Feasibility of an Online, Self-administered Cognitive Screening Tool in Older Patients Undergoing Ambulatory Surgery

Completed

• Conditions: Neurocognitive Disorders; Delirium in Old Age; Alzheimer Disease; Mild Cognitive Impairment
• Interventions: Other: Brain Health Assessment; Other: Demographics questionnaire; Other: PHQ-2; Other: AFT; Other: GAI-SF; Other: pain VAS; Other: IADL; Other: FAM CAM; Other: 4AT; Other: BHA Usability Survey; Other: Clinical Frailty Scale

• Registration Number: NCT05094817
• Lead Sponsor: Women's College Hospital

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.

Study Timeline

• Study First Submitted: 2021-07-05
• Study First Submitted QC: 2021-10-13
• Study First Posted: 2021-10-26
• Study Start: 2022-02-11
• Primary Completion: 2023-07-21
• Study Completion: 2023-07-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Access to Computer	PHQ-2	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.
Access to Computer	BHA Usability Survey	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.
Access to Computer	Demographics questionnaire	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.
Access to Computer	GAI-SF	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.
Access to Computer	Clinical Frailty Scale	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.
Access to Computer	Brain Health Assessment	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.
Access to Computer	IADL	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.
Access to Computer	AFT	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.
Access to Computer	FAM CAM	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.
Access to Computer	4AT	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.
No Access to Computer	PHQ-2	Since participants in previous studies on cognitive screening are usually more educated individuals with higher income, participants who do not have proficiency/or access to a computer will be asked to complete some questionnaires to determine any sociodemographic or baseline differences between patients who are able to complete BHA vs. those who are not able to complete BHA.
No Access to Computer	pain VAS	Since participants in previous studies on cognitive screening are usually more educated individuals with higher income, participants who do not have proficiency/or access to a computer will be asked to complete some questionnaires to determine any sociodemographic or baseline differences between patients who are able to complete BHA vs. those who are not able to complete BHA.
Access to Computer	pain VAS	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.
No Access to Computer	Demographics questionnaire	Since participants in previous studies on cognitive screening are usually more educated individuals with higher income, participants who do not have proficiency/or access to a computer will be asked to complete some questionnaires to determine any sociodemographic or baseline differences between patients who are able to complete BHA vs. those who are not able to complete BHA.
No Access to Computer	AFT	Since participants in previous studies on cognitive screening are usually more educated individuals with higher income, participants who do not have proficiency/or access to a computer will be asked to complete some questionnaires to determine any sociodemographic or baseline differences between patients who are able to complete BHA vs. those who are not able to complete BHA.
No Access to Computer	IADL	Since participants in previous studies on cognitive screening are usually more educated individuals with higher income, participants who do not have proficiency/or access to a computer will be asked to complete some questionnaires to determine any sociodemographic or baseline differences between patients who are able to complete BHA vs. those who are not able to complete BHA.
No Access to Computer	GAI-SF	Since participants in previous studies on cognitive screening are usually more educated individuals with higher income, participants who do not have proficiency/or access to a computer will be asked to complete some questionnaires to determine any sociodemographic or baseline differences between patients who are able to complete BHA vs. those who are not able to complete BHA.

Primary Outcome Measures

Name	Time	Method
Participants that completed BHA/total participants	12 months to 18 months	To determine the feasibility (recruitment capability, rates of completion, resulting sociodemographic characteristics) of using a self-administered cognitive assessment tool (Cogniciti's BHA) in older adults undergoing elective ambulatory surgery.

Secondary Outcome Measures

Name	Time	Method
Usability and acceptability of Cognitici's BHA	12 months to 18 months	The survey aims to assess system usability and acceptability based on standard questions adapted from the validated System Usability Scale. The questions evaluate satisfaction, experience with technology, and comfort level, as well as questions targeting usability concerns typically experienced by older adults, such as typeface and font size, consistent navigation, and writing style.
Percentage of patients who successfully complete Cogniciti's BHA	12 months to 18 months	percentage of enrolled patients who complete all postoperative assessments
To estimate the incidence of pre-existing neurocognitive disorders (NCD) in older adults undergoing elective ambulatory surgery.	12 months to 18 months	Identify neurocognitive disorders among older adults undergoing ambulatory surgeries

Trial Locations

Locations (1)

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada