This is a prospective multicenter cohort study which will evaluate rapid (administration time ≤ 5 minutes) cognitive screening tools that can be administered preoperatively in older patients undergoing noncardiac surgery. Namely, our study will determine the diagnostic accuracy (sensitivity, specificity, and area under the curves \[AUC\]) of two rapid, easily administered cognitive screening tools: the Mini-Cog and the Ascertain Dementia 8-item Questionnaire (AD8) against the Montreal Cognitive Assessment (MoCA). Additionally, we will examine the prevalence of cognitive impairment (CI) in patients meeting the CI criteria by either the AD8, Mini-Cog, MoCA, or a single cognitive question from the Centers for Disease Control and Prevention \[CDC\]. This study will target older patients from surgical offices and/or pre-admission clinics at Toronto General (TGH), Toronto Western (TWH), and Mount Sinai Hospital (MSH), Toronto, Ontario. The identification and recruitment of eligible patients will be a collaborative effort between the nurses, surgeons, anesthesiologists, and the research team. Written informed consent to participate in the study will be obtained from all patients.
The primary aims of the study is to (1) determine the diagnostic accuracy (sensitivity, specificity, and the AUC) of two rapid cognitive screening tools (AD8 and Mini-Cog) against the MoCA in the older surgical population and (2) determine the prevalence of CI as detected by the cognitive screening tests (AD8, Mini-Cog, MoCA, or CDC cognitive question). The secondary aims are to (1) compare the trajectory of patient-reported outcomes at baseline, 30-, and 90-day post-surgery in patients with or without CI as detected by the cognitive screening tests, and (2) compare clinical outcomes in patients with or without CI as detected by the cognitive screening tests. The study consists of four consecutive time points, including one preoperative assessment and three postoperative assessments occurring during participants' hospital stay and at 30- and 90-day post-surgery. In the preoperative assessment 1-30 days before their scheduled surgery, patients will be asked to complete the AD8, Mini-Cog, MoCA, CDC cognitive question, and the STOP-Bang Questionnaire in-person. Additionally, patients will be asked to complete the following assessments via an online survey, over the telephone, or in-person prior to their scheduled surgery: WHODAS-2.0 (World Health Organization Disability Assessment Schedule 2.0), 5-item FRAIL Questionnaire, PHQ-4 (4-Item Patient Health Questionnaire for Anxiety and depression), VAS (visual analog scale) pain, SQS (Single Item Sleep Quality Scale), and a single question on QoL (quality of life). The first postoperative time point will occur during participants' stay at the hospital in which postoperative delirium (POD), postoperative complications, length of stay (LOS), and discharge destination will be assessed. At 30- and 90-day postoperatively, chart review will be performed to assess clinical outcomes, such as postoperative complications, all-cause mortality, and hospital readmission. Patient-reported outcomes, including WHODAS 2.0, 5-item FRAIL Questionnaire, PHQ-4, VAS pain, and QoL, will also be assessed through an online survey or over the telephone.
Study Type
OBSERVATIONAL
Enrollment
383
399 Bathurst St., Toronto Western Hospital, Dept. of Anesthesia
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
The diagnostic accuracy (sensitivity, specificity
The diagnostic accuracy (sensitivity and specificity) of the AD8 (Eight-item Interview to Differentiate Aging and Dementia) and Mini-Cog against the MoCA (Montreal Cognitive Assessment).
Time frame: Pre-surgery
The diagnostic accuracy (AUC)
The AUC (Area under the Receiver Operating Characteristic Curve (ROC)) of the AD8 (Eight-item Interview to Differentiate Aging and Dementia) and Mini-Cog against the MoCA (Montreal Cognitive Assessment).
Time frame: Pre-surgery
Prevalence of cognitive impairment (CI) via cognitive screening tools
The prevalence of CI as detected by the AD8 (Eight-item Interview to Differentiate Aging and Dementia). The AD8 is scored from 0-8 with a score of two or more indicating cognitive impairment.
Time frame: Pre-surgery
Prevalence of cognitive impairment (CI) via cognitive screening tools
The prevalence of CI as detected by the Mini-Cog. The Mini-Cog is scored from 0-5 with a score of two or less indicating cognitive impairment.
Time frame: Pre-surgery
Prevalence of cognitive impairment (CI) via cognitive screening tools
The prevalence of CI as detected by the MoCA (Montreal Cognitive Assessment). The MoCA is scored from 0-30 with a score of 25 or less indicating cognitive impairment.
Time frame: Pre-surgery
Prevalence of cognitive impairment (CI) via cognitive screening tools
The prevalence of CI as detected by the CDC (Centers of Disease Control and Prevention) cognitive question. The CDC cognitive question is a simple yes or no question, with a response of yes indicating cognitive impairment.
Time frame: Pre-surgery
Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
The trajectory and prevalence or incidence of functional disability as measured through the WHODAS 2.0 (World Health Organization Disability Assessment Schedule 2.0) in participants with CI vs those without. A five-point rating scale is used for each question (none = 0, mild = 1, moderate = 2, severe = 3, extreme/cannot do = 4), and a higher WHODAS score indicates greater disability.
Time frame: Pre-surgery, 30- and 90-days post-surgery
Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
The trajectory and prevalence or incidence of frailty as measured through the 5-item FRAIL questionnaire in participants with CI vs those without. It is scored from 0-5 where higher scores indicate frailty.
Time frame: Pre-surgery, 30- and 90-days post-surgery
Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
The trajectory and prevalence or incidence of pain as measured through the VAS Pain (Visual Analog Scale for Pain) in participants with CI vs those without. It is scored from 0-10 where a lower score indicates worse pain.
Time frame: Pre-surgery, 30- and 90-days post-surgery
Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
The trajectory and prevalence or incidence of depression and anxiety as measured through the PHQ-4 (4-Item Patient Health Questionnaire) in participants with CI vs those without. It is scored from 0-12 where a higher score indicates depression and anxiety.
Time frame: Pre-surgery, 30- and 90-days post-surgery
Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
The trajectory and prevalence or incidence of obstructive sleep apnea (OSA) as measured through the STOP-Bang Questionnaire in participants with CI vs those without. It is scored from 0-8 where a higher score indicates higher risk for OSA.
Time frame: Pre-surgery
Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
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The trajectory and prevalence or incidence of sleep disturbances as measured through the SQS (Single Item Sleep Quality Scale) in participants with CI vs those without. It is scored from 0-10 where a lower score indicates sleep disturbances.
Time frame: Pre-surgery
Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
The trajectory and prevalence or incidence of quality of life as measured through the single question on Quality of Life (QoL) in participants with CI vs those without. It is scored from 0-100 where a lower score indicates worse quality of life.
Time frame: Pre-surgery, 30- and 90-days post-surgery
Incidence of clinical outcomes post-surgery
Incidence of postoperative delirium as assessed by the Confusion Assessment Method (CAM) conducted by the nursing team and through medical chart review.
Time frame: 1-3 days post-surgery
Incidence of adverse clinical outcomes post-surgery
Incidence of postoperative complications
Time frame: 1-3 days post-surgery
Clinical outcomes post-surgery
Hospital length of stay (LOS)
Time frame: 1-3 days post-surgery
Clinical outcomes post-surgery
Discharge destination (assess where the participant will be discharged to once out of hospital up to 30-days post-op)
Time frame: 1-3 days post-surgery
Incidence of adverse clinical outcomes post-surgery
Incidence of mortality
Time frame: 30- and 90-days post-surgery
Incidence of adverse clinical outcomes post-surgery
Incidence of readmission
Time frame: 30- and 90-days post-surgery
Incidence of adverse clinical outcomes post-surgery
Incidence of postoperative complications
Time frame: 30- and 90-days post-surgery
Incidence of adverse clinical outcomes post-surgery
Incidence of emergency department visit
Time frame: 30- and 90-days post-surgery
Incidence of adverse clinical outcomes post-surgery
Incidence of re-operation or revision surgery
Time frame: 30- and 90-days post-surgery