ElderlyHFRS FranceNCT03905629
Validation of the Hospital Frailty Score in France
An observational study of Elderly and Emergency Hospitalization, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Older people are increasing users of health care globally. Constraints in bed capacity and resources raise important challenges with regards to management of older people with complex needs, which usually require assertive and holistic assessment. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Elderly, Emergency Hospitalization, Frailty
- What is being tested?
- None (retrospective observational study)
- How many people
- 1,000,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2019to 30 Nov 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients considered will be all patients aged 75 years and older hospitalized as an emergency over a one year period ranging from January to December 2017. According to a preliminary extraction, we expect to include approximately one million patients.
Who may be able to join
- age 75 years or over (on the day of the index admission)
- hospitalized as an emergency (i.e. after visit to ED)
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
France1 site
service de court séjour gériatrique, Hôpital Lyon Sud
Pierre-Bénite, 69495
About this study
Official title: Validation of the Hospital Frailty Risk Score in Combination With Charlson/Elixhauser Comorbidity Coding Algorithms on French Hospital Databases
Older people are increasing users of health care globally. Constraints in bed capacity and resources raise important challenges with regards to management of older people with complex needs, which usually require assertive and holistic assessment. It is important, therefore, to identify aged patients most likely to benefit from such frailty-attuned approaches of care. A previous study using national Hospital Episodes Statistics conducted in the United Kingdom (UK) showed that patients aged over 75 years with characteristics of frailty and at risk of adverse health-care outcomes can be identified using routinely collected data (Gilbert T et al., Lancet 2018). This study lead to the development of the Hospital Frailty Risk Score (HFRS), which is based on International Statistical Classification of Diseases and Related Health Problems 10 (ICD-10) diagnosis codes and has the potential to be used in other countries worldwide, using the ICD-10 coding framework, to identify patients at risk of frailty at the hospital and commissioners levels, as well as for database research purposes. This score has successfully been validated in Canada, Australia and Switzerland. The aim of the present study is to evaluate the ability of the HFRS to predict 30-day in-patient mortality of patients aged 75 years and older admitted to French hospitals as an emergency.
- Conditions
- Elderly, Emergency Hospitalization, Frailty
- Being tested
- None (retrospective observational study)
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None (retrospective observational study)Other
Also called Validation of the HFRS in Combination With Charlson/Elixhauser Comorbidity Coding Algorithms on the French national PMSI database
This multi-centric retrospective observational cohort study is conducted using the PMSI. Predictive ability of HFRS estimated on the basis of 3 binary outcomes: 30-day in-patient mortality (main outcome), 30-day emergency and potentially avoidable readmission, length of stay >15 days. Odds ratios (ORs) and c-statistics calculated and compared to the original UK results in order to validate the use of the HFRS in France. Other secondary objectives include:
- Evaluate agreement between HFRS and Charlson or Elixhauser comorbidity indices
- Evaluate ability of HFRS combined with comorbidity indices (Charlson on one hand, and Elixhauser on other hand), to predict 30-day in-patient mortality, 30-day emergency and potentially avoidable readmissions, and long length of stay
- Identify specific risk associations in France of a high risk of frailty (as assessed by the HFRS) with individual, organizational and territorial factors
| Study group | Role | What they receive |
|---|---|---|
| Patients aged 75 years and older hospitalized as an emergency | Patients considered will be all patients aged 75 years and older (on the day of the index admission) hospitalized as an emergency (i.e. after visit to ED) between january 2017 and december 2017. Receives: Other: None (retrospective observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day in-patient mortality
The main outcome measure will be 30-day in-patient mortality. Mortality data will be limited to in-hospital mortality, which will be directly available from the PMSI database.
Measured: In-patient mortality within 30 days from admission (index hospitalization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start1 Apr 2019
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Retrospective
- Enrolment
- 1,000,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905629
- Sponsor's protocol ID
- 69HCL19_0018
- Acronym
- HFRS France
- Status last verified
- Jul 2022
- First submitted
- 4 Apr 2019
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gilbert T, Cordier Q, Polazzi S, Street A, Conroy S, Duclos A. Combining the Hospital Frailty Risk Score With the Charlson and Elixhauser Multimorbidity Indices to Identify Older Patients at Risk of Poor Outcomes in Acute Care. Med Care. 2024 Feb 1;62(2):117-124. doi: 10.1097/MLR.0000000000001962. Epub 2023 Dec 11.
PubMed 38079225Gilbert T, Cordier Q, Polazzi S, Bonnefoy M, Keeble E, Street A, Conroy S, Duclos A. External validation of the Hospital Frailty Risk Score in France. Age Ageing. 2022 Jan 6;51(1):afab126. doi: 10.1093/ageing/afab126.
PubMed 34185827
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Hospital Frailty Risk Score in Combination With Charlson/Elixhauser Comorbidity Coding Algorithms on French Hospital Databases
- ClinicalTrials.gov ID
- NCT03905629
- Acronym / sponsor ID
- HFRS France / 69HCL19_0018
- Conditions
- Elderly, Emergency Hospitalization, Frailty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000,000 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 5 Apr 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.
Older people are increasing users of health care globally. Constraints in bed capacity and resources raise important challenges with regards to management of older people with complex needs, which usually require assertive and holistic assessment. It is important, therefore, to identify aged patients most likely to benefit from such frailty-attuned approaches of care. A previous study using national Hospital Episodes Statistics conducted in the United Kingdom (UK) showed that patients aged over 75 years with characteristics of frailty and at risk of adverse health-care outcomes can be identified using routinely collected data (Gilbert T et al., Lancet 2018). This study lead to the development of the Hospital Frailty Risk Score (HFRS), which is based on International Statistical Classification of Diseases and Related Health Problems 10 (ICD-10) diagnosis codes and has the potential to be used in other countries worldwide, using the ICD-10 coding framework, to identify patients at risk of frailty at the hospital and commissioners levels, as well as for database research purposes. This score has successfully been validated in Canada, Australia and Switzerland. The aim of the present study is to evaluate the ability of the HFRS to predict 30-day in-patient mortality of patients aged 75 years and older admitted to French hospitals as an emergency.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients aged 75 years and older hospitalized as an emergency | – | Other: None (retrospective observational study)Patients considered will be all patients aged 75 years and older (on the day of the index admission) hospitalized as an emergency (i.e. after visit to ED) between january 2017 and december 2017. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients considered will be all patients aged 75 years and older hospitalized as an emergency over a one year period ranging from January to December 2017. According to a preliminary extraction, we expect to include approximately one million patients.
Key inclusion criteria (2 listed)
- age 75 years or over (on the day of the index admission)
- hospitalized as an emergency (i.e. after visit to ED)
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| None (retrospective observational study)Also: Validation of the HFRS in Combination With Charlson/Elixhauser Comorbidity Coding Algorithms on the French national PMSI databaseThis multi-centric retrospective observational cohort study is conducted using the PMSI. Predictive ability of HFRS estimated on the basis of 3 binary outcomes: 30-day in-patient mortality (main outcome), 30-day emergency and potentially avoidable readmission, length of stay >15 days. Odds ratios (ORs) and c-statistics calculated and compared to the original UK results in order to validate the use of the HFRS in France. Other secondary objectives include: * Evaluate agreement between HFRS and Charlson or Elixhauser comorbidity indices * Evaluate ability of HFRS combined with comorbidity indices (Charlson on one hand, and Elixhauser on other hand), to predict 30-day in-patient mortality, 30-day emergency and potentially avoidable readmissions, and long length of stay * Identify specific risk associations in France of a high risk of frailty (as assessed by the HFRS) with individual, organizational and territorial factors | Other | Patients aged 75 years and older hospitalized as an emergency |
Primary outcome
30-day in-patient mortality
Time frame: In-patient mortality within 30 days from admission (index hospitalization)
The main outcome measure will be 30-day in-patient mortality. Mortality data will be limited to in-hospital mortality, which will be directly available from the PMSI database.
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 13 Jul 2022.
- Derived from this study: PubMed 38079225Gilbert T, Cordier Q, Polazzi S, Street A, Conroy S, Duclos A. Combining the Hospital Frailty Risk Score With the Charlson and Elixhauser Multimorbidity Indices to Identify Older Patients at Risk of Poor Outcomes in Acute Care. Med Care. 2024 Feb 1;62(2):117-124. doi: 10.1097/MLR.0000000000001962. Epub 2023 Dec 11.
- Derived from this study: PubMed 34185827Gilbert T, Cordier Q, Polazzi S, Bonnefoy M, Keeble E, Street A, Conroy S, Duclos A. External validation of the Hospital Frailty Risk Score in France. Age Ageing. 2022 Jan 6;51(1):afab126. doi: 10.1093/ageing/afab126.
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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 Elderly and Emergency Hospitalization, run by Hospices Civils de Lyon 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 13 Jul 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?
30-day in-patient mortality (time frame: In-patient mortality within 30 days from admission (index hospitalization)). 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 NCT03905629, which also lists 2 linked publications.
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 13 Jul 2022.