- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
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Amiens, Frankrike
- CHU d'Amiens
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Beauvais, Frankrike
- CH Beauvais
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Caen, Frankrike
- CHU caen
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Lille, Frankrike
- Hôpital Cardiologique, CHRU
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Lomme, Frankrike
- GHICL, Saint Philibert
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Saint quentin, Frankrike
- CH Saint Quentin
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Number of death after discharge
Tidsramme: 3 months
|
3 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jean-Baptiste Beuscart, MD, PhD, University Hospital, Lille
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2014_23
- 2014-A01670-47 (Annen identifikator: ID-RCB number, ANSM)
- API 13-19-002 (Annen identifikator: PHRC number, DGOS)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Kliniske studier på Geriatrisk lidelse
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Wake Forest University Health SciencesFullførtSelf Geriatric Assessment Measure (SGAM)Forente stater