Trial Outcomes & Findings for Preoperative Cognitive Screening in Older Spinal Surgical Patients (NCT NCT02922634)

NCT ID: NCT02922634

Last Updated: 2021-07-21

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 229 participants
• Primary outcome timeframe: up to 3 days post-op
• Results posted on: 2021-07-21

Participant Flow

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.

Older patients ≥ 70 years of age presenting for elective spine surgery.

Participant milestones

Measure	Older Surgical Patients Having Spine Surgery Older surgical patients (≥ 70 years of age) presenting for elective spine surgery.
Overall Study STARTED	229
Overall Study COMPLETED	219
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Measure	Older Surgical Patients Having Spine Surgery Older surgical patients (≥ 70 years of age) presenting for elective spine surgery.
Overall Study Withdrawal by Subject	5
Overall Study Did not have their surgery	5

Baseline Characteristics

5 patients withdrew from the study, 5 patients did not have their surgery

Baseline characteristics by cohort

Measure	Older Surgical Patients n=219 Participants 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
Age, Categorical <=18 years	0 Participants n=219 Participants • 5 patients withdrew from the study, 5 patients did not have their surgery
Age, Categorical Between 18 and 65 years	0 Participants n=219 Participants • 5 patients withdrew from the study, 5 patients did not have their surgery
Age, Categorical >=65 years	219 Participants n=219 Participants • 5 patients withdrew from the study, 5 patients did not have their surgery
Age, Continuous	75 Year n=219 Participants • 5 Patients withdrew from the study, 5 patients did not have surgery
Sex: Female, Male Female	95 Participants n=219 Participants • 5 patients withdrew from the study and 5 patients did not have surgery
Sex: Female, Male Male	124 Participants n=219 Participants • 5 patients withdrew from the study and 5 patients did not have surgery
Region of Enrollment United States	219 participants n=219 Participants
Frail Scale Score 0	48 Participants n=218 Participants • 5 patients withdrew from the study, 5 patients did not have their surgery and 1 patient left before completing the frail scale.
Frail Scale Score 1-2	117 Participants n=218 Participants • 5 patients withdrew from the study, 5 patients did not have their surgery and 1 patient left before completing the frail scale.
Frail Scale Score 3-5	53 Participants n=218 Participants • 5 patients withdrew from the study, 5 patients did not have their surgery and 1 patient left before completing the frail scale.
Mini-Cog	4 units on a scale n=219 Participants • 5 patients withdrew from the study and 5 patients did not have surgery
Animal Verbal Fluency	18 animals STANDARD_DEVIATION 6 • n=219 Participants • 5 patients withdrew from the study and 5 patients did not have surgery
Surgical Invasiveness Tier 1 and 2	111 Participants n=219 Participants • 5 patients withdrew from the study and 5 patients did not have their surgery
Surgical Invasiveness Tier 3 and 4	108 Participants n=219 Participants • 5 patients withdrew from the study and 5 patients did not have their surgery
Body Mass Index	28 kg/m^2 n=217 Participants • 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
Level of education Bachelors degree or higher	144 Participants n=212 Participants • 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.
Level of education Less than a bachelors degree	68 Participants n=212 Participants • 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.
ASA Physical Status ASA 1 or 2	70 Participants n=219 Participants • 5 patients withdrew from the study and 5 patients did not have their surgery.
ASA Physical Status ASA 3 or 4	149 Participants n=219 Participants • 5 patients withdrew from the study and 5 patients did not have their surgery.
Metabolic equivalents of task METS < 4	60 Participants n=209 Participants • 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.
Metabolic equivalents of task METS ≥ 4	149 Participants n=209 Participants • 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.
Total number of medications	8 total number of medications n=219 Participants • 5 patients withdrew from the study and 5 patients did not have their surgery
Preoperative use of opioids preoperative opioid use	55 Participants n=219 Participants • 5 patients withdrew from the study and 5 patients did not have their surgery
Preoperative use of opioids No preoperative use of opioids	164 Participants n=219 Participants • 5 patients withdrew from the study and 5 patients did not have their surgery
Alcohol consumption Yes	125 Participants n=219 Participants • 5 patients withdrew from the study and 5 patients did not have their surgery.
Alcohol consumption No	94 Participants n=219 Participants • 5 patients withdrew from the study and 5 patients did not have their surgery.
History of depression Yes	39 Participants n=219 Participants • 5 patients withdrew from the study and 5 patients did not have their surgery
History of depression No	180 Participants n=219 Participants • 5 patients withdrew from the study and 5 patients did not have their surgery
Psychiatric History Yes	22 Participants n=219 Participants • 5 patients withdrew from the study and 5 patients did not have their surgery
Psychiatric History No	197 Participants n=219 Participants • 5 patients withdrew from the study and 5 patients did not have their surgery

PRIMARY outcome

Timeframe: up to 3 days post-op

Population: Patients over the age of 70 undergoing spinal surgeries

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.

Outcome measures

Measure	No Delirium n=164 Participants Older surgical patients presenting for elective spine surgery that did not develop post-op delirium	Delirium n=55 Participants Older surgical patients presenting for elective spine surgery that did develop post-op delirium
Delirium by Age	75 years Interval 73.0 to 79.0	77 years Interval 72.0 to 80.0

PRIMARY outcome

Timeframe: up to 3 days post-op

Sex of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.

Outcome measures

Measure	No Delirium n=164 Participants Older surgical patients presenting for elective spine surgery that did not develop post-op delirium	Delirium n=55 Participants Older surgical patients presenting for elective spine surgery that did develop post-op delirium
Number of Participants With or Without Delirium by Sex Male	94 Participants	30 Participants
Number of Participants With or Without Delirium by Sex Female	70 Participants	25 Participants

PRIMARY outcome

Timeframe: up to 3 days post-op

Median body mass index of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.

Outcome measures

Measure	No Delirium n=164 Participants Older surgical patients presenting for elective spine surgery that did not develop post-op delirium	Delirium n=55 Participants Older surgical patients presenting for elective spine surgery that did develop post-op delirium
Delirium by Body Mass Index	28 kg/m^2 Interval 25.0 to 32.0	30 kg/m^2 Interval 26.0 to 34.0

PRIMARY outcome

Timeframe: up to 3 days post-op

Counts of patients with a college degree who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.

Outcome measures

Measure	No Delirium n=164 Participants Older surgical patients presenting for elective spine surgery that did not develop post-op delirium	Delirium n=55 Participants Older surgical patients presenting for elective spine surgery that did develop post-op delirium
Number of Participants With or Without Delirium by College Degree	108 Participants	36 Participants

PRIMARY outcome

Timeframe: up to 3 days post-op

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.

Outcome measures

Measure	No Delirium n=164 Participants Older surgical patients presenting for elective spine surgery that did not develop post-op delirium	Delirium n=55 Participants Older surgical patients presenting for elective spine surgery that did develop post-op delirium
Participants With an ASA Physical Status Score and the Development of Postoperative Delirium ASA Physical status of greater than or equal to 3	105 Participants	44 Participants
Participants With an ASA Physical Status Score and the Development of Postoperative Delirium ASA Physical Status of less than 3	59 Participants	11 Participants

PRIMARY outcome

Timeframe: up to 3 days post-op

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.

Outcome measures

Measure	No Delirium n=164 Participants Older surgical patients presenting for elective spine surgery that did not develop post-op delirium	Delirium n=55 Participants Older surgical patients presenting for elective spine surgery that did develop post-op delirium
Number of Participants With or Without Delirium by Metabolic Equivalent of Task Score < 4	45 Participants	25 Participants

PRIMARY outcome

Timeframe: up to 3 days post-op

Median total number of medications of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.

Outcome measures

Measure	No Delirium n=164 Participants Older surgical patients presenting for elective spine surgery that did not develop post-op delirium	Delirium n=55 Participants Older surgical patients presenting for elective spine surgery that did develop post-op delirium
Delirium by Total Number of Medications Taken at Baseline	8 medications Interval 5.0 to 10.0	9 medications Interval 7.0 to 12.0

PRIMARY outcome

Timeframe: up to 3 days post-op

Patients with chronic use of opioids who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.

Outcome measures

Measure	No Delirium n=164 Participants Older surgical patients presenting for elective spine surgery that did not develop post-op delirium	Delirium n=55 Participants Older surgical patients presenting for elective spine surgery that did develop post-op delirium
Number of Participants With or Without Delirium by Opioid Use	34 Participants	21 Participants

PRIMARY outcome

Timeframe: up to 3 days post-op

Patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method based on alcohol consumption.

Outcome measures

Measure	No Delirium n=164 Participants Older surgical patients presenting for elective spine surgery that did not develop post-op delirium	Delirium n=55 Participants Older surgical patients presenting for elective spine surgery that did develop post-op delirium
Number of Participants With or Without Delirium by Alcohol Consumption	98 Participants	27 Participants

PRIMARY outcome

Timeframe: up to 3 days post-op

Patients with depression who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.

Outcome measures

Measure	No Delirium n=164 Participants Older surgical patients presenting for elective spine surgery that did not develop post-op delirium	Delirium n=55 Participants Older surgical patients presenting for elective spine surgery that did develop post-op delirium
Number of Participants With or Without Delirium by Presence of Depression	26 Participants	13 Participants

PRIMARY outcome

Timeframe: up to 3 days post-op

Patients with a history of psychiatric disorders who did or did not develop post-operative delirium as assessed by the confusion assessment method.

Outcome measures

Measure	No Delirium n=164 Participants Older surgical patients presenting for elective spine surgery that did not develop post-op delirium	Delirium n=55 Participants Older surgical patients presenting for elective spine surgery that did develop post-op delirium
Number of Participants With or Without Delirium by Psychiatric History	14 Participants	8 Participants

PRIMARY outcome

Timeframe: up to 3 days post-op

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.

Outcome measures

Measure	No Delirium n=164 Participants Older surgical patients presenting for elective spine surgery that did not develop post-op delirium	Delirium n=55 Participants Older surgical patients presenting for elective spine surgery that did develop post-op delirium
Delirium by Mini-cog Score	4 scores on a scale Interval 3.0 to 5.0	4 scores on a scale Interval 2.0 to 5.0

PRIMARY outcome

Timeframe: up to 3 days post-op

Robust, pre-frail, and frail patients who did or did not develop post-operative delirium as assessed by the confusion assessment method.

Outcome measures

Measure	No Delirium n=164 Participants Older surgical patients presenting for elective spine surgery that did not develop post-op delirium	Delirium n=54 Participants Older surgical patients presenting for elective spine surgery that did develop post-op delirium
Number of Participants With or Without Delirium by FRAIL Score Frail (score 3-5)	29 Participants	24 Participants
Number of Participants With or Without Delirium by FRAIL Score Robust (score 0)	43 Participants	5 Participants
Number of Participants With or Without Delirium by FRAIL Score Pre-frail (score 1 and 2)	92 Participants	25 Participants

PRIMARY outcome

Timeframe: up to 3 days post-op

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.

Outcome measures

Measure	No Delirium n=164 Participants Older surgical patients presenting for elective spine surgery that did not develop post-op delirium	Delirium n=55 Participants Older surgical patients presenting for elective spine surgery that did develop post-op delirium
Number of Participants With or Without Delirium by Surgical Invasivness Tier 1 + 2	93 Participants	18 Participants
Number of Participants With or Without Delirium by Surgical Invasivness Tier 3 + 4	71 Participants	37 Participants

SECONDARY outcome

Timeframe: duration of hospital stay, up to 30 days

Population: All spine surgery patients enrolled in the study.

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,

Outcome measures

Measure	No Delirium n=219 Participants Older surgical patients presenting for elective spine surgery that did not develop post-op delirium	Delirium Older surgical patients presenting for elective spine surgery that did develop post-op delirium
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. no in-hospital complications	151 Participants	—
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	68 Participants	—

SECONDARY outcome

Timeframe: up to 30 days after the surgical procedure

Location where patients were discharged (Home vs other than home) on the day of patients discharge from the hospital.

Outcome measures

Measure	No Delirium n=219 Participants Older surgical patients presenting for elective spine surgery that did not develop post-op delirium	Delirium Older surgical patients presenting for elective spine surgery that did develop post-op delirium
Participants' Discharge Location (Home vs. Other Than Home) Home	138 Participants	—
Participants' Discharge Location (Home vs. Other Than Home) Place other than home	77 Participants	—
Participants' Discharge Location (Home vs. Other Than Home) Not documented	4 Participants	—

Adverse Events

Postoperative Outcomes in Older Patients After Spine Surgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gregory Crosby

BWH

Phone: 617-732-7330

Email: gcrosby@bwh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place