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NCT Number: NCT06481917

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

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.

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Key information

Conditions

Health Services for the Aged Advance Care Planning

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU d'Amiens, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Advance care plan

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

Other

Ergonomic analysis throughout the intervention

Evaluation of intervention acceptability

Other

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

Primary outcomes

  1. Rate of included patients

    Time frame: 12 months

  2. Rate of patients remaining in the study

    Time frame: 12 months

  3. Advance care planning rate achieved

    Time frame: 12 months

Secondary outcomes

  1. Rate of compliance to advance directives

    Time frame: 12 months

    Rate of compliance with the patient's advance directives one year after discharge from hospital; compliance to the the following situations will be identified:

    • The patient is still alive: wishes to be re-hospitalized / does not wish to be re-hospitalized / has not made a decision.
    • The patient is deceased: place of death specified: hospital, home or other / no decision taken.

  2. Hospital Anxiety and Depression Scale (HADS) of caregivers and carers

    Time frame: 12 months

    Anxiety-depressive symptomatology of caregivers will be assessed using the Hospital Anxiety and Depression Scale (HADS) in the event of patient death, if this occurs within one year of discharge from hospital. The HAD scale is a screening instrument for anxiety and depressive disorders. It comprises 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven to depression (total D), giving two scores (maximum score for each = 21). To screen for anxiety and depressive symptoms, the following interpretation can be proposed for each of the scores (A and D) each of the scores (A and D):

    • 7 or less: no symptoms
    • 8 to 10: doubtful symptomatology - 11 or more: definite symptomatology.

  3. Questionnaire to evaluate the acceptability of the intervention

    Time frame: 12 months

    The acceptability of the intervention will be assessed by a questionnaire after each home visit at 7 days and one month, with patients and caregivers in the intervention group.

  4. EQ-5D-3L scale score

    Time frame: 12 months

    Changes in the quality of life of patients and caregivers one month after hospital discharge will be measured by changes in the EQ-5D-3L scale score. EQ-5D is a standardised measure of health-related quality of life.n EQ-5D-3L, the five dimensions each have three response levels of severity.

    Respondents are asked to choose the statement in each dimension that best describes their health status on the day they are surveyed. Their responses are coded as a number (1, 2, or 3) that corresponds to the respective level of severity: 1 indicates no problems, 2 some problems, and 3 extreme problems. In this way, a person's health state profile can be defined by a 5-digit number, ranging from 11111 (having no problems in any of the dimensions) to 33333 (having extreme problems in all the dimensions).

Study contacts

Contact information is provided by the study sponsor or research team.

Marie Paule LEBITASY

CONTACT

[email protected]

+33 3 20 22 52 69

William's VAN DEN BERGHE

CONTACT

[email protected]

+33320225731

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Registry information

Official study 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

Acronym: SAPHARI

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 1, 2024
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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