Impact of an Early Palliative Approach (MAHO2)

May 15, 2019 updated by: 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

1200

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 Locations

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Usual Practices
Other: Usual practices
the centres applies their usual practices
Other: Early consideration of vulnerability
Strategy promoting early consideration of patients' vulnerability
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of withdraw/withhold of treatment in each group
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death conditions
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

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

Sponsor

Hopital Foch

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2013

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

February 17, 2016

First Submitted That Met QC Criteria

September 19, 2016

First Posted (Estimate)

September 20, 2016

Study Record Updates

Last Update Posted (Actual)

May 17, 2019

Last Update Submitted That Met QC Criteria

May 15, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2013/99
  • 2012-A00444-39 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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