NCT02949635

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,532

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2016

Completed
15 days until next milestone

Study Start

First participant enrolled

September 7, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 31, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 24, 2020

Status Verified

August 1, 2020

Enrollment Period

2.2 years

First QC Date

August 23, 2016

Last Update Submit

August 21, 2020

Conditions

Geriatric Disorder

Keywords

AgedPatient readmissionGeriatric AssessmentMortality

Outcome Measures

Primary Outcomes (1)

  • Number of death after discharge

    3 months

Secondary Outcomes (6)

  • Number of death after discharge

    12 months

  • Number of rehospitalization after discharge

    at 3 and 12 months

  • Number of institutionalization (NH admissions)

    at 12 months

  • Number of nosocomial infectious diseases during the index hospitalization

    60 days

  • Duration of clostridium difficile infection

    60 days

  • +1 more secondary outcomes

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive incident patients aged 75 years and older hospitalized in an acute geriatric unit will be eligible and included in the study.

You may qualify if:

  • Age 75 years and over
  • Hospitalized in Acute Geriatric Unit
  • Covered by a health insurance

You may not qualify if:

  • Refusal to participate to the study, as expressed by the patient or his/her next of kin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CHU d'Amiens

Amiens, France

Location

CH Beauvais

Beauvais, France

Location

CHU Caen

Caen, France

Location

Hôpital Cardiologique, CHRU

Lille, France

Location

GHICL, Saint Philibert

Lomme, France

Location

CH Saint Quentin

Saint-Quentin, France

Location

Related Publications (3)

  • Prod'homme C, Deschasse G, Visade F, Hennion C, Charpentier A, Gaxatte C, Bloch F, Delecluse C, Puisieux F, Beuscart JB. Palliative use of midazolam in acute geriatric units: a multicenter ambispective study. BMC Geriatr. 2025 Apr 10;25(1):241. doi: 10.1186/s12877-025-05860-6.

    PMID: 40211151DERIVED

  • 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.

    PMID: 35609637DERIVED

  • 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.

    PMID: 34375411DERIVED

Study Officials

  • Jean-Baptiste Beuscart, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2016

First Posted

October 31, 2016

Study Start

September 7, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

August 24, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(6)