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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06481917
Acronym
SAPHARI
Enrollment
104
Registered
2024-07-01
Start date
2024-10-31
Completion date
2027-10-31
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advance Care Planning, Health Services for the Aged

Keywords

Elderly, Advance care plan, DAMAGE score, High risk of mortality, Discharge from acute care geriatric department

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.

Interventions

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.

OTHERErgonomic analysis

Ergonomic analysis throughout the intervention

OTHEREvaluation of intervention acceptability

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

Sponsors

Lille Catholic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Rate of included patients12 months
Rate of patients remaining in the study12 months
Advance care planning rate achieved12 months

Secondary

MeasureTime frameDescription
Rate of compliance to advance directives12 monthsRate 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.
EQ-5D-3L scale score12 monthsChanges 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).
Hospital Anxiety and Depression Scale (HADS) of caregivers and carers12 monthsAnxiety-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.
Questionnaire to evaluate the acceptability of the intervention12 monthsThe 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.

Countries

France

Contacts

Primary ContactMarie Paule LEBITASY
urm@ghicl.net+33 3 20 22 52 69
Backup ContactWilliam's VAN DEN BERGHE
VanDenBerghe.Williams@ghicl.net+33320225731

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026