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End-of-Life Patient Identification Assistance in Acute GEriatric Medicine (ARPEGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03549585
Recruitment Status : Active, not recruiting
First Posted : June 8, 2018
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief 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.

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


Condition or disease Intervention/treatment
Old Age Other: Criteria for Screening and Triaging to Appropriate aLternative care

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.


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Study Type : Observational
Actual Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: End-of-Life Patient Identification Assistance in Acute GEriatric Medicine: Construction and Validation of a Prognostic Tool
Actual Study Start Date : June 27, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Intervention Details:
  • Other: Criteria for Screening and Triaging to Appropriate aLternative care
    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.


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. The 8 items of the CriSTAL tool [ Time Frame: 3 months ]
    Socio-demographic data of the geriatric patient in the emergencies

  2. The 8 items of the CriSTAL tool [ Time Frame: 3 months ]
    The reason for admission of geriatric patients in the emergencies

  3. The 8 items of the CriSTAL tool [ Time Frame: 3 months ]
    The variables potentially associated with the three-month death like Cognitive impairment

  4. The 8 items of the CriSTAL tool [ Time Frame: 3 months ]
    The variables potentially associated with the three-month death : Hospitalization in intensive care during the last year

  5. The 8 items of the CriSTAL tool [ Time Frame: 3 months ]
    ECG anomaly : ACFA, tachycardia, rhythm disorder> 5 per min, Q or ST segment abnormality



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patient having expressed his opposition to the use of data related to his hospitalization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549585


Locations
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France
University Hospital Toulouse
Toulouse, France, 31052
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Fati Nourhashemi, MD University Hospital, Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03549585     History of Changes
Other Study ID Numbers: RC31/15/7732
2016-A00116-45 ( Other Identifier: ID-RCB )
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Toulouse:
End of life
Spotting
Emergency
criSTAL