Home-based Nurse Intervention in the Care of High Risk of Death Patients After Discharge From Geriatric Department

NCT ID: NCT06481917

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2027-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Health Services for the Aged Advance Care Planning

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Advance care plan

Scheduling of 2 home visits by an expert nurse in the month following the return home and proposal to carry out an advance care plan.

Group Type EXPERIMENTAL

Advance care plan

Intervention Type OTHER

Scheduling of 2 home visits by an expert nurse in the month following the return home and proposal to carry out an advance care plan.

Ergonomic analysis

Intervention Type OTHER

Ergonomic analysis throughout the intervention

Evaluation of intervention acceptability

Intervention Type OTHER

Evaluation of intervention acceptability after each home visit with patients and caregivers using a questionnaire

Usual care

Usual care with the possibility of proposing ACP according to the department's habits

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Advance care plan

Scheduling of 2 home visits by an expert nurse in the month following the return home and proposal to carry out an advance care plan.

Intervention Type OTHER

Ergonomic analysis

Ergonomic analysis throughout the intervention

Intervention Type OTHER

Evaluation of intervention acceptability

Evaluation of intervention acceptability after each home visit with patients and caregivers using a questionnaire

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lille Catholic University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fabien VISADE

Role: PRINCIPAL_INVESTIGATOR

Hôpital Saint Philibert, GHICL

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU d'Amiens

Amiens, , France

Site Status

CHU de Caen

Caen, , France

Site Status

CHU de Lille

Lille, , France

Site Status

Hôpital Saint Vincent de Paul (GHICL)

Lille, , France

Site Status

Hôpital Saint-Philibert (GHICL)

Lomme, , France

Site Status

CHU de Rouen

Rouen, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Marie Paule LEBITASY

Role: CONTACT

+33 3 20 22 52 69

William's VAN DEN BERGHE

Role: CONTACT

+33320225731

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Guillaume Deschasse

Role: primary

0322455720 ext. +33

Cédric VILLAIN

Role: primary

0231065344 ext. +33

Jean-Baptiste BEUSCART

Role: primary

Pierre MACIEJASZ

Role: primary

0320874910 ext. +33

Fabien VISADE

Role: primary

Frédéric ROCA

Role: primary

0232889039 ext. +33

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RC-P00119

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.