Clinical trial NCT06481917: Home-based Nurse Intervention in the Care of High Risk of Death Patients After Discharge From Geriatric Department
Official title: Feasibility and Effectiveness of a Specialized Home-based Nurse Intervention on the Completion of Advance Care Plans of Patients at High Risk of Death After Discharge From Acute Care Geriatric Departement
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Health Services for the Aged
Advance Care Planning
Keywords: Elderly
Advance care plan
DAMAGE score
High risk of mortality
Discharge from acute care geriatric department
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 104
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study consists to evaluate the feasibility of a case-management intervention of Advance Care Plan (ACP) placement for elderly patients at high risk of death at twelve months discharged alive from acute geriatric medicine.

Feasibility will include the following indicators: rate of patients included and randomized, rate of patients remaining in the study, ACP rates achieved at one month.


Eligibility criteria: Inclusion Criteria:

* Patients aged 75 or over.
* Affiliated to a social security scheme.
* Hospitalized in an acute care geriatric department
* Discharged from hospital to home or residential facilities for dependent elderly people
* Targeted pathology or at least one incurable disease.
* At high risk of death in the twelve months following discharge according to the DAMAGE prognostic score (high-risk score group). A high risk of death is defined by a DAMAGE score \> 50%.
* Rockwood Clinical frailty scale score greater than or equal to 7 at one month.

Exclusion Criteria:

* Refusal to participate in the study expressed by the patient or his/her legal representative, if applicable.
* Patients transferred to another Medicine-Surgery-Obstetrics department (only "medicine or surgery" in the elderly).
* Patients transferred to follow-up care and rehabilitation, palliative care, or returning home in palliative care.
* Patients who have already drawn up advance directives, chosen a trusted support person or discussed their end-of-life wishes with their doctor.
* Patients with proven severe neuro-cognitive disorders (in the medical record with a Mini-Mental State Examination (MMSE) score below 10 or in the absence of knowledge of the degree of severity and/or a recent previous MMSE score taken in a stable period, the referring practitioner, a geriatrician with expertise in this field, will assess whether the patient is unfit to state his or her advance directives at the time of inclusion.

Primary outcomes:
measure: Rate of included patients
timeFrame: 12 months
measure: Rate of patients remaining in the study
timeFrame: 12 months
measure: Advance care planning rate achieved
timeFrame: 12 months
Secondary outcomes:
measure: Rate of compliance to advance directives
timeFrame: 12 months
measure: Hospital Anxiety and Depression Scale (HADS) of caregivers and carers
timeFrame: 12 months
measure: Questionnaire to evaluate the acceptability of the intervention
timeFrame: 12 months
measure: EQ-5D-3L scale score
timeFrame: 12 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU d'Amiens
city: Caen
country: France
facility: CHU de Caen
city: Lille
country: France
facility: CHU de Lille
city: Lille
country: France
facility: Hôpital Saint Vincent de Paul (GHICL)
city: Lomme
country: France
facility: Hôpital Saint-Philibert (GHICL)
city: Rouen
country: France
facility: CHU de Rouen
Study officials:
affiliation: Hôpital Saint Philibert, GHICL
name: Fabien VISADE
role: PRINCIPAL_INVESTIGATOR
References: