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

July 1, 2024 updated by: Lille Catholic University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Marie Paule LEBITASY
  • Phone Number: +33 3 20 22 52 69
  • Email: urm@ghicl.net

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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: 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
No Intervention: Usual care
Usual care with the possibility of proposing ACP according to the department's habits

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of included patients
Time Frame: 12 months
12 months
Rate of patients remaining in the study
Time Frame: 12 months
12 months
Advance care planning rate achieved
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months
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).
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lille Catholic University

Investigators

  • Principal Investigator: Fabien VISADE, Hôpital Saint Philibert, GHICL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

June 25, 2024

First Submitted That Met QC Criteria

June 25, 2024

First Posted (Actual)

July 1, 2024

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

July 1, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RC-P00119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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