Evaluation of Medical and Social Care for Elderly Patients, Between Hospital and Home: TEMPORARY ACCOMMODATION Out of Hospitalization by Nursing Home and Long-Term Care Units in Ile-de-France Region (HTSH)

June 10, 2025 updated by: Gérond'if
Prospective, observational, non-interventional, comparative, multicenter RIPH3 study to investigate the impact of HTSH on length of hospital stay in referring services.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This is a multi-center study involving many hospital departments temporary accommodation at the end of hospitalization in several Nursing home/long term care units in Ile de France region. The temporary accommodation program was designed for elderly people living at home to find an accommodation solution in nursing home to meet a short-term need. Temporary accommodation beds are deployed and perpetuated in the Île-de-France region by the Regional Health Agency, physically grouped together in establishments within units with dedicated staff. The resources allocated to these beds have been increased. The aim of the study is to demonstrate the efficiency of the HTSH circuit, for elderly patients leaving hospital, in their medical and social care and the decision or not to return home. This project is supported by Regional Health Agency (ARS-IDF).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
258

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Cormeilles en parisis, France, 95240
        • Not yet recruiting
        • Résidence ZEMGOR
        • Contact:
      • L'Haÿ-les-Roses, France, 94240
      • Melun, France, 77000
        • Not yet recruiting
        • Groupe Hospitalier Sud Ile de France (GHSIF)
        • Contact:
      • Paris, France, 75010
        • Not yet recruiting
        • GHU Lariboisière
        • Contact:
      • Paris, France, 75013
        • Recruiting
        • Broca Hospital
        • Contact:
      • Paris, France, 75015
        • Recruiting
        • USDL Vaugirard, APHP
        • Contact:
      • Rambouillet, France, 78514
        • Not yet recruiting
        • Centre Hospitalier de Rambouillet
        • Contact:
      • Versailles, France, 78157
        • Active, not recruiting
        • Centre Hospitalier De Versailles
      • Villejuif, France, 94800
        • Not yet recruiting
        • Hôpital Paul Brousse
        • Contact:
    • Ile de France
      • Paris, Ile de France, France, 94270
        • Recruiting
        • Chu Bicetre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

258 subjects in the prospective group. Retrospective data will be collected directly from hospital departments by ARS IDF or from physicians responsible for medical information (RMI) within each hospital center participating in the study, for the 2 years 2021 and 2022 prior to the study and compared with the average length of stay for services to be calculated at the end of the study.

Description

  • Inclusion Criteria:

    1. Patient selection criteria

      • Patient male or female at least 60 years of age, as initially defined with the Regional Health Agency, discharged from hospital,
      • Oral expression of non opposition to participation in the study, documented in the medical record by the physician,
      • Presenting a defined and feasible plan for returning home,
      • Whose social/medical situation (stabilized) does not allow an immediate return home after hospitalization.

    2. Caregiver selection criteria

      • Person with an unpaid caregiving activity for their relative in HTSH,
      • Person verbally expressing their non-opposition to participating in the study, and documented in the medical record of the patient they are helping,
      • A person who is able to understand the study questionnaires and evaluations, and is able to answer them without the help of a third party.

    3. Professional selection criteria

      • Salaried professional, nursing or not, regularly and directly involved in the HTSH circuit, whether in hospital or in nursing home / long term care units, for at least 6 months,
      • Oral expression of non opposition to participation in the study, documented by the establishment.

  • Non-inclusion Criteria:

    • Be already included in another clinical study,
    • Benefit from a legal protection measure or be unable to express their consent, in accordance with article L1121-8 of the French Public Health Code.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Prospective group
258 subjects in the prospective group
Retrospective group
Retrospective data will be collected directly from hospital departments by ARS IDF or from physicians responsible for medical information (RMI) within each hospital center participating in the study, for the 2 years 2021 and 2022 prior to the study and compared with the average length of stay for services to be calculated at the end of the study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Study to investigate the impact of HTSH on length of hospital stay in referring services
Time Frame: 24 months
The main assessment criterion is based on the average length of stay observed at the end of the study, compared with that of the previous two years, 2021 and 2022, in the referring services.
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Analysis of pathways and plans for returning home
Time Frame: 24 months

Evaluation criteria:

Calculation of the proportion of patients in the life project on admission to nursing home / long term care units and the return home at the end of the stay.
24 months
Analysis of HTSH patient profiles a) Proportion of eligible patients and their comorbidities b) Social profile + main reason for hospitalization of patients admitted to HTSH
Time Frame: 24 months

Evaluation criteria:

Ratio of hospital ward activity data to pre-screening data collected during the study.
24 months
Analysis of discharges and patient outcomes
Time Frame: 24 months
Proportion of patients remaining at home in the medium term Patients' functional outcome after the trial
24 months
Quality of life and caregiver benefit analysis
Time Frame: 24 months
Quality of life assessment
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gérond'if

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 20, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-A00023-44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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