Patient Outcomes After Hospitalization in Acute Geriatric Unit

Geriatric Disorder Clinical Trial

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Official title:

Risks of Death, Hospital Readmission, and Institutionalization After Hospitalization in Acute Geriatric Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02949635
• Other study ID #: 2014_23
• Secondary ID: 2014-A01670-47AP
• Status: Completed
• Start date: September 7, 2016
• Est. completion date: December 2018

Study information

• Verified date: August 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3532
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Geriatric Disorder

Locations

Country	Name	City	State
France	CHU d'Amiens	Amiens
France	CH Beauvais	Beauvais
France	CHU Caen	Caen
France	Hôpital Cardiologique, CHRU	Lille
France	GHICL, Saint Philibert	Lomme
France	CH Saint Quentin	Saint quentin

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

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