Impact of an Early Palliative Approach (MAHO2)
keskiviikko 15. toukokuuta 2019 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Lopetettu
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Odotettu)
1200
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Amiens, Ranska, 80000
- CHU
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Antony, Ranska, 92160
- Hopital privé Oncologie Médicale
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Antony, Ranska, 92160
- Hôpital Privé Medecine interne
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Bobigny, Ranska, 93000
- Hopital Avicenne
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Boulogne Billancourt, Ranska, 92100
- Hôpital Ambroise Paré
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Champcueil, Ranska, 91750
- Hôpital Georges Clemenceau
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Dijon, Ranska, 21000
- CHU
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Epernay, Ranska, 51200
- Centre Hospitalier
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Le Kremlin Bicetre, Ranska, 94270
- Hôpital Bicêtre
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Lille, Ranska, 59000
- CHRU
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Paris, Ranska, 75010
- Hopital Lariboisiere Medecine interne
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Paris, Ranska, 75014
- Groupe Hospitalier Paris - Saint-Joseph
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Paris, Ranska, 75014
- Hopital Cochin Gastro-Enterologie
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Poitiers, Ranska, 86000
- Centre Hospitalier Universitaire
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Roubaix, Ranska, 59100
- Centre Hospitalier
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Soissons, Ranska, 02200
- Centre Hospitalier de Soissons
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Suresnes, Ranska, 92150
- Hiopital Foch Néphrologie
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Suresnes, Ranska, 92150
- Hopital Foch Cardiologie
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Suresnes, Ranska, 92150
- Hopital Foch Chirurgie Urologique
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Suresnes, Ranska, 92150
- Hopital Foch Médecine Interne
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Suresnes, Ranska, 92150
- Hopital Foch Neurochirurgie
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Suresnes, Ranska, 92150
- Hopîtal Foch Urgences
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Valenciennes, Ranska, 59300
- CH
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Muut: Usual Practices
|
the centres applies their usual practices
|
|
Muut: Early consideration of vulnerability
Strategy promoting early consideration of patients' 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
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Rate of withdraw/withhold of treatment in each group
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Death conditions
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Päätutkija: Edouard Ferrand, MD, e.ferrand@hopital-foch.org
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
- Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.
- Greer JA, Pirl WF, Jackson VA, Muzikansky A, Lennes IT, Heist RS, Gallagher ER, Temel JS. Effect of early palliative care on chemotherapy use and end-of-life care in patients with metastatic non-small-cell lung cancer. J Clin Oncol. 2012 Feb 1;30(4):394-400. doi: 10.1200/JCO.2011.35.7996. Epub 2011 Dec 27.
- Yoong J, Park ER, Greer JA, Jackson VA, Gallagher ER, Pirl WF, Back AL, Temel JS. Early palliative care in advanced lung cancer: a qualitative study. JAMA Intern Med. 2013 Feb 25;173(4):283-90. doi: 10.1001/jamainternmed.2013.1874.
- Ferrand E, Robert R, Ingrand P, Lemaire F; French LATAREA Group. Withholding and withdrawal of life support in intensive-care units in France: a prospective survey. French LATAREA Group. Lancet. 2001 Jan 6;357(9249):9-14. doi: 10.1016/s0140-6736(00)03564-9.
- Ferrand E, Jabre P, Vincent-Genod C, Aubry R, Badet M, Badia P, Cariou A, Ellien F, Gounant V, Gil R, Jaber S, Jay S, Paillaud E, Poulain P, Regnier B, Reignier J, Socie G, Tardy B, Lemaire F, Brun-Buisson C, Marty J; French Mort-a-l'Hopital Group. Circumstances of death in hospitalized patients and nurses' perceptions: French multicenter Mort-a-l'Hopital survey. Arch Intern Med. 2008 Apr 28;168(8):867-75. doi: 10.1001/archinte.168.8.867.
- Truog RD, Cist AF, Brackett SE, Burns JP, Curley MA, Danis M, DeVita MA, Rosenbaum SH, Rothenberg DM, Sprung CL, Webb SA, Wlody GS, Hurford WE. Recommendations for end-of-life care in the intensive care unit: The Ethics Committee of the Society of Critical Care Medicine. Crit Care Med. 2001 Dec;29(12):2332-48. doi: 10.1097/00003246-200112000-00017. No abstract available.
- Ferrand E, Lemaire F, Regnier B, Kuteifan K, Badet M, Asfar P, Jaber S, Chagnon JL, Renault A, Robert R, Pochard F, Herve C, Brun-Buisson C, Duvaldestin P; French RESSENTI Group. Discrepancies between perceptions by physicians and nursing staff of intensive care unit end-of-life decisions. Am J Respir Crit Care Med. 2003 May 15;167(10):1310-5. doi: 10.1164/rccm.200207-752OC. Epub 2003 Jan 24.
- Ferrand E, Marty J; French LATASAMU Group. Prehospital withholding and withdrawal of life-sustaining treatments. The French LATASAMU survey. Intensive Care Med. 2006 Oct;32(10):1498-505. doi: 10.1007/s00134-006-0292-5. Epub 2006 Aug 2.
- Prendergast TJ, Claessens MT, Luce JM. A national survey of end-of-life care for critically ill patients. Am J Respir Crit Care Med. 1998 Oct;158(4):1163-7. doi: 10.1164/ajrccm.158.4.9801108.
- Sprung CL, Cohen SL, Sjokvist P, Baras M, Bulow HH, Hovilehto S, Ledoux D, Lippert A, Maia P, Phelan D, Schobersberger W, Wennberg E, Woodcock T; Ethicus Study Group. End-of-life practices in European intensive care units: the Ethicus Study. JAMA. 2003 Aug 13;290(6):790-7. doi: 10.1001/jama.290.6.790.
- Ferrand E, Jabre P, Fernandez-Curiel S, Morin F, Vincent-Genod C, Duvaldestin P, Lemaire F, Herve C, Marty J. Participation of French general practitioners in end-of-life decisions for their hospitalised patients. J Med Ethics. 2006 Dec;32(12):683-7. doi: 10.1136/jme.2005.014084.
- Kelley AS, Meier DE. Palliative care--a shifting paradigm. N Engl J Med. 2010 Aug 19;363(8):781-2. doi: 10.1056/NEJMe1004139. No abstract available.
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