Preoperative Cognitive Screening in Older Spinal Surgical Patients

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922634
• Other study ID #: 2016P000012
• Status: Completed
• Start date: April 17, 2017
• Est. completion date: June 9, 2019

Study information

• Verified date: June 2021
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: June 9, 2019
• Est. primary completion date: October 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Frail Elderly Syndrome

Intervention

Other:
• Mini Cog
short cognitive screen, short Frailty screen

Locations

Country	Name	City	State
United States	Weiner Center for Preoperative Evaluation	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	up to 3 days post-op
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.	up to 3 days post-op
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.	up to 3 days post-op
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.	up to 3 days post-op
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.	up to 3 days post-op
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.	up to 3 days post-op
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.	up to 3 days post-op
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.	up to 3 days post-op
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.	up to 3 days post-op
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.	up to 3 days post-op
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.	up to 3 days post-op
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.	up to 3 days post-op
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.	up to 3 days post-op
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.	up to 3 days post-op
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,	duration of hospital stay, up to 30 days
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.	up to 30 days after the surgical procedure