Clinical trial NCT02922634: Preoperative Cognitive Screening in Older Spinal Surgical Patients
Official title: Preoperative Cognitive Screening in Older Spinal Surgical Patients: Feasibility and Utility for Predicting Morbidity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment
Frail Elderly Syndrome
Keywords: postoperative health outcomes
older surgical patients
delirium
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 229
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Delirium by Age
timeFrame: up to 3 days post-op
measure: Number of Participants With or Without Delirium by Sex
timeFrame: up to 3 days post-op
measure: Delirium by Body Mass Index
timeFrame: up to 3 days post-op
measure: Number of Participants With or Without Delirium by College Degree
timeFrame: up to 3 days post-op
measure: Participants With an ASA Physical Status Score and the Development of Postoperative Delirium
timeFrame: up to 3 days post-op
measure: Number of Participants With or Without Delirium by Metabolic Equivalent of Task Score < 4
timeFrame: up to 3 days post-op
measure: Delirium by Total Number of Medications Taken at Baseline
timeFrame: up to 3 days post-op
measure: Number of Participants With or Without Delirium by Opioid Use
timeFrame: up to 3 days post-op
measure: Number of Participants With or Without Delirium by Alcohol Consumption
timeFrame: up to 3 days post-op
measure: Number of Participants With or Without Delirium by Presence of Depression
timeFrame: up to 3 days post-op
measure: Number of Participants With or Without Delirium by Psychiatric History
timeFrame: up to 3 days post-op
measure: Delirium by Mini-cog Score
timeFrame: up to 3 days post-op
measure: Number of Participants With or Without Delirium by FRAIL Score
timeFrame: up to 3 days post-op
measure: Number of Participants With or Without Delirium by Surgical Invasivness
timeFrame: up to 3 days post-op
Secondary outcomes:
measure: 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.
timeFrame: duration of hospital stay, up to 30 days
measure: Participants' Discharge Location (Home vs. Other Than Home)
timeFrame: up to 30 days after the surgical procedure
Other outcomes:
Locations:
city: Boston
country: United States
facility: Weiner Center for Preoperative Evaluation
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Deborah Culley, M.D.
role: PRINCIPAL_INVESTIGATOR
References: