- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06873256
Evaluation of the Hospital Pathway for Frail Elderly Patients Hospitalised for Pathologies Leading to Medical Decompensation (FRAGIL)
People aged over 75 account for 25% of emergency department visits in the Provence Alpes Côte d'Azur region. Depending on the facility, around 50% of these patients are discharged home without being hospitalised. Yet the scientific literature highlights the frequent deterioration in the physical and mental state of the elderly during a visit to the emergency department: discomfort on the stretcher, waiting, loneliness and disorientation are the causes, and therefore increase co-morbidity. Very few studies have been carried out to date to compare the impact on frailty risk factors of direct admission to hospital versus admission via emergency service for a frail elderly population. Studies are usually based on a population aged over 75 as the sole criterion, which no longer corresponds to the definition of a frail elderly person. What's more, there are major challenges in coordinating hospital and outpatient care to optimise resources.
The aim is to assess whether the creation of new care pathways, requiring considerable human and financial resources, will improve the care of frail elderly people. In order to assess the benefits of the systems set up at the hospital this study will compare the outcome of frail elderly people (≥ 75 years old with a geriatric score ≥ 8) hospitalised for medical decompensation pathologies according to their mode of admission, the management of their dependency and their accessibility to the attending physician, whether in individual accommodation or in an Residential Establishment for Dependent Elderly People.
This is a regional multicentre, observational, prospective and retrospective study looking at the future of frail elderly people hospitalised at the hospital during 2024/2025 (from 01/09/2024 to 01/03/2025).
The study will be conducted retrospectively, including patients hospitalised since 1st September 2024, and prospectively, including patients over time until the end of the inclusion period (01/03/2025). Patients will be followed for 90 days after hospitalisation, i.e. data will be collected until 01/06/2025.
Justification of the public interest
This research could make it possible to identify new protective factors against deterioration in the frail elderly, other than direct admission to a hospital ward, which would require fewer human and material resources, such as an Mobile Geriatric Team or a stay in a Short-Term Hospitalization Unit.
If direct admissions lead to fewer patients being admitted back to hospital, this could encourage existing medical and surgical specialties outside geriatrics and support geriatric assessment.
Lastly, this research would make it possible to draw up an inventory of the frailty of the elderly in the Toulon conurbation, in order to optimise the screening of frail elderly people in conjunction with the territorial care coordination west var region.
Data collection begins as soon as the frail elderly person is hospitalised and continues for up to 90 days after the start of hospitalisation (retrospectively and prospectively).
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Var
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Toulon, Var, France, 83100
- Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient aged ≥ 75 years;
- Patient cared for at the Intercommunal Hospital Center of Toulon-La Seyne sur Mer (Sainte Musse and Georges Sand hospitals) between 01/09/2024 and 01/03/2025 and presenting a geriatric score ≥ 8 (score defined by multidisciplinary work);
- Patient requiring hospitalisation for medical decompensation.
Exclusion Criteria:
- Patient with acute pathologies requiring admission to the intensive care unit;
- Patient whose care is in the field of traumatology in isolation;
- Patient's refusal to take part in the research.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Frail patients hospitalized for medical decompensation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The main objective was to assess the 90-day morbidity and mortality of frail elderly people hospitalized, depending on their mode of hospitalization.
Time Frame: 3 months
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The primary endpoint was early re-hospitalization or death within 90 days, depending on the mode of hospitalization (short-term hospital unit, direct admissions and passage via the emergency department).
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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To assess the 30-day morbidity and mortality of frail elderly people hospitalized according to their mode of hospitalization.
Time Frame: 1 month
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Number of early re-hospitalization or death within 30 days, depending on the mode of hospitalization (short-term hospital unit, direct admissions and passage via the emergency department).
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1 month
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Evaluate the proportion of frail patients who have been specifically identified by the territorial care coordination teams prior to hospitalization.
Time Frame: 1 year before hospitalization
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Rate of frail patients identified by the territorial care coordination West Var region (following a report made by a nurse, a doctor or a care assistant) prior to hospitalization, compared to the rate of frail patients hospitalized.
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1 year before hospitalization
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Analyze the patient's destination at the end of the initial hospitalization
Time Frame: Up to 1 month
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The following destinations at discharge from hospitalization will be analyzed: Follow-up and rehabilitation care / Residential establishment for dependent elderly people / Home / Death during hospitalization.
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Up to 1 month
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Evaluate the prognosis of frailty at a distance, based on the presence of a Mobile Geriatric Team during hospitalization and on the implementation of an assistance plan in conjunction with a hospital social worker, enabling a safe return home.
Time Frame: 1 month
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Number of early re-hospitalizations or deaths at 30 days, depending on the presence of a Mobile Geriatric Team during hospitalization (Yes/No) and the request to set up/organize an assistance plan in conjunction with a social worker (Yes/No/Not applicable).
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1 month
|
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Evaluate the prognosis of frailty at a distance, based on the presence of a Mobile Geriatric Team during hospitalization and on the implementation of an assistance plan in conjunction with a hospital social worker, enabling a safe return home.
Time Frame: 3 months
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Number of early re-hospitalizations or deaths at 90 days, depending on the presence of a Mobile Geriatric Team during hospitalization (Yes/No) and the request to set up/organize an assistance plan in conjunction with a social worker (Yes/No/Not applicable).
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3 months
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For the sub-group of patients referred from nursing homes, assess the time between the last General Practitioner referral and hospitalization.
Time Frame: 1 year before hospitalization
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Time in days between last medical contact with a general practitioner and hospitalization.
The date of the last medical contact will be retrieved from the Residential establishment for dependent elderly people's Emergency Liaison File
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1 year before hospitalization
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Collaborators and Investigators
Investigators
- Study Director: Marc FOURNIER, MD, Centre Hospitalier Intercommunal Toulon- La Seyne sur mer
Publications and helpful links
Helpful Links
- The predictive validity of frailty status for hospitalization and mortality. In: The predictive validity of the state of frailty for hospitalization and mortality. Toulouse: The 2016 Gerontological Year; 2016. p. 49 49.Brun M. C3S Coordination Support Sc
- Report of the Hospital and Elderly Persons Workshop
- ICOPE - A program to prevent addiction [Internet]. 2023 [cited 2024 Sep 22].
- Elderly people in the emergency room: a more fragile health requiring longer care: Studies and results 2017; N°1008 Electronic ISSN 1146-9129.
- Hospital emergencies in 2023: what organizations for patient care? Studies and results 2024 N°1305; Electronic ISSN 1146-9129.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-CHITS-011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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