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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04850833
Enrollment
390
Registered
2021-04-20
Start date
2021-07-23
Completion date
2023-05-30
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment (CI)

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.

Interventions

None listed

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum

Inclusion 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,

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of cognitive impairment via remote (virtual/telephone) assessmentPre-surgery, 30-, 90- and 180-days post-surgeryPrevalence 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.
Degree of agreement in screening results (Cohen's Kappa (κ) coefficients)Pre-surgeryThe degree of agreement in screening results among the screening tools by calculating Cohen's Kappa (κ) coefficients.
The trajectories and prevalence or incidence of patient-reported outcomesPre-surgery, 30-, 90- and 180-days post-surgeryThe 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 vs without preoperative functional disability and in participants with vs without CI. 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.

Secondary

MeasureTime frameDescription
Days spent at home (DAH30) of participants post-surgery30-days post-surgeryDAH30 (days spent at home) at 30 days post-surgery
Mortality (number of participants who have died) post-surgery30-, 90- and 180-days post-surgeryMortality
Number of participants who have been re-admitted to the hospital post-surgery30-, 90- and 180-days post-surgeryHospital re-admission
The incidence of postoperative delirium post-surgeryPost-op day 1-3The incidence of postoperative delirium as measured by the Confusion Assessment Method (CAM) conducted by the research and nursing team and medical chart review.
Incidence of postoperative complications of participants post-surgery30-, 90- and 180-days post-surgeryAll-cause postoperative complications
Incidence of re-operation or revision surgery post-surgery30-, 90- and 180-days post-surgeryRe-operation or revision surgery
Risk factors for screening positive on each cognitive screening toolPre-surgeryPreoperative risk factors associated with screening positive on each cognitive screening tool
Number of participants who have visited the emergency department post-surgery30-, 90- and 180-days post-surgeryEmergency department visit
Discharge destination of participants from chart review post-surgeryPost-op day 1-3Discharge destination (assess where the participant will be discharged to once out of hospital up to 30-days post-op)
Hospital length of stay (LOS) of participants post-surgeryPost-op day 1-3Hospital length of stay

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026