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Impact of an Early Palliative Approach (MAHO2)

15 mei 2019 bijgewerkt door: Hopital Foch

Impact of an Early and Collegial Consideration of Patients' Vulnerability Comparing to Usual Care. Cluster Randomized Control Study "Mort-A-l'Hôpital 2"

In 2003, MAHO study (Ferrand E, Jabre P, Vincent-Genod C, et al. Circumstances of death in hospitalized patients and nurses' perceptions: French multicenter Mort-a-l'Hôpital survey. Arch Intern Med. 2008 168: 867-875.) evaluated the way 3793 patients died in 200 French hospitals and showed that their conditions of death were not optimal. The 22th April 2005 French Law precised patient's end of life rights with necessity to refrain from any unreasonable obstinacy, the right to refuse treatments and the obligation of a collegial process decision when the patient is not conscious. Since then, studies haven't demonstrate any improvement and found that palliative strategy in France is much less used than in other developed countries.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

In 2003, MAHO study evaluated the way 3793 patients died en 200 French hospitals and showed that their conditions of death were not optimal. The 22th April 2005 French Law precised patient's end of life rights with necessity to refrain from any unreasonable obstinacy, the right to refuse treatments and the obligation of a collegial process decision when the patient is not conscious. Since then, studies haven't demonstrate any improvement and found that palliative strategy in France is much less used than in other developed countries.

Principal Objective: To evaluate the impact of an early palliative strategy using vulnerability criteria compared to standard care.

Primary endpoint: Rate of withdraw/withhold of treatment in each group.

Secondary objectives: To evaluate the impact of early recognition of patients' vulnerability on death conditions ; to evaluate this strategy impact according to unit type on length of stay, palliative strategy modalities and caregivers' satisfaction.

Secondary endpoints: Rate of therapeutic involvement reflections ; rate of death following withholding or withdrawing of treatments ; traceability of the level of therapeutic involvement process ; Rate of patients deceased with their relatives next to them ; rate of patients deceased with comfort treatment ; rate of palliative care consultation before death ; rate of asks for euthanasia ; Doctor and nurse's perception of quality of support and death process of the patient

Methods: Prospective, controlled, cluster randomized study of routine care 2 groups:

  • Group A: standard care and practice after 1 day of training
  • Group B: 1 day of training, learning the vulnerability criteria that should induce early thinking about level of therapeutic involvement; web accessed forms will be available to help collegial process, withhold and withdraw decisions traceability, using legal requirements Number of patients to include: To detect a 20% absolute difference in palliative strategy used (30 to 50%), we determined that 5040 patients would provide a power of 80% with the use of a two-sided alpha level of 0.05. Sequential analysis is planned in order to early stop the study in case of efficacy or futility (minimal inclusion: 500 patients)

Inclusion criteria:

All patients hospitalized with at least one of the following vulnerability criteria will be included:

  • Evolutive and symptomatic incurable cancer
  • Aged more than 75 years old and presenting several geriatric syndromes (cognitive disorders, isolation, malnutrition, bedridden more than 12h per day)
  • Neurologic pathology, chronic, with loss of autonomy (Performance Status>3)
  • Final organ failure (heart, lungs, liver, kidney) with loss of autonomy (Performance Status>3)
  • Care refusal and/or expressed will to die or repeated request for help to die

Exclusion criteria:

  • Minors
  • Patients without indication for treatment or surveillance with length of stay inferior to 24h
  • Brain dead patients
  • Not consent patients

Duration: 37 months (28 inclusion months for each center and a follow-up to hospital discharge, death or 9 months if the patient is still hospitalized).

Number of participating centers: 20 centers (28 services) were selected and recruit after training program among centers that did not used a formalized process to initiate level of therapeutic involvement reflection.

Studietype

Ingrijpend

Inschrijving (Verwacht)

1200

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Frankrijk
      • Amiens, Frankrijk, 80000
        • CHU
      • Antony, Frankrijk, 92160
        • Hopital privé Oncologie Médicale
      • Antony, Frankrijk, 92160
        • Hôpital Privé Medecine interne
      • Bobigny, Frankrijk, 93000
        • Hopital Avicenne
      • Boulogne Billancourt, Frankrijk, 92100
        • Hôpital Ambroise Paré
      • Champcueil, Frankrijk, 91750
        • Hôpital Georges Clemenceau
      • Dijon, Frankrijk, 21000
        • CHU
      • Epernay, Frankrijk, 51200
        • Centre Hospitalier
      • Le Kremlin Bicetre, Frankrijk, 94270
        • Hôpital Bicêtre
      • Lille, Frankrijk, 59000
        • CHRU
      • Paris, Frankrijk, 75010
        • Hopital Lariboisiere Medecine interne
      • Paris, Frankrijk, 75014
        • Groupe Hospitalier Paris - Saint-Joseph
      • Paris, Frankrijk, 75014
        • Hopital Cochin Gastro-Enterologie
      • Poitiers, Frankrijk, 86000
        • Centre Hospitalier Universitaire
      • Roubaix, Frankrijk, 59100
        • Centre Hospitalier
      • Soissons, Frankrijk, 02200
        • Centre Hospitalier de Soissons
      • Suresnes, Frankrijk, 92150
        • Hiopital Foch Néphrologie
      • Suresnes, Frankrijk, 92150
        • Hopital Foch Cardiologie
      • Suresnes, Frankrijk, 92150
        • Hopital Foch Chirurgie Urologique
      • Suresnes, Frankrijk, 92150
        • Hopital Foch Médecine Interne
      • Suresnes, Frankrijk, 92150
        • Hopital Foch Neurochirurgie
      • Suresnes, Frankrijk, 92150
        • Hopîtal Foch Urgences
      • Valenciennes, Frankrijk, 59300
        • CH

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Patient more than 18 years old hospitalized for at least 24h and who's prognosis (survival or quality of life) should lead to a palliative approach

  • Patient suffering with at least one of the following vulnerability criteria will be included:

    • Evolutive and symptomatic incurable cancer
    • Aged more than 75 years old and presenting several geriatric syndromes (cognitive disorders, isolation, malnutrition, bedridden more than 12h per day)
    • Neurologic pathology, chronic, with loss of autonomy (Performance Status>3)
    • Final organ failure (heart, lungs, liver, kidney) with loss of autonomy (Performance Status>3)
    • Care refusal and/or expressed will to die or repeated request for help to die
  • No opposition to the use of data collected from the patient or a relative or inclusion in emergency and non-opposition collected offline

Exclusion Criteria:

  • Minors
  • Patients without indication for treatment or surveillance with length of stay inferior to 24h
  • Brain dead patients
  • Not consent patients

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: Usual Practices
Ander: Usual practices
the centres applies their usual practices
Ander: Early consideration of vulnerability
Strategy promoting early consideration of patients' vulnerability
Ander: Early consideration of vulnerability
One day training with the provision of vulnerability criteria inciting an early reflection of the level of therapeutic engagement; sheets available on the internet computer support collegial reflection and traceability of decisions to limit and stop treatments, incorporating the provisions of law known Leonetti

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rate of withdraw/withhold of treatment in each group
Tijdsspanne: From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
To evaluate the impact of an early palliative strategy using vulnerability criteria compared to standard care.
From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Death conditions
Tijdsspanne: From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital

rate of death relied to a withholding/withdrawing treatment decision, rate relatives present at the time of death, rate of death with comfort drugs, rate of patient/family/relatives interview with a psychologist.

rate of death relied to a withholding/withdrawing treatment decision, rate relatives present at the time of death, rate of death with comfort drugs, rate of patient/family/relatives interview with a psychologist.
From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
Early vulnerability consideration impact on length of stay
Tijdsspanne: From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
total length of stay in the hospital
From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
Palliative strategy modalities
Tijdsspanne: From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
rate of reflections on level of therapeutic involvement
From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
Early vulnerability consideration impact on caregivers' satisfaction
Tijdsspanne: From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
Physician and nurses' perceptions about care management and conditions of death, caregivers interview with a psychologist
From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hopital Foch

Onderzoekers

  • Hoofdonderzoeker: Edouard Ferrand, MD, e.ferrand@hopital-foch.org

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2013

Primaire voltooiing (Werkelijk)

1 maart 2019

Studie voltooiing (Werkelijk)

1 maart 2019

Studieregistratiedata

Eerst ingediend

17 februari 2016

Eerst ingediend dat voldeed aan de QC-criteria

19 september 2016

Eerst geplaatst (Schatting)

20 september 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 mei 2019

Laatste update ingediend die voldeed aan QC-criteria

15 mei 2019

Laatst geverifieerd

1 mei 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 2013/99
  • 2012-A00444-39 (Andere identificatie: ANSM)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

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