Geriatric Assessment at Discharge From the Intensive Care Unit in Patients Aged 75 Years and Older: a Feasibility Study (PreGEDI)

The number of patients aged over 75 continues to grow, and, according to INSEE, will represent almost 10% of the French population in 2021, an increase of 2.4 points since 2000. This demographic change is also observed in the intensive care units, where admitted patients aged over 80 represent now up to 10-20% of critical care admissions, depending on the facility.

The admission of these patients remains controversial, with questions about the benefit to elderly patients, both in terms of in-hospital and distant survival, as well as induced morbidity or subsequent quality of life: functional status is impaired in up to two-thirds of survivors.

The challenge of identifying the patients most able to withstand a stay is a major one. Indeed, a stay in intensive care represents a major stress for the organism, due to the acute condition associated with one or more organ failure(s). Bed rest, immobilization and the use of drugs are responsible for formidable complications in the elderly: muscle-wasting, loss of adaptation to physical effort, loss of autonomy, delirium and agitation, all of which have their own long-term impact.

While many studies have looked at the prognostic factors on admission of these patients, and the selection of the patient with the greatest probability of surviving the intensive care unit (ICU), improving the outcome of patients who survive to the ICU stay remains a little-investigated subject. However, the impact of physical and psychological disturbances induced by these patients' stay in intensive care is major, and their detection and management could be elements of interest in improving the care of this population. However, the feasibility of carrying out such an assessment immediately after an ICU stay has yet to be evaluated. The aim of this study would be to evaluate the feasibility of a geriatric assessment at the end of the ICU stay (or within 7 days of discharge) and at 6 months. This study is a prospective, randomized, single-center, open-label interventional study.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Frailty; Older People; Geriatric Assessment
• Intervention / Treatment: Other: Geriatric assessment in the 7 days following ICU discharge.; Other: No geriatric assessment in the 7 days following ICU discharge.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julien DEMISELLE; Phone Number: +33 0369551079; Email: julien.demiselle@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Service de Médecine Intensive - Réanimation / CHU Strasbourg - France
    • Contact: Julien DEMISELLE; Phone Number: +33 0369551079; Email: julien.demiselle@chru-strasbourg.fr
    • Contact: Julien DEMISELLE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients over 75 years of age
• Admitted to the intensive care unit, for whatever reason, and having survived their stay, considered as leaving the intensive care unit.
• Subjects affiliated to a health insurance scheme
• Able to understand the aims and risks of the research and to give dated, signed informed consent,
• In the event of confusion on leaving the intensive care unit, a close relative available to give dated, signed informed consent, with the patient's consent collected as soon as his or her condition permits.

Exclusion Criteria:

• Protected subject as defined by law: safeguard of justice, guardianship or curatorship procedures
• Subject moribund, or whose life expectancy as estimated by the clinician in charge is less than 1 month
• Patient not living in Bas-Rhin (visit to M6)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group with geriatric assessment; Patients will be assessed by a geriatric physician, in a global (clinical, physical, psyochological and social) approach at the end of the ICU stay or in the 7 days following. In addition to the first visit in the group "without geriatric assessment", will be collected: Living conditions (home, proxy, home support); Quality of life (SF-36); Covi test and 4-item Geriatric Depression Scale; Katz-ADL and IADL; History of fall, mobility assessment; Nutritional status (BMI, albuminemia, Mini Nutritionnal Assesment); Cognitive assessment (Mini-mental State Examination) The visit at month 6 will be the same in both groups	Other: Geriatric assessment in the 7 days following ICU discharge.; ICU survivors will be assessed by a geriatric physician, in a global (clinical, physical, psyochological and social) approach at the end of the ICU stay or in the 7 days following ICU discharge.
Active Comparator: Group without geriatric assessment; At the end of the ICU stay or in the 7 days following, will be collect: Medical and surgical history, Charlson comorbidity index,; Living place; Regular treatment (number and class); ICU trajectory: ICU length of stay, reason for ICU admission, severity scores (SOFA and SAPS 2 score), organ supports requirement and duration; Limitation of life-sustaining therapy decision At 6 month after ICU discharge, patients will be evaluated during a post-ICU consultation, where will be recorded: Living conditions (home, proxy, home support); Quality of life (SF-36); Covi test and 4-item Geriatric Depression Scale; Katz-ADL and IADL; History of fall, mobility assessment; Nutritional status (BMI, albuminemia, Mini Nutritionnal Assesment); Cognitive assessment (Mini-mental State Examination); Regular treatment (number and class); Hospitalizations between ICU discharge and M6; Additional comorbidity; Family burden assessment (mini-Zarit)	Other: No geriatric assessment in the 7 days following ICU discharge.; No geriatric assessment in the 7 days following ICU discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of patients for whom a geriatric assessment is carried out between the end of their stay in intensive care and 7 days after discharge.	At 6 Month after ICU discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients for whom consultation at M6 is carried out.		At 6 Month after ICU discharge
Frailty, assessed using the Clinical Frailty Scale		At 6 Month after ICU discharge
Total hospital length of stay		At 6 Month after ICU discharge
Number of hospitalization		At 6 Month after ICU discharge
Regular treatment modifications	collection of current treatments on admission to intensive care, on discharge from intensive care and hospitalization, and at M6 (prescription)	At 6 Month after ICU discharge
Modification of place of living	location (single-family dwelling, retirement home, etc.)	At 6 Month after ICU discharge
Evolution of the quality of life assessed by the SF-36 questionnary	For the interventional arm	At 6 Month after ICU discharge
Evolution of the psychological behaviours through the mini Geriatric depression score evolution and the Covi test evolution for the anxiety component.	For the interventional arm	At 6 Month after ICU discharge
Evolution of the psychological behaviours through the Covi test evolution for the anxiety component.	For the interventional arm	At 6 Month after ICU discharge
Evolution of the Katz-ADL score between initial assessment and month 6	For the interventional arm For the control arm,	At 6 Month after ICU discharge
Evolution of the IADL score between initial assessment and month 6	For the interventional arm For the control arm,	At 6 Month after ICU discharge
Evolution of the locomotor abilities		At 6 Month after ICU discharge
Evolution of cognition evaluation: mini Mental State Examination		At 6 Month after ICU discharge
At M6: main organ function assessment		At 6 Month after ICU discharge

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Julien DEMISELLE, Hopitaux universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): January 2, 2027
• Study Completion (Estimated): January 2, 2027

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Frailty; Critical Illness
• Other Study ID Numbers: 9107 (Fred Hutch/University of Washington Cancer Consortium)

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
• product manufactured in and exported from the U.S.: No