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Not yet recruiting NCT06481917

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

No phase Interventional Health Services for the Aged Advance Care Planning

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Advance care plan, Ergonomic analysis, Evaluation of intervention acceptability.
Who it may be relevant to
Registry conditions: Health Services for the Aged, Advance Care Planning. Basic parameters: from 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Other 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.
  • Other Ergonomic analysis
    Ergonomic analysis throughout the intervention
  • Other Evaluation of intervention acceptability
    Evaluation of intervention acceptability after each home visit with patients and caregivers using a questionnaire

Primary outcome measures

  • Rate of included patients [Time frame: 12 months]
  • Rate of patients remaining in the study [Time frame: 12 months]
  • Advance care planning rate achieved [Time frame: 12 months]
Secondary outcome measures (4)
  • Rate of compliance to advance directives [Time frame: 12 months]
  • Hospital Anxiety and Depression Scale (HADS) of caregivers and carers [Time frame: 12 months]
  • Questionnaire to evaluate the acceptability of the intervention [Time frame: 12 months]
  • EQ-5D-3L scale score [Time frame: 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

France · 6 centers
  • CHU d'Amiens — Amiens
  • CHU de Caen — Caen
  • CHU de Lille — Lille
  • Hôpital Saint Vincent de Paul (GHICL) — Lille
  • Hôpital Saint-Philibert (GHICL) — Lomme
  • CHU de Rouen — Rouen

Identifiers

NCT: NCT06481917 · RC-P00119

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗