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

Not Applicable

Recruiting

• Conditions: Geriatric Assessment; Frailty; Critical Illness; Older People
• Interventions: Other: Geriatric assessment in the 7 days following ICU discharge.; Other: No geriatric assessment in the 7 days following ICU discharge.

• Registration Number: NCT06513130
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-16
• Study First Posted: 2024-07-22
• Study Start: 2024-11-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-29
• Primary Completion: 2027-01-02
• Study Completion: 2027-01-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group with geriatric assessment	Geriatric assessment in the 7 days following ICU discharge.	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
Group without geriatric assessment	No geriatric assessment in the 7 days following ICU discharge.	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)

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Service de Médecine Intensive - Réanimation / CHU Strasbourg - France; 🇫🇷 Strasbourg, France