Preoperative Cognitive Screening in Older Spinal Surgical Patients

NCT02922634 | Completed Results

• 1 other identifier: 2016P000012
• Study Type: observational
• Target: 229
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cognitive Impairment; Frail Elderly Syndrome

Keywords

postoperative health outcomes; older surgical patients; delirium

Outcome Measures

Primary Outcomes (14)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• 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 days

• Participants' Discharge Location (Home vs. Other Than Home)

  up to 30 days after the surgical procedure

Study Arms (1)

older surgical patients

Older surgical patients presenting for elective spine surgery

Other: Mini Cog

Interventions

Mini Cog OTHER

short cognitive screen, short Frailty screen

Also known as: Frailty, Animal Fluency

older surgical patients

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

229 consenting subjects ≥ 70 years of age who present to the BWH Weiner Center for Preoperative Evaluation (CPE) prior to elective spine surgery.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Weiner Center for Preoperative Evaluation

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Cognitive Dysfunction; Delirium

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Gregory Crosby
• Organization: BWH

gcrosby@bwh.harvard.edu

617-732-7330

Study Officials

• Deborah Culley, M.D.

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: October 4, 2016
• Study Start: April 17, 2017
• Primary Completion: October 9, 2018
• Study Completion: June 9, 2019
• Last Updated: July 21, 2021
• Results First Posted: July 21, 2021

Record last verified: 2021-06

Locations

US (1)