | 5 patients withdrew from the study and 5 patients did not have their surgery. | Count of Participants | Participants |
|
| Metabolic equivalents of task | scaled score where a higher number means the patient is more physically fit. | 5 of these patients withdrew from the study and 5 did not have their surgical procedure and an additional 10 patients did not have this noted in their medical record. | Count of Participants | Participants |
|
| Total number of medications | 5 patients withdrew from the study and 5 patients did not have their surgery | Median | Inter-Quartile Range | total number of medications |
|
| Preoperative use of opioids | 5 patients withdrew from the study and 5 patients did not have their surgery | Count of Participants | Participants |
|
| Alcohol consumption | patient consumed alcohol preoperatively | 5 patients withdrew from the study and 5 patients did not have their surgery. | Count of Participants | Participants |
|
| History of depression | 5 patients withdrew from the study and 5 patients did not have their surgery | Count of Participants | Participants |
|
| Psychiatric History | History of psychiatric illness | 5 patients withdrew from the study and 5 patients did not have their surgery | Count of Participants | Participants |
|
| OG001 |
| Delirium |
Older surgical patients presenting for elective spine surgery that did develop post-op delirium |
|
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| Primary | Number of Participants With or Without Delirium by Sex | Sex of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method. | Posted | Count of Participants | Participants | up to 3 days post-op |
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| Primary | Delirium by Body Mass Index | Median body mass index of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method. | Posted | Median | Inter-Quartile Range | kg/m^2 | up to 3 days post-op |
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| Primary | Number of Participants With or Without Delirium by College Degree | Counts of patients with a college degree who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method. | Posted | Count of Participants | Participants | No | up to 3 days post-op |
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| Primary | Participants With an ASA Physical Status Score and the Development of Postoperative Delirium | The ASA Physical Status Classification System assesses and communicates a patient's pre-anesthesia medical co-morbidities and is on a scale of I-VI. This study recruited patients with an ASA physical status of I-III. ASA I is defined as a normal healthy patient, ASA II is defined as a patient with a mild systemic disease, ASA III is defined as a patient with severe systemic disease. ASA physical status of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method. | Posted | Count of Participants | Participants | up to 3 days post-op |
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| Primary | Number of Participants With or Without Delirium by Metabolic Equivalent of Task Score < 4 | Patients with a metabolic equivalent of task (METS) score < 4 who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method. The METS score is a ratio of the working metabolic rate relative to the resting metabolic rate and is one way to describe the intensity of an exercise or activity. This was assessed by the preoperative or surgical study staff. A score of < 3 is for light intesity activities, 3-6 for moderate intensity activities, and ≥ 6 for vigorous intensity activities. | Posted | Count of Participants | Participants | No | up to 3 days post-op |
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| Primary | Delirium by Total Number of Medications Taken at Baseline | Median total number of medications of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method. | Posted | Median | Inter-Quartile Range | medications | up to 3 days post-op |
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| Primary | Number of Participants With or Without Delirium by Opioid Use | Patients with chronic use of opioids who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method. | Posted | Count of Participants | Participants | up to 3 days post-op |
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| Primary | Number of Participants With or Without Delirium by Alcohol Consumption | Patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method based on alcohol consumption. | Posted | Count of Participants | Participants | up to 3 days post-op |
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| Primary | Number of Participants With or Without Delirium by Presence of Depression | Patients with depression who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method. | Posted | Count of Participants | Participants | up to 3 days post-op |
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| Primary | Number of Participants With or Without Delirium by Psychiatric History | Patients with a history of psychiatric disorders who did or did not develop post-operative delirium as assessed by the confusion assessment method. | Posted | Count of Participants | Participants | up to 3 days post-op |
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| Primary | Delirium by Mini-cog Score | Median mini-cog score of patients who did or did not develop post-operative delirium as assessed by the confusion assessment method. The Mini-Cog is a brief cognitive screening test for visuospatial representation, recall, and executive function. The test involves that includes recalling three words (banana, sunrise, and chair) and a clock drawing. The Mini-Cog has a scale from 0 to 5, a with higher scores suggesting better cognitive performance. One point is designated for each of 3 words recalled and up to two points for the clock drawing component. | Posted | Median | Inter-Quartile Range | scores on a scale | up to 3 days post-op |
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| Primary | Number of Participants With or Without Delirium by FRAIL Score | Robust, pre-frail, and frail patients who did or did not develop post-operative delirium as assessed by the confusion assessment method. | Posted | Count of Participants | Participants | up to 3 days post-op |
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| Primary | Number of Participants With or Without Delirium by Surgical Invasivness | Surgical invasiveness for patients who did or did not develop post-operative delirium as assessed by the confusion assessment method. The levels of invasiveness were categorized clinically as the following: Tier 1 for microdiscectomy, Tier 2 for lumbar laminectomy, anterior cervical, minimally invasive, foraminotomy, facetectomy, Tier 3 for lumbar fusion, trauma, and post-cervical, and Tier 4 for tumor, infection, deformity, and anterior and posterior cervical. Higher tiers indicate greater levels of invasiveness. Since there were very few patients with an invasiveness of 1 or 4 they were placed into two groups, with invasiveness levels I and 2 or 3 and 4. | Posted | Count of Participants | Participants | up to 3 days post-op |
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| Secondary | Number of Participants With In-hospital Complications Were Observed During Their Length of Stay in the Hospital With Death Postoperative Death Monitored up to Day 30. | In hospital complications after the surgical procedure including: Myocardial Infarction, congestive heart failure (CHF), Cardiac Arrest, Arrythmia, Pneumonia, pulmonary embolism (PE), Reintubation, Stroke, Delirium, Coma>24h, deep wound infection,Superficial wound infection, Sepsis, Renal Failure, urinary tract infection (UTI), Reoperation, deep vein thrombosis (DVT), intensive care unit (ICU) admission, | All spine surgery patients enrolled in the study. | Posted | Count of Participants | Participants | duration of hospital stay, up to 30 days |
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| Secondary | Participants' Discharge Location (Home vs. Other Than Home) | Location where patients were discharged (Home vs other than home) on the day of patients discharge from the hospital. | Posted | Count of Participants | Participants | up to 30 days after the surgical procedure |
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| 0 |
| 219 |
| 0 |
| 219 |
| 0 |
| 219 |
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| D019954 |
| Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Frail (score 3-5) |
|