NCT06481917

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Oct 2024Oct 2027

First Submitted

Initial submission to the registry

June 25, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Expected
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

1.6 years

First QC Date

June 25, 2024

Last Update Submit

July 1, 2024

Conditions

Health Services for the AgedAdvance Care Planning

Keywords

ElderlyAdvance care planDAMAGE scoreHigh risk of mortalityDischarge from acute care geriatric department

Outcome Measures

Primary Outcomes (3)

  • Rate of included patients

    12 months

  • Rate of patients remaining in the study

    12 months

  • Advance care planning rate achieved

    12 months

Secondary Outcomes (4)

  • Rate of compliance to advance directives

    12 months

  • Hospital Anxiety and Depression Scale (HADS) of caregivers and carers

    12 months

  • Questionnaire to evaluate the acceptability of the intervention

    12 months

  • EQ-5D-3L scale score

    12 months

Study Arms (2)

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.

Other: Advance care planOther: Ergonomic analysisOther: Evaluation of intervention acceptability

Usual care

NO INTERVENTION

Usual care with the possibility of proposing ACP according to the department's habits

Interventions

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.

Advance care plan
Ergonomic analysisOTHER

Ergonomic analysis throughout the intervention

Advance care plan
Evaluation of intervention acceptabilityOTHER

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

Advance care plan

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CHU d'Amiens

Amiens, 80054, France

Location

CHU de Caen

Caen, 14033, France

Location

CHU de Lille

Lille, 59000, France

Location

Hôpital Saint Vincent de Paul (GHICL)

Lille, 59000, France

Location

Hôpital Saint-Philibert (GHICL)

Lomme, 59160, France

Location

CHU de Rouen

Rouen, 76000, France

Location

Study Officials

  • Fabien VISADE

    Hôpital Saint Philibert, GHICL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Paule LEBITASY

CONTACT

+33 3 20 22 52 69urm@ghicl.net

William's VAN DEN BERGHE

CONTACT

+33320225731VanDenBerghe.Williams@ghicl.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2024

First Posted

July 1, 2024

Study Start

October 1, 2024

Primary Completion

May 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(6)