Patient Outcomes After Hospitalization in Acute Geriatric Unit (DAMAGE)

August 21, 2020 updated by: University Hospital, Lille

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

3532

Contacts and Locations

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

Study Locations

      • Amiens, France
        • CHU d'Amiens
      • Beauvais, France
        • CH Beauvais
      • Caen, France
        • CHU Caen
      • Lille, France
        • Hôpital Cardiologique, CHRU
      • Lomme, France
        • GHICL, Saint Philibert
      • Saint quentin, France
        • CH Saint Quentin

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

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of death after discharge
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of death after discharge
Time Frame: 12 months
12 months
Number of rehospitalization after discharge
Time Frame: at 3 and 12 months
at 3 and 12 months
Number of institutionalization (NH admissions)
Time Frame: at 12 months
at 12 months
Number of nosocomial infectious diseases during the index hospitalization
Time Frame: 60 days
60 days
Duration of clostridium difficile infection
Time Frame: 60 days
60 days
Length of stay of the index hospitalization
Time Frame: 60 days
The exact duration for this outcome will correspond to the duration of the index hospitalization
60 days

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Jean-Baptiste Beuscart, MD, PhD, University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

September 7, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

August 23, 2016

First Submitted That Met QC Criteria

October 27, 2016

First Posted (Estimate)

October 31, 2016

Study Record Updates

Last Update Posted (Actual)

August 24, 2020

Last Update Submitted That Met QC Criteria

August 21, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2014_23
  • 2014-A01670-47 (Other Identifier: ID-RCB number, ANSM)
  • API 13-19-002 (Other Identifier: PHRC number, DGOS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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