Clinical trial NCT06513130: Geriatric Assessment at Discharge From the Intensive Care Unit in Patients Aged 75 Years and Older: a Feasibility Study
Official title: Geriatric Assessment at Discharge From the Intensive Care Unit in Patients Aged 75 Years and Older: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Illness
Geriatric Assessment
Older People
Frailty
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 70
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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)

Primary outcomes:
measure: 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.
timeFrame: At 6 Month after ICU discharge
Secondary outcomes:
measure: Rate of patients for whom consultation at M6 is carried out.
timeFrame: At 6 Month after ICU discharge
measure: Frailty, assessed using the Clinical Frailty Scale
timeFrame: At 6 Month after ICU discharge
measure: Total hospital length of stay
timeFrame: At 6 Month after ICU discharge
measure: Number of hospitalization
timeFrame: At 6 Month after ICU discharge
measure: Regular treatment modifications
timeFrame: At 6 Month after ICU discharge
measure: Modification of place of living
timeFrame: At 6 Month after ICU discharge
measure: Evolution of the quality of life assessed by the SF-36 questionnary
timeFrame: At 6 Month after ICU discharge
measure: Evolution of the psychological behaviours through the mini Geriatric depression score evolution and the Covi test evolution for the anxiety component.
timeFrame: At 6 Month after ICU discharge
measure: Evolution of the psychological behaviours through the Covi test evolution for the anxiety component.
timeFrame: At 6 Month after ICU discharge
measure: Evolution of the Katz-ADL score between initial assessment and month 6
timeFrame: At 6 Month after ICU discharge
measure: Evolution of the IADL score between initial assessment and month 6
timeFrame: At 6 Month after ICU discharge
measure: Evolution of the locomotor abilities
timeFrame: At 6 Month after ICU discharge
measure: Evolution of cognition evaluation: mini Mental State Examination
timeFrame: At 6 Month after ICU discharge
measure: At M6: main organ function assessment
timeFrame: At 6 Month after ICU discharge
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Médecine Intensive - Réanimation / CHU Strasbourg - France
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Julien DEMISELLE
role: PRINCIPAL_INVESTIGATOR
References: