Health Services for the AgedSAPHARINCT06481917
Home-based Nurse Intervention in the Care of High Risk of Death Patients After Discharge From Geriatric Department
A study testing Advance care plan, Ergonomic analysis and Evaluation of intervention acceptability in people with Health Services for the Aged and Advance Care Planning, run by Lille Catholic University at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Health Services for the Aged, Advance Care Planning
- What is being tested?
- Advance care plan, Ergonomic analysis and Evaluation of intervention acceptability
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 6 sitesFrance
- Study dates
- Oct 2024to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites
CHU d'Amiens
Amiens, 80054
Guillaume Deschasse, 0322455720 ext. +33, Deschasse.Guillaume@chu-amiens.fr
CHU de Caen
Caen, 14033
Cédric VILLAIN, 0231065344 ext. +33, villain-c@chu-caen.fr
CHU de Lille
Lille, 59000
Jean-Baptiste BEUSCART, Jeanbaptiste.BEUSCART@chru-lille.fr
Hôpital Saint Vincent de Paul (GHICL)
Lille, 59000
Pierre MACIEJASZ, 0320874910 ext. +33, Maciejasz.pierre@ghicl.net
Hôpital Saint-Philibert (GHICL)
Lomme, 59160
Fabien VISADE, Visade.Fabien@ghicl.net
CHU de Rouen
Rouen, 76000
Frédéric ROCA, 0232889039 ext. +33, Frederic.roca@chu-rouen.fr
About this study
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
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.
- Being tested
- Advance care plan, Ergonomic analysis, Evaluation of intervention acceptability
- Keywords
- Elderly, Advance care plan, DAMAGE score, High risk of mortality, Discharge from acute care geriatric department
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advance care planOther
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 analysisOther
Ergonomic analysis throughout the intervention
Evaluation of intervention acceptabilityOther
Evaluation of intervention acceptability after each home visit with patients and caregivers using a questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Advance care plan | Experimental | 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. Receives: Other: Advance care plan; Other: Ergonomic analysis; Other: Evaluation of intervention acceptability |
| Usual care | No intervention | Usual care with the possibility of proposing ACP according to the department's habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of included patients
Measured: 12 months
Rate of patients remaining in the study
Measured: 12 months
Advance care planning rate achieved
Measured: 12 months
Secondary outcomes (4)
Rate of compliance to advance directives
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.
Measured: 12 months
Hospital Anxiety and Depression Scale (HADS) of caregivers and carers
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.
Measured: 12 months
Questionnaire to evaluate the acceptability of the intervention
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.
Measured: 12 months
EQ-5D-3L scale score
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study startOct 2024 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Services for the AgedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabien VISADE, Principal investigator, Hôpital Saint Philibert, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481917
- Sponsor's protocol ID
- RC-P00119
- Acronym
- SAPHARI
- Status last verified
- Jul 2024
- First submitted
- 25 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06481917
- Acronym / sponsor ID
- SAPHARI / RC-P00119
- Keywords
- Elderly, Advance care plan, DAMAGE score, High risk of mortality, Discharge from acute care geriatric department
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advance care plan | Experimental | Other: Advance care plan, Other: Ergonomic analysis, Other: Evaluation of intervention acceptabilityScheduling of 2 home visits by an expert nurse in the month following the return home and proposal to carry out an advance care plan. |
| Usual care | No intervention | –Usual care with the possibility of proposing ACP according to the department's habits |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advance care planScheduling 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 | Advance care plan |
| Ergonomic analysisErgonomic analysis throughout the intervention | Other | Advance care plan |
| Evaluation of intervention acceptabilityEvaluation of intervention acceptability after each home visit with patients and caregivers using a questionnaire | Other | Advance care plan |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabien VISADE principal investigator
Hôpital Saint Philibert, GHICL
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advance care plan, Ergonomic analysis and Evaluation of intervention acceptability in people with Health Services for the Aged and Advance Care Planning, run by Lille Catholic University at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Paule LEBITASY (+33 3 20 22 52 69, urm@ghicl.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of included patients (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.