- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02949635
Patient Outcomes After Hospitalization in Acute Geriatric Unit (DAMAGE)
Risks of Death, Hospital Readmission, and Institutionalization After Hospitalization in Acute Geriatric Unit
Three events can be considered of major importance for patients after a hospitalization in an AGU: death, hospital readmission, and institutionalization. Current published data do not allow the clinician to simultaneously estimate the risk of hospital readmission, institutionalization and death of an older patient according to his/her characteristics and various complications that occurred during the hospitalization. However, clinicians often need to estimate these risks at hospital discharge to adapt their therapeutic choices, their proposals post-hospital care, and provide reliable and fair information to the patient and his relatives.
Estimating simultaneously the hazard for each of these three events can be complex. Indeed, a death event hinder the observation of re-hospitalization or institutionalization if death occurs before these events. The death should be considered a competing risk in these analyzes. Hospital readmission may modify the risk of death or institutionalization and should be considered as an intermediate factor for these event. This complexity cannot be accounted with classical statistical models, like logistic regression models.
The purpose of this study is to use more appropriate statistical models (multi-state models) to better estimate simultaneously the risks of hospital readmission, institutionalization, and death of a patient given after hospitalization in AGU, and to show that accuracy of these estimations can be improved by taking into account complications that occurred during the stay in AGU.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Amiens, Frankrig
- CHU d'Amiens
-
Beauvais, Frankrig
- CH Beauvais
-
Caen, Frankrig
- CHU Caen
-
Lille, Frankrig
- Hôpital Cardiologique, CHRU
-
Lomme, Frankrig
- GHICL, Saint Philibert
-
Saint quentin, Frankrig
- CH Saint Quentin
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Age 75 years and over
- Hospitalized in Acute Geriatric Unit
- Covered by a health insurance
Exclusion Criteria:
- Refusal to participate to the study, as expressed by the patient or his/her next of kin
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Number of death after discharge
Tidsramme: 3 months
|
3 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of death after discharge
Tidsramme: 12 months
|
12 months
|
|
Number of rehospitalization after discharge
Tidsramme: at 3 and 12 months
|
at 3 and 12 months
|
|
Number of institutionalization (NH admissions)
Tidsramme: at 12 months
|
at 12 months
|
|
Number of nosocomial infectious diseases during the index hospitalization
Tidsramme: 60 days
|
60 days
|
|
Duration of clostridium difficile infection
Tidsramme: 60 days
|
60 days
|
|
Length of stay of the index hospitalization
Tidsramme: 60 days
|
The exact duration for this outcome will correspond to the duration of the index hospitalization
|
60 days
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jean-Baptiste Beuscart, MD, PhD, University Hospital, Lille
Publikationer og nyttige links
Generelle publikationer
- Deschasse G, Charpentier A, Prod'homme C, Genin M, Delecluse C, Gaxatte C, Gerard C, Bukor Z, Devulder P, Couvreur LA, Bloch F, Puisieux F, Visade F, Beuscart JB. Transition to Comfort Care Only and End-of-Life Trajectories in an Acute Geriatric Unit: A Secondary Analysis of the DAMAGE Cohort. J Am Med Dir Assoc. 2022 Sep;23(9):1492-1498. doi: 10.1016/j.jamda.2022.04.016. Epub 2022 May 21.
- Deschasse G, Bloch F, Drumez E, Charpentier A, Visade F, Delecluse C, Loggia G, Lescure P, Attier-Zmudka J, Bloch J, Gaxatte C, Van Den Berghe W, Puisieux F, Beuscart JB. Development of a Predictive Score for Mortality at 3 and 12 Months After Discharge From an Acute Geriatric Unit as a Trigger for Advanced Care Planning. J Gerontol A Biol Sci Med Sci. 2022 Aug 12;77(8):1665-1672. doi: 10.1093/gerona/glab217.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2014_23
- 2014-A01670-47 (Anden identifikator: ID-RCB number, ANSM)
- API 13-19-002 (Anden identifikator: PHRC number, DGOS)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Geriatrisk lidelse
-
Wake Forest University Health SciencesAfsluttetSelf Geriatric Assessment Measure (SGAM)Forenede Stater