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NCT Number: NCT04850833

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

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.

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Key information

Conditions

Cognitive Impairment (CI) Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

399 Bathurst St., Toronto Western Hospital, Dept. of Anesthesia, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Primary outcomes

  1. Prevalence of cognitive impairment via remote (virtual/telephone) assessment

    Time frame: Pre-surgery, 30-, 90- and 180-days post-surgery

    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.

  2. Prevalence of cognitive impairment via remote (virtual/telephone) assessment

    Time frame: Pre-surgery, 30-, 90- and 180-days post-surgery

    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.

  3. Prevalence of cognitive impairment via remote (virtual/telephone) assessment

    Time frame: Pre-surgery, 30-, 90- and 180-days post-surgery

    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.

  4. Prevalence of cognitive impairment via remote (virtual/telephone) assessment

    Time frame: 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.

  5. Degree of agreement in screening results (Cohen's Kappa (κ) coefficients)

    Time frame: Pre-surgery

    The degree of agreement in screening results among the screening tools by calculating Cohen's Kappa (κ) coefficients.

  6. The trajectories and prevalence or incidence of patient-reported outcomes

    Time frame: Pre-surgery, 30-, 90- and 180-days post-surgery

    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 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.

  7. The trajectories and prevalence or incidence of patient-reported outcomes

    Time frame: Pre-surgery, 30-, 90- and 180-days post-surgery

    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.

  8. The trajectories and prevalence or incidence of patient-reported outcomes

    Time frame: Pre-surgery, 30-, 90- and 180-days post-surgery

    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.

  9. The trajectories and prevalence or incidence of patient-reported outcomes

    Time frame: Pre-surgery, 30-, 90- and 180-days post-surgery

    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.

  10. The trajectories and prevalence or incidence of patient-reported outcomes

    Time frame: Pre-surgery, 30-, 90- and 180-days post-surgery

    The trajectories and prevalence or incidence of depression as measured through the GDS (Geriatric Depression Scale) in participants with vs without preoperative depression and in participants with vs without CI. It is scored from 0-15 where a higher score indicates depression.

  11. The trajectories and prevalence or incidence of patient-reported outcomes

    Time frame: Pre-surgery, 30-, 90- and 180-days post-surgery

    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.

  12. The trajectories and prevalence or incidence of patient-reported outcomes

    Time frame: Pre-surgery, 30-, 90- and 180-days post-surgery

    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 vs without preoperative frailty and in participants with vs without CI. It is scored from 0-5 where higher scores indicate frailty.

  13. The trajectories and prevalence or incidence of patient-reported outcomes

    Time frame: 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 outcomes

  1. The incidence of postoperative delirium post-surgery

    Time frame: 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.

  2. Discharge destination of participants from chart review post-surgery

    Time frame: 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)

  3. Hospital length of stay (LOS) of participants post-surgery

    Time frame: Post-op day 1-3

    Hospital length of stay

  4. Days spent at home (DAH30) of participants post-surgery

    Time frame: 30-days post-surgery

    DAH30 (days spent at home) at 30 days post-surgery

  5. Mortality (number of participants who have died) post-surgery

    Time frame: 30-, 90- and 180-days post-surgery

    Mortality

  6. Number of participants who have been re-admitted to the hospital post-surgery

    Time frame: 30-, 90- and 180-days post-surgery

    Hospital re-admission

  7. Number of participants who have visited the emergency department post-surgery

    Time frame: 30-, 90- and 180-days post-surgery

    Emergency department visit

  8. Incidence of postoperative complications of participants post-surgery

    Time frame: 30-, 90- and 180-days post-surgery

    All-cause postoperative complications

  9. Incidence of re-operation or revision surgery post-surgery

    Time frame: 30-, 90- and 180-days post-surgery

    Re-operation or revision surgery

  10. Risk factors for screening positive on each cognitive screening tool

    Time frame: Pre-surgery

    Preoperative risk factors associated with screening positive on each cognitive screening tool

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2021
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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