Post-operative Functional Disability in Unrecognized Cognitive Impairment (POF) Study
- Conditions
- Cognitive Impairment (CI)
- Registration Number
- NCT04850833
- Lead Sponsor
- University Health Network, Toronto
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 390
- patients ≥ 65 years old;
- patients scheduled for elective non-cardiac surgery
- able to be contacted by telephone for follow up.
Major
- patients with previous dementia diagnosis,
- patients scheduled for outpatient surgery,
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Degree of agreement in screening results (Cohen's Kappa (κ) coefficients) Pre-surgery The degree of agreement in screening results among the screening tools by calculating Cohen's Kappa (κ) coefficients.
Prevalence of cognitive impairment via remote (virtual/telephone) assessment Pre-surgery, 30-, 90- and 180-days post-surgery 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.
The trajectories and prevalence or incidence of patient-reported outcomes Pre-surgery, 30-, 90- and 180-days post-surgery 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
- Secondary Outcome Measures
Name Time Method Hospital length of stay (LOS) of participants post-surgery Post-op day 1-3 Hospital length of stay
Number of participants who have been re-admitted to the hospital post-surgery 30-, 90- and 180-days post-surgery Hospital re-admission
The incidence of postoperative delirium post-surgery Post-op day 1-3 The incidence of postoperative delirium as measured by the Confusion Assessment Method (CAM) conducted by the research and nursing team and medical chart review.
Discharge destination of participants from chart review post-surgery Post-op day 1-3 Discharge destination (assess where the participant will be discharged to once out of hospital up to 30-days post-op)
Days spent at home (DAH30) of participants post-surgery 30-days post-surgery DAH30 (days spent at home) at 30 days post-surgery
Incidence of postoperative complications of participants post-surgery 30-, 90- and 180-days post-surgery All-cause postoperative complications
Mortality (number of participants who have died) post-surgery 30-, 90- and 180-days post-surgery Mortality
Number of participants who have visited the emergency department post-surgery 30-, 90- and 180-days post-surgery Emergency department visit
Incidence of re-operation or revision surgery post-surgery 30-, 90- and 180-days post-surgery Re-operation or revision surgery
Risk factors for screening positive on each cognitive screening tool Pre-surgery Preoperative risk factors associated with screening positive on each cognitive screening tool
Trial Locations
- Locations (2)
399 Bathurst St., Toronto Western Hospital, Dept. of Anesthesia
🇨🇦Toronto, Ontario, Canada
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada