Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-03-05 @ 11:02 AM
Study NCT ID:
NCT02922634
Status:
COMPLETED
Last Update Posted:
2021-07-21
First Post:
2016-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Preoperative Cognitive Screening in Older Spinal Surgical Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073216', 'term': 'Mental Status and Dementia Tests'}], 'ancestors': [{'id': 'D009483', 'term': 'Neuropsychological Tests'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gcrosby@bwh.harvard.edu', 'phone': '617-732-7330', 'title': 'Dr. Gregory Crosby', 'organization': 'BWH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '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.'}}, 'adverseEventsModule': {'timeFrame': 'The patients were observed for postoperative complications during their hospital length of stay and death monitored up to postoperative day 30', 'description': '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', 'eventGroups': [{'id': 'EG000', 'title': 'Postoperative Outcomes in Older Patients After Spine Surgery', 'description': 'Older surgical patients that had elective spine surgery and developed an in-hospital cardiopulmonary, infectious, renal or cerebrovascular complication.', 'otherNumAtRisk': 219, 'deathsNumAtRisk': 219, 'otherNumAffected': 0, 'seriousNumAtRisk': 219, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Delirium by Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Delirium', 'description': 'Older surgical patients presenting for elective spine surgery that did not develop post-op delirium'}, {'id': 'OG001', 'title': 'Delirium', 'description': 'Older surgical patients presenting for elective spine surgery that did develop post-op delirium'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '73', 'upperLimit': '79'}, {'value': '77', 'groupId': 'OG001', 'lowerLimit': '72', 'upperLimit': '80'}]}]}], 'analyses': [{'pValue': '0.508', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 3 days post-op', 'description': "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.", 'unitOfMeasure': 'years', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients over the age of 70 undergoing spinal surgeries'}, {'type': 'PRIMARY', 'title': 'Number of Participants With or Without Delirium by Sex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Delirium', 'description': 'Older surgical patients presenting for elective spine surgery that did not develop post-op delirium'}, {'id': 'OG001', 'title': 'Delirium', 'description': 'Older surgical patients presenting for elective spine surgery that did develop post-op delirium'}], 'classes': [{'categories': [{'title': 'Male', 'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'title': 'Female', 'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.720', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The chi-squared test for both males and females with and without delirium.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 3 days post-op', 'description': 'Sex of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Delirium by Body Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Delirium', 'description': 'Older surgical patients presenting for elective spine surgery that did not develop post-op delirium'}, {'id': 'OG001', 'title': 'Delirium', 'description': 'Older surgical patients presenting for elective spine surgery that did develop post-op delirium'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '32'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '26', 'upperLimit': '34'}]}]}], 'analyses': [{'pValue': '0.025', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 3 days post-op', 'description': 'Median body mass index of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With or Without Delirium by College Degree', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Delirium', 'description': 'Older surgical patients presenting for elective spine surgery that did not develop post-op delirium'}, {'id': 'OG001', 'title': 'Delirium', 'description': 'Older surgical patients presenting for elective spine surgery that did develop post-op delirium'}], 'classes': [{'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.480', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 3 days post-op', 'description': 'Counts of patients with a college degree who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Participants With an ASA Physical Status Score and the Development of Postoperative Delirium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Delirium', 'description': 'Older surgical patients presenting for elective spine surgery with an ASA Physical that did not develop post-op delirium'}, {'id': 'OG001', 'title': 'Delirium', 'description': 'Older surgical patients presenting for elective spine surgery with an ASA physical status of that did develop post-op delirium'}], 'classes': [{'categories': [{'title': 'ASA Physical status of greater than or equal to 3', 'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'title': 'ASA Physical Status of less than 3', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.028', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 3 days post-op', 'description': "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.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With or Without Delirium by Metabolic Equivalent of Task Score < 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Delirium', 'description': 'Older surgical patients presenting for elective spine surgery that did not develop post-op delirium'}, {'id': 'OG001', 'title': 'Delirium', 'description': 'Older surgical patients presenting for elective spine surgery that did develop post-op delirium'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 3 days post-op', 'description': '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.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Delirium by Total Number of Medications Taken at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Delirium', 'description': 'Older surgical patients presenting for elective spine surgery that did not develop post-op delirium'}, {'id': 'OG001', 'title': 'Delirium', 'description': 'Older surgical patients presenting for elective spine surgery that did develop post-op delirium'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '10'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '12'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 3 days post-op', 'description': 'Median total number of medications of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.', 'unitOfMeasure': 'medications', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With or Without Delirium by Opioid Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Delirium', 'description': 'Older surgical patients presenting for elective spine surgery that did not develop post-op delirium'}, {'id': 'OG001', 'title': 'Delirium', 'description': 'Older surgical patients presenting for elective spine surgery that did develop post-op delirium'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 3 days post-op', 'description': 'Patients with chronic use of opioids who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With or Without Delirium by Alcohol Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Delirium', 'description': 'Older surgical patients presenting for elective spine surgery that did not develop post-op delirium'}, {'id': 'OG001', 'title': 'Delirium', 'description': 'Older surgical patients presenting for elective spine surgery that did develop post-op delirium'}], 'classes': [{'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.101', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 3 days post-op', 'description': 'Patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method based on alcohol consumption.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With or Without Delirium by Presence of Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Delirium', 'description': 'Older spine surgery patients who did not develop post-operative delirium'}, {'id': 'OG001', 'title': 'Delirium', 'description': 'Older spine surgery patients who did develop post-operative delirium'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.192', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 3 days post-op', 'description': 'Patients with depression who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With or Without Delirium by Psychiatric History', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Delirium', 'description': 'Older surgical patients presenting for elective spine surgery that did not develop post-op delirium'}, {'id': 'OG001', 'title': 'Delirium', 'description': 'Older surgical patients presenting for elective spine surgery that did develop post-op delirium'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.200', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 3 days post-op', 'description': 'Patients with a history of psychiatric disorders who did or did not develop post-operative delirium as assessed by the confusion assessment method.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Delirium by Mini-cog Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Delirium', 'description': 'Older surgical patients presenting for elective spine surgery that did not develop post-op delirium'}, {'id': 'OG001', 'title': 'Delirium', 'description': 'Older surgical patients presenting for elective spine surgery that did develop post-op delirium'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '0.333', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 3 days post-op', 'description': '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.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With or Without Delirium by FRAIL Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Delirium', 'description': 'Older surgical patients presenting for elective spine surgery that did not develop post-op delirium'}, {'id': 'OG001', 'title': 'Delirium', 'description': 'Older surgical patients presenting for elective spine surgery that did develop post-op delirium'}], 'classes': [{'title': 'Robust (score 0)', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Pre-frail (score 1 and 2)', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Frail (score 3-5)', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'This is a chi-squared test between the FRAIL categories for participants with or without delirium.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 3 days post-op', 'description': 'Robust, pre-frail, and frail patients who did or did not develop post-operative delirium as assessed by the confusion assessment method.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With or Without Delirium by Surgical Invasivness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Delirium', 'description': 'Older surgical patients presenting for elective spine surgery that did not develop post-op delirium'}, {'id': 'OG001', 'title': 'Delirium', 'description': 'Older surgical patients presenting for elective spine surgery that did develop post-op delirium'}], 'classes': [{'categories': [{'title': 'Tier 1 + 2', 'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'Tier 3 + 4', 'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'This is a chi-squared test of the categories for levels of invasiveness for participants with or without delirium.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 3 days post-op', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '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.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'In Hospital Complications', 'description': 'Patients that experienced in hospital complications not including post-operative delirium.'}], 'classes': [{'categories': [{'title': 'no in-hospital complications', 'measurements': [{'value': '151', 'groupId': 'OG000'}]}, {'title': 'in-hospital complications', 'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'duration of hospital stay, up to 30 days', 'description': '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,', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All spine surgery patients enrolled in the study.'}, {'type': 'SECONDARY', 'title': "Participants' Discharge Location (Home vs. Other Than Home)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Discharge Location', 'description': 'Discharge location (home vs place other than home) for patients who participated in this study.'}], 'classes': [{'categories': [{'title': 'Home', 'measurements': [{'value': '138', 'groupId': 'OG000'}]}, {'title': 'Place other than home', 'measurements': [{'value': '77', 'groupId': 'OG000'}]}, {'title': 'Not documented', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 30 days after the surgical procedure', 'description': 'Location where patients were discharged (Home vs other than home) on the day of patients discharge from the hospital.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Older Surgical Patients Having Spine Surgery', 'description': 'Older surgical patients (≥ 70 years of age) presenting for elective spine surgery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '229'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '219'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Did not have their surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'recruitmentDetails': "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.", 'preAssignmentDetails': 'Older patients ≥ 70 years of age presenting for elective spine surgery.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Older Surgical Patients', 'description': 'Older surgical patients presenting for elective spine surgery by neurosurgeons Dr. Groff, Dr. Lu and Dr. Chi\n\nMini Cog: short cognitive screen, short Frailty screen'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '219', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '5 patients withdrew from the study, 5 patients did not have their surgery'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000', 'lowerLimit': '73', 'upperLimit': '79'}]}]}], 'paramType': 'MEDIAN', 'description': 'collected from the medical record', 'unitOfMeasure': 'Year', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': '5 Patients withdrew from the study, 5 patients did not have surgery'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '95', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '124', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'binary sex, male or female', 'unitOfMeasure': 'Participants', 'populationDescription': '5 patients withdrew from the study and 5 patients did not have surgery'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '219', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Frail Scale', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Score 0', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}, {'title': 'Score 1-2', 'measurements': [{'value': '117', 'groupId': 'BG000'}]}, {'title': 'Score 3-5', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '5 point scale with score of 0 meaning robust, 1-2 pre-frail, and scores of 3-5 frail.', 'unitOfMeasure': 'Participants', 'populationDescription': '5 patients withdrew from the study, 5 patients did not have their surgery and 1 patient left before completing the frail scale.'}, {'title': 'Mini-Cog', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000', 'lowerLimit': '3', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': '5 patients withdrew from the study and 5 patients did not have surgery'}, {'title': 'Animal Verbal Fluency', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18', 'spread': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Number of unique animals the patient can say in 1 minute. Higher number of animals named in 1 minute reflects better cognitive performance', 'unitOfMeasure': 'animals', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '5 patients withdrew from the study and 5 patients did not have surgery'}, {'title': 'Surgical Invasiveness', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Tier 1 and 2', 'measurements': [{'value': '111', 'groupId': 'BG000'}]}, {'title': 'Tier 3 and 4', 'measurements': [{'value': '108', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '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.', 'unitOfMeasure': 'Participants', 'populationDescription': '5 patients withdrew from the study and 5 patients did not have their surgery'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000', 'lowerLimit': '25', 'upperLimit': '32'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': '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'}, {'title': 'Level of education', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Bachelors degree or higher', 'measurements': [{'value': '144', 'groupId': 'BG000'}]}, {'title': 'Less than a bachelors degree', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Patients were divided into those that had less than a bachelors degree, and those that had a bachelors degree or higher', 'unitOfMeasure': 'Participants', 'populationDescription': '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.'}, {'title': 'ASA Physical Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'BG000'}]}], 'categories': [{'title': 'ASA 1 or 2', 'measurements': [{'value': '70', 'groupId': 'BG000'}]}, {'title': 'ASA 3 or 4', 'measurements': [{'value': '149', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Scaled score with lower scores having a better functional status than a higher score.', 'unitOfMeasure': 'Participants', 'populationDescription': '5 patients withdrew from the study and 5 patients did not have their surgery.'}, {'title': 'Metabolic equivalents of task', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'BG000'}]}], 'categories': [{'title': 'METS < 4', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}, {'title': 'METS ≥ 4', 'measurements': [{'value': '149', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'scaled score where a higher number means the patient is more physically fit.', 'unitOfMeasure': 'Participants', 'populationDescription': '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.'}, {'title': 'Total number of medications', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000', 'lowerLimit': '5', 'upperLimit': '11'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'total number of medications', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': '5 patients withdrew from the study and 5 patients did not have their surgery'}, {'title': 'Preoperative use of opioids', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'BG000'}]}], 'categories': [{'title': 'preoperative opioid use', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}, {'title': 'No preoperative use of opioids', 'measurements': [{'value': '164', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '5 patients withdrew from the study and 5 patients did not have their surgery'}, {'title': 'Alcohol consumption', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '125', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '94', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'patient consumed alcohol preoperatively', 'unitOfMeasure': 'Participants', 'populationDescription': '5 patients withdrew from the study and 5 patients did not have their surgery.'}, {'title': 'History of depression', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '180', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '5 patients withdrew from the study and 5 patients did not have their surgery'}, {'title': 'Psychiatric History', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '197', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'History of psychiatric illness', 'unitOfMeasure': 'Participants', 'populationDescription': '5 patients withdrew from the study and 5 patients did not have their surgery'}], 'populationDescription': '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.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-28', 'size': 162720, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-30T09:47', 'hasProtocol': True}, {'date': '2019-12-27', 'size': 201949, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-03-30T09:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 229}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2019-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-30', 'studyFirstSubmitDate': '2016-03-14', 'resultsFirstSubmitDate': '2021-02-26', 'studyFirstSubmitQcDate': '2016-10-03', 'lastUpdatePostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-30', 'studyFirstPostDateStruct': {'date': '2016-10-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delirium by Age', 'timeFrame': 'up to 3 days post-op', 'description': "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."}, {'measure': 'Number of Participants With or Without Delirium by Sex', 'timeFrame': 'up to 3 days post-op', 'description': 'Sex of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.'}, {'measure': 'Delirium by Body Mass Index', 'timeFrame': 'up to 3 days post-op', 'description': 'Median body mass index of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.'}, {'measure': 'Number of Participants With or Without Delirium by College Degree', 'timeFrame': 'up to 3 days post-op', 'description': 'Counts of patients with a college degree who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.'}, {'measure': 'Participants With an ASA Physical Status Score and the Development of Postoperative Delirium', 'timeFrame': 'up to 3 days post-op', 'description': "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': 'Number of Participants With or Without Delirium by Metabolic Equivalent of Task Score < 4', 'timeFrame': 'up to 3 days post-op', 'description': '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.'}, {'measure': 'Delirium by Total Number of Medications Taken at Baseline', 'timeFrame': 'up to 3 days post-op', 'description': 'Median total number of medications of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.'}, {'measure': 'Number of Participants With or Without Delirium by Opioid Use', 'timeFrame': 'up to 3 days post-op', 'description': 'Patients with chronic use of opioids who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.'}, {'measure': 'Number of Participants With or Without Delirium by Alcohol Consumption', 'timeFrame': 'up to 3 days post-op', 'description': 'Patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method based on alcohol consumption.'}, {'measure': 'Number of Participants With or Without Delirium by Presence of Depression', 'timeFrame': 'up to 3 days post-op', 'description': 'Patients with depression who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.'}, {'measure': 'Number of Participants With or Without Delirium by Psychiatric History', 'timeFrame': 'up to 3 days post-op', 'description': 'Patients with a history of psychiatric disorders who did or did not develop post-operative delirium as assessed by the confusion assessment method.'}, {'measure': 'Delirium by Mini-cog Score', 'timeFrame': 'up to 3 days post-op', 'description': '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.'}, {'measure': 'Number of Participants With or Without Delirium by FRAIL Score', 'timeFrame': 'up to 3 days post-op', 'description': 'Robust, pre-frail, and frail patients who did or did not develop post-operative delirium as assessed by the confusion assessment method.'}, {'measure': 'Number of Participants With or Without Delirium by Surgical Invasivness', 'timeFrame': 'up to 3 days post-op', 'description': '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.'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': 'duration of hospital stay, up to 30 days', 'description': '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,'}, {'measure': "Participants' Discharge Location (Home vs. Other Than Home)", 'timeFrame': 'up to 30 days after the surgical procedure', 'description': 'Location where patients were discharged (Home vs other than home) on the day of patients discharge from the hospital.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative health outcomes', 'older surgical patients', 'delirium'], 'conditions': ['Cognitive Impairment', 'Frail Elderly Syndrome']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to determine whether identifying patients with baseline cognitive deficits or frailty predict postoperative delirium.', 'detailedDescription': "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.\n\nPatients 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.\n\nDelirium 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '229 consenting subjects ≥ 70 years of age who present to the BWH Weiner Center for Preoperative Evaluation (CPE) prior to elective spine surgery.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients 70 years of age and older presenting to the BWH Weiner Center for Preoperative Evaluation\n* undergoing elective spine surgery\n\nExclusion Criteria:\n\n* include planned ICU admission postoperatively\n* history of stroke or brain tumor\n* uncorrected vision or hearing impairment (unable to see pictures or read or hear instructions)\n* limited use of the dominant hand (limited ability to draw)\n* inability to speak, read, or understand English.'}, 'identificationModule': {'nctId': 'NCT02922634', 'briefTitle': 'Preoperative Cognitive Screening in Older Spinal Surgical Patients', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Preoperative Cognitive Screening in Older Spinal Surgical Patients: Feasibility and Utility for Predicting Morbidity', 'orgStudyIdInfo': {'id': '2016P000012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'older surgical patients', 'description': 'Older surgical patients presenting for elective spine surgery', 'interventionNames': ['Other: Mini Cog']}], 'interventions': [{'name': 'Mini Cog', 'type': 'OTHER', 'otherNames': ['Frailty', 'Animal Fluency'], 'description': 'short cognitive screen, short Frailty screen', 'armGroupLabels': ['older surgical patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Weiner Center for Preoperative Evaluation', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Deborah Culley, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Deborah Culley, MD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}