Health ImpairmentNCT04018898
Older Emergency Department Users and Short-term Adverse Events at the Index Visit
An observational study of Health Impairment and Adverse Event, run by Jewish General Hospital at 1 site in Canada.
Trial summary
This study evaluates the difference between PRISMA-7 and ER2 tool. There are some differences between PRISMA-7 and ER2 tool. The differences consist in evaluation criteria that are used to perform the both surveys. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Health Impairment, Adverse Event, Hospitalization
- How many people
- 10,971 participants
- Where
- 1 siteCanada
- Study dates
- 23 Jul 2019to 1 Jul 2024
- 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
- Older adult
Study population: In this study will be enrolled people who are 75 years and over, and who come at Emergency not only for medical reason but also for social.
Who may be able to join
- Being 75 years old and over
- Brought at Emergency on medical stretcher
Who cannot join
- Being less than 75 years old
- Never come at Emergency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Older Emergency Department Users and Short-term Adverse Events at the Index Visit: Which Clinical Prognostic Tool is Used?
This study evaluates the difference between PRISMA-7 and ER2 tool. There are some differences between PRISMA-7 and ER2 tool. The differences consist in evaluation criteria that are used to perform the both surveys. We suppose that evaluation criteria of PRISMA-7 is not accurately enough to calculate the length of hospital stay and to predict the short-term outcomes.
Read the detailed description
The "Program of Research on Integration of Services for the Maintenance of Autonomy" (PRISMA-7) is the Ministry of Health and Social Services' reference tool for the assessment of older ED users in Quebec (Canada). PRISMA-7 has been initially designed to screen disability in community-dwelling older adults and has never been validated for risk for short-term adverse events in older ED users. "Emergency room evaluation and recommendations" (ER2) is another clinical tool which is currently evaluated in Quebec. Compared to PRISMA-7, ER2 has been especially designed for assessing risk for short-term ED adverse events. No study has compared PRISMA-7 and ER2 risk for short-term adverse events. We hypothesised that ER2 could be a better prognostic tool compared to PRISMA-7 for long length of stay in ED and hospital stay, and hospital admission because it was designed and validated for this specific goal. The study aims to 1) examine and compared PRISMA-7 and ER2 risk for long length of ED and hospital stay and hospital admission, and 2) to establish their performance criteria (i.e., sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratios) for these three short-term adverse events in older ED users.
- Conditions
- Health Impairment, Adverse Event, Hospitalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational | Each participant will be evaluated at Emergency Department based on ER2 screening tool (Emergency Room Evaluation and Recommendation Form). Six closed-ended format questions (i.e., yes versus no) composed ER2 assessment: 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 its type, and temporal disorientation (inability to give the current month and/or year). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term adverse events
The adverse event is defined as an adverse outcome related to an ED encounter, this adverse event is related to ED care.
Measured: Around 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start23 Jul 2019
- Primary completion1 Mar 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health ImpairmentStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 10,971 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Beauchet, Jewish General Hospital
- Investigators
- Oliver Beauchet, MD, Principal investigator, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018898
- Sponsor's protocol ID
- 2020-1881
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2019
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Older Emergency Department Users and Short-term Adverse Events at the Index Visit: Which Clinical Prognostic Tool is Used?
- ClinicalTrials.gov ID
- NCT04018898
- Acronym / sponsor ID
- 2020-1881
- Conditions
- Health Impairment, Adverse Event, Hospitalization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,971 participants (actual)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 15 Jul 2019 (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 evaluates the difference between PRISMA-7 and ER2 tool. There are some differences between PRISMA-7 and ER2 tool. The differences consist in evaluation criteria that are used to perform the both surveys. We suppose that evaluation criteria of PRISMA-7 is not accurately enough to calculate the length of hospital stay and to predict the short-term outcomes.
Detailed description
The "Program of Research on Integration of Services for the Maintenance of Autonomy" (PRISMA-7) is the Ministry of Health and Social Services' reference tool for the assessment of older ED users in Quebec (Canada). PRISMA-7 has been initially designed to screen disability in community-dwelling older adults and has never been validated for risk for short-term adverse events in older ED users. "Emergency room evaluation and recommendations" (ER2) is another clinical tool which is currently evaluated in Quebec. Compared to PRISMA-7, ER2 has been especially designed for assessing risk for short-term ED adverse events. No study has compared PRISMA-7 and ER2 risk for short-term adverse events. We hypothesised that ER2 could be a better prognostic tool compared to PRISMA-7 for long length of stay in ED and hospital stay, and hospital admission because it was designed and validated for this specific goal. The study aims to 1) examine and compared PRISMA-7 and ER2 risk for long length of ED and hospital stay and hospital admission, and 2) to establish their performance criteria (i.e., sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratios) for these three short-term adverse events in older ED users.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | –Each participant will be evaluated at Emergency Department based on ER2 screening tool (Emergency Room Evaluation and Recommendation Form). Six closed-ended format questions (i.e., yes versus no) composed ER2 assessment: 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 its type, and temporal disorientation (inability to give the current month and/or year). |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- In this study will be enrolled people who are 75 years and over, and who come at Emergency not only for medical reason but also for social.
Key inclusion criteria (2 listed)
- Being 75 years old and over
- Brought at Emergency on medical stretcher
Key exclusion criteria (2 listed)
- Being less than 75 years old
- Never come at Emergency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Short-term adverse events
Time frame: Around 10 months
The adverse event is defined as an adverse outcome related to an ED encounter, this adverse event is related to ED care.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 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.
Oliver Beauchet, MD principal investigator
Jewish General Hospital
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 Health Impairment and Adverse Event, 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 23 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Short-term adverse events (time frame: Around 10 months). 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 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.