Skip to content

Preoperative Cognitive Screening in Older Spinal Surgical Patients

Preoperative Cognitive Screening in Older Spinal Surgical Patients: Feasibility and Utility for Predicting Morbidity

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02922634
Enrollment
229
Registered
2016-10-04
Start date
2017-04-17
Completion date
2019-06-09
Last updated
2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment, Frail Elderly Syndrome

Keywords

postoperative health outcomes, older surgical patients, delirium

Brief summary

The objectives of this study are to determine whether identifying patients with baseline cognitive deficits or frailty predict postoperative delirium.

Detailed description

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.

Interventions

short cognitive screen, short Frailty screen

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* patients 70 years of age and older presenting to the BWH Weiner Center for Preoperative Evaluation * undergoing elective spine surgery

Exclusion criteria

* include planned 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) * inability to speak, read, or understand English.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With or Without Delirium by Surgical Invasivnessup to 3 days post-opSurgical 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.
Delirium by Mini-cog Scoreup to 3 days post-opMedian 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.
Number of Participants With or Without Delirium by FRAIL Scoreup to 3 days post-opRobust, pre-frail, and frail patients who did or did not develop post-operative delirium as assessed by the confusion assessment method.
Delirium by Ageup to 3 days post-opThe 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.
Number of Participants With or Without Delirium by Sexup to 3 days post-opSex of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.
Delirium by Body Mass Indexup to 3 days post-opMedian body mass index of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.
Number of Participants With or Without Delirium by College Degreeup to 3 days post-opCounts of patients with a college degree who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.
Participants With an ASA Physical Status Score and the Development of Postoperative Deliriumup to 3 days post-opThe 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.
Number of Participants With or Without Delirium by Metabolic Equivalent of Task Score < 4up to 3 days post-opPatients 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.
Delirium by Total Number of Medications Taken at Baselineup to 3 days post-opMedian total number of medications of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.
Number of Participants With or Without Delirium by Opioid Useup to 3 days post-opPatients with chronic use of opioids who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.
Number of Participants With or Without Delirium by Alcohol Consumptionup to 3 days post-opPatients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method based on alcohol consumption.
Number of Participants With or Without Delirium by Presence of Depressionup to 3 days post-opPatients with depression who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.
Number of Participants With or Without Delirium by Psychiatric Historyup to 3 days post-opPatients with a history of psychiatric disorders who did or did not develop post-operative delirium as assessed by the confusion assessment method.

Secondary

MeasureTime frameDescription
Participants' Discharge Location (Home vs. Other Than Home)up to 30 days after the surgical procedureLocation where patients were discharged (Home vs other than home) on the day of patients discharge from the hospital.
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.duration of hospital stay, up to 30 daysIn 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,

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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

Participants by arm

ArmCount
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
219
Total219

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyDid not have their surgery5
Overall StudyWithdrawal by Subject5

Baseline characteristics

CharacteristicOlder Surgical Patients
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
219 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Age, Continuous75 Year
Alcohol consumption
No
94 Participants
Alcohol consumption
Yes
125 Participants
Animal Verbal Fluency18 animals
STANDARD_DEVIATION 6
ASA Physical Status
ASA 1 or 2
70 Participants
ASA Physical Status
ASA 3 or 4
149 Participants
Body Mass Index28 kg/m^2
Frail Scale
Score 0
48 Participants
Frail Scale
Score 1-2
117 Participants
Frail Scale
Score 3-5
53 Participants
History of depression
No
180 Participants
History of depression
Yes
39 Participants
Level of education
Bachelors degree or higher
144 Participants
Level of education
Less than a bachelors degree
68 Participants
Metabolic equivalents of task
METS < 4
60 Participants
Metabolic equivalents of task
METS ≥ 4
149 Participants
Mini-Cog4 units on a scale
Preoperative use of opioids
No preoperative use of opioids
164 Participants
Preoperative use of opioids
preoperative opioid use
55 Participants
Psychiatric History
No
197 Participants
Psychiatric History
Yes
22 Participants
Race and Ethnicity Not Collected— Participants
Region of Enrollment
United States
219 participants
Sex: Female, Male
Female
95 Participants
Sex: Female, Male
Male
124 Participants
Surgical Invasiveness
Tier 1 and 2
111 Participants
Surgical Invasiveness
Tier 3 and 4
108 Participants
Total number of medications8 total number of medications

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 219
other
Total, other adverse events
0 / 219
serious
Total, serious adverse events
0 / 219

Outcome results

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.

Time frame: up to 3 days post-op

Population: Patients over the age of 70 undergoing spinal surgeries

ArmMeasureValue (MEDIAN)
No DeliriumDelirium by Age75 years
DeliriumDelirium by Age77 years
p-value: 0.508Wilcoxon (Mann-Whitney)
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.

Time frame: up to 3 days post-op

ArmMeasureValue (MEDIAN)
No DeliriumDelirium by Body Mass Index28 kg/m^2
DeliriumDelirium by Body Mass Index30 kg/m^2
p-value: 0.025Wilcoxon (Mann-Whitney)
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.

Time frame: up to 3 days post-op

ArmMeasureValue (MEDIAN)
No DeliriumDelirium by Mini-cog Score4 scores on a scale
DeliriumDelirium by Mini-cog Score4 scores on a scale
p-value: 0.333Wilcoxon (Mann-Whitney)
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.

Time frame: up to 3 days post-op

ArmMeasureValue (MEDIAN)
No DeliriumDelirium by Total Number of Medications Taken at Baseline8 medications
DeliriumDelirium by Total Number of Medications Taken at Baseline9 medications
p-value: 0.002Wilcoxon (Mann-Whitney)
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.

Time frame: up to 3 days post-op

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
No DeliriumNumber of Participants With or Without Delirium by Alcohol Consumption98 Participants
DeliriumNumber of Participants With or Without Delirium by Alcohol Consumption27 Participants
p-value: 0.101Chi-squared
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.

Time frame: up to 3 days post-op

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
No DeliriumNumber of Participants With or Without Delirium by College Degree108 Participants
DeliriumNumber of Participants With or Without Delirium by College Degree36 Participants
p-value: 0.48Chi-squared
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.

Time frame: up to 3 days post-op

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
No DeliriumNumber of Participants With or Without Delirium by FRAIL ScoreRobust (score 0)43 Participants
No DeliriumNumber of Participants With or Without Delirium by FRAIL ScorePre-frail (score 1 and 2)92 Participants
No DeliriumNumber of Participants With or Without Delirium by FRAIL ScoreFrail (score 3-5)29 Participants
DeliriumNumber of Participants With or Without Delirium by FRAIL ScorePre-frail (score 1 and 2)25 Participants
DeliriumNumber of Participants With or Without Delirium by FRAIL ScoreRobust (score 0)5 Participants
DeliriumNumber of Participants With or Without Delirium by FRAIL ScoreFrail (score 3-5)24 Participants
p-value: 0.001Chi-squared
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.

Time frame: up to 3 days post-op

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
No DeliriumNumber of Participants With or Without Delirium by Metabolic Equivalent of Task Score < 445 Participants
DeliriumNumber of Participants With or Without Delirium by Metabolic Equivalent of Task Score < 425 Participants
p-value: 0.007Chi-squared
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.

Time frame: up to 3 days post-op

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
No DeliriumNumber of Participants With or Without Delirium by Opioid Use34 Participants
DeliriumNumber of Participants With or Without Delirium by Opioid Use21 Participants
p-value: 0.01Chi-squared
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.

Time frame: up to 3 days post-op

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
No DeliriumNumber of Participants With or Without Delirium by Presence of Depression26 Participants
DeliriumNumber of Participants With or Without Delirium by Presence of Depression13 Participants
p-value: 0.192Chi-squared
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.

Time frame: up to 3 days post-op

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
No DeliriumNumber of Participants With or Without Delirium by Psychiatric History14 Participants
DeliriumNumber of Participants With or Without Delirium by Psychiatric History8 Participants
p-value: 0.2Chi-squared
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.

Time frame: up to 3 days post-op

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
No DeliriumNumber of Participants With or Without Delirium by SexMale94 Participants
No DeliriumNumber of Participants With or Without Delirium by SexFemale70 Participants
DeliriumNumber of Participants With or Without Delirium by SexFemale25 Participants
DeliriumNumber of Participants With or Without Delirium by SexMale30 Participants
p-value: 0.72Chi-squared
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.

Time frame: up to 3 days post-op

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
No DeliriumNumber of Participants With or Without Delirium by Surgical InvasivnessTier 1 + 293 Participants
No DeliriumNumber of Participants With or Without Delirium by Surgical InvasivnessTier 3 + 471 Participants
DeliriumNumber of Participants With or Without Delirium by Surgical InvasivnessTier 1 + 218 Participants
DeliriumNumber of Participants With or Without Delirium by Surgical InvasivnessTier 3 + 437 Participants
p-value: 0.002Chi-squared
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.

Time frame: up to 3 days post-op

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
No DeliriumParticipants With an ASA Physical Status Score and the Development of Postoperative DeliriumASA Physical status of greater than or equal to 3105 Participants
No DeliriumParticipants With an ASA Physical Status Score and the Development of Postoperative DeliriumASA Physical Status of less than 359 Participants
DeliriumParticipants With an ASA Physical Status Score and the Development of Postoperative DeliriumASA Physical status of greater than or equal to 344 Participants
DeliriumParticipants With an ASA Physical Status Score and the Development of Postoperative DeliriumASA Physical Status of less than 311 Participants
p-value: 0.028Chi-squared
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,

Time frame: duration of hospital stay, up to 30 days

Population: All spine surgery patients enrolled in the study.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
No DeliriumNumber 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 complications151 Participants
No DeliriumNumber 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 complications68 Participants
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.

Time frame: up to 30 days after the surgical procedure

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
No DeliriumParticipants' Discharge Location (Home vs. Other Than Home)Not documented4 Participants
No DeliriumParticipants' Discharge Location (Home vs. Other Than Home)Home138 Participants
No DeliriumParticipants' Discharge Location (Home vs. Other Than Home)Place other than home77 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026