Preoperative Cognitive Screening in Older Spinal Surgical Patients



Status:Active, not recruiting
Conditions:Cognitive Studies, Cognitive Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:65 - Any
Updated:12/19/2018
Start Date:April 17, 2017
End Date:March 2019

Use our guide to learn which trials are right for you!

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

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

This project is designed as a prospective, single-center observational study. The cohort will
consist of 500 consenting subjects ≥ 65 years of age who present to the Brigham and Women's
Hospital Weiner Center for Preoperative Evaluation (CPE) prior to elective thoracic surgery
(specifically, thoracoscopic lung resection, lobectomy, thoracotomy, or esophagectomy) and to
neurological posterior thoracolumbar spine surgery by neurosurgeons Dr. Groff, Dr. Lu and Dr.
Chi. 250 subjects undergoing thoracic surgery will be recruited into one arm of the study and
250 subjects undergoing neurological posterior thoracolumbar spine surgery will be recruited
(500 total). These ages are chosen as significant clinical data demonstrate increased
cognitive impairment in community dwelling elders. Eligibility criteria include: patients ≥
65 years of age with an American Society of Anesthesiologists (ASA) physical status
classification of I-III presenting for elective thoracic surgery or spinal 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
standard instruments to assess social support (MOS Social Support Survey, a 12-item
self-report questionnaire) in thoracic surgical patients. The Modified Brief Pain Inventory
Short-Form (mBPI-sf) will be administered to spinal surgical patients. 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 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
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 whether they had
surgical procedure, time to postoperative anesthesia care unit (PACU) discharge, discharge to
place other than home (rehabilitation, skilled nursing facility), hospital length of stay
(LOS), 30-day reoperation or readmission rate, and 30-day and 1-year 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.

Inclusion Criteria:

- patients 65 years of age and older presenting to the BWH Weiner Center for
Preoperative Evaluation

- undergoing elective thoracic surgery or neurological posterior thoracolumbar 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.
We found this trial at
1
site
Boston, Massachusetts 02115
?
mi
from
Boston, MA
Click here to add this to my saved trials