Detect CI (Cognitive Impairment) Study (CI)

Evaluation of Rapid Cognitive Screening Tools for Detection of Cognitive Impairment in Older Surgical Patients: A Prospective Cohort Study - Detect CI Study

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, or MoCA and the prevalence of elevated levels of plasma biomarker of phosphorylated tau 181 (pTau181) and neurofilament-light chain (NfL) in the patients meeting the CI criteria. 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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment (CI)

Detailed Description

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, or MoCA) and to determine the prevalence of elevated plasma biomarkers associated with neurodegenerative and/or vascular diseases using plasma (pTau181 or NfL) biomarkers in those with CI as detected by the screening tools. The secondary aims are to (1) describe the distribution of plasma pTau181 or NfL biomarkers in patients meeting the CI criteria by the AD8, Mini-Cog, or MoCA, (2) 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 (3) 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 and the STOP-Bang Questionnaire in-person. If a patient screens positive on one or more of the three cognitive screening tools, they will have blood drawn for pTau181 and NfL bioassay analysis. Additionally, patients will be asked to complete the following assessments via an online survey or over the telephone 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 (Estimated): 213

Contacts and Locations

• Study Contact: Name: Sazzadul Islam; Phone Number: 4166622686; Email: sazzadul.islam@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Recruiting
      • Mount Sinai Hospital
      • Contact: Sazzadul Islam; Phone Number: 14166622686; Email: sazzadul.islam@uhn.ca
      • Principal Investigator: David He, MD PhD FRCPC
    • Toronto, Ontario, Canada, M5T2S8
      • Recruiting
      • 399 Bathurst St., Toronto Western Hospital, Dept. of Anesthesia
      • Principal Investigator: Frances Chung, MBBS FRCPC
      • Contact: Sazzadul Islam, M.Sc.; Phone Number: 416 662 2686; Email: sazzadul.islam@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to undergo elective inpatient non-cardiac surgery under general and/ or regional anesthesia

Description

Inclusion Criteria:

• patients ≥ 65 years old;
• competent to provide informed consent in English;
• undergoing elective non-cardiac surgery;
• education ≥ 8 years;
• able to be contacted by telephone.

Exclusion Criteria:

• previous neurocognitive disorder (e.g., dementia) diagnosis;
• uncontrolled psychiatric disorders;
• hearing and/or vision impairment;
• unable to write or hold pen;
• undergoing neurosurgery;
• unable to provide informed consent.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The diagnostic accuracy (sensitivity, specificity, and AUC)	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).	Pre-surgery
The diagnostic accuracy (sensitivity, specificity, and 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).	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.	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.	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.	Pre-surgery
Prevalence of elevated plasma biomarkers	The prevalence of elevated plasma biomarkers associated with neurogenerative and/or vascular diseases using plasma pTau181 biomarkers in those with CI as detected by the screening tools.	Pre-surgery
Prevalence of elevated plasma biomarkers	The prevalence of elevated plasma biomarkers associated with neurogenerative and/or vascular diseases using plasma NfL biomarkers in those with CI as detected by the screening tools.	Pre-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of plasma biomarkers	The distribution of plasma pTau181 biomarkers in patients meeting the CI criteria by the cognitive screening tools.	Pre-surgery
Distribution of plasma biomarkers	The distribution of plasma NfL biomarkers in patients meeting the CI criteria by the cognitive screening tools.	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.	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.	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.	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.	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.	Pre-surgery
Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery	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.	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.	Pre-surgery, 30- and 90-days post-surgery
Clinical outcomes post-surgery	The incidence of postoperative delirium as assessed by the Confusion Assessment Method (CAM) conducted by the nursing team and through medical chart review.	1-3 days post-surgery
Clinical outcomes post-surgery	Postoperative complications	1-3 days post-surgery
Clinical outcomes post-surgery	Hospital length of stay (LOS)	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)	1-3 days post-surgery
Clinical outcomes post-surgery	Mortality	30- and 90-days post-surgery
Clinical outcomes post-surgery	Readmission	30- and 90-days post-surgery
Clinical outcomes post-surgery	Postoperative complications	30- and 90-days post-surgery

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Frances Chung, MBBS FRCPC, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): August 30, 2025

Study Registration Dates

• First Submitted: August 11, 2023
• First Submitted That Met QC Criteria: September 1, 2023
• First Posted (Actual): September 11, 2023

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 22-5810

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No