Clinical trial NCT06030765: Detect CI (Cognitive Impairment) Study
Official title: Evaluation of Rapid Cognitive Screening Tools for Detection of Cognitive Impairment in Older Surgical Patients: A Prospective Cohort Study - Detect CI Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cognitive Impairment (CI)
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 383
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled to undergo elective inpatient non-cardiac surgery under general and/ or regional anesthesia

Brief summary: 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.

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, 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The diagnostic accuracy (sensitivity, specificity
timeFrame: Pre-surgery
measure: The diagnostic accuracy (AUC)
timeFrame: Pre-surgery
measure: Prevalence of cognitive impairment (CI) via cognitive screening tools
timeFrame: Pre-surgery
measure: Prevalence of cognitive impairment (CI) via cognitive screening tools
timeFrame: Pre-surgery
measure: Prevalence of cognitive impairment (CI) via cognitive screening tools
timeFrame: Pre-surgery
measure: Prevalence of cognitive impairment (CI) via cognitive screening tools
timeFrame: Pre-surgery
Secondary outcomes:
measure: Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
timeFrame: Pre-surgery, 30- and 90-days post-surgery
measure: Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
timeFrame: Pre-surgery, 30- and 90-days post-surgery
measure: Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
timeFrame: Pre-surgery, 30- and 90-days post-surgery
measure: Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
timeFrame: Pre-surgery, 30- and 90-days post-surgery
measure: Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
timeFrame: Pre-surgery
measure: Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
timeFrame: Pre-surgery
measure: Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
timeFrame: Pre-surgery, 30- and 90-days post-surgery
measure: Incidence of clinical outcomes post-surgery
timeFrame: 1-3 days post-surgery
measure: Incidence of adverse clinical outcomes post-surgery
timeFrame: 1-3 days post-surgery
measure: Clinical outcomes post-surgery
timeFrame: 1-3 days post-surgery
measure: Clinical outcomes post-surgery
timeFrame: 1-3 days post-surgery
measure: Incidence of adverse clinical outcomes post-surgery
timeFrame: 30- and 90-days post-surgery
measure: Incidence of adverse clinical outcomes post-surgery
timeFrame: 30- and 90-days post-surgery
measure: Incidence of adverse clinical outcomes post-surgery
timeFrame: 30- and 90-days post-surgery
measure: Incidence of adverse clinical outcomes post-surgery
timeFrame: 30- and 90-days post-surgery
measure: Incidence of adverse clinical outcomes post-surgery
timeFrame: 30- and 90-days post-surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: 399 Bathurst St., Toronto Western Hospital, Dept. of Anesthesia
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Frances Chung, MBBS FRCPC
role: PRINCIPAL_INVESTIGATOR
References: