Post-operative Functional Disability in Unrecognized Cognitive Impairment (POF) Study

Cognitive Impairment (CI) Clinical Trial

Official title:

Post-operative Functional Disability in Unrecognized Cognitive Impairment (POF) Study: an Observational Cohort Study in Patients Undergoing Non-cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04850833
• Other study ID #: 20-6186
• Status: Recruiting
• Start date: July 25, 2021
• Est. completion date: April 15, 2024

Study information

• Verified date: July 2023
• Source: University Health Network, Toronto
• Contact: Sazzadul Islam
• Phone: 4166622686
• Email: sazzadul.islam[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 determine the (1) the diagnostic accuracy (sensitivity, specificity, and area under the curve (AUC)) of the AD8, CDC single cognitive question, and T-MoCA against the TICS-M and (2) the correlation between CI and measures of postoperative delirium, sleep disturbances, functional disability, instrumental activities of daily living (IADL), depression, quality of health, frailty, and pain in older surgical patients. 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.

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 diagnostic accuracy of the AD8, CDC single cognitive question, and T-MoCA against the TICS-M, and (3) compare the trajectory of preoperative and postoperative outcomes between those with and without 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: April 15, 2024
• Est. primary completion date: April 15, 2024
• Gender: All
• Age group: 65 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment (CI)

Locations

Country	Name	City	State
Canada	399 Bathurst St., Toronto Western Hospital, Dept. of Anesthesia	Toronto	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Frances Chung

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of cognitive impairment via remote (virtual/telephone) assessment	Prevalence of cognitive impairment via remote (virtual/telephone) assessment as detected by the TICS-m (modified telephone interview for cognitive status). The TICS-m is scored from 0-50 with a score of 31 or below indicating cognitive impairment.	Pre-surgery, 30-, 90- and 180-days post-surgery
Primary	Prevalence of cognitive impairment via remote (virtual/telephone) assessment	Prevalence of cognitive impairment via remote (virtual/telephone) assessment as detected by the T-MoCA (telephone Montreal cognitive assessment). The T-MoCA is scored from 0-22 with a score of 18 or below indicating cognitive impairment.	Pre-surgery, 30-, 90- and 180-days post-surgery
Primary	Prevalence of cognitive impairment via remote (virtual/telephone) assessment	Prevalence of cognitive impairment via remote (virtual/telephone) assessment 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, 30-, 90- and 180-days post-surgery
Primary	Prevalence of cognitive impairment via remote (virtual/telephone) assessment	Prevalence of cognitive impairment via remote (virtual/telephone) assessment as detected by the CDC Single Cognitive Question. The CDC Single Cognitive Question is a yes/no question where answers of yes indicate cognitive impairment.	Pre-surgery, 30-, 90- and 180-days post-surgery
Primary	The diagnostic accuracy (sensitivity, specificity, and AUC)	The diagnostic accuracy (sensitivity, specificity, and AUC [Area under the Receiver Operating Characteristic Curve (ROC)]) of the T-MoCA, AD8, and CDC Single Cognitive Question compared against the TICS-M.	Pre-surgery
Primary	The trajectories and prevalence or incidence of patient-reported outcomes	The trajectories 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-, 90- and 180-days post-surgery
Primary	The trajectories and prevalence or incidence of patient-reported outcomes	The trajectories and prevalence or incidence of instrumental activities of daily living (IADL) as measured through the IADL in participants with CI vs those without. It is scored from 0-8 where a higher score indicates high function and independence.	Pre-surgery, 30-, 90- and 180-days post-surgery
Primary	The trajectories and prevalence or incidence of patient-reported outcomes	The trajectories and prevalence or incidence of sleep disturbances as measured through the PSQI (Pittsburgh Sleep Quality Index) in participants with CI vs those without. It is scored from 0-21 where a higher score indicates worse sleep quality.	Pre-surgery, 30-, 90- and 180-days post-surgery
Primary	The trajectories and prevalence or incidence of patient-reported outcomes	The trajectories and prevalence or incidence of sleep quality 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 higher score indicates better sleep quality.	Pre-surgery, 30-, 90- and 180-days post-surgery
Primary	The trajectories and prevalence or incidence of patient-reported outcomes	The trajectories and prevalence or incidence of depression as measured through the GDS (Geriatric Depression Scale) in participants with CI vs those without. It is scored from 0-15 where a higher score indicates depression.	Pre-surgery, 30-, 90- and 180-days post-surgery
Primary	The trajectories and prevalence or incidence of patient-reported outcomes	The trajectories 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-, 90- and 180-days post-surgery
Primary	The trajectories and prevalence or incidence of patient-reported outcomes	The trajectories and prevalence or incidence of frailty as measured through the 5-item FRAIL questionnaire (Fatigue, resistance, ambulation, illnesses, and loss of weight) in participants with CI vs those without. It is scored from 0-5 where higher scores indicate frailty.	Pre-surgery, 30-, 90- and 180-days post-surgery
Primary	The trajectories and prevalence or incidence of patient-reported outcomes p	The trajectories and prevalence or incidence of quality of health as measured through the EQ5D5L (EuroQol 5 Dimension) in participants with CI vs those without. Each dimension on the tool has five response levels and one level from each dimension is combined to give a health state ranging from 11111 (full health) to 55555 (worst health). The health states are converted into a single index utility where lower values indicate worse quality of health	Pre-surgery, 30-, 90- and 180-days post-surgery
Secondary	The incidence of postoperative delirium post-surgery	The incidence of postoperative delirium as measured by the Confusion Assessment Method (CAM) conducted by the research and nursing team and medical chart review.	Post-op day 1-3
Secondary	Discharge destination of participants from chart review post-surgery	Discharge destination (assess where the participant will be discharged to once out of hospital up to 30-days post-op)	Post-op day 1-3
Secondary	Hospital length of stay (LOS) of participants post-surgery	Hospital length of stay	Post-op day 1-3
Secondary	Days spent at home (DAH30) of participants post-surgery	DAH30 (days spent at home) at 30 days post-surgery	30-days post-surgery
Secondary	Mortality (number of participants who have died) post-surgery	Mortality	30-, 90- and 180-days post-surgery
Secondary	Number of participants who have been re-admitted to the hospital post-surgery	Hospital re-admission	30-, 90- and 180-days post-surgery
Secondary	Number of participants who have visited the emergency department post-surgery	Emergency department visit	30-, 90- and 180-days post-surgery
Secondary	Incidence of postoperative complications of participants post-surgery	Postoperative complications	30-, 90- and 180-days post-surgery