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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Rate of included patients [Срок оценки: 12 months]
• Rate of patients remaining in the study [Срок оценки: 12 months]
• Advance care planning rate achieved [Срок оценки: 12 months]

Вторичные конечные точки (4)

• Rate of compliance to advance directives [Срок оценки: 12 months]
• Hospital Anxiety and Depression Scale (HADS) of caregivers and carers [Срок оценки: 12 months]
• Questionnaire to evaluate the acceptability of the intervention [Срок оценки: 12 months]
• EQ-5D-3L scale score [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Франция · 6 центров

• 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

Идентификаторы

NCT: NCT06481917 · RC-P00119

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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