Clinical trial NCT05094817: Feasibility of an Online, Self-administered Cognitive Screening Tool in Older Patients Undergoing Ambulatory Surgery
Official title: Feasibility of an Online, Self-administered Cognitive Screening Tool in Older Patients Undergoing Ambulatory Surgery (FOCUS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium in Old Age
Alzheimer Disease
Mild Cognitive Impairment
Neurocognitive Disorders
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
First posted: 2021-10-26
Enrollment: 78
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly patients ≥65 years old from pre-operative clinics at WCH and TWH will be approached. Research personnel will identify participants that meet the inclusion criteria and informed consent will be obtained from eligible participants.

Brief summary: Delirium is common in older adults after inpatient surgery and may be associated with cognitive decline. Advances in surgical and anesthetic techniques have led to increasing numbers of older adults undergoing surgery on an outpatient basis. However, few studies have investigated cognitive disorders of older adults before or after ambulatory surgery. Increased age and pre-existing cognitive impairment are strong risk factors for cognitive decline after surgery, yet older adults are not screened for cognitive impairment before surgery. Existing screening tools require specially trained staff for test administration and in-person testing. Virtual cognitive screening has not been evaluated in surgical patients. In this study, investigators will determine the feasibility of using Cogniciti's Brain Health Assessment (BHA) - a validated online cognitive screening tool that can be self-administered from a patient's home before surgery - to screen older adults before ambulatory surgery.

Detailed description: Older adults (≥60 years of age) are the fastest growing age group in Canada, and by the year 2026, will constitute more than 1 of every 5 Canadians. World-wide, about 703 million people are ≥65 years of age, and this number is projected to double to 1.5 billion in 2050. Higher life expectancy and advancements in anesthetic techniques have led to more older adults with high burdens of co-morbidities to undergo ambulatory surgeries.

Approximately 40-53% of all surgeries performed are on patients \>65 years of age. Neurocognitive disorders (NCD) are common in the community with 14-48% of those \>age 70 years suffering mild cognitive impairment (MCI).

Impairments in cognitive ability are the most common complications in older adults undergoing major surgery. These impairments include 1) delirium (which may last up to 7 days after surgery), 2) delayed neurocognitive recovery (cognitive decline up to 30 days after surgery) 3) Neurocognitive disorder (postoperative) mild or major (30 days to 12 months after surgery). The decline in executive function, memory, and other cognitive domains may last for weeks to months after surgery. While most patients recover from cognitive impairment, a small minority of patients have persistent impairment. Older adults who are diagnosed with PND have longer hospital length of stay, are less likely to be discharged home, increased health care costs, and a higher incidence of mortality at one year after surgery.

Investigators hypothesize that it is feasible to utilize the BHA to screen for NCDs, and to assess cognitive changes in elderly patients undergoing elective ambulatory surgery.

Eligibility criteria: Inclusion Criteria:

* Adults (≥65 years old)
* Undergoing elective ambulatory surgery
* Participants must be competent to provide informed consent,
* Be proficient in English (Grade 6 reading level)
* Have cognitive, visual, and physical capability necessary to complete the questionnaires and/or online assessment tool.
* Participants completing the BHA should be at least somewhat comfortable or very comfortable with using a computer and mouse and should use a computer at least once a week.

Exclusion Criteria:

* Inability to speak, read or understand English
* Previous intracranial surgery
* A previous diagnosis of major NCD e.g. dementia, and current significant uncontrolled psychiatric disorders.

Primary outcomes:
measure: Participants that completed BHA/total participants
timeFrame: 12 months to 18 months
Secondary outcomes:
measure: Usability and acceptability of Cognitici's BHA
timeFrame: 12 months to 18 months
measure: Percentage of patients who successfully complete Cogniciti's BHA
timeFrame: 12 months to 18 months
measure: To estimate the incidence of pre-existing neurocognitive disorders (NCD) in older adults undergoing elective ambulatory surgery.
timeFrame: 12 months to 18 months
Other outcomes:
measure: The sociodemographic characteristics of patients completing Cogniciti's BHA vs. those who that do not.
timeFrame: 12 months to 18 months
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: Women's College Hospital
name: Jean Wong, MD
role: PRINCIPAL_INVESTIGATOR
References: