Cognitive FrailtyNCT04235738
Cognitive Impairment in Older Emergency Department Users and Associated Adverse Outcomes
An observational study of Cognitive Frailty and Physical Frailty, run by Jewish General Hospital at 1 site in Canada.
Trial summary
This study examines the prevalence and incidence of older ER users with cognitive impairment (i.e., dementia and/or delirium) using the ER2 item temporal disorientation in older ED users who are participants of the ER2 cohort study database. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Cognitive Frailty, Physical Frailty, Older Emergency Department Users
- What is being tested?
- Observational
- How many people
- 4,724 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jan 2020to 1 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Individuals eligible for this study are the participants in the ER2 study.
Who may be able to join
- An unplanned ED visit and to be on a stretcher
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Impairment in Older Emergency Department Users and Associated Adverse Outcomes: Results From the ER2 Cohort Study Database
This study examines the prevalence and incidence of older ER users with cognitive impairment (i.e., dementia and/or delirium) using the ER2 item temporal disorientation in older ED users who are participants of the ER2 cohort study database.
Read the detailed description
The Emergency Departments (EDs) in North America are under duress because of overcrowding, delays and diversions, which increase to epidemic proportions. The aging of Canadian's population amplifies the magnitude of this situation because older ED users are the fastest increasing group of ED users and they have complex and specific needs.
There are simple interventions with which providers must proceed in order to cure or prevent short-term ED adverse events. Delirium, motor deconditioning, polypharmacy-related adverse drug reactions, and inappropriate home support are the main conditions to target when taking care of older ED users. We previously demonstrated that acting on these conditions may significantly accelerate the discharge and significantly reduce the length of ED and hospital stay. Evidence-based medicine showed that simple and early interventions may prevent delirium (e.g., through hydration, avoiding restraint, mobilizing and satisfying basic needs, time and place reorientation) and motor deconditioning (e.g., through encouraging mobility, up to chair at mealtime during daytime hours, providing appropriate walking aid) in older patients. Medication reconciliation is also an efficient intervention to prevent adverse drug reactions. Furthermore, an early assessment of home support is a crucial step in adjusting services for an early and smooth discharge back home. Based on this evidence, we have modified the 6-item Emergency Room Evaluation and Recommendations (ER2) by adding an interventional component to the assessment portion of the tool. The interventional part depends on the assessment's results and is based on recommendations designed to encourage easy and basic interventions that prevent delirium, motor deconditioning, adverse drug interactions and inappropriate home support. These recommendations are based on answers to the ER2 items
- Being tested
- Observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
ER2 is a simple and standardized clinical tool. The results of the questionnaires performed in ER2 study will be used. The assessment component of ER2 consists of 6 very simple closed-ended format questions (i.e., yes versus no) which are: Age category (≥ 85), male, polypharmacy (≥ 5 different medications per day), use of formal (health care or social professional) and/or informal (family and/or friend) home support, use of a walking aid regardless of its type, and temporal disorientation (inability to give the current month and/or year). A score of five points is assigned to the items "use of walking aid" and "temporal disorientation", whereas, for the other items, the assigned score is one point. The weighting of points for ER2 items is based on the results of our previous studies. Scores range from 0 (lowest risk) to 14 (highest risk). ER2 scores stratify the risk for short-term ED adverse events into three levels: low, moderate and high.
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
The length of hospital stay is defined as the average number of days that patients spend in hospital. It will be used the ER2 tool ( Emergency Room Evaluation and Recommendation) to calculate the length of hospital stay.
Measured: 12 months
Dementia
The diagnosis of dementia
Measured: 12 months
Delirium
The diagnosis of delirium
Measured: 12 months
Length of stay in ED
The length of ED stay is defined as the average number of days that patients spend in the ED. It will use the ER2 tool ( Emergency Room Evaluation and Recommendation) to calculate the length of ED stay.
Measured: 12 months
Hospital admission rate
The number of individuals admitted to the hospital
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start17 Jan 2020
- Primary completion1 Feb 2022
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,724 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Beauchet, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235738
- Sponsor's protocol ID
- 2020-2184
- Status last verified
- Feb 2024
- First submitted
- 17 Jan 2020
- Last updated
- 23 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Impairment in Older Emergency Department Users and Associated Adverse Outcomes: Results From the ER2 Cohort Study Database
- ClinicalTrials.gov ID
- NCT04235738
- Acronym / sponsor ID
- 2020-2184
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,724 participants (estimated)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the prevalence and incidence of older ER users with cognitive impairment (i.e., dementia and/or delirium) using the ER2 item temporal disorientation in older ED users who are participants of the ER2 cohort study database.
Detailed description
The Emergency Departments (EDs) in North America are under duress because of overcrowding, delays and diversions, which increase to epidemic proportions. The aging of Canadian's population amplifies the magnitude of this situation because older ED users are the fastest increasing group of ED users and they have complex and specific needs.
There are simple interventions with which providers must proceed in order to cure or prevent short-term ED adverse events. Delirium, motor deconditioning, polypharmacy-related adverse drug reactions, and inappropriate home support are the main conditions to target when taking care of older ED users. We previously demonstrated that acting on these conditions may significantly accelerate the discharge and significantly reduce the length of ED and hospital stay. Evidence-based medicine showed that simple and early interventions may prevent delirium (e.g., through hydration, avoiding restraint, mobilizing and satisfying basic needs, time and place reorientation) and motor deconditioning (e.g., through encouraging mobility, up to chair at mealtime during daytime hours, providing appropriate walking aid) in older patients. Medication reconciliation is also an efficient intervention to prevent adverse drug reactions. Furthermore, an early assessment of home support is a crucial step in adjusting services for an early and smooth discharge back home. Based on this evidence, we have modified the 6-item Emergency Room Evaluation and Recommendations (ER2) by adding an interventional component to the assessment portion of the tool. The interventional part depends on the assessment's results and is based on recommendations designed to encourage easy and basic interventions that prevent delirium, motor deconditioning, adverse drug interactions and inappropriate home support. These recommendations are based on answers to the ER2 items
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Individuals eligible for this study are the participants in the ER2 study.
Key inclusion criteria (1 listed)
- An unplanned ED visit and to be on a stretcher
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalER2 is a simple and standardized clinical tool. The results of the questionnaires performed in ER2 study will be used. The assessment component of ER2 consists of 6 very simple closed-ended format questions (i.e., yes versus no) which are: Age category (≥ 85), male, polypharmacy (≥ 5 different medications per day), use of formal (health care or social professional) and/or informal (family and/or friend) home support, use of a walking aid regardless of its type, and temporal disorientation (inability to give the current month and/or year). A score of five points is assigned to the items "use of walking aid" and "temporal disorientation", whereas, for the other items, the assigned score is one point. The weighting of points for ER2 items is based on the results of our previous studies. Scores range from 0 (lowest risk) to 14 (highest risk). ER2 scores stratify the risk for short-term ED adverse events into three levels: low, moderate and high. | Other | – |
Primary outcome
Length of hospital stay
Time frame: 12 months
The length of hospital stay is defined as the average number of days that patients spend in hospital. It will be used the ER2 tool ( Emergency Room Evaluation and Recommendation) to calculate the length of hospital stay.
Dementia
Time frame: 12 months
The diagnosis of dementia
Delirium
Time frame: 12 months
The diagnosis of delirium
Length of stay in ED
Time frame: 12 months
The length of ED stay is defined as the average number of days that patients spend in the ED. It will use the ER2 tool ( Emergency Room Evaluation and Recommendation) to calculate the length of ED stay.
Hospital admission rate
Time frame: 12 months
The number of individuals admitted to the hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Frailty and Physical Frailty, run by Jewish General Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.