Old AgeARPEGENCT03549585
End-of-Life Patient Identification Assistance in Acute GEriatric Medicine
An observational study of Old Age, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The main objective of this project is to build a tool, adapted to the French geriatric population, that will predict the risk of death at three months after hospitalization in acute geriatric medicine. This tool will be built using selected items via a review of the literature published in 2015. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Old Age
- What is being tested?
- Criteria for Screening and Triaging to Appropriate aLternative care
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jun 2017to 30 Sep 2019
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All consecutive patients above 65 years old hospitalized in the 2 departments of PUG Toulouse of University Hospital will be included, over a period of 9 months.
Who may be able to join
- Any geriatric patient hospitalized via emergencies at Post Emergencies Geriatric (PUG) unity
- Oral agreement of non-opposition to the use of the data relative to their hospitalization and relative to their evolution within 3 months following the hospitalization
Who cannot join
- Patient having expressed his opposition to the use of data related to his hospitalization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: End-of-Life Patient Identification Assistance in Acute GEriatric Medicine: Construction and Validation of a Prognostic Tool
The main objective of this project is to build a tool, adapted to the French geriatric population, that will predict the risk of death at three months after hospitalization in acute geriatric medicine. This tool will be built using selected items via a review of the literature published in 2015.
The 8 items of the CriSTAL tool will be collected prospectively in all patients hospitalized successively in the 2 post-emergency geriatric services (PUG) of the University Hospital of Toulouse, over a period of 9 months, by a dedicated clinical research associate. Patient survival will be assessed by obtaining the vital status of the cohort via CépiDC
Read the detailed description
As the population ages, the prevalence of chronic diseases increases. Let's take the example of cardiovascular, respiratory or neurological diseases, including Alzheimer's disease. These pathologies are at the origin of decompensations requiring sometimes multiple hospitalizations. It is clear that the goals of care (curative or palliative) are not always related to life expectancy. Decision making, especially in an acute context, is often tricky. The use of a tool with certain parameters of the patient could help to guide the reflection. The present study propose a tool proposed by an Australian team (CriSTAL), which lists items described in the literature as a risk factor for the death of elderly patients. This tool is currently being studied in several types of populations around the world (general population, cancer patients, hospitalized etc.).
This is a prospective study aimed at evaluating routine, single-center care, conducted at Toulouse University Hospital.
The successive inclusion of hospitalized patients in Post Emergencies Geriatric (PUG) unity will be carried out over a period of 9 months.
The primary outcome will be the vital status (alive / deceased) at 3 months of hospitalization in acute geriatric medicine.
- Conditions
- Old Age
- Being tested
- Criteria for Screening and Triaging to Appropriate aLternative care
- Keywords
- End of life, Spotting, Emergency, criSTAL
- Medical subject headings
- Death, Metrorrhagia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Criteria for Screening and Triaging to Appropriate aLternative careOther
CriSTAL Tool (Criteria for Screening and Treatment of Appropriate Long-Term Care) is a multidimensional geriatric tool that lists 18 elements of the literature, under construction and validation by an Australian retrospective study. This tool is a practical questionnaire and easy to use in current care, with items adapted to the geriatric dimension. The investigators chose to target hospitalized geriatric patients through emergencies.
What is being measured
The primary outcome is the main question the study is designed to answer.
The vital status (alive / deceased) at 3 months
The vital status (alive / deceased) at 3 months of hospitalization in acute geriatric medicine.Survival will be collected in a data base.
Measured: 3 months
Secondary outcomes (5)
The 8 items of the CriSTAL tool
Socio-demographic data of the geriatric patient in the emergencies
Measured: 3 months
The 8 items of the CriSTAL tool
The reason for admission of geriatric patients in the emergencies
Measured: 3 months
The 8 items of the CriSTAL tool
The variables potentially associated with the three-month death like Cognitive impairment
Measured: 3 months
The 8 items of the CriSTAL tool
The variables potentially associated with the three-month death : Hospitalization in intensive care during the last year
Measured: 3 months
The 8 items of the CriSTAL tool
ECG anomaly : ACFA, tachycardia, rhythm disorder> 5 per min, Q or ST segment abnormality
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start27 Jun 2017
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Old AgeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fati Nourhashemi, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549585
- Sponsor's protocol ID
- RC31/15/7732
- Other IDs
- 2016-A00116-45
- Acronym
- ARPEGE
- Status last verified
- Jan 2022
- First submitted
- 25 May 2018
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Steinmeyer Z, Piau A, Thomazeau J, Kai SHY, Nourhashemi F. Mortality in hospitalised older patients: the WHALES short-term predictive score. BMJ Support Palliat Care. 2021 Nov 25:bmjspcare-2021-003258. doi: 10.1136/bmjspcare-2021-003258. Online ahead of print.
PubMed 34824134
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End-of-Life Patient Identification Assistance in Acute GEriatric Medicine: Construction and Validation of a Prognostic Tool
- ClinicalTrials.gov ID
- NCT03549585
- Acronym / sponsor ID
- ARPEGE / RC31/15/7732
- Conditions
- Old Age
- Keywords
- End of life, Spotting, Emergency, criSTAL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 27 Jun 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 8 Jun 2018 (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.
The main objective of this project is to build a tool, adapted to the French geriatric population, that will predict the risk of death at three months after hospitalization in acute geriatric medicine. This tool will be built using selected items via a review of the literature published in 2015.
The 8 items of the CriSTAL tool will be collected prospectively in all patients hospitalized successively in the 2 post-emergency geriatric services (PUG) of the University Hospital of Toulouse, over a period of 9 months, by a dedicated clinical research associate. Patient survival will be assessed by obtaining the vital status of the cohort via CépiDC
Detailed description
As the population ages, the prevalence of chronic diseases increases. Let's take the example of cardiovascular, respiratory or neurological diseases, including Alzheimer's disease. These pathologies are at the origin of decompensations requiring sometimes multiple hospitalizations. It is clear that the goals of care (curative or palliative) are not always related to life expectancy. Decision making, especially in an acute context, is often tricky. The use of a tool with certain parameters of the patient could help to guide the reflection. The present study propose a tool proposed by an Australian team (CriSTAL), which lists items described in the literature as a risk factor for the death of elderly patients. This tool is currently being studied in several types of populations around the world (general population, cancer patients, hospitalized etc.).
This is a prospective study aimed at evaluating routine, single-center care, conducted at Toulouse University Hospital.
The successive inclusion of hospitalized patients in Post Emergencies Geriatric (PUG) unity will be carried out over a period of 9 months.
The primary outcome will be the vital status (alive / deceased) at 3 months of hospitalization in acute geriatric medicine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All consecutive patients above 65 years old hospitalized in the 2 departments of PUG Toulouse of University Hospital will be included, over a period of 9 months.
Key inclusion criteria (2 listed)
- Any geriatric patient hospitalized via emergencies at Post Emergencies Geriatric (PUG) unity
- Oral agreement of non-opposition to the use of the data relative to their hospitalization and relative to their evolution within 3 months following the hospitalization
Key exclusion criteria (1 listed)
- Patient having expressed his opposition to the use of data related to his hospitalization
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 |
|---|---|---|
| Criteria for Screening and Triaging to Appropriate aLternative careCriSTAL Tool (Criteria for Screening and Treatment of Appropriate Long-Term Care) is a multidimensional geriatric tool that lists 18 elements of the literature, under construction and validation by an Australian retrospective study. This tool is a practical questionnaire and easy to use in current care, with items adapted to the geriatric dimension. The investigators chose to target hospitalized geriatric patients through emergencies. | Other | – |
Primary outcome
The vital status (alive / deceased) at 3 months
Time frame: 3 months
The vital status (alive / deceased) at 3 months of hospitalization in acute geriatric medicine.Survival will be collected in a data base.
5 secondary outcomes
The 8 items of the CriSTAL tool
Time frame: 3 months
The 8 items of the CriSTAL tool
Time frame: 3 months
The 8 items of the CriSTAL tool
Time frame: 3 months
The 8 items of the CriSTAL tool
Time frame: 3 months
The 8 items of the CriSTAL tool
Time frame: 3 months
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 15 Feb 2022.
- Results publication: PubMed 34824134Steinmeyer Z, Piau A, Thomazeau J, Kai SHY, Nourhashemi F. Mortality in hospitalised older patients: the WHALES short-term predictive score. BMJ Support Palliat Care. 2021 Nov 25:bmjspcare-2021-003258. doi: 10.1136/bmjspcare-2021-003258. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Fati Nourhashemi, MD principal investigator
University Hospital, Toulouse
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 Old Age, run by University Hospital, Toulouse at 1 site in France.
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 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: finished, as of the sponsor's last update on 15 Feb 2022. 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 France. 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?
The vital status (alive / deceased) at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03549585, which also lists 1 linked publication.
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 15 Feb 2022.