Clinical trial NCT04850833: Post-operative Functional Disability in Unrecognized Cognitive Impairment (POF) Study
Official title: Post-operative Functional Disability in Unrecognized Cognitive Impairment (POF) Study: an Observational Cohort Study in Patients Undergoing Non-cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment (CI)
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 390
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
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 determine the prevalence of preoperative cognitive impairment (CI) using the Modified Telephone Interview for Cognitive Status (TICS-M), Eight-items interview to Differentiate Aging and Dementia (AD8), Telephone Montreal Cognitive Assessment (T-MoCA), and a single cognitive question from the Centers for Disease Control and Prevention (CDC). We would also determine the (1) the degree of agreement in screening results between each cognitive screening tool, (2) risk factors associated with screening positive for CI on each tool, and (3) the prevalence and/or trajectory of postoperative delirium, sleep disturbances, functional disability, instrumental activities of daily living (IADL), depression, quality of health, frailty, and pain in older surgical patients and its association with CI. This study will target older patients from the pre-operative clinics at Toronto Western Hospital and Mount Sinai Hospital (MSH), Toronto. Research staff will identify eligible patients who are scheduled for elective non-cardiac surgery. Written informed consent to participate in the study will be obtained from all patients.

Detailed description: The primary aim of this study is to (1) determine the prevalence of CI preoperatively in older surgical adults using virtual or telephone cognitive instruments, (2) determine the degree of agreement in screening results between each cognitive screening tool, and (3) explore the prevalence and trajectory of preoperative and postoperative outcomes and its association with CI. The outcomes include functional disability, IADL, sleep disturbances, quality of health, frailty, pain and depression.

In a preoperative assessment 1-30 days prior to their scheduled surgery, patients will be asked via telephone to complete TICS-M and T-MoCA and an online questionnaire, including the AD8, CDC single cognitive question, World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), IADL, EuroQol 5 Dimension (EQ-5D-5L), Geriatric Depression Scale (GDS), 5-item FRAIL questionnaire, (FRAIL), visual analog pain scale (VAS pain), Single-item Sleep Quality Scale (SQS), Pittsburgh Sleep Quality Index (PSQI), and STOP questionnaire. These questionnaires will be repeated at follow-up visits at 30-, 90-, and 180-days post-surgery. At the hospital on post-operatively days 1-3, the Confusion Assessment Method (CAM), SQS, and VAS pain will be administered during the in-person visit. Chart review of delirium will also be conducted during patients' stay at the hospital.

Eligibility criteria: Major Inclusion Criteria:

* patients ≥ 65 years old;
* patients scheduled for elective non-cardiac surgery
* able to be contacted by telephone for follow up.

Major Exclusion Criteria:

* patients with previous dementia diagnosis,
* patients scheduled for outpatient surgery,

Primary outcomes:
measure: Prevalence of cognitive impairment via remote (virtual/telephone) assessment
timeFrame: Pre-surgery, 30-, 90- and 180-days post-surgery
measure: Prevalence of cognitive impairment via remote (virtual/telephone) assessment
timeFrame: Pre-surgery, 30-, 90- and 180-days post-surgery
measure: Prevalence of cognitive impairment via remote (virtual/telephone) assessment
timeFrame: Pre-surgery, 30-, 90- and 180-days post-surgery
measure: Prevalence of cognitive impairment via remote (virtual/telephone) assessment
timeFrame: Pre-surgery, 30-, 90- and 180-days post-surgery
measure: Degree of agreement in screening results (Cohen's Kappa (κ) coefficients)
timeFrame: Pre-surgery
measure: The trajectories and prevalence or incidence of patient-reported outcomes
timeFrame: Pre-surgery, 30-, 90- and 180-days post-surgery
measure: The trajectories and prevalence or incidence of patient-reported outcomes
timeFrame: Pre-surgery, 30-, 90- and 180-days post-surgery
measure: The trajectories and prevalence or incidence of patient-reported outcomes
timeFrame: Pre-surgery, 30-, 90- and 180-days post-surgery
measure: The trajectories and prevalence or incidence of patient-reported outcomes
timeFrame: Pre-surgery, 30-, 90- and 180-days post-surgery
measure: The trajectories and prevalence or incidence of patient-reported outcomes
timeFrame: Pre-surgery, 30-, 90- and 180-days post-surgery
measure: The trajectories and prevalence or incidence of patient-reported outcomes
timeFrame: Pre-surgery, 30-, 90- and 180-days post-surgery
measure: The trajectories and prevalence or incidence of patient-reported outcomes
timeFrame: Pre-surgery, 30-, 90- and 180-days post-surgery
measure: The trajectories and prevalence or incidence of patient-reported outcomes
timeFrame: Pre-surgery, 30-, 90- and 180-days post-surgery
Secondary outcomes:
measure: The incidence of postoperative delirium post-surgery
timeFrame: Post-op day 1-3
measure: Discharge destination of participants from chart review post-surgery
timeFrame: Post-op day 1-3
measure: Hospital length of stay (LOS) of participants post-surgery
timeFrame: Post-op day 1-3
measure: Days spent at home (DAH30) of participants post-surgery
timeFrame: 30-days post-surgery
measure: Mortality (number of participants who have died) post-surgery
timeFrame: 30-, 90- and 180-days post-surgery
measure: Number of participants who have been re-admitted to the hospital post-surgery
timeFrame: 30-, 90- and 180-days post-surgery
measure: Number of participants who have visited the emergency department post-surgery
timeFrame: 30-, 90- and 180-days post-surgery
measure: Incidence of postoperative complications of participants post-surgery
timeFrame: 30-, 90- and 180-days post-surgery
measure: Incidence of re-operation or revision surgery post-surgery
timeFrame: 30-, 90- and 180-days post-surgery
measure: Risk factors for screening positive on each cognitive screening tool
timeFrame: Pre-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 MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: