Preoperative Cognitive Screening in Older Spinal Surgical Patients

NCT ID: NCT02922634

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 229 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-17
• Study Completion Date: 2019-06-09

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.

Conditions

Cognitive Impairment; Frail Elderly Syndrome

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

older surgical patients

Older surgical patients presenting for elective spine surgery

Mini Cog

Intervention Type: OTHER

short cognitive screen, short Frailty screen

Interventions

Mini Cog

short cognitive screen, short Frailty screen

Intervention Type: OTHER

Other Intervention Names

Frailty; Animal Fluency

Eligibility Criteria

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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Deborah Culley, MD

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah Culley, M.D.

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Weiner Center for Preoperative Evaluation

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2016P000012

Identifier Type: -

Identifier Source: org_study_id